Package leaflet: Information for the patient

Symtiver, 20 mg + 40 mg, tablets
Cinnarizinum + Dimenhydrinatum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
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.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Symtiver is and what it is used for
What you need to know before taking Symtiver
How to take Symtiver
Possible side effects
How to store Symtiver
Contents of the pack and other information

1. What Symtiver is and what it is 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 known as calcium antagonists. Dimenhydrinate belongs to a group of antihistamine medicines.
Both substances help reduce symptoms of vertigo (a sensation of dizziness or "spinning") and nausea. When both substances are used together, they are more effective than when used separately.
Symtiver is used in adults for the treatment of vertigo of various origins. Vertigo may have different causes. Treatment with Symtiver may help in performing daily activities that are impaired due to vertigo.

2. Important information before using Symtiver

When not to use Symtiver:

in patients under 18 years of age;
if the patient is allergic to cynarizine, dimenhydrinate or diphenhydramine, or to 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). This medicine should not be used without a doctor's recommendation;
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 tumour);
in patients who abuse alcohol;
in patients with urinary tract or prostate disorders which make urination difficult;
in patients with liver or kidney failure.

Warnings and precautions
Before starting to use Symtiver, discuss this with your doctor or pharmacist if the patient has:

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

Using Symtiver may worsen the patient's condition. Symtiver may still be suitable for the patient, but the doctor must take the above factors into account.
Symtiver with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Symtiver may interact with other medicines the patient is taking.
If Symtiver is used together with the following medicines, it may cause fatigue or drowsiness:

barbiturates (medicines often used as sedatives);
opioid analgesics, such as morphine (strong painkillers, such as morphine);
sedatives (medicines used in the treatment of depression and anxiety);
monoamine oxidase inhibitors (medicines used in the treatment of depression and anxiety).

Symtiver may intensify the effects of the following medicines:

tricyclic antidepressants (used in the treatment of depression and anxiety);
atropine (a muscle-relaxing medicine, often used during ophthalmological examinations);
ephedrine (may be used in the treatment of cough or nasal congestion);
procarbazine (a medicine used in the treatment of certain cancers);
medicines used to lower blood pressure.

Aminoglycosides (a type of antibiotic) can damage the inner ear. When Symtiver is used, such damage may go unnoticed.
Do not take Symtiver with medicines used to treat irregular heartbeat (antiarrhythmics). In addition, Symtiver may alter skin reactions to allergens during skin testing.
Symtiver with food, drink and alcohol
Symtiver may cause indigestion. This can be reduced by taking the tablets after meals. Do not drink alcohol while taking Symtiver, as it may cause fatigue and drowsiness.
Pregnancy and breastfeeding
Do not use Symtiver if the patient is pregnant or breastfeeding, or suspects she may be pregnant.
Driving and operating machinery
Symtiver may cause drowsiness. If this side effect occurs, the patient must not drive or operate machinery.
Sodium
This medicinal product contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Symtiver

This medicine should always be used exactly as directed by the doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The recommended dose of Symtiver is: 1 tablet taken three times daily after meals, with liquid. The tablet should be swallowed whole, without chewing. Symtiver is usually used for up to 4 weeks.
Your doctor will inform you if it is necessary to extend the treatment period with Symtiver.

Taking more Symtiver than recommended
If too many tablets are accidentally taken or if tablets are swallowed by a child, contact a doctor immediately.
If an excessive amount of Symtiver is taken, the patient may experience severe fatigue, dizziness and seizures. Pupil dilation and inability to urinate may occur. Dry mouth, sudden facial flushing, increased heart rate, fever, sweating and headache may appear.
If a very large amount of Symtiver is taken, seizures, hallucinations, high blood pressure, tremors, excitement and breathing difficulties may occur. Coma may develop.

Missing a dose of Symtiver
If a dose of Symtiver is missed, simply skip it. Take the next dose at the usual time. Do not take a double dose to make up for the missed tablet.

Stopping Symtiver
Do not stop taking Symtiver without your doctor's advice. If the medicine is stopped prematurely, symptoms of dizziness (dizziness and "spinning") may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If an infection with fever and a significant worsening of the patient's general condition occurs, consult a doctor and inform him about the medicine being taken.

Common adverse reactions (may affect up to 1 in 10 patients):

drowsiness;
dry mouth;
headache;
abdominal pain.

Such reactions are usually mild in nature and resolve within a few days, even if Symtiver continues to be used.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

sweating;
skin redness;
indigestion;
nausea;
diarrhoea;
nervousness;
cramps;
lack of concentration;
tinnitus (ringing in the ears);
paraesthesia (tingling of hands or feet);
tremors (shaking).

Rare adverse reactions (may affect up to 1 in 1,000 patients):

vision disturbances;
allergic reactions (e.g. skin reactions);
light sensitivity;
difficulty in passing urine.

Very rare adverse reactions (may affect up to 1 in 10,000 patients):

decrease in white blood cell and platelet counts;
significant decrease in red blood cell count, causing weakness, bruising and increased susceptibility to infections.

Other possible adverse reactions (frequency cannot be estimated from the available data), which may occur in connection with the use of 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 symptoms (an eye disease associated with increased intraocular pressure);
uncontrolled movements;
unusual excitement or restlessness (especially in children);
severe skin reactions.

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 of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Symtiver

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Symtiver contains

The active substances are cynarizine and dimenhydrinate. Each tablet contains 20 mg of cynarizine and 40 mg of dimenhydrinate.
The other ingredients are: microcrystalline cellulose, pregelatinized corn 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 approximately 8 mm.
Symtiver is available in packs containing 30, 60, 90 or 120 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel.: +48 22 822 93 06
e-mail: [email protected]

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, Abrunheira, 2710-089 Sintra, Portugal