Ketotifen hasco

Package leaflet: Information for the patient

KETOTIFEN HASCO
1 mg/5 ml, syrup
Ketotifenum
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

Ketotifen HASCO syrup is an antiallergic (antihistamine) medicine containing the active substance
ketotifen. Its action consists of inhibiting the release of mediators involved in allergic reactions.
It non-competitively blocks histamine H receptors, meaning that increased histamine concentration
does not reduce the drug's effect.
It inhibits the development of bronchial hyperreactivity, resulting in reduced frequency and severity of asthma attacks.
For the prevention of bronchial asthma, full therapeutic effect may require several weeks of treatment.
Ketotifen HASCO is used for the prevention of bronchial asthma and for symptomatic treatment of allergic rhinitis and allergic conjunctivitis (seasonal and perennial).
This medicine is not effective in terminating an acute asthma attack.

2. Important information before using Ketotifen HASCO

When not to use Ketotifen HASCO

• If the patient is allergic to ketotifen or any of the other ingredients of this medicine (listed in section 6),
• if the patient is concurrently using oral antidiabetic medicines.

Warnings and precautions

• To achieve the full therapeutic effect of ketotifen in the prevention of bronchial asthma, treatment may need to continue for several weeks,
• during the initial period of treatment, do not discontinue other anti-asthmatic medicines, especially steroid preparations (systemic-acting corticosteroids) and adrenocorticotropic hormone (ACTH), due to the risk of adrenal insufficiency; in such cases, the return to normal pituitary-adrenal response to stress may take up to a year,
• caution should be exercised during ketotifen treatment, especially in patients with a history of epilepsy, due to the possibility of seizures,
• if discontinuation is necessary, Ketotifen HASCO should be withdrawn gradually over a period of 2 to 4 weeks; recurrence of asthma symptoms should be anticipated,
• during treatment with Ketotifen HASCO, results of allergy tests may be falsely negative; therefore, the medicine should be discontinued for several days (3–4 days) before performing such tests.

Ketotifen HASCO with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Ketotifen may enhance the effects of medicines that depress the central nervous system (sedatives, hypnotics) and antihistamines (e.g. certain antiallergic medicines).
Concurrent use with oral antidiabetic medicines may lead to a decrease in platelet count (see section "When not to use Ketotifen HASCO").

Ketotifen HASCO and alcohol
Ketotifen HASCO may enhance the effects of alcohol; therefore, alcohol should not be consumed during treatment with this medicine.

Ketotifen HASCO and food
The medicine should be taken during meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Ketotifen HASCO may be used during pregnancy only if absolutely necessary.
Due to ketotifen passing into breast milk, Ketotifen HASCO should not be used in women who are breastfeeding.

Driving and operating machinery
During the first few days of treatment, reactions may be slowed; therefore, patients should not drive or operate machinery until they know how they individually react to the medicine.

Ketotifen HASCO contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Ketotifen HASCO contains sorbitol
The medicine contains 2250 mg of sorbitol in 5 ml of syrup.
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down fructose—the patient should consult a doctor before taking the medicine or giving it to a 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 (delayed-type reactions possible).

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

Ketotifen HASCO contains sodium
Sodium originates from the excipient disodium phosphate dodecahydrate. The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of syrup; therefore, the medicine is considered "sodium-free".

3. How to use Ketotifen Hasco

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor.
The medicine should be taken orally.
Recommended dose
Children from 7 months to 3 years of age – 0.25 ml of syrup (0.05 mg ketotifen)/kg body weight twice
daily, in the morning and evening, during meals.
Do not administer more than 2.5 ml of syrup twice daily.
Children over 3 years of age and adults – 5 ml of syrup (1 mg ketotifen) twice daily, in the morning
and evening, during meals. In patients sensitive to the sedative effect of ketotifen, the doctor may
recommend gradual dose escalation during the first week of treatment, starting with 2.5 ml of syrup
(0.5 mg ketotifen) twice daily, then increasing the dose until the full therapeutic dose is reached.
A measuring device is provided with the package to accurately measure the required amount of syrup.
Taking more Ketotifen Hasco than recommended
If more than the recommended dose is taken, seek immediate medical advice from a doctor or
pharmacist.
The main symptoms of overdose include dizziness, excessive sedation and drowsiness, confusion
and disorientation, increased heart rate, hypotension, circulatory and respiratory collapse,
coma, and particularly in children, hyperexcitability or seizures.
Symptomatic treatment should be administered. If the medicine was taken within the last hour,
induce vomiting or perform gastric lavage. Administration of activated charcoal may be beneficial.
In case of agitation or seizures, short-acting barbiturates or benzodiazepines may be given. In case of
coma, controlled ventilation and circulatory support medications should be used. If necessary,
symptomatic treatment and monitoring of cardiovascular function are recommended.
Missing a dose of Ketotifen Hasco
Do not take a double dose to make up for a missed dose.
Stopping Ketotifen Hasco treatment
Sudden discontinuation of ketotifen may cause recurrence of asthma symptoms. If discontinuation is
necessary, the medicine should be tapered gradually over a period of 2 to 4 weeks, after prior
consultation with the doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Common adverse reactions (in 1 to 10 patients out of 100):

• Excitement, irritability, insomnia, restlessness; these symptoms were observed especially in children.

Uncommon adverse reactions (in 1 to 10 patients out of 1,000):

• Cystitis, dizziness, dryness of the oral mucosa.

Rare adverse reactions (in 1 to 10 patients out of 10,000):

• Weight gain, drug-induced sedation.

Very rare adverse reactions (in less than 1 patient out of 10,000):

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

Drug-induced sedation, dryness of the oral mucosa, and dizziness may occur at the beginning of treatment, but usually resolve during continued therapy.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ketotifen HASCO contains

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

What Ketotifen HASCO looks like and contents of the pack
A bottle containing 100 ml of syrup, in a cardboard box.
Strawberry-flavoured syrup.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicinal product
tel.: + 48 22 742 00 22
e-mail: [email protected]