Ketotifen Hasco

Package Leaflet: Information for the Patient

KETOTIFEN HASCO

1 mg/5 ml, syrup

Ketotifen

Read the package 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.
• This medicine has been prescribed for you personally. Do not pass it on to others. The medicine 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. See section 4.

Table of Contents of the Leaflet

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

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

Ketotifen HASCO, syrup is an antiallergic (antihistamine) medicine containing the active substance ketotifen. Its action involves inhibiting the release of allergic reaction mediators. It non-competitively blocks histamine H receptors, meaning that an increase in histamine concentration does not weaken the action of the medicine.
It inhibits the development of bronchial hyperreactivity, which manifests as a decrease in the frequency and severity of asthma attacks.
In the prevention of bronchial asthma, achieving full therapeutic effect may require treatment lasting several weeks.
Ketotifen HASCO is used in the prevention of bronchial asthma and in the symptomatic treatment of allergic rhinitis and allergic conjunctivitis (seasonal and perennial).
The medicine is not effective in interrupting a bronchial asthma attack.

2. Important information before taking Ketotifen HASCO

When not to take Ketotifen HASCO

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

Warnings and precautions

• In order to achieve full therapeutic effect of ketotifen in the prevention of bronchial asthma, treatment lasting several weeks may be necessary,
• in the initial period of taking the medicine, do not stop taking other anti-asthmatic medicines, especially steroid preparations (systemic corticosteroids) and adrenocorticotropic hormone (ACTH), due to the possibility of adrenal insufficiency; in such cases, the return to normal pituitary-adrenal response to stress may take up to a year,
• when taking ketotifen, be cautious, especially in patients with a history of epilepsy, due to the possibility of seizures,
• if it is necessary to discontinue Ketotifen HASCO, do so gradually, over a period of 2 to 4 weeks; be prepared for a relapse of asthma symptoms,
• during treatment with Ketotifen HASCO, the results of allergy tests may be falsely negative, so discontinue the medicine for a few days (3-4) before performing these tests.

Ketotifen HASCO and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.
Ketotifen may enhance the effect of medicines that depress the activity of the central nervous system (sedatives, hypnotics) and antihistamines (e.g. some antiallergic medicines).
Concomitant use with oral antidiabetic medicines may cause a decrease in the number of platelets (see section "When not to take Ketotifen HASCO").

Ketotifen HASCO with alcohol

Ketotifen HASCO may enhance the effect of alcohol, so do not drink alcohol while taking this medicine.

Ketotifen HASCO with food

Take the medicine with a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Ketotifen HASCO may be used during pregnancy only if absolutely necessary.
Due to the passage of ketotifen into breast milk, do not take Ketotifen HASCO if you are breastfeeding.

Driving and using machines

During the first few days of taking the medicine, reactions may be slowed down, so do not drive or operate machinery until you know how the medicine affects you.

Ketotifen HASCO contains sucrose

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

Ketotifen HASCO contains sorbitol

The medicine contains 2250 mg of sorbitol in 5 ml of syrup.
Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, consult your doctor before taking the medicine or giving it to your child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Ketotifen HASCO contains propyl parahydroxybenzoate and methyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

Ketotifen HASCO contains propylene glycol

The medicine contains 100 mg of propylene glycol in 5 ml of syrup.

Ketotifen HASCO contains sodium

Sodium comes from the excipient disodium phosphate dodecahydrate. The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup, which means the medicine is considered "sodium-free".

3. How to take Ketotifen HASCO

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor.
Take the medicine orally.
Recommended dose
Children from 7 months to 3 years of age – 0.25 ml of syrup (0.05 mg of ketotifen)/kg of body weight twice a day, in the morning and evening, with a meal.
Do not take more than 2.5 ml of syrup twice a day.
Children over 3 years of age and adults – 5 ml of syrup (1 mg of ketotifen) twice a day, in the morning and evening, with a meal. In patients sensitive to the sedative effect of ketotifen, the doctor may recommend gradual dose increase over the first week of treatment, starting with 2.5 ml of syrup (0.5 mg of ketotifen) twice a day, and then increasing the dose to the full therapeutic dose.
A measuring cup is attached to the packaging to measure the appropriate amount of syrup.

Taking a higher dose of Ketotifen HASCO than recommended

If you take more than the recommended dose, contact your doctor or pharmacist immediately.
The main symptoms of overdose are dizziness, excessive sedation and drowsiness, confusion and disorientation, rapid heartbeat, low blood pressure, circulatory and respiratory failure, coma, and especially in children, hyperactivity or seizures.
Apply symptomatic treatment. If the medicine was taken within the last hour, induce vomiting or perform gastric lavage. Activated charcoal may be beneficial. In case of excitement or seizures, short-acting barbiturates or benzodiazepines can be administered, in case of coma, controlled respiration and cardiovascular supportive therapy can be applied. If necessary, apply symptomatic treatment and monitor cardiovascular function.

Missing a dose of Ketotifen HASCO

Do not take a double dose to make up for a forgotten dose .

Stopping treatment with Ketotifen HASCO

Sudden discontinuation of ketotifen may cause a relapse of asthma symptoms. If it is necessary to discontinue the medicine, do so gradually, over a period of 2 to 4 weeks, after consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Frequent side effects(in 1 to 10 patients out of 100):

• hyperactivity, irritability, insomnia, nervousness; these symptoms are especially observed in children.

Uncommon side effects(in 1 to 10 patients out of 1000):

• urinary tract infection, dizziness, dry mouth.

Rare side effects(in 1 to 10 patients out of 10,000):

• weight gain, sedation.

Very rare side effects(in less than 1 patient out of 10,000):

• erythema multiforme, Stevens-Johnson syndrome (a severe form of erythema multiforme), severe skin reactions, seizures, hepatitis, increased liver enzyme activity.

Sedation, dry mouth, and dizziness may occur at the beginning of treatment, but usually disappear during further treatment.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 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 this medicine.

5. How to store Ketotifen HASCO

Store in the original packaging, at a temperature not exceeding 25°C. Protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not throw away medicines 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 HASCO contains

• The active substance of the medicine is ketotifen 1 mg in the form of ketotifen hydrogen fumarate 1.38 mg.
• The other ingredients (excipients) are: sucrose, non-crystallizing liquid sorbitol, anhydrous citric acid, disodium phosphate dodecahydrate, propylene glycol, propyl parahydroxybenzoate, methyl parahydroxybenzoate, strawberry flavor AR 0012/F, purified water.

What Ketotifen HASCO looks like and what the pack contains

Bottle containing 100 ml of syrup, in a cardboard box.
Syrup with a strawberry flavor.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel.: + 48 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: