Clemastinum Vzf

Leaflet attached to the packaging: patient information

CLEMASTINUM WZF, 1 mg, tablets

Clemastinum

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Clemastinum WZF and what is it 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. Package contents and other information

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

Clemastinum WZF is an antihistamine medicine that relieves allergic symptoms, especially of the skin and nasal mucosa. It is used in adults and children over 12 years old to treat:

• nasal and eye symptoms associated with allergic rhinitis (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);
• contact dermatitis (symptoms: redness, itching of the skin with the formation of blisters, cracks, and even ulcers);
• urticaria;
• pruritus;
• atopic dermatitis (symptoms: dryness, redness, scaling, and itching of the skin);
• angioedema (symptoms: swelling of the skin and mucous membranes).

2. Important information before taking Clemastinum WZF

When not to take Clemastinum WZF

• in case of concomitant use of monoamine oxidase inhibitors (MAOIs) - see section: "Clemastinum WZF and other medicines".

Warnings and precautions

Before starting treatment with Clemastinum WZF, discuss it with your doctor, pharmacist, or nurse:

If allergy tests are planned, the patient should stop taking the medicine a few days before the tests.
During treatment with Clemastinum WZF, as with other antihistamines, the patient should not drink alcohol.

Clemastinum WZF and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

• Concomitant use of certain medicines with clemastine may affect the central nervous system, especially if the patient is taking:
• barbiturates (sleeping pills and sedatives);
• tricyclic antidepressants (used to treat depression);
• medicines used in parkinsonism;
• strong painkillers (from the opioid group, e.g., morphine).
• Certain antidepressants (monoamine oxidase inhibitors - MAOIs) prolong and enhance the effect of clemastine.

Clemastinum WZF with food and drink

Food does not significantly affect the absorption of the medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The medicine may be used during pregnancy only if 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 side effects in breastfed infants.

Driving and operating machinery

Due to the possibility of side effects (such as drowsiness, fatigue, dizziness), the patient should not drive vehicles or operate machinery while taking the medicine.

Clemastinum WZF contains lactose

The medicine contains lactose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Clemastinum WZF

Take this medicine always exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Clemastinum WZF is taken orally.
The medicine can be taken before, during, or after a meal.
Usual doses of the medicine are given below.
Children under 12 years old: clemastine syrup is recommended.
Adults and children over 12 years old:
1 mg (1 tablet) twice a day, in the morning and evening. If necessary, the dose can be increased to 3-4 tablets a day.

Duration of treatment

The duration of treatment is determined by the doctor.

Overdose of Clemastinum WZF

In case of overdose, consult a doctor immediately, who will decide on further action.
After taking a higher dose than recommended, the following may occur:

• in children: excitement, hallucinations, ataxia, coordination disorders, muscle tremors, involuntary movements, overheating, cyanosis, seizures, worsening of circulation and breathing disorders leading to their inhibition. Additionally, the following may occur: dry mouth, pupil dilation, facial redness, increased body temperature.
• in adults, more frequent central nervous system disorders occur, manifested by drowsiness, and even coma.

Missed 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 dose according to the recommended dosing schedule. Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clemastinum WZF can cause side effects, although not everybody gets them.
The following side effects are listed with their frequency of occurrence.
The most common are:

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

The following may occur:

• fatigue, confusion, anxiety, excessive excitement (especially in children), weakness, headache, tremors, insomnia, blurred vision, double vision, tinnitus, seizures;
• loss of appetite, dry mouth;
• feeling of pressure in the chest, wheezing, dryness of the nasal and throat mucosa, feeling of a stuffy nose;
• decreased blood pressure, palpitations, accelerated heart rate, extrasystoles;
• changes in blood count (decreased platelet count, granulocytopenia in peripheral blood, hemolytic anemia);
• urination disorders, urinary retention;
• urticaria, rash;
• excessive sweating, chills, hypersensitivity to light.

In patients over 60 years old, there is a higher likelihood of decreased blood pressure, drowsiness, fatigue, and dizziness.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor, 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 gather more information on the safety of the medicine.

5. How to store Clemastinum WZF

Keep the medicine out of the sight and reach of children.
Store in the original packaging to protect from light and moisture.
Store at 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. Package contents and other information

What Clemastinum WZF contains

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

What Clemastinum WZF looks like and what the pack contains

Clemastinum WZF is a white, round, flat tablet with beveled edges.
Each pack of the medicine contains 30 tablets in 2 blisters of Al/PVC foil, each containing 15 tablets, 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 update of the leaflet:December 2024