Ketotifen Sopharma hydrogenfumarate 20 mg / ml 125ml syrup
Description:
KETOTIFEN SYRUP 125 ML. SOPHARMA
1. WHAT IS Ketotifen Sopharma hydrogenfumarate 20 mg / ml 125ml syrup?
Ketotifen Sopharma belongs to the group of anti-allergic medicines called antihistamines. It suppresses the release of histamine and other substances that are formed in the body during allergies. It is used as an additional agent in the long-term treatment of poorly expressed atopic (allergic) bronchial asthma; symptomatic treatment of allergic conditions, incl. allergic rhinitis (inflammation of the nasal mucosa) and conjunctivitis (inflammation of the ocular envelope).
Ketotifen Sopharma has no effect on asthma attacks.
2. BEFORE YOU TAKE Ketotifen Sopharma hydrogenfumarate 20 mg / ml 125ml syrup
Do not take Ketotifen Sopharma
if you are allergic (hypersensitive) to the active substance or any of the other ingredients of syrup
during pregnancy (first three months) and lactation.
Take special care with Ketotifen Sopharma hydrogenfumarate 20 mg / ml 125ml syrup
Do not use Ketotifen Sopharma for the treatment of acute bronchial asthma! If you are taking corticosteroids and start taking Ketotifen Sopharma syrup, do not stop taking corticosteroids abruptly. It should be discontinued with gradual dose reduction and only after consultation with a physician.
If an infection occurs during treatment with syrup, it should be treated with specific anti-infectives.
Ketotifen Sopharma syrup should be used with caution in patients with convulsions.
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 oral antidiabetic agents may result in a reversible reduction in platelet count (thrombocytopenia). It is also possible to enhance the effect of sedating, sleeping and other anti-allergic (antihistamine) agents, atropine and alcohol, and such combinations should be avoided.
Taking Ketotifen Sopharma hydrogenfumarate 20 mg / ml 125ml syrup with food and drink
With concomitant use with alcohol, the suppressing effect of Ketotifen Sopharma on the central nervous system may be increased.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Ketotifen Sopharma syrup does not apply during the first three months of a noseth. In the remaining months it should only be used after consultation with a doctor. Due to its passage into breast milk, breast-feeding during treatment with the drug should be discontinued.
Driving and using machines
Due to the possible occurrence of drowsiness and delayed reactions, especially at the beginning of treatment, Ketotifen Sopharma syrup should be used with caution by vehicle drivers and machine operators.
Important information about some of the ingredients of Ketotifen Sopharma
Syringes contain ingredients that in some cases may pose a certain risk to the patient:
Methyl- and propyl parahydroxybenzoate may cause allergic reactions (they may be delayed).
Sorbitol. 10 g of syrup contains 3.5 g of sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Ethanol. This medicinal product contains 2.46% by volume of ethanol (alcohol), ie. to 100 mg per dose corresponding to 2.46 ml of beer or 1.025 ml of wine. It is harmful to people suffering from alcoholism. It should be considered in pregnant, breast-feeding, children and at risk groups such as patients with liver disease or epilepsy.
3. HOW TO TAKE Ketotifen Sopharma hydrogenfumarate 20 mg / ml 125ml syrup?
Always take Ketotifen Sopharma syrup exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Syrup is taken orally during meals.
Adults and children over 3 years: 5 ml syrup (1 mg) twice a day, morning and evening. If you are sensitive to the sedative effect of the medicine, talk to your doctor if it is possible at first to reduce your prescribed dose.
If necessary, the daily dose may be increased to 4 mg – 10 ml syrup twice a day.
The duration of treatment should not be less than 2-3 months.
Discontinuation of treatment should not take place abruptly, but gradually, within 2-4 weeks. If you take more Ketotifen Sopharma than you should If you have taken a dose greater than prescribed, contact your doctor immediately. You may need medical attention. Within the first few hours vomiting should be induced.
If you forget to take Ketotifen Sopharma
If you miss a dose, take it as soon as possible. If it’s almost time for the next dose, take it as usual by skipping the dose you have forgotten. Do not take a double dose to make up for forgotten. Continue to take the medicine as instructed by your doctor.
If you stop using Ketotifen Sopharma
Do not stop or stop taking Ketotifen Sopharma syrup before discussing it with your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS Ketotifen Sopharma hydrogenfumarate 20 mg / ml 125ml syrup
Like all medicines, Ketotifen Sopharma syrup can cause side effects, although not everyone gets them.
Some very rare side effects may be serious: The probability of occurrence is less than I and 10,000 users.
– If you have skin rashes, reddening of the skin, cracking of the lips, blistering of the skin, eyes, mouth and genitals, accompanied by fever, chills, headaches, coughing and pains on the body;
– If you have yellowing of the skin or eyes, discoloration of the stools, darkening of the urine (signs of jaundice, hepatitis).
Very rare cases of seizures have been reported during treatment with ketotifen. If any of these symptoms occur, tell your doctor immediately.
Other side effects:
Common (affects 1 to 10 users in 100): agitation, irritability, insomnia, anxiety.
Uncommon (affects 1 to 10 users in 1,000): dizziness, burning sensation when urinating, frequent urination (cystitis), dry mouth.
Rare (affects 1 to 10 users in 10,000): Drowsiness, weight gain.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Ketotifen Sopharma hydrogenfumarate 20 mg / ml 125ml syrup?
Store in the original package, at temperatures below 25 ° C. The syrup can be used up to 1 month after opening the bottle. Keep out of the reach and sight of children.
Do not use Ketotifen Sopharma after the expiry date which is stated on the pack. 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 your unnecessary medicines. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION Ketotifen Sopharma hydrogenfumarate 20 mg / ml 125ml syrup
What is Ketotifen Sopharma?
The active substance is: ketotifen hydrogenfumarate, eq. of 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 essence, purified water.
What does Ketotifen Sopharma look like and what does it contain?
Clear, viscous, colorless to pale yellow liquid with specific strawberry flavor. 125 ml syrup in a dark glass bottle with an aluminum or polyethylene cap or in a dark polyethylene terephthalate bottle with a polyethylene cap together with a measuring cup and a cardboard box.
Marketing Authorization Holder and Manufacturer:
Sopharma LTD
16, Iliensko shose Str. 1220 Sofia, Bulgaria
