- Prophallerge Tablets: Each tablet contains: Ketotifen (as fumarate) 1 mg.
- Prophallerge Syrup: Each teaspoon (5 ml) of syrup contains: Ketotifen (as fumarate) 1 mg.
What Is The Medicine Intended For?
- As a prophylactic treatment of bronchial asthma.
- For symptomatic treatment of allergic conditions such as: bronchitis, rhinitis, hay fever, and skin rash (urticaria).
Therapeutic group: Other antihistamines for systemic treatment.
How Should You Use The Medicine?
The usual dosage is generally:
- Dosage for adults and children over 3 years of age: 1 tablet twice a day or 1 teaspoon of syrup (5 ml 1 mg ketotifen) twice a day.
- Dosage for children from 6 months to 3 years of age: ½ teaspoon of syrup (2.5 ml = 0.5 mg ketotifen) twice a day.
Always use according to the doctor’s instructions. Check with the doctor or pharmacist if you are uncertain. The dosage and treatment regimen will be determined by the doctor only.
- Do not exceed the recommended dose. Take the medicine with a meal.
- Tablets: Do not chew; can be halved or crushed. Swallow the medicine with a little water.
- Syrup: Be sure to measure the dose in the provided measuring cup.
- If you took an overdose or if a child has accidentally swallowed the medicine, immediately refer to a doctor or proceed to a hospital emergency room, and bring the package of the medicine with you.
- If you forgot to take this medicine at the required time, do not take a double dose. Take the next dose when you remember, unless it is almost time to take the next dose. If it is almost time to take the next dose, take the next dose as usual and skip the forgotten dose.
- Adhere to the treatment regimen recommended by the doctor. Even if there is an improvement in your health, do not stop treatment with the medicine without consulting the doctor.
As with any medicine, use of Prophallerge may cause side effects in some users. Do not be alarmed when reading the list of side effects. You may not suffer from any of them. Discontinue use and refer to a doctor immediately if:
- you notice any of the following rare symptoms: A severe skin reaction, which includes blistering or peeling of the skin. These may be symptoms of an allergic reaction.
- you have an epileptic seizure.
Additional Side Effects
- Up to 1 in 10 people have experienced: Hyperactivity, agitation or irritability or sleep disturbances.
- Up to 1 in 100 people have experienced: Cystitis (burning or pain when passing urine), dizziness or dry mouth. Up to 1 in 1,000 people have experienced: Weight gain, drowsiness.
- Very rare side effects that occur in less than one in 10,000 users: Severe skin reactions including rashes, blistering or peeling of the skin; convulsions; liver problems, including jaundice or an increase in liver enzymes (will only be seen in a blood test).
Effects of drowsiness, dry mouth and dizziness usually pass a few days after starting treatment. If a side effect occurs, if one of the side effects worsens or if you suffer from a side effect not mentioned in this leaflet, consult with the doctor.
Do not use the medicine if:
Special Warnings Regarding Use Of Prophallerge
Since this medicine is intended for asthma prophylaxis, it is not effective in cases of acute asthma attacks. In such cases, use other preparations.
When you start treatment with Prophallerge, do not stop taking anti-asthma preparations you are currently using (especially preparations containing corticosteroids) without the doctor’s permission.
Before treatment with Prophallerge, tell the doctor if:
- You are pregnant, planning to become pregnant or are breastfeeding.
- You are suffering from epilepsy.
- You are suffering from a hereditary intolerance to certain sugars.
If you are taking, or have recently taken, other medicines, including non-prescription medicines and nutritional supplements, tell the doctor or pharmacist. It is especially important to tell the doctor or pharmacist if you are taking:
- Oral anti-diabetic medicines.
- Medicines to treat insomnia or sedatives.
- Antihistamines to treat allergic reactions such as itching, rash or rhinitis.
Use Of The Medicine And Food
Take the medicine with a meal.
Use Of The Medicine And Alcohol Consumption
Prophallerge may increase the effects of alcohol. Do not consume alcohol while using the medicine.
Pregnancy And Breastfeeding
If you are pregnant or planning to become pregnant, consult the doctor before using Prophallerge. Inform the doctor immediately if you become pregnant during the course of treatment with the medicine.
The medicine is excreted in breast milk; therefore, do not breastfeed while using the medicine.
Driving And Use Of Machinery
During the first few days of treatment, you may feel that your reactions are slower than usual. Some people may feel drowsy or dizzy. If you experience any effects, do not drive or perform any activity which requires alertness (e.g., operating tools or machines) until the effects pass. Children should be cautioned against riding a bicycle or playing near the road, and the like.
How Should The Medicine Be Stored?
- Avoid poisoning! This medicine and any other medicine must be kept in a safe place out of the reach of children and/or infants to avoid poisoning. Do not induce vomiting unless explicitly instructed to do so by the doctor.
- Do not use the medicine after the expiry date (exp. date) that appears on the package. The expiry date refers to the last day of that month.
- Storage conditions: Store in the original package, in a cool place, below 25°C.
- Prophallerge Syrup: After first opening, can be used for the duration of two months.
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