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Jedara® Cream may be used for three different conditions. Your doctor may prescribe Jedara® Cream for the treatment of: 
- Warts (condylomata acuminata) on the surface of the genitals (sexual organs) and around the anus (back passage).
- Superficial basal cell carcinoma.
This is a common slow-growing form of skin cancer with a very small likelihood of spread to other parts of the body. It usually occurs in middle-aged and elderly people, especially those who are fair-skinned and is caused by too much sun exposure. If left untreated, basal cell carcinoma can disfigure, especially on the face – therefore early recognition and treatment are important.
- Actinic keratosis.
Actinic keratoses are rough areas of skin found in people who have been exposed to a lot of sunshine over the course of their lifetime. Some are skin coloured, others are greyish, pink, red or brown. They can be flat and scaly, or raised, rough, hard and warty.
Jedara® should only be used for flat actinic keratoses on the face and scalp in patients with a healthy immune system where your doctor has decided that Jedara® is the most appropriate treatment for you.
Jedara® Cream helps your body´s own immune system to produce natural substances which help fight your basal cell carcinoma, actinic keratosis or the virus that has caused your warts.
Do not use Jedara® Cream
- If you are allergic to imiquimod or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Jedara® Cream:
- If you have previously used Jedara® Cream or other similar preparations tell your doctor before starting this treatment.
- If you suffer from autoimmune disorders.
- If you have had an organ transplant.
- Do not use Jedara® Cream until the area to be treated has healed after previous drug or surgical treatment.
- Do not apply the cream internally.
- Do not use more cream than your doctor has advised.
- Do not cover the treated area with bandages or other dressings after you have applied Jedara® Cream.
- If the treated site becomes too uncomfortable, wash the cream off with mild soap and water. As soon as the problem has stopped you may restart to apply the cream.
- Tell your doctor if you have an abnormal blood count.
Because of the way Jedara® works, there is a possibility that the cream may worsen existing inflammation in the treatment area.
- If you are being treated for genital warts follow these additional precautions:
Men with warts under the foreskin should pull the foreskin back each day and wash underneath it. If not washed daily the foreskin may be more likely to show signs of tightness, swelling and wearing away of the skin and result in difficulty in pulling it back. If these symptoms occur, stop the treatment immediately and call your doctor.
If you have open sores: do not start using Jedara® Cream until after the sores have healed.
If you have internal warts: do not use Jedara® Cream in the urethra (the hole from which urine is passed), the vagina
(birth canal), the cervix (internal female organ), or anywhere inside your anus (rectum).
Do not use this medication for more than one course if you have problems with your immune system, either due to illness or because of the medicines you are already taking. If you think this applies to you talk to your doctor.
If you are HIV positive you should inform your doctor as Jedara® Cream has not been shown to be as effective in HIV positive patients. If you decide to have sexual relations while you still have warts, apply Jedara® Cream after – not before - sexual activity. Jedara® Cream may weaken condoms and diaphragms, therefore the cream should not be left on during sexual activity. Remember,
Jedara® Cream does not protect against giving HIV or other sexually transmitted diseases to someone else.
- If you are being treated for basal cell carcinoma or actinic keratosis follow these additional precautions:
Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Jedara® cream. Wear protective clothing and wide brimmed hats when outdoors.
Whilst using Jedara® Cream and until healed, the treatment area is likely to appear noticeably different from normal skin
Children and adolescents
Use in children and adolescents is not recommended.
Other medicines and Jedara® Cream
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
There are no medicines known to be incompatible with Jedara® Cream.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
You must tell your doctor if you are pregnant or intend to become pregnant. Your doctor will discuss the risks and benefits of using Jedara® Cream during pregnancy. Studies in animals do not indicate direct or indirect harmful effects in pregnancy.
Do not breast-feed your infant during treatment with Jedara® Cream, as it is not known whether imiquimod is secreted in human milk.
Driving and using machines
This medicine has no or negligible influence on the ability to drive and use machines.
Jedara® Cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol
Methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed). Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 5 mg benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions and mild local irritation.
Children and adolescents:
Use in children and adolescents is not recommended.
Adults:
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Wash hands carefully before and after applying the cream. Do not cover the treated area with bandages or other dressings after you have applied Jedara® Cream.
Open a new sachet each time you use the cream. Dispose of any cream left in the sachet after use. Do not save the opened sachet
for use at a later date.
The treatment frequency and duration differ for genital warts; basal cell carcinoma and actinic keratosis (see specific instructions for each indication).
Jedara® Cream Application Instructions
If you are being treated for genital warts:
Application Instructions – (Mon, Wed and Fri)
1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and squeeze some cream onto your fingertip.
3. Apply a thin layer of Jedara® Cream onto clean, dry wart area and rub gently into the skin until cream vanishes.
4. After application of the cream, throw away the opened sachet and wash hands with soap and water.
5. Leave Jedara® Cream on the warts for 6 to 10 hours. Do not shower or bathe during this time.
6. After 6 to 10 hours wash the area where Jedara® Cream was applied with mild soap and water.
Apply Jedara® Cream 3 times per week. For example, apply the cream on Monday, Wednesday and Friday. One sachet contains enough cream to cover a wart area of 20 cm² (approx. 3 square inches).
Men with warts under the foreskin should pull the foreskin back each day and wash underneath it (see section 2 “Warnings and precautions”).
Continue to use Jedara® Cream as instructed until your warts have completely gone (half the females who clear will do so in 8 weeks, half the males who clear will do so in 12 weeks but in some patients warts may clear as early as 4 weeks).
Do not use Jedara® Cream for more than 16 weeks in the treatment of each episode of warts.
If you have the impression that the effect of Jedara® Cream is too strong or too weak, talk to your doctor or pharmacist.
If you are being treated for basal cell carcinoma:
Application Instructions – (Mon, Tues, Wed, Thurs and Fri)
1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and squeeze some cream onto your fingertip.
3. Apply Jedara® Cream to the affected area and 1 cm (approx. 0.5 inch) around the affected area. Rub gently into the skin until the cream vanishes.
4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.
5. Leave Jedara® Cream on the skin for about 8 hours. Do not shower or bathe during this time.
6. After about 8 hours, wash the area where Jedara® Cream was applied with mild soap and water.
Apply sufficient Jedara® Cream to cover the treatment area and 1 cm (about ½ an inch) around the treatment area each day for 5 consecutive days each week for 6 weeks. For example, apply the cream from Monday to Friday. Do not apply the cream on Saturday and Sunday.
If you are being treated for actinic keratosis:
Application Instructions – (Mon, Wed and Fri)
1. Before going to bed, wash your hands and the treatment area with mild soap and water. Dry thoroughly.
2. Open a new sachet and squeeze some cream onto your fingertip.
3. Apply the cream to the affected area. Rub gently into the area until the cream vanishes.
4. After application of the cream, throw away the opened sachet. Wash hands with soap and water.
5. Leave Jedara® Cream on the skin for about 8 hours. Do not shower or bathe during this time.
6. After about 8 hours, wash the area where Jedara® Cream was applied with mild soap and water.
Apply Jedara® Cream 3 times per week. For example, apply the cream on Monday, Wednesday and Friday.
One sachet contains enough cream to cover an area of 25 cm² (approx. 4 square inches). Continue treatment for four weeks. Four weeks after finishing this first treatment, your doctor will assess your skin. If the lesions have not all disappeared, further four weeks of treatment may be necessary.
If you use more Jedara® Cream than you should
Wash the extra away with mild soap and water. When any skin reaction has gone you may then continue with your treatment. If you accidentally swallow Jedara® Cream please contact your doctor.
If you forget to use Jedara® cream
If you miss a dose, apply cream as soon as you remember and then continue in your regular schedule. Do not apply the cream more than once per day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
The frequency of side effects is classified as follows:
Very common side effects (likely to occur in more than 1 in 10 patients). Common side effects (likely to occur in fewer than 1 in 10 patients).
Uncommon side effects (likely to occur in fewer than 1 in 100 patients). Rare side effects (likely to occur in fewer than 1 in 1,000 patients).
Very rare side effects (likely to occur in fewer than 1 in 10,000 patients).
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Jedara® Cream.
Some patients have experienced changes in skin colour in the area where Jedara® Cream was applied. While these changes have tended to improve with time, in some patients they may be permanent.
If your skin reacts badly when using Jedara® Cream, stop applying the cream, wash the area with mild soap and water and contact your doctor or pharmacist.
In some individuals a lowering of blood counts was noted. A lowering of blood counts might make you more susceptible to infections, make you bruise more easily or cause fatigue. If you notice any of these symptoms, tell your doctor.
Some patients who suffer from autoimmune disorders may experience worsening of their condition. If you notice any change during treatment with Jedara® Cream, tell your doctor.
Serious skin reactions have been reported rarely. If you experience skin lesions or spots on your skin that start out as small red areas and progress to look like mini targets, possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores, stop using Jedara® Cream and tell your doctor immediately.
A small number of patients have experienced hair loss at the treatment site or surrounding area.
If you are being treated for genital warts:
Many of the undesirable effects of Jedara® Cream are due to its local action on your skin.
Very common effects include redness (61% patients), wearing away of the skin (30% patients), flakiness and swelling. Hardening under the skin, small open sores, a crust that forms during healing, and small bubbles under the skin may also occur. You might also feel itching (32% patients), a burning sensation (26% patients) or pain in areas where you have applied Jedara® Cream (8% patients). Most of these skin reactions are mild and the skin will return to normal within about 2 weeks after stopping treatment.
Commonly some patients (4% or less) have experienced headache.
Uncommonly fevers and flu like symptoms, joint and muscle pains; prolapse of the womb; pain on intercourse in females; erection difficulties; increase in sweating; feeling sick; stomach and bowel symptoms; ringing in the ears; flushing; tiredness; dizziness; migraine; pins and needles; insomnia; depression; loss of appetite; swollen glands; bacterial, viral and fungal infections (e.g. cold sores); vaginal infection including thrush; cough and colds with sore throat.
Very rarely severe and painful reactions have occurred, particularly when more cream has been used than recommended. Painful skin reactions at the opening of the vagina have very rarely made it difficult for some women to pass urine. If this occurs you should seek medical help immediately.
If you are being treated for basal cell carcinoma:
Many of the undesirable effects of Jedara® Cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.
Very common the treated skin may be slightly itchy.
Commonly effects include: pins and needles, small swollen areas in the skin, pain, burning, irritation, bleeding, redness or rash. If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Jedara® Cream for a few days (i.e. to have a short rest from treatment).
If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include swollen glands and back pain.
Uncommonly some patients experience changes at the application site (discharge, inflammation, swelling,
scabbing, skin breakdown, blisters, dermatitis) or irritability, feeling sick, dry mouth, flu-like symptoms and tiredness.
If you are being treated for actinic keratosis:
Many of the undesirable effects of Jedara® Cream are due to its local action on your skin. Local skin reactions can be a sign that the drug is working as intended.
Very common the treated skin may be slightly itchy.
Commonly effects include pain, burning, irritation or redness.
If a skin reaction becomes too uncomfortable during treatment, speak to your doctor. He/she may advise you to stop applying Jedara® Cream for a few days (i.e. to have a short rest from treatment).
If there is pus (matter) or other suggestion of infection, discuss this with your doctor. Apart from reactions in the skin, other common effects include headache, anorexia, nausea, muscle pain, joint pain and tiredness.
Uncommonly some patients experience changes at the application site (bleeding, inflammation, discharge, sensitivity,
swelling, small swollen areas in the skin, pins and needles, scabbing, scarring, ulceration or a feeling of warmth or discomfort), or inflammation of the lining of the nose, stuffy nose, flu or flu-like symptoms, depression, eye irritation, swelling of the eyelid, throat pain, diarrhoea, actinic keratosis, redness, swelling of the face, ulcers, pain in extremity, fever, weakness or shivering.
Reporting of side effects
Reporting suspected side effects after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the National Pharmacovigilance Center (NPC):
SFDA Call Center: 19999
E-mail: npc.drug@sfda.gov.sa Website: https://ade.sfda.gov.sa
Other GCC States: Please contact the relevant competent authority.
Keep this medicine out of the sight and reach of children. Store at temperature below 30 °C.
Do not use this medicine after the expiry date which is stated on the outer carton and the label after EXP. Sachets should not be re-used once opened.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
- The active substance is imiquimod. Each sachet contains 0.25 g cream (100 mg cream contains 5 mg imiquimod).
- The other ingredients are isostearic acid, benzyl alcohol, cetyl alcohol, stearyl alcohol, white soft paraffin, polysorbate 60, sorbitan stearate, glycerol, methyl hydroxybenzoate (E 218), propyl hydroxybenzoate (E 216), Xanthan gum, purified water. (See also section 2 “Jedara® Cream contains methyl hydroxybenzoate, propyl hydroxybenzoate, cetyl alcohol, stearyl alcohol and benzyl alcohol”).
Marketing Authorization Holder and Manufacturer
Jerash Pharmaceuticals Co. Ltd.
يمكن استخدام جيدارا® كريم لمعالجة ثلاث حالات مختلفة، يمكن أن يصف الطبيب جيدارا® كريم لمعالجة ما يلي:
• لمعالجة الثآليل (كونديلوماتا اكيوميناتا) الورمية التناسلية، التي تتواجد حول سطح الأعضاء التناسلية و محيط فتحة الشرج.
• لمعالجة سرطان الخلايا السطحية القاعدية.
و التي هي عبارة عن شكل شائع من سرطان الجلد بطيء النمو، تنتشر بأحجام صغيرة جداً على أجزاء أخرى لسطح الجسم. و تصيب عادة الأشخاص في منتصف العمر و كبار السن، خاصة ذوي البشرة البيضاء و الشقراء، إثر تعرض أجسامهم لفترات طويلة لأشعة الشمس. و إذا تركت بدون معالجة، فمن شأنها أن تحدث غدداً ورمية سرطانية خبيثة، و تشوه سطح الجسم، خاصة على الوجه. و لهذا من الضروري التعرف عليها و الكشف عنها و معالجتها مبكراً.
• لمعالجة التقرنات الجلدية الموضعية الحرشفية الورمية.
و إنّ هذه التقرنات الجلدية الموضعية الحرشفية الورمية، هي عبارة عن أماكن خشنة صلبة من الجلد، تم اكتشافها على الأشخاص الذين يتعرضون لأشعة الشمس الشديدة لفترات طويلة خلال حياتهم. بعضها بلون الجلد، و بعضها رمادي، أو وردي أو أحمر، أو بني. و تتواجد بأشكال مسطحة أو ذات قشور، أو نافرة بارزة و خشنة و صلبة و ثؤلوثية. لذا، يتوجب فقط استعمال جيدارا® كريم لحالات الغدد الورمية السرطانية السطحية فقط، التي قد تنتشر على وجوه و فروات رؤوس المرضى الذين لديهم جهاز مناعي صحي، حيث أن الطبيب يكون قد قرر، بأن جيدارا® كريم هو أفضل علاج دوائي مناسب لك.
إنّ جيدارا® كريم يساعد جهازك المناعي على إفراز مواد طبيعية، و التي تساعد في مكافحة كل من: الخلايا الغدية الورمية و السرطانية السطحية القاعدية، أو التقرنات الجلدية الموضعية الحرشفية الورمية، أو الفيروسات التي تسبب لك الثآليل.
موانع استعمال جيدارا® كريم
• إذا كنت تعاني من حساسية تجاه الإميكيمود (المادة الفعّالة) أو أي من المكونات الأخرى المذكورة في القسم ٦.
الاحتياطات عند استعمال جيدارا® كريم
• إذا استخدمت جيدارا® كريم سابقاً أو أي مستحضر آخر مماثل، أخبر طبيبك بذلك قبل البدء بهذا العلاج.
• أخبر طبيبك إذا كنت تعاني من مشاكل في جهاز مناعتك.
• لا تستخدم جيدارا® كريم حتى يلتئم الموضع المراد معالجته، بعد العلاج الدوائي أو الجراحي السابق.
• تجنب ملامسة هذا الكريم للعيون أو الشفتين أو فتحتي الأنف. في حالة التلامس العرضي، قم بإزالة الكريم من خلال غسله بالماء.
• لا تقم باستخدام الكريم داخلياً.
• لا تستخدم كريم أكثر مما وصفه لك الطبيب.
• لا تقم بتغطية الموضع المراد علاجه، بأية لفافات أو ضمادات أخرى، بعد دهنها بجيدارا® كريم.
• إذا أصبح الموضع المراد معالجته غير مريح بشدة، قم بغسل الكريم باستخدام الماء و الصابون. و بمجرد زوال المشكلة، يمكنك إعادة وضع الكريم من جديد.
• أخبر طبيبك إذا كان تعداد كريات الدم غير طبيعي.
نظراً للطريقة التي يعمل بها جيدارا® كريم، فهنالك احتمالية بأن تسوء حالة الإلتهاب الموجودة في موضع المعالجة.
• إذا كًنت تعالج ثآليل الأعضاء التناسلية بهذا الكريم، تقيد بالمحاذير الوقائية الإضافية التالية:
يتوجب على الذكور الذين يعانون من ثآليل تحت القلفة الذكرية سحبها إلى الخلف يومياً و غسل ما بأسفلها. حيث إذا لم يتم غسلها يومياً، فعلى الأرجح بأن تصبح أكثر شدة و تضيقاً و انتفاخاً و عرضة لتمزق الجلد مما ينجم عنه صعوبة سحبها للخلف فيما بعد. و في حال ظهور مثل هذه الأعراض، أوقف العلاج فوراً و اتصل بطبيبك.
و في حال وجود تقرحات مفتوحة: لا تبدأ باستخدام جيدارا® كريم حتى تلتئم هذه التقرحات.
إذا كنت تعاني من ثآليل داخلية: لا تستخدم جيدارا® كريم داخل مجرى البول (الإحليل)، أو المهبل (قناة الولادة) أو عنق الرحم (عضو إنثوي داخلي) أو أي موضع داخل فتحة الشرج.
لا تستخدم هذا العلاج لأكثر من دورة علاجية واحدة، إذا كنت تعاني من مشاكل بجهازك المناعي سواء أكان السبب مرضي، أو الأدوية التي استخدمتها فعلاً. و إذا كنت تعتقد أن هذه الأعراض المشار إليها تنطبق عليك. يرجى الاتصال بالطبيب.
إذا كنت تعاني من مرض الإيدز (نقص المناعة المكتسبة) يتوجب عليك إخبار الطبيب، حيث أن استخدام جيدارا® كريم لا يجدي نفعاً مع مرضى الإيدز. و في حال الجماع، يرجى استخدامه بعد الجماع و ليس قبله. حيث أن جيدارا® كريم يضعف الأغشية و الحواجز الوقائية الذكرية، لذا يتوجب عدم إبقائه عند الجماع. و تذكر، جيدارا® كريم لا يحمي من انتقال عدوى الإيدز، أو انتقال عدوى الأمراض الجنسية الآخرى من شخص لآخر.
• إذا كنت قيد المعالجة لسرطان الخلايا السطحية القاعدية أو لمعالجة التقرنات الجلدية الموضعية الحرشفية، يرجى اتباع المحاذير الوقائية الإضافية التالية:
لا تستخدم المصابيح و الأسرة الشمسية، و تفادى التعرض لأشعة الشمس بقدر الإمكان خلال فترة المعالجة بجيدارا® كريم. ارتدي الملابس الواقية، و القبعات ذات الحواف العريضة، عندما تكون خارج المنزل.
أثناء العلاج بجيدارا® كريم و حتى الإلتئام، من المحتمل أن تبدو منطقة العلاج مختلفة بشكل ملحوظ عن الجلد الطبيعي.
التداخلات الدوائية من أخذ هذا المستحضر مع أي أدوية أخرى
أخبر طبيبك أو الصيدلي إذا كنت تتناول أو تناولت مؤخراً أو قد تتناول أي أدوية أخرى بما في ذلك التي تصرف بدون وصفة طبية.
لا توجد أدوية معروفة بأنها غير متوافقة مع جيدارا® كريم.
الحمل و الرضاعة
اسأل طبيبك أو الصيدلي للحصول على المشورة قبل استخدام أي دواء.
يجب عليكِ إخبار طبيبك إذا كنتِ حاملاً أو تريدِ الحمل. سيناقش طبيبك مخاطر و فوائد استخدام جيدارا® كريم خلال فترة الحمل. لقد أظهرت الدراسات التي أجريت على الحيوانات إلى عدم وجود أي آثار ضارة مباشرة أو غير مباشرة لاستخدام هذا الكريم خلال فترة الحمل.
لا تقوم بارضاع طفلك أثناء العلاج بجيدارا® كريم، حيث أنه من غير المعروف ما إذا كان يتم إفراز الإميكويمود في حليب الأم.
معلومات هامة حول بعض مكونات جيدارا® كريم
قد يسبب ميثيل هيدروكسي بنزوات ) ٢١٨E) و بروبيل هيدروكسي بنزوات (٢١٦E) تفاعلات حساسية (ربما تتأخر). قد يتسبب كحول سيتيل و كحول ستيريل في تفاعلات جلدية موضعية (مثل إلتهاب الجلد التماسي.)
يحتوي هذا الدواء على ٥ ملغ من كحول بنزيل في كل مغلف. قد يسبب كحول بنزيل ردود فعل تحسسية و تهيج موضعي خفيف.
استخدم هذا الدواء دائماً تماماً كما أخبرك طبيبك. استشر طبيبك أو الصيدلي إذا لم تكن متأكداً.
اغسل يديك بعناية كاملة قبل و بعد استخدام الكريم. لا تقم بتغطية المنطقة المعالجة بأية لفافًات أو ضمادات أخرى بعد دهن الكريم.
افتح مغلف جديد في كل مرة تستخدم فيها الكريم. تخلص من الكريم المتبقي بالمغلف بعد الاستخدام. لا تحتفظ بالمغلف المفتوح لاستخدامه مرة أخرى.
إن تكرار العلاج و مدته تختلف فيما إذا كان من أجل معالجة ثآليل الأعضاء التناسلية، أو لمعالجة سرطان الخلايا السطحية القاعدية، أو لمعالجة التقرنات الجلدية الموضعية الحرشفية الورمية (انظر التعليمات المحددة لكل حالة على حدا.)
تعليمات استخدام جيدارا® كريم
• إذا كنت تعالج ثآليل الأعضاء التناسلية:
تعليمات الاستخدام - أيام (الإثنين و الأربعاء و الجمعة)
1. قبل الذهاب إلى السرير، اغسل يديك و المنطقة المراد معالجتها بالماء و الصابون. ثم جففها جيداً.
2. افتح مغلف جديد، و ضع بعضاً من الكريم على طرف إصبعك.
3. ادهن طبقة رقيقة من جيدارا® كريم على منطقة الثآليل النظيفة و الجافة و افركها برفق حتى يتلاشى الكريم.
4. بعد دهن الكريم، تخلص من المغلف المفتوح ثم اغسل اليدين بالماء و الصابون.
5. اترك جيدارا® كريم على الثآليل لمدة ٦ إلى ١٠ ساعات. مع عدم الاستحمام أو الاغتسال خلال هذه المدة.
6. بعد انقضاء مدة ٦ إلى ١٠ ساعات، اغسل المنطقة التي تم وضع عليها جيدارا® كريم بالماء و الصابون.
استخدم جيدارا® كريم ٣ مرات في الأسبوع، على سبيل المثال، ضع الكريم أيام الإثنين و الأربعاء و الجمعة. يحتوي المغلف الواحد على كمية كافية من الكريم لتغطية ثؤلول مساحته ٢٠ سم مربع (ما يعادل ٣ إنشات مربعة.)
يجب على الذكور الذين يعانون من ثآليل الأعضاء التناسلية، سحب القلفة الذكرية إلى الخلف يوميا و غسل ما بأسفلها (انظر القسم ٢ " الإحتياطات عند استعمال جيدارا® كريم"). استمر في استخدام جيدارا® كريم، وفقاً للنعليمات حتى تختفي الثآليل تماماً (وقد اختفت ثآليل نصف النساء المصابات خلال 8 أسابيع من العلاج، واختفت ثآليل نصف المصابين من الرجال خلال 12 أسبوع من العلاج، وهناك بعض الثآليل تختفي قبل ذلك في غضون 4 أسابيع من العلاج).
لا تستخدم جيدارا® كريم لأكثر من 16 أسبوع لمعالجة الثآليل في كل دورة علاجية.
إذا كان لديك انطباع بأن تأثير جيدارا® كريم قوي جداً أو ضعيف جداً، أخبر طبيبك أو الصيدلي.
• إذا كنت تعالج سرطان الخلايا السطحية القاعدية:
تعليمات الاستخدام – أيام (الإثنين و الثلاثاء و الأربعاء و الخميس و الجمعة)
1. قبل الذهاب إلى السرير، اغسل يديك و المنطقة المراد معالجتها بالماء و الصابون. ثم جففها جيداً.
2. افتح مغلف جديد، و ضع بعضاً من الكريم على طرف إصبعك.
3. ادهن طبقة رقيقة من جيدارا® كريم على المنطقة المصابة. و أضف 1 سم (0.5 إنش تقريباً) حول المنطقة المصابة. و افركها برفق حتى يتلاشى الكريم.
4. بعد دهن الكريم، تخلص من المغلف المفتوح ثم اغسل اليدين بالماء و الصابون.
5. اترك جيدارا® كريم على المنطقة المصابة لمدة ٨ ساعات تقريباً. مع عدم الاستحمام أو الاغتسال خلال هذه المدة.
6. بعد انقضاء مدة ٨ ساعات، اغسل المنطقة التي تم وضع عليها جيدارا® كريم بالماء و الصابون.
ضع كمية كافية من جيدارا® كريم لتغطية المنطقة المعالجة، و إضافة 1 سم (0.5 إنش تقريباً حول المنطقة المصابة كل يوم لمدة حمس أيام متتالية كل أسبوع لمدة 6 أسابيع. على سبيل المثال، ضع الكريم من يوم الإثنين ولغاية يوم الجمعة. وعدم وضعه يومي السبت و الأحد.
• إذا كنت تعالج التقرنات الجلدية الموضعية الحرشفية الورمية:
تعليمات الاستخدام – أيام (الإثنين و الأربعاء و الجمعة)
1. قبل الذهاب إلى السرير، اغسل يديك و المنطقة المراد معالجتها بالماء و الصابون. ثم جففها جيداً.
2. افتح مغلف جديد، و ضع بعضاً من الكريم على طرف إصبعك.
3. ادهن طبقة رقيقة من جيدارا® كريم على المنطقة المصابة. و افركها برفق حتى يتلاشى الكريم.
4. بعد دهن الكريم، تخلص من المغلف المفتوح ثم اغسل اليدين بالماء و الصابون.
5. اترك جيدارا® كريم على المنطقة المصابة لمدة ٨ ساعات تقريباً. مع عدم الاستحمام أو الاغتسال خلال هذه المدة.
6. بعد انقضاء مدة ٨ ساعات، اغسل المنطقة التي تم وضع عليها جيدارا® كريم بالماء و الصابون.
استخدم جيدارا® كريم ٣ مرات في الأسبوع، على سبيل المثال، ضع الكريم أيام الإثنين و الأربعاء و الجمعة.
يحتوي المغلف الواحد على كمية كافية من الكريم لتغطية مساحة ٢٥ سم مربع (ما يعادل ٤ إنشات مربعة.)
استمر في العلاج لمدة ٤ أسابيع. بعد انتهاء ٤ أسابيع من المعالجة الأولى، سيقوم طبيبك بتقييم حالة الجلد. إذا لم تختفي جميع الآفات، يصبح من الضرورة استئناف دورة علاجية أخرى جديدة لمدة ٤ أسابيع.
الجرعة الزائدة من جيدارا® كريم
اغسل الكمية الزائدة بالماء و الصابون، و عند اختفاء أي من التفاعلات الجلدية، يمكنك بعد ذلك متابعة علاجك.
في حال ابتلاعك لجيدارا® كريم عن طريق الخطأ، يرجى الاتصال بالطبيب.
نسيان استعمال جرعة جيدارا® كريم
إذا فاتتك جرعة، ضعها فور تذكرك لها، ثم استأنف برنامجك العلاجي المعتاد. لا تضع الكريم أكثر من مرة واحدة في اليوم.
إذا كان لديك أي أسئلة أخرى حول استخدام هذا الدواء، اسأل طبيبك أو الصيدلي.
لقد تم تصنيف تكرار حدوث التأثيرات الجانبية كالتالي:
آثار جانبية شائعة جداً: (تحدث على الأرجح لأكثر من مريض واحد من بين ١٠ مرضى.)
آثار جانبية شائعة: (تحًدث على الأرجح لأقل من مريض واحد من بين ١٠ مرضى.)
آثار جانبية غير شائعة: (تحدث على الأرجح لأقل من مريض واحد من بين ١٠٠ مريض.)
آثار جانبية نادرة: (تحدث على الأرجح لأقل من مريض واحد من بين ١٠٠٠ مريض.)
آثار جانبية نادرة جداً: (تحدث على الأرجح لأقل من مريض واحد من بين ١٠٠٠٠ مريض.)
مثل جميع الأدوية، يمًكن أن يسبب هذا الدواء آثاراً جانبية، على الرغم من عدم حدوثها لدى الجميع.
أخبر طبيبك أو الصيدلي في أقرب وقت ممكن إذا كنت لا تشعر بصحة جيدة أثناء استخدام جيدارا® كريم.
تحدث لبعض المرضى تغيرات في لون جلد المنطقة التي تم وضع عليها جيدارا® كريم، بالرغم من تحسن هذه التغييرات بمرور الوقت، إلا أنها تبقى ملازمة لبعض المرضى.
إذا تأثر جلدك بصفة سيئة عند استخدام جيدارا® كريم، توقف فوراً عن وضع الكريم، و قم بغسل المنطقة بالماء و الصابون ثم اتصل بطبيبك أو الصيدلي.
لوحظ انخفاض في تعداد كريات الدم عند بعض الأفراد. قد يجعلك انخفاض تعداد كريات الدم أكثر عرضة للإصابة بالعدوى، أو تصاب بالكدمات بسهولة، أو قد يسبب احساساً بالتعب، إذا لاحظت أي من هذه الأعراض، أخبر طبيبك.
نادراً ما يتم الإبلاغ عن تفاعلات جلدية خطيرة. و في حال ظهور آفات جلدية أو بقع على جلدك تبدأ كمناطق حمراء صغيرة و تتطور لتبدو كبقع دائرية صغيرة، من المحتمل أن تكون مصحوبة بأعراض مثل: الحكة، الحمّى، الإعياء العام، ألم المفاصل، مشاكل في الرؤية، الحرقان، ألم أو حكة بالعينين و تقرحات بالفم، فعند ذلك، توقف عن استخدام جيدارا® كريم و أخبر طبيبك على الفور.
يعاني عدد قليل من المرضى من تساقط الشعر في منطقة العلاج أو المنطقة المحيطة لها.
قم بالاتصال بطبيبك المعالج أو الصيدلي في حال زيادة حدة الأعراض الجانبية أو الإصابة بعرض جانبي لم يتم ذكره في هذه النشرة.
• إذا كنت تعالج ثآليل الأعضاء التناسلية:
العديد من الآثار الجانبية الغير مرغوب فيها لجيدارا® كريم تحدث بسبب تأثيره الموضعي على الجلد.
آثار شائعة جداً و تشمل الاحمرار( ٦١٪ من المرضى)، تمزق في الجلد (٣٠٪ من المرضى)، تقشر و تورم. تصلب تحت الجلد، تقرحات صغيرة مفتوحة، قشرة تتشكل أثناء الشفاء، و قد يحدث أيضاً فقاعات صغيرة تحت الجلد. قد تشعر أيضا بالحكة (٣٢٪ من المرضى)، أو شعور بالحرقان (٢٦٪ من المرضى)، أو ألم في الأماكن التي وضع عليها جيدارا® كريم (٨٪ من المرضى). معظم هذه الآثار الجانبية خفيفة و يعود الجلد إلى طبيعته خلال أسبوعين تقريباً بعد التوقف عن العلاج.
آثار شائعة مثل الصداع، يعاني منه بعض المرضى (٤٪ أو أقل.)
آثار غير شائعة مثل الحمى و أعراض تشبه الانفلونزا، آلام المفاصل و العضلات، هبوط الرحم، ألم عند النساء خلال الجماع، صعوبات في الانتصاب، زيادة التعرق ،الشعور بالمرض، أعراض مرضية بالمعدة و الأمعاء، طنين في الأذنين، التورد، الشعور بالتعب، الدوخة، الصداع النصفي، الشعور بالوخز كالدبابيس و الإبر، الأرق، الإكتئاب، فقدان الشهية، تورم الغدد، إلتهابات بكتيرية و فيروسية و فطرية (مثل تقرحات نزلات البرد)، إلتهاب المهبل بما في ذلك داء المبيضات، السعال و نزلات البرد مع تقرّح الحلق.
آثار نادرة جداً شديدة و مؤلمة خاصة عند استخدام كمية من الكريم أكثر من الموصى بها. نادراً ما تؤدي تفاعلات الجلد المؤلمة عند فتحة المهبل إلى صعوبة التبول لدى بعض النساء. في حالة حدوث ذلك، يجب طلب المساعدة الطبية على الفور.
• إذا كنت تعالج سرطان الخلايا السطحية القاعدية:
العديد من الآثار الجانبية الغير مرغوب فيها لجيدارا® كريم تحدث بسبب تأثيره الموضعي على الجلد. يمكن أن تعتبر التفاعلات الموضعية للجلد دلالة على أن الدواء يعمل بشكل صحيح.
آثار شائعة جداً مثل إصابة الجلد المعالج بحكة بسيطة.
آثار شائعة تتضمن الشعور بالوخز كالدبابيس و الإبر، انتفاخ مساحات صغيرة من الجلد، ألم، حرقة، تهيج، نزيف، احمرار أو طفح جلدي.
إذا أصبحت تفاعلات الجلد غير مريحة للغاية أثناء العلاج، أخبر طبيبك. قد ينصحك/تنصحك بالتوقف عن استخدام جيدارا® كريم لبضعة أيام (أي الحصول على راحة قصيرة من العلاج). إذا كان هناك صديد (مادة) أو على وشك حدوث إلتهاب، فعندها ناقش ذلك مع طبيبك. بالإضافة إلى تفاعلات الجلد، فإن الآثار الشائعة تتضمن تورم الغدد و آلام الظهر.
آثار غير شائعة يعاني بعض المرضى بتغييرات في موضع العلاج (إفرازات، إلتهاب، تورم، جرب، تكسّر في الجلد، بثور، إلتهاب الجلد)، أو تهيج، الشعور بالمرض، جفاف الفم، أعراض تشبه الإنفلونزا و الشعور بالتعب.
• إذا كنت تعالج التقرنات الجلدية الموضعية الحرشفية الورمية:
العديد من الآثار الجانبية الغير مرغوب فيها لجيدارا® كريم تحدث بسبب تأثيره الموضعي على الجلد. يمكن أن تعتبر التفاعلات الموضعية للجلد دلالة على أن الدواء يعمل بشكل صحيح.
آثار شائعة جداً مثل إصابة الجلد المعالج بحكة بسيطة.
آثار شائعة تتضمن الألم، الحرقة، التهيج أو الاحمرار.
إذا أصبحت تفاعلات الجلد غير مريحة للغاية أثناء العلاج، أخبر طبيبك. قد ينصحك/تنصحك بالتوقف عن استخدام جيدارا® كريم لبضعة أيام (أي الحصول على راحة قصيرة من العلاج). إذا كان هناك صديد (مادة) أو على وشك حدوث إلتهاب، فعندها ناقش ذلك مع طبيبك. بالإضافة إلى تفاعلات الجلد، فإن الآثار الشائعة تتضمن الصداع، فقدان الشهية، غثيان، آلم العضلات، آلم المفاصل و التعب.
آثار غير شائعة يعاني بعض المرضى بتغييرات في موضع العلاج (نزيف، إلتهاب، إفرازات، حساسية، تورم، انتفاخ مساحات صغيرة من الجلد، الشعور بالوخز كالدبابيس و الإبر، جرب، ندب، تقرح أو شعور بالدفء أو عدم الراحة)، أو إلتهاب بطانة الأنف، انسداد الأنف، الإنفلونزا أو أعراض تشبه أعراض الأنفلونزا، الاكتئاب، تهيج العين، تورم الجفن، ألم في الحلق، الإسهال، سرطان الخلايا السطحية القاعدية، الاحمرار، تورم الوجه، القرحة، ألم في الأطراف، الحمى، الضعف أو الإرتعاش.
الإبلاغ عن الأعراض الجانبية:
المملكة العربية السعودية:
− المركز الوطني للتيقظ و السلامة الدوائية
* فاكس: 966-11-205-7662+
* للاتصال بالمركز الموحد للهيئة العامة للغذاء و الدواء ١٩٩٩٩
* الهاتف المجاني: ٨٠٠٢٤٩٠٠٠٠
* البريد الإلكتروني: npc.drug@sfda.gov.sa
* الموقع الإلكتروني: www.sfda.gov.sa/npc
احفظ هذا الدواء بعيداً عن مرآى و متناول الأطفال.
يحفظ بدرجة حرارة أقل من ٣٠ °م.
لا تستخدم هذا الدواء بعد تاريخ انتهاء الصلاحية المدون على الكرتونة و الملصق بعد EXP. يشير تاريخ انتهاء الصلاحية إلى اليوم الأخير من ذلك الشهر.
يجب عدم إعادة استخدام المغلفات بعد فتحها.
لا تتخلص من الأدوية عن طريق مياه الصرف الصحي أو نفايات المنزل، اسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد تحتاجها. هذه الإجراءات تساعد في حماية البيئة.
• إن المادة الفعالة هي إميكيمود. يحتوي كل مغلف على ٠٫٢٥ غ من الكريم (١٠٠ ملغ من الكريم يحتوي على ٥ ملغ إميكيمود.)
• المواد الأخرى هي حامض الآيزوستيريك، كحول بنزل، كحول سيتل، كحول ستيريل، بارافين أبيض ناعم، بوليسوربيت ٦٠، ستيريت سوربيتان، غليسيرول، ميثيل هيدروكسي بنزوات(٢١٨E)، بروبيل هيدروكسي بنزوات(٢١٦E)، صمغ زانثان، ماء نقي.
• يحتوي كل مغلف من جيدارا® ٥٪ كريم على ٠٫٢٥ غ من كريم أبيض مائل إلى الصفرة.
• تحتوي كل عبوة على ١٢ مغلف مصنوع من الألمنيوم متعدد الطبقات للاستخدام مرة واحدة فقط.
اسم و عنوان مالك رخصة التسويق و المصنع
شركة جرش للصناعات الدوائية ذ.م.م
عمان - الأردن
Imiquimod cream is indicated for the topical treatment of:
- External genital and perianal warts (condylomata acuminata) in adults.
- Small superficial basal cell carcinomas (sBCCs) in adults.
- Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK.s) on the face or scalp in immunocompetent adult patients when size or number oflesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.
Posology
The application frequency and duration of treatment with imiquimod cream is different for each indication.
External genital warts in adults:
lmiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours. Imiquimod cream treatment should continue until the clearance of visible genital or perianal warts or for a maximum of 16 weeks per episode of warts.
For quantity to be applied see section 4.2 Method of administration.
Superficial basal cell carcinoma in adults:
Apply imiquimod cream for 6 weeks, 5 times per week (example: Monday to Friday) prior to normal sleeping hours, and leave on the skin for approximately 8 hours.
For quantity to be applied see 4.2 Method of administration.
Actinic keratosis in adults
Treatment should be initiated and monitored by a physician. Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday and Friday) for four weeks prior to normal sleeping hours, and left on the skin for approximately 8 hours. Sufficient cream should be applied to cover the treatment area. After a 4-week treatment-free period, clearance of AKs should be assessed. If any lesions persist, treatment should be repeated for another four weeks.
The maximum recommended dose is one sachet. The maximum recommended treatment duration is 8 weeks.
An interruption of dosing should be considered if intense local inflammatory reactions occur (see section 4.4) or if infection is observed at the treatment site. In this latter case, appropriate other measures should be taken. Each treatment period should not be extended beyond 4 weeks due co missed doses or rest periods.
lf the treated lesion(s) show an incomplete response at the follow-up examination at 4-8 weeks after the second treatment period, a different therapy should be used (see section 4.4)
Information applicable to all indications:
If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she should continue with the regular schedule. However the cream should not be applied more than once.
Paediatric population
Use in the paediatric patient population is not recommended. There are no data available on the use of imiquimod in children and adolescents in the approved indications.
Jedara should not be used in children with molluscum contagiosum due to lack of efficacy in this indication (see section 5.1).
Method of administration
External genital warts:
Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream vanishes. Only apply to affected areas and avoid any application on internal surfaces. Imiquimod cream should be applied prior to nonnal sleeping hours. During the 6 to IO hour treatment period, showering or bathing should be avoided. After this period it is essential that imiquimod cream is removed with mild soap and water. Application of an excess of cream or prolonged contact with the skin may result in a severe application site reaction (see sections 4.4, 4.8 and 4.9). A single-use sachet is sufficient to cover a wart area of 20 cm2 (approx. 3 inches2). Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream.
Uncircumcised males treating warts under the foreskin should retract the foreskin and wash the area daily (see section 4.4).
Superficial basal cell carcinoma:
Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly, sufficient cream should be applied to cover the treatment area including one centimetre of skin surrounding the tumour. The cream should be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours. During this period, showering and bathing should be avoided. After this period, it is essential that imiquimod cream is removed with mild soap and water.
Sachets should not be re-used once opened. Hands should be washed carefully before and after
application of cream.
Response of the treated tumour to imiquimod cream should be assessed 12 weeks after the end of treatment. If the treated tumour shows an incomplete response, a different therapy should be used (see section 4.4).
A rest period of several days may be taken (see section 4.4) if the local skin reaction to imiquimod cream causes excessive discomfort to the patient, or if infection is observed at the treatment site. In this latter case, appropriate other measures should be taken.
Actinic keratosis:
Before applying imiquimod cream, patients should wash the treatment area with mild soap and water and dry thoroughly. Sufficient cream should be applied to cover the treatment area. The cream should be rubbed into the treatment area until the cream vanishes. The cream should be applied prior to normal sleeping hours and remain on the skin for approximately 8 hours. During this period, showering and bathing should be avoided. After this period, it is essential that imiquimod cream is removed with mild soap and water. Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream.
External genital warts, superficial basal cell carcinoma and actinic keratosis:
Avoid contact with the eyes, lips and nostrils.
Imiquimod has the potential to exacerbate inflammatory conditions of the skin.
Imiquimod cream should be used with caution in patients with autoimmune conditions (refer to section 4.5). Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with a possible worsening of their autoimmune condition.
Imiquimod cream should be used with caution in organ transplant patients (refer to section 4.5). Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with the possibility of organ rejection or graft-versus-host disease.
Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or surgical treatment. Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events (refer to section 4.8 and 4.9)
The use of an occlusive dressing is not recommended with imiquimod cream therapy.
The excipients methyl hydroxybenzoate (E 218) and propyl hydroxybenzoate (E 216) may cause allergic reactions (possibly delayed). Cetyl alcohol and stearyl alcohol may cause local skin reactions (e.g. contact dermatitis). This medicine contains 5 mg benzyl alcohol in each sachet. Benzyl alcohol may cause allergic reactions and mild local irritation.
Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of imiquimod cream. Local inflammatory reactions may be accompanied, or even preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and rigors. An interruption of dosing should be considered.
Imiquimod should be used with caution in patients with reduced haematologic reserve (refer to section 4.8d).
External genital warts:
There is limited experience in the use of imiquimod cream in the treatment of men with foreskin-associated warts. The safety database in uncircumcised men treated with imiquimod cream three times weekly and carrying out a daily foreskin hygiene routine is less than 100 patients. In other studies, in which a daily foreskin hygiene routine was not followed, there were two cases of severe phimosis and one case of stricture leading to circumcision. Treatment in this patient population is therefore recommended only in men who are able or willing to follow the daily foreskin hygiene routine. Early signs of stricture may include local skin reactions (e.g. erosion, ulceration, oedema, induration), or increasing difficulty in retracting the foreskin. If these symptoms occur, the treatment should be stopped immediately. Based on current knowledge, treating urethral, intra-vaginal, cervical, rectal or intra-anal warts is not recommended. Imiquimod cream therapy should not be initiated in tissues where open sores or wounds exist until after the area has healed.
Local skin reactions such as erythema, erosion, excoriation, flaking and oedema are common. Other local reactions such as induration, ulceration, scabbing, and vesicles have also been reported. Should an intolerable skin reaction occur, the cream should be removed by washing the area with mild soap and water. Treatment with imiquimod cream can be resumed after the skin reaction has moderated.
The risk of severe local skin reactions may be increased when imiquimod is used at higher than recommended doses (see section 4.2). However, in rare cases severe local reactions that have required treatment and/or caused temporary incapacitation have been observed in patients who have used imiquimod according to the instructions. Where such reactions have occurred at the urethral meatus, some women have experienced difficulty in urinating, sometimes requiring emergency catheterisation and treatment of the affected area.
No clinical experience exists with imiquimod cream immediately following treatment with other cutaneously applied drugs for treatment of external genital or perianal warts. Imiquimod cream should be washed from the skin before sexual activity. Imiquimod cream may weaken condoms and diaphragms, therefore concurrent use with imiquimod cream is not recommended. Alternative forms of contraception should be considered.
In immunocompromised patients, repeat treatment with imiquimod cream is not recommended.
While limited data have shown an increased rate of wart reduction in HIV positive patients, imiquimod cream has not been shown to be as effective in terms of wart clearance in this patient group.
Superficial basal cell carcinoma:
Imiquimod has not been evaluated for the treatment of basal cell carcinoma within 1 cm of the eyelids, nose, lips or hairline.
During therapy and until healed, affected skin is likely to appear noticeably different from normal skin. Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy. There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema). These local skin reactions may be related to the stimulation of local immune response. If required by the patient's discomfort or the severity of the local skin reaction, a rest period of several days may be taken. Treatment with imiquimod cream can be resumed after the skin reaction has moderated.
The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 12 weeks after the end of treatment.
No clinical experience exists with the use of imiquimod cream in immunocompromised patients.
No clinical experience exists in patients with recurrent and previously treated BCCs, therefore use for previously treated tumours is not recommended.
Data from an open label clinical trial suggest that large tumours (>7.25 cm2) are less likely to respond to imiquimod therapy.
The skin surface area treated should be protected from solar exposure.
Actinic keratosis
Lesions clinically atypical for AK or suspicious for malignancy should be biopsied to determine appropriate treatment.
Imiquimod has not been evaluated for the treatment of actinic keratoses on the eyelids, the inside of the nostrils or ears, or the lip area inside the vermilion border.
There are very limited data available on the use of imiquimod for the treatment of actinic keratoses in anatomical locations other than the face and scalp. The available data on actinic keratosis on the forearms and hands do not support efficacy in this indication and therefore such use is not recommended.
Imiquimod is not recommended for the treatment of AK lesions with marked hyperkeratosis or hypertrophy as seen in cutaneous horns.
During therapy and until healed, affected skin is likely to appear noticeably different from normal skin. Local skin reactions are common but these reactions generally decrease in intensity during therapy or resolve after cessation of imiquimod cream therapy. There is an association between the complete clearance rate and the intensity of local skin reactions (e.g. erythema). These local skin reactions may be related to the stimulation of local immune response. If required by the patient's discomfort or the intensity of the local skin reaction, a rest period of several days may be taken. Treatment with imiquimod cream can be resumed after the skin reaction has moderated.
Each treatment period should not be extended beyond 4 weeks due to missed doses or rest periods.
The clinical outcome of therapy can be determined after regeneration of the treated skin, approximately 4-8 weeks after the end of treatment.
No clinical experience exists with the use of imiquimod cream in immunocompromised patients.
Information on re-treating actinic keratosis lesions that have cleared after one or two courses of treatment and subsequently recur is given in section 4.2 and 5.1.
Data from an open-label clinical trial suggest that subjects with more than 8 AK lesions showed a decreased rate of complete clearance compared to patients with less than 8 lesions.
The skin surface area treated should be protected from solar exposure.
No interaction studies have been performed. This includes studies with immunosuppressive drugs. Interactions with systemic drugs would be limited by the minimal percutaneous absorption of imiquimod cream.
Due to its immunostimulating properties, imiquimod cream should be used with caution in patients who are receiving immunosuppressive medication (see section 4.4).
Pregnancy
For imiquimod no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant women.
Breast-feeding
As no quantifiable levels (> 5 ng/ml) of imiquimod are detected in the serum after single and multiple topical doses, no specific advice can be given on whether to use or not in lactating mothers.
Jedara cream has no or negligible influence on the ability to drive and use machines.
a) General Description:
External genital warts:
In the pivotal trials with 3 times a week dosing, the most frequently reported adverse drug reactions judged to be probably or possibly related to imiquimod cream treatment were application site reactions at the wart treatment site (33.7% of imiquimod treated patients). Some systemic adverse reactions, including headache (3.7%), influenza-like symptoms (1.1%), and myalgia (1.5%) were also reported.
Patient reported adverse reactions from 2292 patients treated with imiquimod cream in placebo controlled and open clinical studies are presented below. These adverse events are considered at least possibly causally related to treatment with imiquimod.
Superficial basal cell carcinoma:
In trials with 5 times per week dosing 58% of patients experienced at least one adverse event. The most frequently reported adverse events from the trials judged probably or possibly related to imiquimod cream are application site disorders, with a frequency of 28.1%. Some systemic adverse reactions, including back pain (1.1%) and influenza-like symptoms (0.5%) were reported by imiquimod cream patients.
Patient reported adverse reactions from 185 patients treated with imiquimod cream in placebo controlled phase III clinical studies for superficial basal cell carcinoma are presented below. These adverse events are considered at least possibly causally related to treatment with imiquimod.
Actinic keratosis
In the pivotal trials with 3 times per week dosing for up to 2 courses each of 4 weeks, 56% of imiquimod patients reported at least one adverse event. The most frequently reported adverse event from these trials judged probably or possibly related to imiquimod cream was application site reactions (22% of imiquimod treated patients). Some systemic adverse reactions, including myalgia (2%) were reported by imiquimod treated patients.
Patient reported adverse reactions from 252 patients treated with imiquimod cream in vehicle controlled phase III clinical studies for actinic keratosis are presented below. These adverse events are considered at least possibly causally related to treatment with imiquimod.
b) Tabular Listing of adverse events:
Frequencies are defined as Very common (≥1/10), Common (≥1/100 to <1/10) and Uncommon (≥1/1,000 to <1/100). Lower frequencies from clinical trials are not reported here.
External genital warts (3x/ wk,16wks) N = 2292 | Superficial basal cell carcinoma (5x/wk, 6 wks) N = 185 | Actinic keratosis (3x/wk, 4 or 8 wks) N = 252 | |
Infections and infestations: | |||
Infection | Common | Common | Uncommon |
Pustules | Common | Uncommon | |
Herpes simplex | Uncommon | ||
Genital candidiasis | Uncommon | ||
Vaginitis | Uncommon | ||
Bacterial infection | Uncommon | ||
Fungal infection | Uncommon | ||
Upper respiratory tract infection | Uncommon | ||
Vulvitis | Uncommon | ||
Rhinitis | Uncommon | ||
Influenza | Uncommon | ||
Blood and lymphatic system disorders: | |||
Lymphadenopathy | Uncommon | Common | Uncommon |
Metabolism and nutrition disorders: | |||
Anorexia | Uncommon | Common | |
Psychiatric disorders: | |||
Insomnia | Uncommon | ||
Depression | Uncommon | Uncommon | |
Irritability | Uncommon | ||
Nervous system disorders: |
|
|
|
Headache | Common |
| Common |
Paraesthesia | Uncommon |
|
|
Dizziness | Uncommon |
|
|
Migraine | Uncommon |
|
|
Somnolence | Uncommon |
|
|
Eye disorders |
|
|
|
Conjunctival irritation |
|
| Uncommon |
Eyelid oedema |
|
| Uncommon |
Ear and labyrinth disorders: |
|
|
|
Tinnitus | Uncommon |
|
|
Vascular disorders: |
|
|
|
Flushing | Uncommon |
|
|
Respiratory, thoracic and mediastinal disorders: |
|
|
|
Pharyngitis | Uncommon |
|
|
Rhinitis | Uncommon |
|
|
Nasal congestion |
|
| Uncommon |
Pharyngo laryngeal pain |
|
| Uncommon |
Gastrointestinal disorders: |
|
|
|
Nausea | Common | Uncommon | Common |
Abdominal pain | Uncommon |
|
|
Diarrhoea | Uncommon |
| Uncommon |
Vomiting | Uncommon |
|
|
Rectal disorder | Uncommon |
|
|
Rectal tenesmus | Uncommon |
|
|
Dry mouth |
| Uncommon |
|
Skin and subcutaneous tissue disorders: |
|
|
|
Pruritus | Uncommon |
|
|
Dermatitis | Uncommon | Uncommon |
|
Folliculitis | Uncommon |
|
|
Rash erythematous | Uncommon |
|
|
Eczema | Uncommon |
|
|
Rash | Uncommon |
|
|
Sweating increased | Uncommon |
|
|
Urticaria | Uncommon |
|
|
Actinic keratosis |
|
| Uncommon |
Erythema |
|
| Uncommon |
Face oedema |
|
| Uncommon |
Skin ulcer |
|
| Uncommon |
Musculoskeletal and connective tissue disorders: |
|
|
|
Myalgia | Common |
| Common |
Arthralgia | Uncommon |
| Common |
Back pain | Uncommon | Common |
|
Pain in extremity |
|
| Uncommon |
Renal and urinary disorders: |
|
|
|
Dysuria | Uncommon |
|
|
Reproductive system and breast disorders: |
|
|
|
Genital pain male | Uncommon |
|
|
Penile disorder | Uncommon |
|
|
Dyspareunia | Uncommon |
|
|
Erectile dysfunction | Uncommon |
|
|
Uterovaginal prolapse | Uncommon |
|
|
Vaginal pain | Uncommon |
|
|
Vaginitis atrophic | Uncommon |
|
|
Vulval disorder | Uncommon |
|
|
General disorders and administration site conditions: |
|
|
|
Application site pruritus | Very common | Very common | Very common |
Application site pain | Very common | Common | Common |
Application site burning | Common | Common | Common |
Application site irritation | Common | Common | Common |
Application site erythema |
| Common | Common |
Application site reaction |
|
| Common |
Application site bleeding |
| Common | Uncommon |
Application site papules |
| Common | Uncommon |
Application site paraesthesia |
| Common | Uncommon |
Application site rash |
| Common |
|
Fatigue | Common |
| Common |
Pyrexia | Uncommon |
| Uncommon |
Influenza-like illness | Uncommon | Uncommon |
|
Pain | Uncommon |
|
|
Asthenia | Uncommon |
| Uncommon |
Malaise | Uncommon |
|
|
Rigors | Uncommon |
| Uncommon |
Application site dermatitis |
|
| Uncommon |
Application site discharge |
| Uncommon | Uncommon |
Application site hyperaesthesia |
|
| Uncommon |
Application site inflammation |
| Uncommon |
|
Application site oedema |
| Uncommon | Uncommon |
Application site scabbing |
| Uncommon | Uncommon |
Application site scar |
|
| Uncommon |
Application site skin breakdown |
| Uncommon |
|
Application site swelling |
| Uncommon | Uncommon |
Application site ulcer |
|
| Uncommon |
Application site vesicles |
| Uncommon | Uncommon |
Application site warmth |
|
| Uncommon |
Lethargy |
| Uncommon |
|
Discomfort |
|
| Uncommon |
Inflammation |
|
| Uncommon |
c) Frequently occurring adverse events:
External genital warts:
Investigators of placebo controlled trials were required to evaluate protocol mandated clinical signs (skin reactions). These protocol mandated clinical sign assessments indicate that local skin reactions including erythema (61%), erosion (30%), excoriation/flaking/scaling (23%) and oedema (14%) were common in these placebo controlled clinical trials with imiquimod cream applied three times weekly (see section 4.4). Local skin reactions, such as erythema, are probably an extension of the pharmacologic effects of imiquimod cream.
Remote site skin reactions, mainly erythema (44%), were also reported in the placebo controlled trials. These reactions were at non-wart sites which may have been in contact with imiquimod cream. Most skin reactions were mild to moderate in severity and resolved within 2 weeks of treatment discontinuation. However, in some cases these reactions have been severe, requiring treatment and/or causing incapacitation. In very rare cases, severe reactions at the urethral meatus have resulted in dysuria in women (see section 4.4).
Superficial basal cell carcinoma:
Investigators of the placebo controlled clinical trials were required to evaluate protocol mandated clinical signs (skin reactions). This protocol mandated clinical sign assessments indicate that severe erythema (31%) severe erosions (13%) and severe scabbing and crusting (19%) were very common in these trials with imiquimod cream applied 5 times weekly. Local skin reactions, such as erythema, are probably an extension of the pharmacologic effect of imiquimod cream.
Skin infections during treatment with imiquimod have been observed. While serious sequelae have not resulted, the possibility of infection in broken skin should always be considered.
Actinic keratosis
In clinical trials of imiquimod cream 3 times weekly for 4 or 8 weeks the most frequently occurring application site reactions were itching at the target site (14%) and burning at the target site (5%). Severe erythema (24%) and severe scabbing and crusting (20%) were very common. Local skin reactions, such as erythema, are probably an extension of the pharmacologic effect of imiquimod cream. See 4.2 and 4.4 for information on rest periods.
Skin infections during treatment with imiquimod have been observed. While serious sequelae have not resulted, the possibility of infection in broken skin should always be considered.
d) Adverse events applicable to all indications:
Reports have been received of localised hypopigmentation and hyperpigmentation following imiquimod cream use. Follow-up information suggests that these skin colour changes may be permanent in some patients. In a follow-up of 162 patients five years after treatment for sBCC a mild hypopigmentation was observed in 37% of the patients and a moderate hypopigmentation was observed in 6% of the patients. 56% of the patients have been free of hypopigmentation; hyperpigmentation has not been reported.
Clinical studies investigating the use of imiquimod for the treatment of actinic keratosis have detected a 0.4% (5/1214) frequency of alopecia at the treatment site or surrounding area. Postmarketing reports of suspected alopecia occurring during the treatment of sBCC and EGW have been received.
Reductions in haemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials. These reductions are not considered to be clinically significant in patients with normal haematologic reserve. Patients with reduced haematologic reserve have not been studied in clinical trials. Reductions in haematological parameters requiring clinical intervention have been reported from postmarketing experience. There have been postmarketing reports of elevated liver enzymes.
Rare reports have been received of exacerbation of autoimmune conditions.
Rare cases of remote site dermatologic drug reactions, including erythema multiforme, have been reported from clinical trials. Serious skin reactions reported from postmarketing experience include erythema multiforme, Stevens Johnson syndrome and cutaneous lupus erythematosus.
e) Paediatric population:
Imiquimod was investigated in controlled clinical studies with paediatric patients (see sections 4.2 and 5.1). There was no evidence for systemic reactions. Application site reactions occurred more frequently after imiquimod than after vehicle, however, incidence and intensity of these reactions were not different from that seen in the licensed indications in adults. There was no evidence for serious adverse reaction caused by imiquimod in paediatric patients.
To report any side effect:
The National Pharmacovigilance and Drug Safety Center (NPC)
· Fax: +966-11-205-7662
· SFDA call center: 19999
· Toll free phone: 8002490000
· E-mail: npc.drug@sfda.gov.sa
· Website: www.sfda.gov.sa/npc
When applied topically, systemic overdosage with imiquimod cream is unlikely due to minimal percutaneous absorption. Studies in rabbits reveal a dermal lethal dose of greater than 5 g/kg. Persistent dermal overdosing of imiquimod cream could result in severe local skin reactions.
Following accidental ingestion, nausea, emesis, headache, myalgia and fever could occur after a single dose of 200 mg imiquimod which corresponds to the content of approximately 16 sachets. The most clinically serious adverse event reported following multiple oral doses of ≥ 200 mg was hypotension which resolved following oral or intravenous fluid administration.
Pharmacotherapeutic group: Chemotherapeutics for topical use, antivirals, ATC Code: D06BB10
Imiquimod is an immune response modifier. Saturable binding studies suggest a membrane receptor for imiquimod exists on responding immune cells. Imiquimod has no direct antiviral activity. In animal models imiquimod is effective against viral infections and acts as an antitumour agent principally by induction of alpha interferon and other cytokines. The induction of alpha interferon and other cytokines following imiquimod cream application to genital wart tissue has also been demonstrated in clinical studies.
Increases in systemic levels of alpha interferon and other cytokines following topical application of imiquimod were demonstrated in a pharmacokinetic study.
External genital warts:
Clinical Efficacy
The results of 3 phase III pivotal efficacy studies showed that treatment with imiquimod for sixteen weeks was significantly more effective than treatment with vehicle as measured by total clearance of treated warts.
In 119 imiquimod-treated female patients, the combined total clearance rate was 60% as compared to 20% in 105 vehicle-treated patients (95% CI for rate difference: 20% to 61%, p<0.001). In those imiquimod patients who achieved total clearance of their warts, the median time to clearance was 8 weeks.
In 157 imiquimod-treated male patients, the combined total clearance rate was 23% as compared to 5% in 161 vehicle-treated patients (95%CI for rate difference: 3% to 36%, p<0.001). In those imiquimod patients who achieved total clearance of their warts, the median time to clearance was 12 weeks.
Superficial basal cell carcinoma:
Clinical efficacy:
The efficacy of imiquimod 5 times per week for 6 weeks was studied in two double-blind vehicle controlled clinical trials. Target tumours were histologically confirmed single primary superficial basal cell carcinomas with a minimum size of 0.5 cm2 and a maximum diameter of 2 cm. Tumours located within 1 cm of the eyes, nose, mouth, ears or hairline were excluded. In a pooled analysis of these two studies, histological clearance was noted in 82% (152/185) of patients. When clinical assessment was also included, clearance judged by this composite endpoint was noted in 75% (139/185) of patients. These results were statistically significant (p<0.001) by comparison with the vehicle group, 3% (6/179) and 2% (3/179) respectively. There was a significant association between the intensity of local skin reactions (e.g. erythema) seen during the treatment period and complete clearance of the basal cell carcinoma.
Five -year data from a long-term open-label uncontrolled study indicate that an estimated 77.9% [95% CI (71.9%, 83.8%)] of all the subjects who initially received treatment became clinically clear and remained clear at 60 months.
Actinic keratosis:
Clinical efficacy:
The efficacy of imiquimod applied 3 times per week for one or two courses of 4 weeks, separated by a 4 week treatment-free period, was studied in two double-blind vehicle controlled clinical trials. Patients had clinically typical, visible, discrete, nonhyperkeratotic, nonhypertrophic AK lesions on the balding scalp or face within a contiguous 25 cm2 treatment area. 4-8 AK lesions were treated. The complete clearance rate (imiquimod minus placebo) for the combined trials was 46.1% (CI 39.0%, 53.1%).
One-year data from two combined observational studies indicate a recurrence rate of 27% (35/128 patients) in those patients who became clinically clear after one or two courses of treatment. The recurrence rate for individual lesions was 5.6% (41/737). Corresponding recurrence rates for vehicle were 47% (8/17 patients) and 7.5% (6/80 lesions). The rate of progression to squamous cell carcinoma (SCC) was reported in 1.6% (2/128 patients).
There are no data on recurrence and pro gression rates beyond 1 year.
Paediatric population
The approved indications genital warts, actinic keratosis and superficial basal cell carcinoma are conditions not generally seen within the paediatric population and were not studied.
Jedara Cream has been evaluated in four randomised, vehicle controlled, double-blind trials in children aged 2 to 15 years with molluscum contagiosum (imiquimod n = 576, vehicle n = 313). These trials failed to demonstrate efficacy of imiquimod at any of the tested dosage regimens (3x/week for ≤16 weeks and 7x/week for ≤8 weeks).
External genital warts, superficial basal cell carcinoma and actinic keratosis:
Less than 0.9% of a topically applied single dose of radiolabelled imiquimod was absorbed through the skin of human subjects. The small amount of drug which was absorbed into the systemic circulation was promptly excreted by both urinary and faecal routes at a mean ratio of approximately 3 to 1. No quantifiable levels (>5 ng/ml) of drug were detected in serum after single or multiple topical doses.
Systemic exposure (percutaneous penetration) was calculated from recovery of carbon-14 from [14C] imiquimod in urine and faeces.
scalp and hands/ anns groups. Dose proportionality was not observed. An apparent half-life was
calculated that was approximately 10 times greater than the 2 hour half-life seen following
subcutaneous dosing in a previous study, suggesting prolonged retention of drug in the skin. Urinary recovery was less than 0.6% of the applied dose at week 16 in these patients.
Paediatric population
The pharmacokinetic properties of imiquimod following single and multiple topical application in paediatric patients with molluscum contagiosum (MC) have been investigated. The systemic exposure data demonstrated that the extent of absorption of imiquimod following topical application to the MC lesional skin of the paediatric patients aged 6-12 years was low and comparable to that observed in healthy adults and adults with actinic keratosis or superficial basal cell carcinoma. In younger patients aged 2-5 years absorption, based on Cmax values, was higher compared to adults.
Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, mutagenicity and teratogenicity.
In a four-month rat dermal toxicity study, significantly decreased body weight and increased spleen weight were observed at 0.5 and 2.5 mg/kg; similar effects were not seen in a four month mouse dermal study. Local dermal irritation, especially at higher doses, was observed in both species.
A two-year mouse carcinogenicity study by dermal administration on three days a week did not induce tumours at the application site. However, the incidences of hepatocellular tumours among treated animals were greater than those for controls. The mechanism for this is not known, but as imiquimod has low systemic absorption from human skin, and is not mutagenic, any risk to humans from systemic exposure is likely to be low. Furthermore, tumours were not seen at any site in a 2-year oral carcinogenicity study in rats.
Imiquimod cream was evaluated in a photocarcinogenicity bioassay in albino hairless mice exposed to simulated solar ultraviolet radiation (UVR). Animals were administered imiquimod cream three times per week and were irradiated 5 days per week for 40 weeks. Mice were maintained for an additional 12 weeks for a total of 52 weeks. Tumours occurred earlier and in greater number in the group of mice administered the vehicle cream in comparison with the low UVR control group. The significance for man is unknown. Topical administration of imiquimod cream resulted in no tumour enhancement at any dose, in comparison with the vehicle cream group.
Isostearic acid, Benzyl alcohol, Cetyl alcohol, Stearyl alcohol, White soft paraffin, Polysorbate 60, Sorbitan stearate, Glycerol, Methyl hydroxybenzoate (E 218), Propyl hydroxybenzoate (E 216), Xanthan gum, Purified water.
Not applicable.
Do not store above 30 °C.
Sachets should not be re-used once opened.
Boxes of 12 single-use multi-layer laminated sachets, containing 250 mg of cream.
No special requirements.
