Flunarizinum wzf

Package leaflet: Information for the patient

FLUNARIZINUM WZF, 5 mg, tablets
Flunarizinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

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

Flunarizinum WZF contains flunarizine, which belongs to a group of medicines called calcium antagonists, preventing narrowing of blood vessels.
Flunarizinum WZF is used:

• for the prevention of classic (with aura) or common (without aura) migraine;
• for the symptomatic treatment of vestibular (labyrinthine) vertigo – for example, caused by disorders or damage to the vestibular apparatus in the ear.

2. Important information before using Flunarizinum WZF

When not to use Flunarizinum WZF:

• if the patient is allergic to flunarizine or to any of the other ingredients of this medicine (listed in section 6.);
• if the patient suffers from Parkinson's disease (a chronic condition characterized by symptoms such as muscle stiffness, tremor of limbs and head, reduced facial expression);
• if the patient has previously experienced movement disorders, bradykinesia, stiffness, tremor (referred to as extrapyramidal symptoms);
• if the patient has previously experienced depressive disorders;
• if the patient is pregnant or breastfeeding.

Warnings and precautions
Before starting treatment with Flunarizinum WZF, consult your doctor.
Warning: Do not increase the dose of the medicine if the patient anticipates an oncoming migraine attack.
Flunarizinum WZF does not stop a migraine attack.
Consult a doctor if:

• the patient experiences increasing fatigue, tiredness, or reduced effectiveness of the medicine during treatment;
• the patient is taking sedatives or other medicines that depress the central nervous system – see section: “Flunarizinum WZF and other medicines”;
• the patient is taking medicines used for psychiatric disorders belonging to the phenothiazine derivatives group (e.g. chlorpromazine, perphenazine), because when these medicines are taken together with flunarizine, movement disorders, bradykinesia, stiffness, or tremor may occur.

During treatment, especially long-term, the patient should regularly visit the doctor and strictly follow the doctor’s recommendations regarding the duration of treatment – see section 3 of the leaflet “How to use Flunarizinum WZF”.

Elderly patients
In elderly patients, there is a risk of developing bradykinesia, stiffness, inability to sit, or tremor; therefore, such patients should strictly follow the doctor’s dosing instructions – see also section 3 of the leaflet “How to use Flunarizinum WZF”.
If the above symptoms occur, the patient should discontinue the medicine and immediately contact the doctor.
Children and adolescents
Flunarizinum WZF should not be used in children and adolescents due to uncertainties regarding safety in this age group.
Flunarizinum WZF and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.

• Medicines with central nervous system depressant effects, e.g. sedatives taken together with Flunarizinum WZF, may cause excessive sedation – simultaneous use should be avoided.
• In women taking Flunarizinum WZF and female sex hormones (estrogens, progestogens), galactorrhea (milk secretion outside breastfeeding period) has been reported.
• Carbamazepine and phenytoin (antiepileptic medicines) used concomitantly with Flunarizinum WZF may accelerate the metabolism of this medicine in the body. In such cases, the doctor may recommend increasing the dose of Flunarizinum WZF.

Flunarizinum WZF with food, drink, and alcohol
The medicine should be taken orally, preferably immediately after dinner, to avoid gastric irritation. Tablets should be swallowed whole with water – see section 3 “How to use Flunarizinum WZF”.
Alcohol should not be consumed during treatment with Flunarizinum WZF, as it may cause excessive sedation and drowsiness.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine.
Flunarizinum WZF should not be used during pregnancy and while breastfeeding.
Driving and operating machinery
Flunarizinum WZF may impair the ability to drive and operate machinery, especially at the beginning of treatment. These activities should be avoided until such disturbances subside.
Flunarizinum WZF contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Flunarizinum WZF

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor.

• The tablets should be taken orally, preferably immediately after dinner, swallowed whole with water.
• The dosage and duration of treatment are determined individually by the doctor for each patient.
• During treatment with Flunarizinum WZF, follow the dosage recommended by your doctor – do not exceed the recommended dose.

Prevention of migraine
Initial doses:

• adults under 65 years: 2 tablets (10 mg) once daily;
• adults over 65 years: 1 tablet (5 mg) once daily.

Maintenance doses (continuation of treatment):

• take the usual dose for 5 days per week, then do not take the medicine for the following 2 days.

If no improvement is observed after 2 months of treatment for prevention of migraine attacks, treatment should be discontinued and medical advice should be sought.

Dizziness
Use the same doses as for migraine prevention.
If no improvement is observed after one month of treatment for chronic dizziness, or after two months for prevention of episodic dizziness, treatment should be discontinued and medical advice should be sought.

Use in children and adolescents
Flunarizinum WZF is not indicated for use in children and adolescents (under 18 years of age).

• see section "Warnings and precautions".

Taking more Flunarizinum WZF than recommended
After taking a higher than recommended dose, sedation and feelings of weakness, fatigue, and helplessness (asthenia) may occur. After ingestion of a large number of Flunarizinum WZF tablets, symptoms such as excessive sedation, agitation, and increased heart rate (palpitations) may occur. If these symptoms occur, seek medical advice.

Missed dose of Flunarizinum WZF
If a dose of Flunarizinum WZF is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

Stopping Flunarizinum WZF
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.

Common (less than 1 in 10 people):

• increased appetite and body weight;
• excessive drowsiness and (or) fatigue (usually transient).

Uncommon (less than 1 in 100 people):

• insomnia, restlessness;
• depression (especially in patients who previously experienced depression);
• tremor, muscle stiffness, involuntary movement disorders, including around the mouth (particularly reported in patients on long-term treatment and in elderly patients);
• heartburn, nausea, stomach pain, dryness of the mouth;
• muscle pain;
• skin rashes;
• milk secretion outside the breastfeeding period, particularly in women taking female hormones (estrogens, progestagens) together with Flunarizinum WZF.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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
Phone: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Flunarizinum WZF

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Keep in the outer packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month indicated.
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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Flunarizinum WZF contains

• The active substance is flunarizine dihydrochloride. Each tablet contains 5 mg of flunarizine (as flunarizine dihydrochloride).
• Other ingredients: monohydrate lactose, corn starch, povidone K-25, stearic acid, colloidal anhydrous silica.

What Flunarizinum WZF looks like and contents of the pack
Flunarizinum WZF – white or almost white, biconvex tablets with bevelled edges.
The cardboard box contains 30 tablets in blisters made of Aluminium/PVC foil.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
POLPHARMA S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
POLPHARMA S.A. Pharmaceutical Works
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba