Ketotifen tablets 1 mg 30 pcs.

• active ingredient: ketotifen hydrofumarate;
• 1 tablet contains 1.38 mg of ketotifen hydrofumarate, which is equivalent to 1 mg of ketotifen;
• excipients: calcium hydrogen phosphate anhydrous, microcrystalline cellulose, wheat starch, magnesium stearate.

Hypersensitivity to the active substance or to any of the excipients of the drug.

Avoid concomitant use of ketotifen and oral antidiabetic agents (risk of reversible thrombocytopenia) until this phenomenon is sufficiently studied.

• Infections and infestations: uncommon – cystitis.
• On the part of the immune system: very rarely – severe skin reactions, erythema multiforme, Stevens-Johnson syndrome; with an unknown frequency – skin rashes.
• Metabolism and nutrition disorders: rarely – weight gain due to increased appetite.
• Mental disorders: often – psychomotor agitation, irritability, insomnia, restlessness, nervousness; with an unknown frequency – disorientation, drowsiness.
• From the nervous system: infrequently – dizziness; rarely – sedative effect; very rarely – convulsions.
• On the part of the gastrointestinal tract: infrequently – dry mouth; with an unknown frequency – stomach pain, constipation, nausea, vomiting, dyspeptic disorders.

Take the tablets orally during meals, with water.

Adults: 1 tablet (1 mg) 2 times a day, morning and evening with meals. For patients who experience significant sedation, a slow dose increase is recommended during the first week, starting with 0.5 mg 2 times a day, and gradually increasing it until the therapeutic dose is reached. If necessary, the daily dose can be increased to 4 mg (4 tablets) of 2 tablets 2 times a day. When using a higher dose, a faster onset of therapeutic effect can be expected.

Children from 6 months to 3 years of age: use ketotifen in a different dosage form (syrup).

Children over 3 years of age: 1 tablet (1 mg) 2 times a day, morning and evening, during meals.

Use during pregnancy or breastfeeding

During pregnancy, ketotifen is contraindicated for use in the first trimester of pregnancy. In the second and third trimesters of pregnancy, it should be prescribed only after a strict assessment of the presence of direct indications, in cases where the expected benefit of treatment outweighs the potential risk to the fetus.

Ketotifen passes into breast milk, so women should stop breastfeeding if the drug is necessary.

Children

Use for children aged 3 years and over.

Clinical observations support the pharmacokinetic properties and indicate that children may require a higher mg/kg dose than adults to achieve optimal results. Higher doses are as well tolerated as lower doses.

Ability to influence reaction speed when driving vehicles or other mechanisms

At the beginning of treatment, Ketotifen Sopharma may slow down the speed of reactions, which requires the patient to be especially careful when driving vehicles and working with automated mechanisms.

Symptoms: significant impairment of psychomotor reactions, drowsiness to severe sedation, confusion, headache, disorientation, tachycardia, decreased blood pressure, in children – hyperexcitability or convulsions, reversible coma. Bradycardia, arrhythmia, depression of the respiratory center, nystagmus are also observed.

In case of the above symptoms, the patient should be carefully examined.

Treatment: general measures to remove unabsorbed drug from the digestive tract: induce vomiting, wash the stomach. The use of activated charcoal may have a beneficial effect. If necessary, symptomatic treatment and monitoring of the cardiovascular and respiratory systems are recommended. In cases of agitation, short-acting barbiturates or benzodiazepines can be used.

There is a risk of reversible thrombocytopenia when ketotifen is used concomitantly with oral antidiabetic agents. In such patients, monitoring of platelet counts is recommended.

The simultaneous use of atropine, agents with atropine-like action and ketotifen increases the risk of adverse reactions such as urinary retention, constipation, and dry mouth.

Ketotifen may potentiate the effects of other drugs that depress the central nervous system (sedatives, hypnotics).

Concomitant use of ketotifen with other antihistamines may lead to mutual potentiation of their effects.

During treatment with ketotifen, alcohol consumption should be avoided, as ethanol enhances the depressant effect of ketotifen on the central nervous system.

Keep out of reach of children.

Store in the original packaging at a temperature not exceeding 25 °C.