Ketotifen Vzf

Package Leaflet: Information for the Patient

KETOTIFEN WZF, 1 mg, tablets

Ketotifen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Ketotifen WZF and what is it used for
• 2. Important information before taking Ketotifen WZF
• 3. How to take Ketotifen WZF
• 4. Possible side effects
• 5. How to store Ketotifen WZF
• 6. Contents of the pack and other information

1. What is Ketotifen WZF and what is it used for

Ketotifen WZF is an antiallergic medicine containing ketotifen, used in adults and children over 3 years old:

• to prevent asthma attacks in patients with bronchial asthma;
• to treat nasal and eye symptoms associated with allergic rhinitis and allergic conjunctivitis (such as a stuffy nose, excessive watery discharge from the nose, itching of the nose, frequent sneezing, redness of the eyes, tearing, itching of the eyes).

2. Important information before taking Ketotifen WZF

When not to take Ketotifen WZF:

• If you are allergic to ketotifen or any of the other ingredients of this medicine (listed in section 6).
• If you have epilepsy.
• If you are taking oral antidiabetic medicines.
• If you are breastfeeding.

Warnings and precautions

Before starting treatment with Ketotifen WZF, discuss it with your doctor or pharmacist.

Note: Ketotifen WZF is not effective in treating acute allergic reactions and in interrupting asthma attacks.

• If you have epilepsy or have had seizures, you should consult your doctor before taking the medicine.
• If allergy tests are planned, you should stop taking the medicine 10-14 days before they are performed.
• In the initial period of treatment with ketotifen, you should not suddenly stop taking previously used anti-asthmatic medicines, especially corticosteroids, as adrenal insufficiency may occur. Therefore, it is recommended to gradually discontinue corticosteroids over a longer period while taking ketotifen.
• If you are taking antidiabetic medicines, you should inform your doctor. In patients taking Ketotifen WZF together with oral antidiabetic medicines, transient decreases in platelet count have been observed in rare cases, so you should not take antidiabetic medicines and Ketotifen WZF at the same time (see section "When not to take Ketotifen WZF").

Ketotifen WZF may enhance the effect of alcohol. Therefore, you should not drink alcohol while taking Ketotifen WZF.
In case of slowed reaction in the patient, probably due to the sedative effect of the medicine, you should consult your doctor, who will reduce the dose.

Ketotifen WZF and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take. It is especially important to inform your doctor about taking:

• other medicines used to treat asthma, including bronchodilators;
• sedatives, sleeping pills or other medicines that cause drowsiness;
• strong painkillers;
• oral antidiabetic medicines (see section "When not to take Ketotifen WZF");
• antihistamines (e.g. some medicines used to treat allergies, colds and flu);
• anticoagulants.

Taking Ketotifen WZF with food and drink

The medicine should be taken during meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will decide whether you can take Ketotifen WZF during pregnancy.
Do not breastfeed while taking Ketotifen WZF.

Driving and using machines

During the first few days of treatment, the medicine may impair your ability to drive and use machines, so you should not drive or operate machines until you know how the medicine affects you.

3. How to take Ketotifen WZF

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Ketotifen WZF is taken orally.
Ketotifen WZF should be taken regularly – the full effect of the medicine occurs after several weeks of treatment.
Usual doses of the medicine are given below.
Children over 3 years old:
1 tablet (1 mg) twice a day, every 12 hours, in the morning and evening, during meals.
It is recommended to use ketotifen in the form of syrup for children.
Adults:
1 tablet (1 mg) twice a day, every 12 hours, in the morning and evening, during meals.
In patients sensitive to the sedative effect of ketotifen, the doctor may recommend gradual increase of the dose over the first week of treatment, starting with half a tablet (0.5 mg ketotifen) twice a day, and then increasing the dose to the full therapeutic dose. If necessary, the doctor may recommend increasing the daily dose to 4 mg, i.e. 2 mg ketotifen twice a day. In elderly patients, there is no need to modify the dosage.
If you feel that the effect of Ketotifen WZF is too strong or too weak, ask your doctor.

Duration of treatment

The duration of treatment is determined by your doctor.

Taking a higher dose of Ketotifen WZF than recommended

The main symptoms of overdose are: drowsiness to excessive sedation; dizziness, confusion and disorientation; rapid heart rate and hypotension; hyperactivity or seizures (especially in children); transient coma.
If you have taken more than the recommended dose of the medicine, seek medical attention immediately. Within the first few hours after taking an overdose of the medicine, vomiting should be induced in the patient.

Missing a dose of Ketotifen WZF

If you miss a dose of Ketotifen WZF, take the missed dose as soon as possible. Do not take the medicine if there are less than 4 hours left before the next dose. In this case, take the next dose at the usual time.
Do not take a double dose of the medicine to make up for the missed dose.

Stopping treatment with Ketotifen WZF

If you need to stop treatment with Ketotifen WZF, consult your doctor.
The medicine should be discontinued gradually over a period of 2 to 4 weeks due to the possibility of asthma symptoms returning.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ketotifen WZF can cause side effects, although not everybody gets them.
The following side effects are listed with their frequency:

• -rash, redness of the skin, formation of blistering lesions (mainly on the lips, eyelids and in the mouth), accompanied by fever, chills, headache, cough and body aches (Stevens-Johnson syndrome),
• jaundice, dark urine (symptoms of liver dysfunction, hepatitis).

If you experience any of these symptoms, tell your doctor immediately.
Common (occurring in less than 1 in 10 people):

• -psychomotor agitation;
• irritability;
• insomnia;
• nervousness. These symptoms are especially observed in children.

Uncommon (occurring in less than 1 in 100 people):

• cystitis (feeling of burning or pain while urinating, frequent urination);
• dizziness;
• dryness of the mucous membranes of the mouth.

Rare (occurring in less than 1 in 1,000 people):

• weight gain;
• -sedation.

Very rare (occurring in less than 1 in 10,000 people):

• erythema multiforme;
• Stevens-Johnson syndrome - see information provided at the beginning of section 4 of the leaflet;
• severe skin reactions;
• seizures;
• hepatitis;
• increased liver enzyme activity.

Frequency not known (frequency cannot be estimated from the available data):

• drowsiness;
• headache;
• nausea, vomiting, diarrhea;
• rash, urticaria.

At the beginning of treatment, sedation, dryness of the mucous membranes of the mouth, and dizziness may occur, but they usually disappear on their own during continued treatment.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw,
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store Ketotifen WZF

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ketotifen WZF contains

• The active substance of the medicine is ketotifen. Each tablet contains 1 mg of ketotifen (in the form of ketotifen hydrogen fumarate).
• The other ingredients are: magnesium stearate, corn starch, calcium hydrogen phosphate.

What Ketotifen WZF looks like and contents of the pack

Ketotifen WZF is a white or slightly creamy tablet with a broken edge, round, flat, with a dividing line on one side.
Each pack of the medicine contains 30 tablets in aluminum/PVC blisters in a cardboard box.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: + 48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba
Date of last revision of the leaflet:December 2024