Cinnarizinum aflofarm

Package leaflet: Information for the user

Cinnarizinum Aflofarm, 25 mg tablets
Cinnarizinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Cinnarizinum Aflofarm is and what it is 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 pack and other information

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

Cinnarizinum Aflofarm is a medicine in tablet form, containing the active substance - cinnarizine.
Cinnarizine inhibits calcium ion influx into smooth muscle cells of blood vessels.
It dilates cerebral and peripheral vessels, improves circulation and oxygen supply. It has antiallergic, antiemetic, and mild sedative properties. It suppresses nystagmus.
Therapeutic indications

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

2. Important information before taking Cinnarizinum Aflofarm

When not to take Cinnarizinum Aflofarm:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has extrapyramidal disorders;
• if the patient has Parkinson's disease.

Warnings and precautions
Before starting treatment with Cinnarizinum Aflofarm, consult a doctor:

• if the patient has difficulty urinating, e.g. due to benign prostatic hyperplasia (enlarged prostate), bladder neck obstruction;
• if the patient has pyloric stenosis (which hinders the passage of food from the stomach to the duodenum);
• if the patient has cardiovascular diseases;
• if the patient has epilepsy;
• if the patient has hyperthyroidism;
• if the patient has low blood pressure.

In elderly patients (over 65 years of age) taking cinnarizine, the doctor may recommend periodic examinations.
The anticholinergic effect of the drug may provoke an attack of glaucoma.
The drug may affect the results of allergy tests. It should not be taken for at least 4 days before such tests are performed.
Children
The safety of Cinnarizinum Aflofarm in children has not been established.
Cinnarizinum Aflofarm with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
If the patient is taking any of the following medicines, they should inform their doctor:

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

If the patient is unsure whether they are taking any of the above medicines, they should contact their doctor or pharmacist.
Cinnarizinum Aflofarm with food and alcohol
This medicine should be taken after a meal.
Alcohol should not be consumed during treatment with this medicine.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
This medicine should be used during pregnancy and breastfeeding only if the doctor considers it absolutely necessary.
Use of this medicine is not recommended during pregnancy and breastfeeding.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery. If drowsiness occurs, especially at the beginning of treatment, the patient should not drive or operate machinery.
Cinnarizinum Aflofarm contains monohydrate lactose and sodium
The medicine contains 100 mg of monohydrate lactose in each tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains 0.105 mg of sodium in each tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Cinnarizinum Aflofarm

This medicine should always be taken as directed by a physician. In case of doubt, consult a doctor or pharmacist.
The medicine is taken orally.

Dosage
Adults
For vestibular disorders:
1 tablet 3 times daily (daily dose 75 mg). At the beginning of treatment, doses twice as high may be used.

For motion sickness:
1 tablet 2 hours before travel, then if necessary 1 tablet every 8 hours during the day of travel.

Treatment duration should not exceed 3 months. The medicine should be taken after meals.

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 insufficiency, dosage adjustment is not required. However, in patients with hepatic insufficiency, the physician may consider adjusting the dosage.

Taking more than the recommended dose of Cinnarizinum Aflofarm
If more tablets have been taken than recommended, consult a doctor immediately.
Symptoms of overdose may include vomiting, drowsiness, coma, tremor, and decreased arterial blood pressure.

Missed dose of Cinnarizinum Aflofarm
Do not take a double dose to make up for a missed dose. Continue taking the medicine as prescribed without increasing the next dose.

If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:

• drowsiness;
• gastrointestinal disturbances;
• headache;
• dry mouth;
• sweating;
• allergic reactions.

With long-term treatment, rare cases may occur such as:

• weight gain; or very rare:
• lichen planus;
• lupus-like skin lesions;
• cholestatic jaundice (occurring as a result of impaired bile flow).

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

• muscle stiffness;
• reduced facial expression;
• bradykinesia;
• motor restlessness;
• involuntary muscle contractions and involuntary movements (sometimes associated with depression);
• hypotension.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Cinnarizinum Aflofarm

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep 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 stated month.
Markings on the blister:
Lot - batch number
EXP - expiry date
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Cinnarizinum Aflofarm contains

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

What Cinnarizinum Aflofarm looks like and contents of the pack
Cinnarizinum Aflofarm is in the form of tablets.
Pack: 50 tablets in a cardboard box.
Marketing Authorisation 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