Cinnarizinum Vzf

Package Leaflet: Information for the Patient

CINNARIZINUM WZF, 25 mg, tablets

Cinnarizinum

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, pharmacist, or nurse.
• 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 those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

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

Cinnarizine, the active substance in this medicine, belongs to a group of so-called calcium antagonists.
Cinnarizinum WZF is used:

• in peripheral circulation disorders (Raynaud's syndrome, intermittent claudication, muscle cramps);
• in vascular disorders in the central nervous system (e.g., circulation disorders in the vertebrobasilar system);
• in ischemic syndromes in ophthalmology;
• prophylactically in motion sickness (kinetosis);
• as an adjunct in vestibular disorders (dizziness, tinnitus, nausea, vomiting), e.g., in Meniere's syndrome.

2. Important information before taking Cinnarizinum WZF

When not to take Cinnarizinum WZF:

• if you are allergic to cinnarizine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Cinnarizinum WZF, consult your doctor, pharmacist, or nurse.
Before taking Cinnarizinum WZF, you should consult your doctor if you have:

• Parkinson's disease;
• severe blood disease (porphyria);
• low blood pressure;
• liver or kidney function disorders. Cinnarizinum WZF should be discontinued 4 days before allergy testing.

Cinnarizinum WZF and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.
Cinnarizinum WZF enhances the effect of medicines that have a sedative effect on the central nervous system - sedatives, hypnotics, potent analgesics, tricyclic antidepressants.

Cinnarizinum WZF with food and drink or alcohol

Cinnarizinum WZF should be taken after a meal, as this helps reduce or avoid gastrointestinal disorders.
The medicine enhances the effect of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not recommended to take the medicine during pregnancy and breastfeeding.

Driving and using machines

Cinnarizine may cause drowsiness, especially at the beginning of treatment. Patients who experience such symptoms should not drive or operate machinery.

Cinnarizinum WZF contains lactose and sucrose

The medicine contains lactose and sucrose; if you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Cinnarizinum WZF

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Take the medicine orally, after a meal.
In dizziness and other ischemic disorders:
1 tablet (25 mg) three times a day (75 mg).
In the initial treatment period, twice the recommended dose may be used.
Prophylactically in motion sickness:
1 tablet (25 mg) 2 hours before travel, and then as needed 1 tablet (25 mg) every 8 hours during travel.

Overdose of Cinnarizinum WZF

After taking a higher dose of Cinnarizinum WZF than recommended, the following may occur: vomiting, drowsiness, coma, tremors, hypotension. Contact your doctor immediately.
If it has been less than one hour since the intake of a dose several times higher than the therapeutic dose, the doctor will consider gastric lavage with activated charcoal administration.
If more than one hour has passed since the overdose, the doctor will initiate symptomatic treatment.
There is no specific antidote.

Missed dose of Cinnarizinum WZF

Do not take a double dose to make up for a missed dose.
If you have any further questions about taking this medicine, ask your doctor, pharmacist, or nurse.

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.
Common (may affect up to 1 in 10 people):

• weight gain (with long-term use of the medicine);
• drowsiness.

Uncommon (may affect up to 1 in 100 people):

• gastrointestinal disorders, usually transient;
• excessive sweating.

Rare (may affect up to 1 in 1,000 people):

• dry mouth.

Very rare (may affect up to 1 in 10,000 people):

• skin changes (lichen planus, lupus-like changes) - may occur with long-term use of the medicine.

Frequency not known (cannot be estimated from the available data):

• allergic reactions;
• headache;
• cholestatic jaundice (symptoms - yellowing of the skin, mucous membranes, and whites of the eyes);
• extrapyramidal symptoms - occurrence or worsening of extrapyramidal symptoms (sometimes associated with depression) has been reported, especially in the elderly during long-term use of the medicine. Extrapyramidal symptoms include muscle stiffness, facial rigidity, slow movements, restlessness, involuntary muscle contractions, and involuntary movements - if they occur, discontinue the medicine.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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
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.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Cinnarizinum WZF

Store in a temperature below 25°C.
Store blisters in the outer packaging to protect from moisture.
Keep the medicine out of the sight and reach of children.
Do not use Cinnarizinum WZF 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cinnarizinum WZF contains

• The active substance is cinnarizine. One tablet contains 25 mg of cinnarizine.
• The other ingredients are: lactose monohydrate, potato starch, sucrose, talc, povidone K-25, magnesium stearate.

What Cinnarizinum WZF looks like and contents of the pack

Cinnarizinum WZF is a white, flat, beveled-edged tablet with the inscription '25' on one side.
The carton contains 50 tablets (2 blisters of 25 tablets each).

Marketing authorization holder and manufacturer

Marketing authorization holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Manufacturer
Warszawskie Zakłady Farmaceutyczne Polfa S.A.
ul. Karolkowa 22/24; 01-207 Warsaw
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2; 39-460 Nowa Dęba

Date of last revision of the leaflet