Ketotifen 125 ml.

WHAT Ketotifen?

Ketotifen Sopharma belongs to the group of anti-allergic drugs called antihistamines. It inhibits the release of histamine and other substances, which are formed in the body for allergies. Used as an additional tool for long-term treatment of slightly outlined atopic (allergic) asthma; symptomatic treatment of allergic conditions, including. allergic rhinitis (inflammation of the nasal mucosa) and conjunctivitis (inflammation of the eye covering).

Ketotifen Sopharma no effect in asthma attacks.

2. BEFORE YOU TAKE ketotifen SOPHARMA

Do not take ketotifen Sopharma

if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of the syrup
in pregnancy (first trimester) and lactation.

Take special care with Ketotifen Sopharma

Do not use Ketotifen Sopharma for treatment of acute attack of bronchial asthma! If you are taking korgikosteroidi and start taking Ketotifen Sopharma syrup, do not stop suddenly treatment with corticosteroids. It should be discontinued with a gradual reduction of doses and only after consulting a doctor.

If during treatment with the syrup, an infection, it must be treated with specific anti-infective drugs.

Sopharma Ketotifen syrup should be used with caution in patients with a history of seizures.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Concomitant use of ketotifen Sopharma syrup with antidiabetic agents that are taken orally, can lead to reversible reduction in the number of blood platelets (thrombocytopenia). It is also possible strengthening effect of calming (sedative), sleeping pills and other allergy (antihistamine) agents atropine and alcohol, which is why such combinations should be avoided.

Taking ketotifen Sopharma with food and drink

With concomitant use with alcohol may increase depressant effect of ketotifen Sopharma on the central nervous system.

Pregnancy and lactation

Ask your doctor or pharmacist before taking any medicine. Sopharma ketotifen syrup does not apply in the first three months of pregnancy. In the remaining months should be used only after consulting a doctor. Due to its passage into breast milk breastfeeding during treatment with the drug should be discontinued.

Driving and using machines

Due to possible drowsiness and slow reactions, especially early in treatment, Sopharma Ketotifen syrup should be used with caution by drivers and machine operators.

Important information about some of the ingredients of Ketotifen Sopharma

The composition of the syrup include excipients, which in some cases may pose some risk to the patient:

Methyl and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).

Sorbitol. In 10 ml of syrup contains 3,5 g of sorbitol. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product. Ethanol. This medicinal product contains 2.46 vol.% Ethanol (alcohol), ie to 100 mg per dose, corresponding to 2,46 ml 1,025 ml of beer or wine. Harmful for those suffering from alcoholism. It should be taken into account in pregnant or breastfeeding women, children and high-risk groups such as patients with liver disease or epilepsy.

3. HOW TO TAKE ketotifen SOPHARMA?

Always take ketotifen syrup Sopharma exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist. The syrup is taken orally during the meal.

Vazrastnn and children over 3 years: 5 ml syrup (1 mg) two times a day, morning and evening. If you are sensitive to the soothing effect of the drug, consult your doctor whether it is possible to start to reduce the prescribed dose.

If necessary, the daily dose may be increased to 4 mg - 10 ml of syrup 2 times per day.

The duration of treatment should not be less than 2-3 months.

Discontinuation of treatment should not be done abruptly but gradually, within 2-4 weeks.

If you take more than the amount of ketotifen Sopharma

If you take a dose larger than prescribed, immediately contact your doctor. You may need medical attention. Within the first few hours should induce vomiting.
If you forget to take Ketotifen Sopharma

If you miss a dose, take it as soon as possible. If it is almost was time for your next dose, take it as usual, as skip the dose you forgot. Do not take a double dose to make up for the forgotten. Continue to take the medicine as prescribed by your doctor.

If you stop using Ketotifen Sopharma

Do not interrupt or suspend treatment with ketotifen Sopharma syrup before you have discussed this with your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Sopharma Ketotifen syrup can cause side effects, although not everybody gets them.

Some very rare side effects can be serious: likely to occur is less than I and 10,000 users.

- If you have a skin rash, redness of the skin, chapped lips, blistering of the skin, eyes, mouth and genitals, accompanied by fever, chills, headache, cough and body aches;
- If you have yellowing of the skin or eyes, light-colored stools, dark urine (signs of jaundice, hepatitis).

In very rare cases during treatment with ketotifen have reported seizures. If any of these symptoms, tell your doctor immediately.

Other side effects:

Common (affects I to 10 users in 100): agitation, irritability, insomnia, anxiety.

Uncommon (affects I-10 of 1000 users): dizziness, burning sensation during urination, frequent urination (cystitis), dry mouth.

Rare (affects 1 to 10 10 000 users): sleepiness, weight gain.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE ketotifen SOPHARMA?

Store in the original container at a temperature below 25 ° C. The syrup can be used within 1 month of opening the bottle. Keep out of reach of children.

Do not use Ketotifen Sopharma after the expiry date stated on the packaging. The expiry date refers to the last day of that month.

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.

6. FURTHER INFORMATION

What Ketotifen Sopharma?

The active substance is ketotifen hydrogen, eq. 0,2 mg of ketotifen in 1 ml of syrup.

The other ingredients are: sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, disodium phosphate dodecahydrate, ethanol, saccharin sodium, strawberry flavor, purified water.

Looks Ketotifen Sopharma and contents of the pack?

Clear, viscous, colorless to pale yellow liquid with a characteristic smell of strawberry. Syrup 125 ml in a dark glass bottle with aluminum or polyethylene cap or dark polyethylene terephthalate, polyethylene cap with measuring cup and leaflet in a carton.