Package leaflet: Information for the patient

CINNARIZINUM HASCO
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 doubts, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are similar.
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

What Cinnarizinum Hasco is and what it is used for
Important information before taking Cinnarizinum Hasco
How to take Cinnarizinum Hasco
Possible side effects
How to store Cinnarizinum Hasco
Contents of the pack and other information

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

Cinnarizine prevents spasm of smooth muscles of blood vessels induced by various substances (e.g. adrenaline, noradrenaline, serotonin, dopamine) through a common mechanism involving reduction of calcium permeability across the membranes of smooth muscle cells, thereby inhibiting calcium influx into the cells. As a result, cinnarizine causes dilation of cerebral and peripheral blood vessels, thus improving circulation and tissue oxygenation.
Cinnarizine reduces stimulation of the vestibular system. It has antiemetic and mild sedative effects.
Cinnarizine is a histamine H-receptor antagonist and exhibits antiallergic activity.

Indications:

Treatment of symptoms of vestibular disorders and Ménière’s disease, such as vertigo, nausea, vomiting;
Prevention of motion sickness;
Treatment of symptoms of cerebral (e.g. vertigo, tinnitus, headaches) and peripheral circulatory disorders (e.g. intermittent claudication, Raynaud’s disease).

2. Important information before using Cinnarizinum Hasco

When not to use Cinnarizinum Hasco:

if the patient is allergic to cinnarizine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Cinnarizinum Hasco syrup, discuss this with your doctor,
pharmacist, or nurse.
Cinnarizine does not cause a significant reduction in blood pressure. However, caution should be exercised when using
cinnarizine in high doses (150 mg/day) or in patients with hypotension.
Patients with porphyria should not use cinnarizine.
In patients with Parkinson's disease, cinnarizine may be administered only if the expected benefits outweigh the potential risk of worsening the disease.

Cinnarizinum Hasco and other medicines
Tell your doctor or pharmacist about all medicines currently taken or taken recently, as well as any medicines the patient plans to use.
Cinnarizine enhances the sedative effect of central nervous system depressants such as
tricyclic antidepressants, anxiolytics, hypnotics, and opioid analgesics.
Antihistamines may suppress the skin reaction to allergens caused by histamine; therefore, cinnarizine should be discontinued a few days before performing skin tests.

Cinnarizinum Hasco with food, drink, and alcohol
Like other antihistamines, cinnarizine may cause gastric irritation. Therefore, it is recommended to take the medicine after meals.
Alcohol enhances the sedative and calming effects of cinnarizine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Cinnarizinum Hasco may cause drowsiness and impair psycho-motor performance, affecting the ability to drive or operate machinery.

Cinnarizinum Hasco contains 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 Cinnarizinum Hasco

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
This medicine is for oral use.
This medicine is intended for use in adults.
Vestibular disorders: 1 tablet three times daily.
Motion sickness: 1 tablet 2 hours before travel. Then, if necessary, 1 tablet every 8 hours during travel.
Do not exceed a dose of 150 mg (6 tablets) per day.
Use of a higher than recommended dose of Cinnarizinum Hasco
Symptoms of overdose include: vomiting, drowsiness, hypotension, gait disturbances, hallucinations,
stupor, and even coma, which may be preceded by increased excitation, including motor agitation,
nystagmus, marked increase in body temperature (hyperthermia), and convulsions. Severe symptoms
of overdose include: acute respiratory failure syndrome, metabolic acidosis, convulsions, acute
kidney failure, muscle tissue damage (rhabdomyolysis), and decreased body temperature (hypothermia).
There is no specific antidote for cinnarizine; however, in case of overdose, gastric lavage and administration
of activated charcoal may be performed.
If a higher than recommended dose of the medicine has been taken, seek immediate medical advice
from a physician or pharmacist.
Missed dose of Cinnarizinum Hasco
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
The medicine may cause drowsiness, fatigue, tiredness, and gastrointestinal disturbances, which are usually transient.
Dryness of the oral mucous membranes and increased thirst may occur.
Rarely reported are: weight gain, headache, excessive sweating, and allergic reactions.
In rare cases, worsening or onset of extrapyramidal disorders (e.g. tremor, muscle rigidity, hypokinesia – reduced mobility) and depression – mainly in elderly patients during long-term treatment – may be observed. In such cases, the medicine should be discontinued.
Very rarely reported are: lichen planus, skin lesions similar to those in lupus, and jaundice.
Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. 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:
Aleje Jerozolimskie 181C, 02 - 222 Warsaw
tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cinnarizinum Hasco

Store below 25°C. Keep in the original packaging to protect from light and moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the package and other information

What Cinnarizinum Hasco contains

The active substance is cinnarizine. Each tablet contains 25 mg of cinnarizine.
The other ingredients (excipients) are: lactose monohydrate, sodium carboxymethyl starch (type A), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.

What Cinnarizinum Hasco looks like and contents of the pack
Cinnarizinum Hasco is in the form of biconvex, white tablets with a smooth, uniform surface.
One pack contains 50 tablets.

Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Medicinal product information
tel. +48 22 742 00 22
e-mail: [email protected]