Clemastinum Vzf

Package Leaflet: Information for the Patient

CLEMASTINUM WZF, 1 mg/10 ml, Syrup

Clemastinum

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 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, please tell your doctor or pharmacist. 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. Contents of the pack and other information

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

Clemastinum WZF is an antihistamine medicine, relieving allergic symptoms, especially of the skin and nasal mucosa, used in adults and children over 12 months in the treatment of the following diseases and conditions:

• 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

• if you are allergic to clemastine or any of the other ingredients of this medicine (listed in section 6) and chlorpheniramine or diphenhydramine (substances with a similar structure to clemastine, which are part of other medicines);
• if the child is under 12 months old;
• in case of concomitant use of monoamine oxidase inhibitors - see section: "Clemastinum WZF and other medicines".

Warnings and precautions

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

• if you have glaucoma or increased eye pressure;
• if you have stomach or duodenal ulcers, or other severe gastrointestinal disorders (pyloric stenosis);
• if you have prostatic hyperplasia or have had urinary retention for other reasons;
• if you have asthma;
• if you have hyperthyroidism;
• if you have cardiovascular diseases and hypertension;
• if you have porphyria (disorders of heme production - a red pigment that is part of some enzymes), as the medicine may exacerbate porphyria symptoms;
• if you are over 60 years old, as it cannot be excluded that increased drowsiness, fatigue, or decreased blood pressure may occur.

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

Clemastinum WZF and other medicines

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

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

Clemastinum WZF with food and drink

Food does not affect the absorption of the medicine in a noticeable way.

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.
The medicine may be used during pregnancy only if necessary. The doctor will decide whether Clemastinum WZF can be used during pregnancy.
Do not take the medicine while breastfeeding, as clemastine passes into breast milk in small amounts and may cause side effects in breastfed infants.

Driving and using machines

Due to the possibility of side effects (e.g., drowsiness, fatigue, dizziness), do not drive vehicles or operate machines while taking the medicine.

Clemastinum WZF contains sorbitol (E 420), ethanol, propylene glycol, propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), sodium, and potassium

The medicine contains 350 mg of sorbitol in each ml of syrup. Sorbitol is a source of fructose. If you or your child 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, you should consult your doctor before taking the medicine or giving it to your child.
If the dose of sorbitol taken with Clemastinum WZF exceeds 140 mg/kg body weight per day, sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
This medicine contains 50 mg of alcohol (96% ethanol) in each ml of syrup. The amount of alcohol in each ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The amount of alcohol in this medicine is unlikely to have an effect on adults and adolescents, and its effect on children is unlikely to be noticeable. It may cause some effect in younger children, such as drowsiness. The alcohol in this medicine may alter the effect of other medicines. If you are taking other medicines, consult your doctor or pharmacist.
If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are addicted to alcohol, consult your doctor or pharmacist before taking this medicine.
The medicine contains 75.52 mg of propylene glycol in each ml of syrup. Before administering the medicine to a child under 5 years of age, consult your doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol. Patients with liver or kidney disorders should not take this medicine without consulting their doctor. The doctor may decide to perform additional tests on such patients.
Methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) may cause allergic reactions (possible late reactions).
The medicine contains less than 1 mmol (23 mg) of sodium in 10 ml of syrup, i.e., the medicine is considered "sodium-free".
The medicine contains less than 1 mmol (39 mg) of potassium in 10 ml of syrup, i.e., the medicine is considered "potassium-free".

3. How to take Clemastinum WZF

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
A measuring cup with a total capacity of 10 ml with a scale allowing for measuring 2.5 ml, 5 ml, 10 ml of syrup is attached to the packaging.
2.5 ml of syrup contains 0.25 mg of clemastine.
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 over 1 year of age to 3 years:
0.25 mg to 0.5 mg (2.5 ml to 5 ml of syrup) twice a day, in the morning and evening.
Children from 3 to 6 years of age:
0.5 mg (5 ml of syrup) twice a day, in the morning and evening.
Children from 6 to 12 years of age:
0.5 mg to 1 mg (5 ml to 10 ml of syrup) twice a day, in the morning and evening.
Adults and adolescents over 12 years of age:
1 mg (10 ml of syrup) twice a day, in the morning and evening.

Duration of treatment

The duration of treatment is determined by the doctor.

Taking a higher dose of Clemastinum WZF than recommended

If you have taken more than the recommended dose of the medicine, seek medical attention immediately.
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 are disorders of the central nervous system, manifested by 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 dose according to the recommended dosing schedule. Do not take a double dose of the medicine to make up for the missed dose.
If you have any further questions about taking 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.
The following side effects are listed with their frequency of occurrence.
Most common:

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

May occur:

• fatigue, confusion, anxiety, excessive stimulation (especially in children), weakness, headache, tremors, insomnia, blurred vision, double vision, tinnitus, seizures;
• loss of appetite, dry mouth;
• feeling of chest tightness, wheezing, dryness of the nasal and throat mucosa, feeling of a stuffy nose;
• decreased blood pressure, palpitations, increased 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 of age, there is a higher likelihood of decreased blood pressure, drowsiness, fatigue, and dizziness.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 this medicine.

5. How to store Clemastinum 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 on the bottle after: EXP. The expiry date stated is the last day of the given month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
The shelf life of the medicine after opening the bottle is 3 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Clemastinum WZF contains

• The active substance of the medicine is clemastine. 10 ml of syrup contains 1 mg of clemastine (in the form of clemastine fumarate).
• Other ingredients are: peach flavor, lemon flavor, sodium saccharin (E 954), propyl parahydroxybenzoate (E 216), methyl parahydroxybenzoate (E 218), disodium phosphate dodecahydrate, potassium dihydrogen phosphate, ethanol 96%, propylene glycol, sorbitol (E 420), purified water.

What Clemastinum WZF looks like and contents of the pack

Clemastinum WZF is a clear, colorless liquid.
A brown PET bottle with a polyethylene (HDPE) cap containing 100 ml of syrup, along with a polypropylene (PP) measuring cup, in a cardboard box.
The measuring cup allows for measuring 2.5 ml, 5 ml, 10 ml of syrup.

Marketing authorization holder

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

Manufacturer

Warszawskie Zakłady Farmaceutyczne Polfa S.A.
Karolkowa Street 22/24, 01-207 Warsaw
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
Władysław Łokietek Street 10, 98-200 Sieradz

Date of last revision of the leaflet: