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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
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Lora fm belongs to a group of medicines known as antihistamines.
Antihistamines help to reduce allergic symptoms by preventing the effects of a substance called histamine, which is produced in the body.
The medicine relieves symptoms associated with allergic rhinitis (for example, hay fever), such as sneezing, runny or itchy nose, and burning or itchy eyes. The medicine may also be used to help relieve symptoms of urticaria (itching and redness, which is often known as nettle rash).
Do not take Lora fm
• If you are allergic (hypersensitive) to loratadine or any of its other ingredients.
• If you are pregnant or breastfeeding.
Take special care with Lora fm
Before taking this medicine, tell your doctor or pharmacist:
• If you have liver disease.
Taking other medicines
If you are taking any other medicines, including medicines taken without a prescription, please consult your pharmacist or doctor before use.
Laboratory tests:
If you are scheduled to have any skin tests for allergies you should not take Lora fm for two days before.
Taking Lora fm with food and drink
The medicine can be taken with or without a meal.
Driving and using machinery
At the recommended dose, Lora fm is not expected to cause you to be drowsy or less alert. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machinery.
Take one tablet once daily. Peel off backing and gently push out tablet from the blister taking care to avoid crushing. Allow to disperse in the mouth and swallow. No water or other liquid is required.
GIVING THIS MEDICINE TO CHILDREN
Loratadine syrup may be preferable for children. It is important to know how much your child weighs to make sure that you give the correct amount of medicine. For example, a 9 year old child weighs about 30kg. If in doubt weigh your child and then follow the instructions in the table.
Do not give to children under 6 years or who weigh less than 30 kg.
| Age | How much to take | How often to take |
| Adults and children over 12 years | 1 x tablet | Once daily |
| Children of 6 to 12 years who weigh more than 30 kg. | 1 x tablet | Once daily |
| If you have severe liver problems your doctor or pharmacist may advise you to take the recommended amount every other day. If this applies to you follow their instructions. | ||
f you take more Lora fm than you should
No serious problems are expected with accidental overdose. However, if you take more medicine than recommended, contact your doctor or pharmacist immediately.
If you forget to take your medicine
If you forget to take your dose on time, take it as soon as possible, then go back to your regular dosing schedule. Do not take a double dose to make up for a forgotten dose.
If you stop taking your medicine
Stop taking this medicine when your doctor or pharmacist tells you to stop.
If you have any further questions on the use of this product, ask your pharmacist or doctor.
Like all medicines, Lora fm can cause side effects, although not everybody gets them.
Patients have very rarely experienced hypersensitive reactions, such as difficulty in breathing, swelling of the face, neck, tongue or throat after use of this product. If you experience any of these side effects stop taking the medicine and contact your pharmacist or doctor at once.
The most commonly reported side effects in children aged 2 through 12 years include headache, nervousness and tiredness. The most commonly reported side effects in adults and adolescents include drowsiness, headache, increased appetite, and difficulty sleeping.
other side effects reported very rarely were dizziness, irregular or rapid heartbeat, nausea (feeling sick), dry mouth, upset stomach, liver problems, hair loss, rash and tiredness.
If you develop serious side effects, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Store in the original package in order to protect from moisture.
Store below 25°C.
Keep out of the reach and sight of children. Do not use Lora fm after the expiry date which is stated on the blister. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The active substance is micronized loratadine 10mg.
The other ingredients are:
Pharmaburst B2, Citric Acid Monohydrate, Sodium Saccharin, Peppermint flavor and Magnesium Stearate.
Manufactured by: DAMMAM PHARMA
Dammam Pharmaceutical Plant
Saudi Arabia
ينتمي لورا اف ام إلى مجموعة من الأدوية التي تعرف باسم مضادات الهستامين. مضادات الهستامين تساعد على الحد من أعراض الحساسية من خلال منع تأثيرات مادة تسمى الهستامين، وهي مادة يتم انتاجها في الجسم.
هذا الدواء يخفف من الأعراض المرتبطة بالتهاب الأنف التحسسي (على سبيل المثال، حمى القش)، مثل العطس، سيلان أو حكة الأنف، وحرق أو حكة في العينين.
ويمكن أيضا استخدام هذا الدواء للمساعدة في تخفيف أعراض الشرى ( الحكة والاحمرار، والتي غالبا ماتعرف باسم طفح القراص).
لا تقم بتناول لورا اف ام في الحالات الآتية :
- إذا كنت تعاني من فرط التحسس تجاه مادة لوراتادین أو أي من المكونات الأخرى لهذا الدواء.
- إذا كنت حاملا أو ترضعين طفلك طبيعيا ۔
ينبغي توخي الحذر عند تناول أقراص لورا اف ام
قبل البدء في تناول أقراص لورا اف ام ، أخبر طبيبك المعالج أو الصيدلي في الحالات الآتية :
- إذا كنت مصابا بمرض بالكبد .
تناول أدوية أخرى :
إذا كنت تناول أي أدوية أخرى ، بما فيها تلك التي حصلت عليها بدون وصفة طبية ، فضلا أخبر الصيدلي او طبيبك المعالج قبل البدء في تناول هذا الدواء .
الاختبارات المعملية
إذا كان من المقرر لك إجراء أي اختبارات لحساسية الجلد يجب عليك عدم تناول لورا اف ام لمدة يومين قبل إجراء تلك الاختبارات.
تناول أقراص لورا اف ام مع الطعام والشراب
يمكن تناول هذا الدواء مع الطعام أو بدونه .
القيادة واستخدام الآلات
في حالة تناول الجرعة الموصى بها ، ليس من المتوقع أن يسبب لك لورا اف ام نعاسة أو يقلل من انتباهك . ومع ذلك ، من النادر جدا قد يتعرض بعض الناس إلى النعاس ، مما قد يؤثر على قدرتهم على القيادة أو استخدام الآلات .
قم بتناول قرص واحد يوميا. قم بإخراج القرص من الشريط مع الحرص لتجنب تكسير القرص. قم بابتلاع القرص بعد ذوبانه بالفم. ليس من الضروري شرب الماء أو أي سوائل أخرى.
إعطاء هذا الدواء للأطفال
قد يكون من الأفضل بالنسبة للأطفال استخدام لوراتادين شراب. من الضروري معرفة وزن الطفل للتأكد من الجرعة التي يجب عليك إعطائها للطفل. على سبيل المثال، طفل في سن 9 سنوات من العمر يزن حوالي 30 كجم.
وفي حالة الشك قم بوزن طفلك ثم اتبع التعليمات المذكورة في الجدول أدناه.
لاتقم بإعطاء هذا الدواء للأطفال الأقل في العمر من 6 سنوات أو الأقل في الوزن من 30 كجم.
| العمر | الجرعة | عدد مرات تناول الجرعة |
| البالغين والأطفال الأكثر من 12 سنة من العمر | قرص واحد | مرة واحدة يوميا |
| الأطفال من سن 6 سنوات إلى 12 سنة من العمر في وزن أكثر من 30 كجم | قرص واحد | مرة واحدة يوميا |
| إذا كنت مصابا بمشاكل حادة بالكبد قد ينصحك طبيبك المعالج أو الصيدلي بتناول الجرعة الموصى بها مرة كل يومين. في حالة انطباق تلك الحالة عليك اتبع تعليماتهم. | ||
في حالة تناول أقراص لورا اف ام أكثر مما ينبغي
ليس من المتوقع حدوث مشاكل خطيرة في حالة تناول جرعة زائدة عن طريق الخطأ. ومع ذلك، إذا تناولت جرعة زائدة عن تلك الموصى بها، تواصل مع طبيبك المعالج أو الصدلي فورا.
في حالة نسيانك لتناول الجرعة من هذا الدواء
في حالة نسيانك لتناول جرعة من هذا الدواء في وقتها المحدد، قم بتناولها في أقرب وقت ممكن، ثم اتبع الجدول الزمني المعتاد لبقية الجرعات. لاتقم بمضاعفة الجرعة لتعويض الجرعة المنسية.
إذا توقفت عن تناول الدواء الخاص بك
توقف عن تناول هذا الدواء عندما يخبرك طبيبك المعالج أو الصيدلي بذلك.
إذا كان لديك أي أسئلة أخرى عن استخدام هذا الدواء، اسأل الصيدلي أو الطبيب.
مثل جميع الأدوية، قد يسبب لورا اف ام بعض الأعراض الجانبية وإن لم تكن تحدث لكل من يتناول هذا الدواء.
من النادر جدا تعرض بعض المرضى لتفاعلات تحسسية، مثل صعوبة في التنفس أو تورم الوجه أو الرقبة أو اللسان أو الحلق بعد تناول هذا الدواء. إذا تعرضت لأي من هذا الأعراض توقف عن تناول هذا الدواء وتواصل مع طبيبك المعالج أو الصيدلي في الحال.
الأعراض الجانبية الأكثؤ شيوعا في حالة الأطفال من سن سنتين إلى 12 سنة من العمر تشمل صداع وتوتر وتعب.
الأعراض الجانبية الأكثر شيوعا في البالغين والمراهقين تشمل النعاس والصداع وزيادة الشهية وصعوبة في النوم.
تم رصد أعراض جانبية أخرى نادرة جدا مثل الدوخة، وعدم انتظام أو تسارع في ضربات القلب، والغثيان (الشعور بالإعياء)، وجفاف الفم، واضطراب في المعدة ومشاكل في الكبد، وفقدان الشعر، والطفح الجلدي والتعب.
إذا تعرضت لأي أعراض جانبية خطيرة، أو لاحظت ظهور أي أعراض جانبية لم يتم ذكرها في هذه النشرة، فضلا أخبر طبيبك المعالج أو الصيدلي.
يحفظ هذا الدواء في عبوته الأصلية لحمايته من الرطوبة.
يحفظ هذا الدواء في درجة حرارة أقل من 25 درجة مئوية.
يحفظ هذا الدواء بعيدا عن نظر ومتناول الأطفال. لاتقم باستخدام لورا افف ام بعد انتهاء تاريخ الصلاحية المدون على الشريط. علما بأن تاريخ الصلاحية يشير إلى آخر يوم في الشهر المذكور على الشريط.
يجب عدم التخلص من الأدوية عبر النفايات المنزلية أو مياه الصرف الصحي. إسأل الصيدلي عن كيفية التخلص من الأدوية التي لم تعد بحاجة إليها. سوف تساعد هذه الدابير في حماية البيئة.
المادة الفعالة هي مايكرونايزدلوراتادين 10 ملجم.
مكونات أخرى وهي: فارمابيرست B2 حمض الستريك أحادي التميه، سكارين الصوديوم، نكهة النعناع وستيارات المغنسيوم.
لورا اف ام يتوفر على هيئة أقراص غير مغلفة مستديرة، ثنائية التحدب، لونها من أبيض إلى أبيض فاتح، لها سطح جلي من الجانبين.
إتناج الدمام فارما
مصنع الأدوية بالدمام
المملكة العربية السعودية
Lora FM 10mg Fast-melting Tablet is indicated for the symptomatic treatment of allergic rhinitis (AR) and chronic idiopathic urticaria (CIU). |
Lora FM 10mg Fast-melting Tablets should be handled with caution and with dry hands only.
Lora FM 10mg Fast-melting Tablets are intended for oral use.
The tablet shall be put on the tongue and wait until it is thoroughly disintegrated. Water or other liquid is not needed to swallow the dose.
The Fast-melting tablet may be taken without regard to mealtime.
Adults and children over 12 years of age
10 mg once daily (one Fast-melting tablet once daily).
Paediatric population
Children 6 to 12 years of age with body weight more than 30 kg: 10 mg once daily (one Fast-melting tablet once daily).
The 10 mg strength Fast-melting tablet is not appropriate in children with a body weight less than 30 kg.
The 10 mg strength Fast-melting tablet is not recommended for children less than 6 years old as there is no evidence for the efficacy and safety for this age group.
Severe Hepatic impairment
Patients with severe hepatic impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg.
Elderly or Renal impairment
No dosage adjustments are required in the elderly or in patients with renal insufficiency.
Loratadine should be administered with caution in patients with severe hepatic impairment (see section 4.2).
The administration of loratadine should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
When administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies.
Potential interaction may occur with all known inhibitors of CYP3A4 or CYP2D6 resulting in elevated levels of loratadine (see Section 5.2), which may cause an increase in adverse events.
Pregnancy category B.
Loratadine was not teratogenic in animal studies. The safe use of loratadine during pregnancy has not been established. The use of loratadine during pregnancy is therefore not recommended.
Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breastfeeding women.
In clinical trials that assessed driving ability, no impairment occurred in patients receiving loratadine. However, patients should be informed that very rarely some people experience drowsiness, which may affect their ability to drive or use machines. |
In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%). In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2 % of patients in excess of those treated with placebo. The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%). Other adverse reactions reported very rarely during the post-marketing period are listed in the following table.
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To report any side effect(s): The National Pharmacovigilance and Drug Safety Centre (NPC) o Fax: +966-11-205-7662 o Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340. o Toll free phone: 8002490000 o E-mail: npc.drug@sfda.gov.sa o Website: www.sfda.gov.sa/npc
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Overdosage with loratadine increased the occurrence of anticholinergic symptoms. Somnolence, tachycardia, and headache have been reported with overdoses.
In the event of overdose, general symptomatic and supportive measures are to be instituted and maintained for as long as necessary. Administration of activated charcoal as a slurry with water may be attempted. Gastric lavage may be considered. Loratadine is not removed by haemodialysis and it is not known if loratadine is removed by peritoneal dialysis. Medical monitoring of the patient is to be continued after emergency treatment.
Pharmacotherapeutic group: antihistamines – H1 antagonist, ATC code: R06A X13.
Loratadine, the active ingredient in the medicinal product, is a tricyclic antihistamine with selective, peripheral Hl-receptor activity.
Loratadine has no clinically significant sedative or anticholinergic properties in the majority of the population and when used at the recommended dosage.
During long-term treatment there were no clinically significant changes in vital signs, laboratory test values, physical examinations or electrocardiograms.
Loratadine has no significant H2-receptor activity. It does not inhibit norepinephrine uptake and has practically no influence on cardiovascular function or on intrinsic cardiac pacemaker activity.
After oral administration, loratadine is rapidly and well absorbed and undergoes an extensive first pass metabolism, mainly by CYP3A4 and CYP2D6. The major metabolite -desloratadine (DL)- is pharmacologically active and responsible for a large part of the clinical effect. Loratadine and DL achieve maximum plasma concentrations (Tmax) between 1-1.5 hours and 1.5-3.7 hours after administration, respectively.
Increase in plasma concentrations of loratadine has been reported after concomitant use with ketoconazole, erythromycin, and cimetidine in controlled trials, but without clinically significant changes (including electrocardiographic).
Loratadine is highly bound (97 % to 99 %) and its active metabolite moderately bound (73 % to 76 %) to plasma proteins.
In healthy subjects, plasma distribution half-lives of loratadine and its active metabolite are approximately 1 and 2 hours, respectively. The mean elimination half-lives in healthy adult subjects were 8.4 hours (range = 3 to 20 hours) for loratadine and 28 hours (range = 8.8 to 92 hours) for the major active metabolite.
Approximately 40 % of the dose is excreted in the urine and 42 % in the faeces over a 10 day period and mainly in the form of conjugated metabolites. Approximately 27 % of the dose is eliminated in the urine during the first 24 hours. Less than 1 % of the active substance is excreted unchanged in active form, as loratadine or DL.
The bioavailability parameters of loratadine and of the active metabolite are dose proportional.
The pharmacokinetic profile of loratadine and its metabolites is comparable in healthy adult volunteers and in healthy geriatric volunteers.
Concomitant ingestion of food can delay slightly the absorption of loratadine but without influencing the clinical effect.
In patients with chronic renal impairment, both the AUC and peak plasma levels (Cmax) increased for loratadine and its metabolite as compared to the AUCs and peak plasma levels (Cmax) of patients with normal renal function. The mean elimination half-lives of loratadine and its metabolite were not significantly different from that observed in normal subjects. Haemodialysis does not have an effect on the pharmacokinetics of loratadine or its active metabolite in subjects with chronic renal impairment.
In patients with chronic alcoholic liver disease, the AUC and peak plasma levels (Cmax) of loratadine were double while the pharmacokinetic profile of the active metabolite was not significantly changed from that in patients with normal liver function. The elimination half-lives for loratadine and its metabolite were 24 hours and 37 hours, respectively, and increased with increasing severity of liver disease.
Loratadine and its active metabolite are excreted in the breast milk of lactating women.
Preclinical data reveal no special hazard based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
In reproductive toxicity studies, no teratogenic effects were observed. However, prolonged parturition and reduced viability of offspring were observed in rats at plasma levels (AUC) 10 times higher than those achieved with clinical doses.
No evidence of mucous membrane irritation was observed after daily administration of up to 12 tablets (120 mg) of oral lyophilisates into the hamster cheek pouch for five days.
Pharmaburst B2
Citric Acid Monohydrate
Sodium Saccharin
Peppermint flavor
Magnesium Stearate
Not applicable.
Store below 25°C.
10 tablets/pack
Transparent thermoformed PVC/PVDC blister strips with hard tempered aluminium foil lid.
No Special Disposal.
