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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
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1 g of Fenistil Gel contains 1 mg of dimetindene maleate as
active ingredient.
Excipients with known effect: Propylene glycol and
benzalkonium chloride solution 50%
Other excipients: Carbomer, Sodium Hydroxide, Disodium edetate,
purified water.
It is used for Relief of pruritus associated with dermatoses,
urticaria, insect bites, sunburn and superficial burns.
A- Do not use Fenistil:
Contraindicated in patients with a prior hypersensitivity reaction
to dimetindene maleate or any other ingredient of the preparation.
B-Take special care in case:
When using this product you may experience:
dry skin, skin burning sensation, itchy rash
In case of very severe pruritus or extensive lesions, the local
application of dimetindene maleate should be supplemented by
a systemic treatment with an oral form of dimetindene maleate.
Prolonged exposure to the sun of extensively treated areas should
be avoided.
In infants and small children, avoid use on extensive areas of the
skin, particularly if raw or inflamed.
Dimetindene maleate gel contains:
Propylene glycol which may cause mild, localized skin irritation.
Benzalkonium chloride which is irritant, and may cause
skin reactions.
Do not give the product to children under 2 years of age without a
medical prescription.
For Adults & children above 2 years : Apply 2 to 4 times daily to
affected area. Do not apply gel or cutaneous emulsion for more
than 7 days without consulting a doctor Prolonged exposure to
the sun of extensively treated areas should be avoided.
In infants and small children, avoid use on extensive areas of the
skin, particularly if raw or inflamed.
In children less than 2 years old: Fenisitil gel can only be used
under medical prescription.
Tabulated list of adverse reactions
Adverse reactions are listed below by system organ class and
frequency. Frequencies are defined as: very common (≥ 1/10);
common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to <1/100);
rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not
known (can not to be estimated from available data). Within each
frequency grouping, adverse reactions are presented in order of
decreasing seriousness.
Skin disorders:
Uncommon: Skin dryness, burning sensation.
Post-marketing experience
Skin disorders: Very rare cases of allergic dermatitis have been
observed
Interactions
No interaction studies have been performed; however since the
systemic absorption of dimetindene maleate from topical
application is very low, interactions are very unlikely.
Pregnancy and Lactation
Fertility
There are no adequate data from the use of dimetindene malate
in women of childbearing potential. No effects on fertility have
been observed in animal studies. Caution should be exercised
when prescribing to women of childbearing potential.
Pregnancy
For dimetindene maleate no clinical data on exposed pregnancies
are available.
Animal studies do not indicate direct or indirect harmful effects
with respect to pregnancy or the health of the foetus / new-born
child. Dimetindene maleate should not be used during pregnancy
unless the benefit to the mother outweighs the potentialrisk to
the foetus and only under the direction of a physician.
During pregnancy, dimetindene maleate should not be used on
extensive areas of the skin, especially if raw or inflamed.
Lactation
During lactation, dimetindene maleate should not be used on
extensive areas of the skin, especially if raw or inflamed.
Moreover, the product should not be applied to the nipples
during lactation.
Ability to perform tasks that require judgement, motor or
cognitive skill
Dimetindene maleate topical formulations have no influence on
the ability to drive or use machines.
Overdosage
Symptoms and Signs
Accidental swallowing of a considerable amount of topical
dimetindenemaleate might induce some symptoms characteristic
of overdosage with H1 antihistamines: CNS depression with
drowsiness (mainly in adults), CNS stimulation and antimuscarinic
effects (especially in children and elderly), including excitement,
ataxia, hallucinations, tonic-clonic spasms, mydriasis, dry mouth,
flushed face, urinary retention and fever. Hypotension may
also occur.
To report any side effect(s):
Kingdom of Saudi Arabia
-National Pharmacovigilance centre (NPC)
Fax: +966-11-205-7662
Reporting Hotline: 19999
E-mail: npc.drug@sfda.gov.sa
Website: https://ade.sfda.gov.sa
-Haleon Saudi Arabia - Head Office, Jeddah
Tel: +966-12-601-5444
Mobile: +966-53-553-3647
Email: mystory.sa@haleon.com
P.O. Box 48034, Jeddah 21572, Saudi Arabia
For any information about this medicinal product, please contact:
Haleon Saudi Arabia - Head Office, Jeddah
Tel: +966-12-601-5444
Email: mystory.sa@haleon.com
P.O. Box 48034, Jeddah 21572, Saudi Arabia
Keep out of the sight and reach of children.
Do not use this medicine after the ‘EXP’ date shown on the pack.
Store below 30°C.
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GSK Consumer Healthcare SARL, Nyon, Switzerland.
MAH: GSK Consumer Healthcare Schweiz AG, Switzerland.
يحتوي 1 جم من فنستيل جل على 1 مجم ماليات الديمتيندين كمادة فعالة. المواد الأضافية ذات التأثير المعروف: جليكول البربيلين, كلوريد البنزالكونيوم محلول 50%. المواد الأضافية الأخرى: إيديتات ثنائي الصوديوم، كربومير، هيدروكسيد الصوديوم، يستخدم في تخفيف الحكة المصاحبة للأمراض الجلدية ولدغات الحشرات وحروق الشمس والحروق السطحية. |
لا تستخدم في حالة: يُمنع استعماله في المرضى الذين يعانون من تفاعل فرط حساسية سابق تجاه ديميتيندين ماليات أو أي مكوِّن آخر من مكونات المستحضر. تحذيرات واحتياطات عند استخدام هذا المنتج قد تواجه: جفاف الجلد، حرقان الجلد، طفح جلدي مثير للحكة في حالة الحكة الشديدة أو الإصابات الواسعة النطاق، يجب استكمال الاستخدام الموضعي للديميتيندين ماليات عن طريق علاج شامل باستخدام الشكل الفموي من ديميتيندين ماليات. يجب تجنب التعرض المطول لأشعة الشمس في المناطق المعالجة بشكل مكثف. في الأطفال الرضع والأطفال الصغار، تجنب الاستخدام على مناطق كبيرة من الجلد، خاصة إذا كانت مكشوفة أو ملتهبة. يحتوي جل ديميتيندين ماليات على: • البروبيلين جليكول الذي قد يسبب تهيجًا خفيفًا موضعيًا للجلد. • كلوريد البنزالكونيوم المهيج والذي قد يسبب تفاعلات جلدية. لا تعطي المنتج للأطفال دون سن السنتين من العمربدون وصفة طبية. |
البالغين و الأطفال الأكبر من عامين: توضع طبقة رقيقة من دواء فنستيل ما بين 2 إلى 4 مرات في المناطق التي تخضع للعلاج، وتدلك بلطف. تجنب تعرض مناطق الجلد المعالجة بشكل مكثف لأشعة الشمس بصورة مطولة. استشر طبيبك إذا لم تتحسن الأعراض في غضون 7 ايام. في الأطفال الرضع والأطفال الصغار، لا تستخدمه على مناطق كبيرة من الجلد، خاصة إذا كانت مكشوفة أو ملتهبة. في الأطفال أقل من سنتين: لا يمكن استخدام فنستيل جل إلا بموجب وصفة |
تم إدراج التفاعلات السلبية حسب التصنيف العضوي الجهازي ومعدّل التكرار فيما يلي. يتم تحديد معدلات التكرار على النحو التالي: شائع جدا (≥10/1)، شائع (≥100/1 إلى <10/1)، غير شائع اضطرابات الجلد غير شائع: جفاف الجلد، حرقان. تجربة ما بعد التسويق اضطرابات الجلد: حالات نادرة جدا من التهاب الجلد التحسسي كانت التفاعلات لم يتم إجراء دراسات على التفاعل؛ ولكن نظراً إلى أن الامتصاص المجموعي لديميتيندين ماليات من الاستخدام الموضعي منخفض جداً، من غير المحتمل أن تحدث تفاعلات. الحمل والرضاعة الخصوبة لا توجد بيانات كافية عن استخدام ديميتيندين ماليات في النساء اللاتي لديهن احتمالية للإنجاب. لم يُلاحظ أي آثار على الخصوبة في الدراسات التي أجُريت على الحيوانات. يجب توخي الحذر عند وصف هذا الدواء للنساء اللاتي لديهن احتمالية للإنجاب. الحمل
للإبلاغ عن أي آثار جانبية: المملكة العربية السعودية - المركز الوطني للتيقظ والسلامة الدوائية (NPC) فاكس: 7662-205-11-966 + الاتصال بالرقم الموحد: 19999 البريد الإلكتروني: npc.drug@sfda.gov.sa الموقع الإلكتروني: https://ade.sfda.gov.sa - هاليون السعودية العربية – المكتب الرئيسي، جدة. هاتف: +966-12-601-5444 جوال: 3647-553-53-966+ البريد الإلكتروني: mystory.sa@haleon.com ص.ب. 48034، جدة 21572، المملكة العربية السعودية. للاستفسار عن أي معلومات عن هذا المستحضر الدوائي، يرجى الاتصال بالأرقام التالية: هاليون السعودية العربية – المكتب الرئيسي، جدة. هاتف: +966-12-601-5444 البريد الإلكتروني: mystory.sa@haleon.com ص.ب. 48034، جدة 21572، المملكة العربية السعودية. |
يُحفَظ بعيدًا عن رؤية ومُتناوَل الأطفال. لا تستخدم هذا الدَّواء بعد تاريخ انتهاء الصلاحية المدوَّن على العبوة. يُحفَظ في درجة حرارة أقل من 30 درجة مئوية. |
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Skin disorders with itching, for example insect bites, mild localised sunburn, small surface burns, and localise allergic dermatoses. |
Adults and children from 2 years of age Apply 2 to 4 times per day on the areas to be treated in a thin layer and massage lightly. Maximum duration of use: if there is no visible improvement after 7 days, seek medical advice. In children under 2 years of age, the product can only be used with a medical prescription. |
Do not use the product on children under 2 years of age without a medical prescription. Avoid applying over large areas or to open wounds, large areas of damaged skin or extensive injuries (such as burns), especially in infants and young children. Avoid prolonged exposure of the treated areas to the sun. Information about the excipients Fenistil Gel contains: Propylene glycol (E1520, 150 mg/g): Propylene glycol may cause skin irritation. Benzalkonium chloride (0.05 mg/g): Benzalkonium chloride may irritate the skin. Use during pregnancy and lactation has no harmful effects on the mother since absorption of benzalkonium chloride through the skin is minimal. Not indicated for application to mucous membranes. |
No study of interactions has been conducted. |
Pregnancy Experimental studies conducted with dimethindene on animals revealed no teratogenic potential or direct or indirect toxicity with an impact on pregnancy, embryonic development, the development of the fetus and/or postnatal development (see “Preclinical data").
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Fenistil has no influence or a negligible influence on the ability to drive and use machines. |
The most commonly reported adverse effects are transient and mild skin reactions in the area of administration. Adverse effects are listed below based on system organ class and frequency. The frequencies are indicated as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000). Skin and subcutaneous tissue disorders Uncommon: Skin dryness, burning sensation. Post-marketing experience Skin and subcutaneous tissue disorders Very rare cases of allergic dermatitis have been observed. The reporting of suspected adverse effects that occur after authorisation is extremely important. It enables the benefit-risk balance of the medicinal product to be evaluated continuously. To report any side effect(s): Kingdom of Saudi Arabia -National Pharmacovigilance centre (NPC) Fax: +966-11-205-7662 Reporting Hotline: 19999 E-mail: npc.drug@sfda.gov.sa Website: https://ade.sfda.gov.sa -Haleon Saudi Arabia - Head Office, Jeddah Tel: +966-12-601-5444 Mobile: +966-53-553-3647 Email: mystory.sa@haleon.com P.O. Box 48034, Jeddah 21572, Saudi Arabia For any information about this medicinal product, please contact: Haleon Saudi Arabia - Head Office, Jeddah Tel: +966-12-601-5444 Email: mystory.sa@haleon.com P.O. Box 48034, Jeddah 21572, Saudi Arabia |
Signs and symptoms Symptoms of intoxication resembling those observed following overdose of H1 antihistamines may appear in case of involuntary oral absorption of a large quantity of topical dimethindene maleate. The symptoms are as follows: CNS depression with dizziness (especially in adults), CNS stimulation and an antimuscarinic effect (especially in children and elderly patients) with agitation, ataxia, hallucinations, tonic-clonic seizures, mydriasis, dry mouth, facial redness, urinary retention and fever. Hypotension may also occur. Treatment Treatment should be based on the clinical symptoms or on the Tox Info Suisse guidelines. |
Properties/Effects ATC code D04AA13 Mechanism of action. Dimethindene is an H1 histamine receptor agonist. It has a strong affinity for H1 receptors and reduces capillary hyperpermeability associated with an immediate hypersensitivity reaction. When applied topically, dimethindene maleate has a local anaesthetic effect. Fenistil Gel is effective against pruritus of various origins and quickly soothes itching and irritation. The gel base facilities penetration of the active substance through the skin. Pharmacodynamics No additional data. Clinical efficacy No additional data. |
Absorption Fenistil Gel rapidly penetrates the skin and its antihistaminic effect occurs within a few minutes. Maximum efficacy is reached after 1 to 4 hours. Distribution After topical application, the systemic bioavailability of dimethindene maleate in healthy volunteers is approximately 10% of the dose applied. Metabolism No additional data. Elimination No additional data. |
Preclinical safety pharmacology, repeat-dose toxicity and genotoxicity studies conducted with dimethindene did not indicate a special risk for use in humans. No teratogenic effect was discovered in rats and rabbits. No effect on fertility or peri- and postnatal development of progeny was observed in rats after oral administration of 15 mg/kg and 25 mg/kg. |
Propylene glycol 150 mg/g (E 1520), sodium edetate, sodium hydroxide, carbomers, benzalkonium chloride 0.05 mg/g, purified water. |
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Specific remarks for storage
Store at room temperature (15-25°C).
Keep out of the reach of children.
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