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Anti-allergic & Antihistaminic drugs

INN: Ketotifen

Код АТХ: D04AA 0; R06AX 17


One tablet contains 1.38 mg ketotifen hydrogen fumarate, equivalent to 1 mg ketotifen. 5 ml syrup contains 138 mg ketotifen hydrogen fumarate, equivalent to 1 mg ketotifen. 1 g gel contains 10 mg ketotifen hydrogen fumarate.


For prophylactic of all forms of bronchial asthma, allergic bronchitis and asthmatic symptoms in hay fever. Prophylactic and treatment of other allergic diseases: acute and chronic urticaria, atopic dermatitis, allergic rhinitis and conjunctivitis.

Dosage and administration:

Tablets: adults – 1 tablet twice daily during meals. In insufficient therapeutic effect after a treatment course of 4 weeks, the dose can be increased to 2 tablets twice daily. Children up to 35 kg body mass - Ѕ tablet twice daily during meals, above 35 kg - 1 tablet twice daily. The therapy duration is prescribed by the doctor. Syrup: adults – 5 ml syrup peroral by a measuring cup twice daily, usually in the morning and evening during meals. In insufficient therapeutic effect after a treatment course of 4 weeks, the dose can be increased to 10 ml syrup twice daily.

Children above 3 years – 0.125 ml syrup per kg body mass twice daily; 12-18 kg – 2 ml; 19-25 kg – 3 ml; 26-35 kg – 4 ml; above 35 kg – 5 ml. Normally, well manifested therapeutic effect is reached after 10-weeks period of treatment. Gel: it is applied locally, 2-3 times daily on the affected area. When allergen is known and there will be a contact with it, gel may be applied prophylactically.


Hypersensitivity to the product; pregnancy, lactation. Ketotifen gel is applied in impetigo and exudative eczema. To be applied with caution to motor vehicle drivers.

Drug interactions:

Concomitant treatment with oral antidiabetics enhances a risk of reversible thrombocytopenia. It is possible to potentiate the effect of sedatives, hypnotics, antihistamines and alcohol (tablets and syrup). Ketotifen gel can be applied alone or in a combination with peroral forms of the product – tablets and syrup.

Adverse reactions:

In the beginning of the treatment may appear xerostomia, drowsiness, light vertigo, fatigue, which disappear spontaneously within several days. Sometimes body mass gain is noticed due to increased appetite. Rarely: abdominal pains, nausea or vomiting; excitation, irritation, insomnia and anxiety, especially in children; cystitis, dark urine; elevation of hepatic enzymes; skin reactions - itching, erythema and skin desquamation, rashes; muscular spasms of extremities. Rarely hypersensitivity to the active substance and photosensibilization effect.


30 tablets (1 mg)

Vial of 100 or 125 ml syrup

Tube of 40 g gel (1%)


On doctor’s prescription.

Serving from:
Las Vegas, NV 89135
Sofia, Bulgaria 1125

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