Clemastinum wzf

Package leaflet: Information for the patient

CLEMASTINUM WZF, 1 mg, tablets
Clemastinum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual only. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

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

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

Clemastinum WZF is an antiallergic medicine that relieves allergic symptoms, particularly affecting the skin and nasal mucosa. It is used in adults and children over 12 years of age for the treatment of:

• Nasal and ocular symptoms associated with allergic rhinitis (such as nasal congestion, profuse watery nasal discharge, nasal itching, frequent sneezing, eye redness, tearing, and eye itching);
• Contact dermatitis (symptoms: skin redness, itching, formation of blisters, fissures, and even ulceration);
• Urticaria;
• Skin itching;
• Atopic eczema (symptoms: dryness, redness, scaling, and itching of the skin);
• Angioedema (symptoms: swelling of the skin and mucous membranes).

2. Important information before using Clemastinum WZF

When not to use Clemastinum WZF

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6) or to chlorpheniramine or diphenhydramine (substances with a similar structure to Clemastine, contained in other medicines);
• if the child has not completed 12 months of age;
• during concomitant use of medicines called monoamine oxidase inhibitors (MAO inhibitors) – see section: "Clemastinum WZF with other medicines".

Warnings and precautions
Before starting treatment with Clemastinum WZF, discuss this with your doctor, pharmacist, or nurse:

• if the patient suffers from glaucoma or has increased intraocular pressure;
• if the patient has gastric or duodenal ulcers or other severe gastrointestinal disorders (e.g. pyloric stenosis);
• if the patient has been diagnosed with prostate enlargement or has experienced urinary retention due to other causes;
• if the patient suffers from asthma;
• if the patient has hyperthyroidism;
• if the patient has cardiovascular diseases or hypertension;
• if the patient has porphyria (disorders of heme formation – the red pigment which is also a component of certain enzymes), as the drug may exacerbate symptoms of porphyria;
• if the patient is over 60 years of age, as pronounced drowsiness, fatigue, or hypotension cannot be excluded.

If allergy testing is planned, the patient should discontinue taking the medicine several days before the test.
While taking Clemastinum WZF, as with other antiallergic medicines, the patient should not drink alcohol.

Clemastinum WZF with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient intends to use.

• Concomitant use of certain medicines with Clemastine may affect the central nervous system, especially if the patient is taking:
• barbiturates (sedatives and hypnotics);
• tricyclic antidepressants (used in the treatment of depression);
• medicines used in Parkinson's disease;
• strong analgesics (opioid-type, e.g. morphine).
• Some antidepressants (monoamine oxidase inhibitors – MAO inhibitors) prolong and intensify the effect of Clemastine.

Clemastinum WZF with food and drink
Food does not noticeably affect the absorption of the medicine.

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 her doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy only if clearly necessary. The doctor will decide whether Clemastinum WZF can be used during pregnancy.
The medicine should not be used during breastfeeding, as Clemastine passes into breast milk in small amounts and may cause adverse effects in breastfed infants.

Driving and operating machinery
Due to the possibility of adverse effects (e.g. drowsiness, fatigue, dizziness) occurring during treatment, driving vehicles or operating machinery should be avoided.

Clemastinum WZF contains lactose
The medicine contains lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.

3. How to use Clemastinum WZF

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Clemastinum WZF is taken orally.
The medicine may be taken before, during, or after a meal.
The usual doses are given below.
Children under 12 years of age: clemastine in syrup form is recommended.
Adults and children over 12 years of age:
1 mg (1 tablet) twice daily, in the morning and evening. If necessary, the dose may be increased
to 3–4 tablets per day.
Duration of treatment
The duration of treatment is determined by the doctor.
Taking more than the recommended dose of Clemastinum WZF
If you take more than the recommended dose, seek immediate medical advice.
Your doctor will decide on further management.
After taking a higher than recommended dose, the following may occur:

• in children: excitation, hallucinations, incoordination (ataxia), motor coordination disorders, muscle tremors, involuntary movements, hyperthermia, cyanosis, seizures, worsening circulatory and respiratory disturbances leading to suppression of these functions. Additionally, dry mouth, pupil dilation, facial flushing, and elevated body temperature may occur.
• in adults, central nervous system disturbances are more common, manifesting as drowsiness, and even coma.

Missing a dose of Clemastinum WZF
Take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next one according to the prescribed schedule. Do not take a double dose to make up for a missed dose.
If you have further doubts regarding 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 everybody gets them.
The adverse reactions listed below are grouped according to their frequency of occurrence.
Most common adverse reactions include:

• sedation, drowsiness, coordination disorders, dizziness;
• abdominal pain, heartburn, nausea, vomiting, diarrhoea, constipation;
• increased density of respiratory tract secretions.

The following may also occur:

• fatigue, confusion, restlessness, excessive excitation (especially in children), weakness, headache, tremors, insomnia, blurred vision, double vision, tinnitus, seizures;
• loss of appetite, dryness of the oral mucosa;
• feeling of chest tightness, wheezing, dryness of nasal and throat mucosa, sensation of nasal congestion;
• decreased blood pressure, palpitations, accelerated heart rate, extrasystoles;
• changes in blood picture (reduced platelet count, peripheral granulocyte deficiency, haemolytic anaemia);
• difficulty in urination, urinary retention;
• urticaria, rash;
• excessive sweating, chills, photosensitivity.

In patients over 60 years of age, there is a higher probability of occurrence of decreased blood pressure, drowsiness, fatigue and dizziness.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. 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
Tel.: + 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 responsible entity.
Reporting adverse reactions enables continuous monitoring of the benefit-risk balance of the medicine and contributes to improving its safety.

5. How to store Clemastinum WZF

Keep this medicine out of sight and reach of children.
Store in the original packaging to protect from light and moisture.
Store 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 specified month.
The marking on the packaging following "EXP" indicates the expiry date, and following "Lot/LOT" indicates the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Clemastinum WZF contains

• The active substance is clemastine. One tablet contains 1 mg of clemastine (as clemastine fumarate).
• The other ingredients are: monohydrate lactose, rice starch, povidone K-25, magnesium stearate, talc.

What Clemastinum WZF looks like and contents of the pack
Clemastinum WZF is white, round, biconvex tablets with bevelled edges.
Each pack contains 30 tablets in 2 blisters made of Al/PVC foil with 15 tablets each,
in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Site in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba