Simtiver

Package Leaflet: Information for the Patient

Symtiver, 20 mg + 40 mg, Tablets

Cinnarizine + Dimenhydrinate

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 or pharmacist.
• This medicine has been prescribed for you. 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 or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Symtiver and what is it used for

Symtiver contains two active substances: cinnarizine and dimenhydrinate.
These substances belong to different groups of medicines. Cinnarizine belongs to a group of medicines called calcium antagonists. Dimenhydrinate belongs to a group of antihistamine medicines.
Both substances reduce the symptoms of dizziness (feeling of dizziness or "spinning") and nausea. If both substances are taken at the same time, they work more effectively than when taken separately.
Symtiver is used in adults to treat dizziness of various origins. There may be different causes of dizziness. Taking Symtiver can help with daily activities that are difficult due to dizziness.

2. Important information before taking Symtiver

When not to take Symtiver:

• in patients under 18 years of age;
• if the patient is allergic to cinnarizine, dimenhydrinate, or diphenhydramine, or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to any other antihistamine medicine (e.g., astemizole, chlorpheniramine, and terfenadine used as antiallergic medicines). Do not take this medicine without consulting a doctor;
• in patients with closed-angle glaucoma (a type of eye disease);
• in patients who have seizures (epilepsy);
• in patients with increased intracranial pressure (e.g., due to a tumor);
• in patients who abuse alcohol;
• in patients with urethral or prostate diseases that make urination difficult;
• in patients with liver or kidney failure.

Warnings and precautions

Before taking Symtiver, discuss it with your doctor or pharmacist if you have:

• low or high blood pressure;
• increased eye pressure;
• intestinal obstruction;
• enlarged prostate;
• hyperthyroidism;
• severe heart disease;
• Parkinson's disease.

Taking Symtiver may worsen your condition. Symtiver may still be suitable for you, but your doctor must consider the above factors.

Symtiver and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Symtiver may interact with other medicines you are taking.
If Symtiver is taken with the following medicines, it may cause drowsiness or sleepiness:

• barbiturates (medicines often used as sedatives);
• opioid painkillers, such as morphine (strong painkillers, such as morphine);
• sedatives (medicines used to treat depression and anxiety);
• monoamine oxidase inhibitors (medicines used to treat depression and anxiety).

Symtiver may enhance the effects of the following medicines:

• tricyclic antidepressants (used to treat depression and anxiety);
• atropine (a muscle relaxant, often used during eye exams);
• ephedrine (may be used to treat cough or cold);
• procarbazine (a medicine used to treat certain cancers);
• medicines used to lower blood pressure.

Aminoglycosides (a type of antibiotic) can damage the inner ear. When taking Symtiver, such damage may go unnoticed.
Do not take Symtiver with medicines used to treat irregular heart rhythms (antiarrhythmic medicines). Additionally, Symtiver may change skin reactions to allergens during skin tests.

Symtiver with food, drink, and alcohol

Symtiver may cause indigestion. This can be reduced by taking the tablets after a meal. Do not drink alcohol while taking Symtiver, as it may cause drowsiness and sleepiness.

Pregnancy and breastfeeding

Do not take Symtiver if you are pregnant or breastfeeding, or think you may be pregnant.

Driving and using machines

Symtiver may cause sleepiness. If this occurs, do not drive or operate machinery.

Sodium

This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Symtiver

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Symtiver is: 1 tablet taken three times a day after a meal and swallowed with a liquid. The tablet should be swallowed whole without chewing. Symtiver is usually taken for up to 4 weeks.
Your doctor will tell you if it is necessary to extend the treatment period with Symtiver.

Taking a higher dose of Symtiver than recommended

If you accidentally take more tablets than recommended or if a child swallows some tablets, contact your doctor immediately.
If you take too much Symtiver, you may experience extreme drowsiness, dizziness, and seizures. Your pupils may become dilated, and you may have difficulty urinating. You may also experience dry mouth, sudden flushing of the face, increased heart rate, fever, sweating, and headache.
If you take a very high dose of Symtiver, you may experience seizures, hallucinations, high blood pressure, tremors, agitation, and difficulty breathing.
Coma may occur.

Missing a dose of Symtiver

If you miss a Symtiver tablet, simply omit it. Take the next Symtiver tablet at the usual time. Do not take a double dose to make up for the missed tablet.

Stopping Symtiver treatment

Do not stop taking Symtiver without consulting your doctor. If you stop taking the medicine too early, the symptoms of dizziness (dizziness and "spinning") may return.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Symtiver can cause side effects, although not everybody gets them.
If you experience infection with fever and significant deterioration of your general condition, tell your doctor and inform them about the medicine you are taking.
Common side effects(may affect up to 1 in 10 people):

• drowsiness;
• dry mouth;
• headache;
• stomach pain. Such reactions are usually mild and disappear within a few days, even if Symtiver is continued. Uncommon side effects(may affect up to 1 in 100 people):
• sweating;
• flushing;
• indigestion;
• nausea;
• diarrhea;
• nervousness;
• cramps;
• confusion;
• ringing in the ears (tinnitus);
• paresthesia (tingling of hands or feet);
• tremors (shaking).

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

• vision disturbances;
• allergic reactions (e.g., skin reactions);
• sensitivity to light;
• difficulty urinating.

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

• decreased white blood cell and platelet count;
• significant decrease in red blood cell count, causing weakness, bruising, and increased risk of infection. Other possible side effects (frequency cannot be estimated from available data) that may occur with this type of medicine include:
• weight gain;
• constipation;
• feeling of pressure in the chest;
• jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders);
• worsening of closed-angle glaucoma (eye disease characterized by increased eye pressure);
• uncontrolled movements;
• abnormal excitement or restlessness (especially in children);
• severe skin reactions.

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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 30, 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 Symtiver

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
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 Symtiver contains

• The active substances are cinnarizine and dimenhydrinate. Each tablet contains 20 mg of cinnarizine and 40 mg of dimenhydrinate.
• The other ingredients are: microcrystalline cellulose, maize starch, hypromellose 2910 15 mPa·s, sodium croscarmellose, talc, and magnesium stearate.

What Symtiver looks like and contents of the pack

Symtiver is a round, convex, white tablet with a diameter of about 8 mm.
Symtiver is available in packs of 30, 60, 90, or 120 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: biuro@farmakinternational.pl

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira, 2710-089 Sintra, Portugal
Date of last revision of the leaflet:April 2025