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نشرة الممارس الصحي نشرة معلومات المريض بالعربية نشرة معلومات المريض بالانجليزية صور الدواء بيانات الدواء
  SFDA PIL (Patient Information Leaflet (PIL) are under review by Saudi Food and Drug Authority)

Fungo® Cream contains Clotrimazole 0.01 mg.

Funfo® is used to treat skin infections, yeast - mold (eg, aspergil-lus species) and other fungus species.


Do not use Fungo® Cream and tell your doctor or pharmacist if you have:

- The use of patients with an allergic history of clotrimazole or any other ingredients is prohibited.

- Prevent use on the eye.Warnings and precautions:

 

Talk to your doctor or pharmacist before taking Fexotel if:

- You have problems with your liver or kidneys

- You have or ever had heart disease, since this kind of medicine may lead to a fast or irregular heart beat.

- You are elderly.

- If any of these apply to you, or if you are not sure, tell your doctor before taking Fexotel.

 

Using other medicinesBefore you use this medicine, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time. If you are unsure about interactions with any medicines,

 

talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

 

Pregnancy and breast-feedingPregnancy: There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.

 

Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration (see section 5.3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.


Apply a layer of cream to the skin area affected by fungus and surrounding area with gently massage twice daily (morning and evening) or as advised by the doctor and depends on the duration of treatment on the location and severity of injury.


In rare cases, skin reactions such as burning, stinging or redness may occur in the skin.


- Keep out of the reach of children.

- Do not use Fexotel® tablets after the expiry date (EXP) which is stated on the box and blister.

- Don’t Store above 30 °C.

- 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: Clotrimazole

The other ingredients are: White Soft Paraffin, Liquid Paraffin, Cetostearyl Alcohol, Cetomacrogol - 1000, Propylene Glycolm Glycerin, Methyl Hydroxybenzoate, Propyl Hydroxybenzoate, Purified Water.


Fungo® is white to creamy white smooth cream. Fungo® presented as carton box containing aluminum tube of 20 gram along with a leaflet.

BATTERJEE PHARMA

Street No.: 401, Road No.: 403,

Industrial Area-Phase-IV,

P.O. Box: 10667,

Jeddah-21443,

Kingdom of Saudi Arabia.


05/2020
  نشرة الدواء تحت مراجعة الهيئة العامة للغذاء والدواء (اقرأ هذه النشرة بعناية قبل البدء في استخدام هذا المنتج لأنه يحتوي على معلومات مهمة لك)

فانجو® كریم یحتوي على كلوتاریماوزل ۰٫۰۱ملجم. یستعمل فانجو® كریم لمعالجة عدوى الجلد، الخمائر – العفن(مثل أنواع الاسبرجللس) وأنواع الفطریات الأخرى

لا تستعمل فانجو® كریم وأخبر طبیبك أو الصیدلي إذا كنت تعاني من:

یمنع استخدام للمرضى الذین لدیھم تاریخ مرضي بالحساسیة من الكلوترایمازول أو أي من المكونات الأخرى.

یمنع استخدام على العین.

 

استخدام أدویة أخر

ىقبل استخدام ھذا الدواء، تأكد من أن تخبر الصیدلي عن أي أدویة أخرى قد تستخدمھا في نفس الوقت وھذا یشمل الأدویة الموصوفة من قبل الطبیب وغیرھا من العلاجات الطبیعیة بما في ذلك الأعشاب والعلاجات المثلیة.

 

الحمل والرضاعة الطبیعیة

ھناك بیانات محدودة عن استخدام كلوتریمازول في النساء الحوامل.

الحمل:وقد أظھرت الدراسات الحیوانیة مع كلوتریمازول أن لھ تأثیرات سمیة في جرعات عالیة عن طریق الفم (انظر القسم ٥ه۳). لا یمكن التنبؤ بالآثار الضارة فیما یتعلق السمیة الإنجابیة. كلوتریمازول یمكن استخدامھ أثناء الحمل، ولكن فقط تحت إشراف الطبیب. لقد أظھرت البیانات الدوائیة / السمیة المتاحة في الحیوانات إفراز

الرضاعة:كلوتریمازول / الأیض في الحلیب عن طریق الورید (انظر القسم ٥،۳). لا یمكن استبعاد الخطر على الطفل الرضیع. ویجب اتخاذ قرار بشأن ما إذا كان ینبغي التوقف عن الرضاعة الطبیعیة أو التوقف عن الامتناع عن العلاج بالكلوتریمازول مع مراعاة

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توضع طبقة من الكریم على منطقة الجلد المصابة بالفطریات والمنطقة المحیطة بھا مع الدلك برفق مرتین یومیا (صباحا ومساء) أو كما نصح الطبیب وتعتمد مدة العلاج على مكان الإصابة وشدتھا

في حالات نادرة قد تحدث تفاعلات جلدیة مثل حرقان او لدغ او إحمرار في الجلد

- لا تستخدم فانجو® كریم بعد تاریخ انتھاء الصلاحیة المذكور على العلبة والشریط بعد كلمة EXP

- یحفظ في درجة حرارة لا تزید عن ۳۰درجة مئویة.

- وینبغي أن لا یتم التخلص من الأدویة عن طریق میاه الصرف الصحي أو النفایات المنزلیة.

- اسأل الصیدلي حول كیفیة التخلص من الأدویة التي لم تعد مطلوبة .وستساعد ھذه التدابیر على حمایة البیئة . ٦ شھور بعد الفتح.

- مدة الاستخدام:٦.

 المادة الفعالة ھي: أبیض البارافین لینة، البارافین السائل، سیتوستیریل الكحول،

المكونات الأخرى ھي:سیتوماكروغول -۱۰۰۰، البروبیلین غلیكول الغلیسرین، ھیدروكسي بنزوات المیثیل، ھیدروكسي بنزوات بروبیل، المیاه النقیة

یبدو فانجو® ككریم أبیض كریمي ناعم.

یوجد فانجو ® كریم في علبة كرتون تحتوي على أنبوبة ألومنیوم ۲۰ جرام ونشرة داخلیة

بترجي فارما

الشارع رقم ٤۰۱ ،شارع رقم ٤۰۳ ،

منطقة المرحلة الرابعة الصناعیة،

ص. مربع: ۱۰٦٦۷ ،

جدة ۲۱٤٤۳ ،

المملكة العربیة السعودیة

05/2020
 Read this leaflet carefully before you start using this product as it contains important information for you

FUNGO®Cream

Each gram contains 0.01 gm of Clotrimazole. For full list of excipients see section 6.1

Cream. White to creamy white smooth cream

For the treatment of tinea pedis and tinea cruris.


The cream should be applied thinly 2-3 times daily and rubbed in gently. A strip of cream (½ cm long) is enough to treat an area of about the size of the hand. If the feet are infected they should be washed and dried, especially between the toes, before applying the cream. The treatment should be continued for at least one month to prevent re-infection; however a physician should be consulted if symptoms do not improve within 7 days.


FUNGO® Cream is contraindicated in those patients with a history of sensitivity reactions to Clotrimazole, or any other components of the cream.

− FUNGO® Cream is not intended for ophthalmic use.
− After washing, the feet must always be dried thoroughly, paying particular attention to the areas between the toes.


There are no known drug interactions with topical Clotrimazole.


Pregnancy:
There is a limited amount of data from the use of clotrimazole in pregnant women. Animal studies with clotrimazole have shown reproductive toxicity at high oral doses (see section 5.3). At the low systemic exposures of clotrimazole following topical treatment, harmful effects with respect to reproductive toxicity are not predicted. Clotrimazole can be used during pregnancy, but only under the supervision of a physician or midwife.
Lactation:
Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration (see section 5.3). A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from clotrimazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.


Not applicable.


As the listed undesirable effects are based on spontaneous reports, assigning an accurate frequency of occurrence for each is not possible.
Immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticaria).
Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, erythema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning.


No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favourable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). Gastric lavage should be carried out only if the airway can be protected adequately.


Pharmacotherapeutic group: Antifungals for topical use – imidazole and triazole derivatives
ATC Code: D01A C01
FUNGO® Cream, contains Clotrimazole, a broad spectrum antifungal agent, which inhibits the growth of pathogenic dermatophytes (Epidermophyton, Microsporum and Trichophyton species), Candida albicans, Malassezia furfur and Cutaneous corynebacterium.
Following topical application of FUNGO® Cream, Clotrimazole readily penetrates the stratum corneum of the skin and acts directly on the fungal cell wall causing an increase in their permeability to various intracellular substances. Clinical improvement, including relief of pruritus, usually occurs within one week of FUNGO® treatment and sensitive organisms do not develop resistance to its action.
Besides its soothing effect, FUNGO® Cream is well tolerated and causes no local irritation or staining.


Pharmacokinetic investigations after dermal application have shown that clotrimazole is minimally absorbed from the intact or inflamed skin into the human blood circulation. The resulting peak serum concentrations of clotrimazole were below the detection limit of 0.001 μg/ml, suggesting that clotrimazole applied topically is unlikely to lead to measurable systemic effects or side effects.


No available data.


White Soft Paraffin
Liquid Paraffin
Cetostearyl Alcohol
Cetomacrogol -1000
Propylene Glycol
Glycerin
Methyl Hydroxybenzoate
Propyl Hydroxybenzoate
Purified Water


Not applicable.


24 months. 6 months from opening the tube.

Do not store above 30°C


FUNGO® 1 % Cream is presented as carton box containing aluminum tube of 20 gram along with a leaflet.


No special requirements


BATTERJEE PHARMA Street No.: 401, Road No.: 403, Industrial Area-Phase-IV, P.O. Box: 10667, Jeddah-21443, Kingdom of Saudi Arabia

March 2019
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