Properties
What is it?
What is Ketotifen Sopharma and what is it used for? Ketotifen Sopharma belongs to a group of anti-allergy medications called antihistamines. It blocks the release of histamine and other substances that are produced in the body during allergies. It is used as an adjunct in the long-term treatment of mild atopic (allergic) bronchial asthma; for symptomatic treatment of allergic conditions, including allergic rhinitis (inflammation of the nasal mucous membrane) and conjunctivitis (inflammation of the conjunctiva of the eye). Ketotifen Sopharma is ineffective for asthma attacks. For more information, see the blog: What is Ketotifen used for? — Important information before taking the medication. Before using Ketotifen Sopharma. Do not take Ketotifen Sopharma: - if you are allergic (hypersensitive) to the active substance or any of the excipients of the preparation; - during the first three months of pregnancy or during lactation; Use Ketotifen Sopharma with caution: - if Ketotifen Sopharma is used to treat an acute asthma attack. - if you are undergoing treatment with corticosteroids and start taking ketotifen, you should not stop corticosteroid treatment suddenly. Treatment should be discontinued gradually, only after consulting a doctor. - if an infection is detected during Ketotifen Sopharma treatment, it requires treatment with specific anti-infective therapy. - Ketotifen Sopharma should be used with caution by patients who have experienced seizures. Taking other medicines. Please tell your doctor or pharmacist if you are taking or have recently taken any medicines, including those obtained without a prescription. Taking Ketotifen Sopharma with oral antidiabetic agents may cause a reversible decrease in platelet count (thrombocytopenia). It may enhance the sedative, hypnotic, and other anti-allergic (antihistamine) effects of atropine and ethyl alcohol, so such combinations should be avoided. Ketotifen Sopharma should not be taken with food and drinks. Alcohol use. Alcohol should not be consumed during Ketotifen Sopharma treatment due to its central nervous system depressant effects. Pregnancy and lactation. Consult your doctor or pharmacist before taking any medicine. Ketotifen should not be taken during the first three months of pregnancy. In the following months, the preparation should be taken only after consulting a doctor. The preparation passes into breast milk, so its use should be discontinued during lactation. Driving and operating machinery. Due to the possibility of drowsiness and slowed reactions, especially at the beginning of treatment, caution should be exercised when driving vehicles and operating machinery while taking Ketotifen Sopharma syrup. Important information about the components of Ketotifen Sopharma. The syrup contains excipients that may be hazardous to the patient in some cases: Methyl and propyl parahydroxybenzoates may cause allergic reactions (possibly delayed). Sorbitol: 10 ml of syrup contains 3.5 g of sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult him before using this preparation. Ethanol. This preparation contains 2.46% v/v ethanol (alcohol), which is up to 100 mg per dose, equivalent to 2.46 ml of beer or 1.025 ml of wine. It is harmful to people with alcoholism. This fact should be taken into account when used by pregnant patients, during lactation, in children, and in high-risk patients, such as patients with liver disease or epilepsy. How to use Ketotifen Sopharma. Always take Ketotifen Sopharma syrup exactly as prescribed by your doctor. If you are unsure about anything, ask your doctor or pharmacist. Ketotifen Sopharma syrup is taken orally during meals. Adults: 5 ml of syrup (1 mg) twice a day, morning and evening. If you are sensitive to the sedative effect of the preparation, consult your doctor, the dose may be reduced at the beginning of treatment. If necessary, the daily dose can be increased up to 4 mg - 10 ml of syrup twice a day. Children over 3 years of age: 1 mg (5 ml syrup) twice a day. Children from 6 months to 3 years of age: 0.5 mg (2.5 ml) twice a day, morning and evening. The duration of treatment should not exceed 2-3 months. Treatment should not be stopped abruptly; treatment should be discontinued gradually over 2-4 weeks. If you take more Ketotifen Sopharma syrup than you should. If you take an overdose, seek medical attention immediately. Medical assistance may be required. Vomiting should be induced within the first few hours. If you miss a dose of Ketotifen Sopharma syrup. If you miss a recommended dose, take it as soon as you remember. However, if it is already time for the next dose, take the next dose as usual. Do not take a double dose to compensate for a missed dose. Continue treatment as prescribed by your doctor. If you want to stop taking Ketotifen Sopharma syrup. Do not stop treatment without your doctor's recommendation. If you have any further questions, ask your doctor or pharmacist. Possible side effects. Like all medicines, Ketotifen Sopharma syrup can cause side effects, but not everyone gets them. Some very rare side effects can be serious: their probability is less than 1 in 10,000 users: - Skin rash, redness of the skin, cracking of the lips, formation of blisters on the skin, eyes, mouth and genitals, accompanied by high temperature, fever, headache, cough and pain throughout the body. - Yellowing of the skin or eyes, pale stools, dark urine (signs of jaundice, hepatitis). Seizures have been reported in very rare cases during treatment. Inform your doctor promptly about any complaints. Other side effects: Frequent (occurs in 1 to 10 out of 100 patients): excitability, irritability, insomnia, anxiety. Uncommon (occurs in 1 to 10 out of 1000 patients): dizziness, burning sensation during urination, frequent urination (cystitis), dry mouth. Rare (occurs in 1 to 10 out of 10,000 patients): drowsiness, increased appetite. If any side effect becomes serious, or if you notice any reaction not listed in the leaflet, consult your doctor or pharmacist. Storage conditions for Ketotifen Sopharma. Store in the original packaging, at a temperature not exceeding 25°C. Shelf life after opening the bottle: 1 (one) month. Keep out of reach of children. Do not use Ketotifen Sopharma after the expiry date indicated on the packaging. The expiry date applies to the last day of the specified month. The preparation should not be disposed of in drains or household waste. Please ask your pharmacist about its disposal. These measures will help protect the environment. Additional information. What Ketotifen Sopharma contains. Active substance: Ketotifen hydrogen fumarate, equivalent to 1 mg of ketotifen in 5 ml of syrup. Excipients: Sorbitol (E420), Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Citric acid monohydrate, Disodium phosphate dodecahydrate, Ethanol, Saccharin sodium, Liquid "strawberry" essence, Purified water. Appearance and contents of Ketotifen Sopharma syrup packaging. A clear, viscous, colorless to pale yellow liquid with a specific strawberry aroma. Primary packaging - 125 mg syrup in a polyethylene terephthalate bottle with a polyethylene cap. Secondary packaging - 1 (one) bottle in a cardboard box with a measuring cup and leaflet. Dispensing category: Pharmaceutical product group II (for use on prescription)
