Cinnarizinum Aflofarm

Leaflet attached to the packaging: patient information

Cinnarizinum Aflofarm, 25 mg tablets

Cinnarizinum

Read the 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 any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Cinnarizinum Aflofarm is a medicine in the form of tablets, containing the active substance - cinnarizine.
Cinnarizine inhibits the influx of calcium ions into the smooth muscle cells of blood vessels.
It dilates cerebral and peripheral blood vessels, improves circulation and oxygen supply. It has anti-allergic, anti-emetic and slightly sedative effects. It inhibits nystagmus.

Indications for use

• Vestibular disorders: dizziness, tinnitus, nausea and vomiting, such as in Meniere's disease.
• Motion sickness.

2. Important information before taking Cinnarizinum Aflofarm

When not to take Cinnarizinum Aflofarm:

Warnings and precautions

Before taking Cinnarizinum Aflofarm, discuss it with your doctor:

In elderly patients (over 65 years old) taking cinnarizine, the doctor will prescribe periodic tests.
The anticholinergic effect of the medicine may cause an attack of glaucoma.
The medicine may affect the results of allergy tests. Do not take it for at least 4 days before performing such tests.

Children

The safety of Cinnarizinum Aflofarm in children has not been established.

Cinnarizinum Aflofarm and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
If you are taking any of the following medicines, tell your doctor:

• medicines that inhibit the central nervous system;
• tricyclic antidepressants (e.g. amitriptyline).

If you are not sure if you are taking any of the above medicines, contact your doctor or pharmacist.

Cinnarizinum Aflofarm with food and alcohol

Take the medicine after a meal.
Do not drink alcohol while taking this medicine.

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 can be used during pregnancy and breastfeeding only if the doctor considers it absolutely necessary.
It is not recommended to use the medicine during pregnancy and breastfeeding.

Driving and using machines

The medicine may affect your ability to drive and use machines. If you experience drowsiness, especially at the beginning of treatment - do not drive or operate machines.

Cinnarizinum Aflofarm contains lactose monohydrate and sodium

The medicine contains 100 mg of lactose monohydrate in each tablet.
If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.
The medicine contains 0.105 mg of sodium in each tablet.
The medicine contains less than 1 mmol (23 mg) of sodium in each tablet, which means the medicine is considered "sodium-free".

3. How to take Cinnarizinum Aflofarm

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.

Adults

In vestibular disorders:
1 tablet 3 times a day (daily dose 75 mg). At the beginning of treatment, twice the dose is allowed.
In motion sickness:
1 tablet 2 hours before travel, then if necessary 1 tablet every 8 hours on the day of travel.
The treatment period should not be longer than 3 months. Take the medicine after a meal.

Use in children

The safety of Cinnarizinum Aflofarm in children has not been established.

Use of Cinnarizinum Aflofarm in patients with renal and/or hepatic impairment

In patients with renal failure, there is no need to change the dosage. However, in patients with hepatic failure, the doctor will consider changing the dosage of the medicine.

Taking a higher dose of Cinnarizinum Aflofarm than recommended

If you take more of the medicine than recommended, contact your doctor.
After an overdose, the following may occur: vomiting, drowsiness, coma, tremors, and decreased blood pressure.

Missing a dose of Cinnarizinum Aflofarm

Do not take a double dose to make up for a missed dose. Continue taking the medicine, without increasing the next dose.
If you have any further questions about the use of 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 may occur:

• drowsiness;
• gastrointestinal disorders;
• headaches;
• dry mouth;
• sweating;
• allergic reactions.

In the case of long-term treatment, the following rare cases may occur:

• weight gain; or very rare:
• psoriasis;
• lupus-like skin changes;
• cholestatic jaundice (which develops as a result of bile flow disorders).

Long-term use or high doses in elderly patients may cause extrapyramidal symptoms, which manifest as:

• muscle stiffness;
• poor facial expressions;
• slow movement;
• restlessness;
• involuntary muscle contractions and involuntary movements (sometimes associated with depression);
• decreased blood pressure.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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, Tel.: +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 Cinnarizinum Aflofarm

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the blister and carton after EXP.
The expiry date refers to the last day of the month.
Markings on the blister:
Lot - batch number
EXP - expiry date
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 packaging and other information

What Cinnarizinum Aflofarm contains

• The active substance of the medicine is cinnarizine. One tablet contains 25 mg of cinnarizine.
• The other ingredients are: lactose monohydrate, sodium carboxymethyl starch (type A), magnesium stearate, potato starch, talc, povidon 30, calcium hydrogen phosphate, colloidal silica anhydrous.

What Cinnarizinum Aflofarm looks like and contents of the pack

The medicine is in the form of tablets.
Packaging: 50 tablets in a cardboard box.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów
Date of last revision of the leaflet:22.06.2020