Package leaflet: Information for the user

Stabivert 20 mg/40 mg tablets

cinnarizine/dimenhydrinate
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Stabivert is and what it is used for

Stabivert contains two active substances: cinnarizine and dimenhydrinate. These two substances belong to different groups of medicines. Cinnarizine belongs to the so-called calcium antagonists, while dimenhydrinate belongs to the so-called antihistamines.
Both substances act by reducing the symptoms of vertigo (a sensation of dizziness or spinning) and nausea (feeling unwell). When these two substances are used in combination, they are more effective than each of them used alone.
Stabivert is used for the treatment of various types of vertigo in adults. Vertigo may have different causes. The use of Stabivert can help in performing daily activities that are made difficult by vertigo.

2. What you need to know before taking Stabivert

Do not take Stabivert

if you are allergic to cinnarizine, dimenhydrinate or diphenhydramine, to other antihistamines (such as astemizole, chlorpheniramine and terfenadine, used as antiallergic medicines), or to any of the other ingredients of this medicine (listed in section 6)
if you have closed-angle glaucoma (a specific type of eye disorder)
if you have epilepsy
if you have increased pressure inside the brain (e.g. due to a tumour)
if you have a history of alcohol abuse
if you have prostate problems causing difficulty in urination
if you have liver or kidney failure.

Warnings and precautions
Talk to your doctor or pharmacist before taking Stabivert if you have:

hypotension or hypertension
increased intraocular pressure
intestinal obstruction
enlarged prostate
overactive thyroid
severe heart disease
Parkinson's disease.

The use of Stabivert may worsen these conditions. Although Stabivert might still be appropriate for you, your doctor must take these factors into account.
Stabivert may also alter your skin's response to allergy tests.
Children and adolescents
The safety and efficacy of Stabivert in children and adolescents under 18 years of age have not been established. No data are available.
Other medicines and Stabivert
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Stabivert can interact with other medicines you are taking.
When taken together with the following medicines, Stabivert may cause tiredness or drowsiness:

barbiturates (medicines often taken to induce a calm state)
narcotic analgesics (strong painkillers such as morphine)
tranquillisers (a type of medicine used to treat depression and anxiety)
monoamine oxidase inhibitors (used to treat depression and anxiety).

Stabivert may enhance the effects of the following medicines:

tricyclic antidepressants (used to treat depression and anxiety)
atropine (a medicine that relaxes muscles and is often used in eye examinations)
ephedrine (may be used to treat cough or nasal congestion)
procarbazine (a medicine used to treat certain types of cancer)
medicines used to lower blood pressure.

Aminoglycosides (a type of antibiotic) can damage the inner ear. If you are taking Stabivert, you may not notice such damage.
You must not take Stabivert with medicines used to correct heart rhythm problems (antiarrhythmics).
Stabivert with food, beverages and alcohol
Do not drink alcohol during treatment with Stabivert, as it may cause tiredness or drowsiness.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Stabivert may cause drowsiness. If this occurs, you must not drive or operate machinery.
Stabivert contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Stabivert

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet three times a day.
Route of administration
Stabivert is for oral use.
The tablet should be swallowed whole with some liquid, without chewing.
Stabivert may cause indigestion, which can be reduced by taking the tablets after meals.
Stabivert is usually taken for up to 4 weeks. Your doctor will advise you if it is necessary to
take Stabivert for a longer period.
If you take more Stabivert than you should
Seek urgent medical advice if you have accidentally taken too many tablets or if a child has
ingested any.
Excessive intake of Stabivert may cause severe fatigue, drowsiness, and instability. Your
pupils may dilate and you may be unable to urinate.
You may experience dry mouth, facial flushing, increased heart rate, fever, sweating, and headache.
If you take a massive dose of Stabivert, you may develop seizures, hallucinations, hypertension, tremors,
excitability, and breathing difficulties. You may fall into a coma.
If you forget to take Stabivert
If you forget to take a tablet, skip that dose. Take the next tablet at your usual time. Do not take a double
dose to make up for the missed tablet.
If you stop taking Stabivert
Do not stop taking Stabivert unless your doctor tells you to. If you stop treatment too early, symptoms of
vertigo (dizziness and sensation of spinning) are likely to return.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Common side effects (may affect up to 1 in 10 people): drowsiness, dry mouth, headache, and stomach pain. These are usually mild and disappear within a few days, even while continuing treatment with Stabivert.
Uncommon side effects (may affect up to 1 in 100 people): sweating, skin flushing, indigestion, nausea (feeling unwell), diarrhoea, nervousness, cramps, forgetfulness, tinnitus (ringing in the ears), paraesthesia (tingling of hands or feet), tremor.
Rare side effects (may affect up to 1 in 1,000 people): visual disturbances, allergic reactions (e.g. skin reactions), light sensitivity, and difficulty in urination.
Very rare side effects (may affect up to 1 in 10,000 people): reduction in white blood cell and platelet counts, and a marked decrease in red blood cell count, which may cause weakness, bruising, or increase the likelihood of developing infections. If you experience infections with fever and a serious worsening of your general health, consult your doctor and inform him/her about the medicine you are taking.
Other possible reactions [frequency not known (frequency cannot be estimated from the available data)] that may occur with this type of medicine include: weight gain, constipation, chest tightness, jaundice (yellowing of the skin or whites of the eyes due to blood or liver problems), worsening of closed-angle glaucoma (an eye condition with increased eye pressure), uncontrollable movements, unusual excitement and restlessness (particularly in children), and severe skin reactions.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Stabivert

Keep this medicine out of the sight and reach of children.
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 that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Stabivert contains

The active substances are cinnarizine and dimenhydrinate. Each tablet contains 20 mg of cinnarizine and 40 mg of dimenhydrinate.
The other components are: microcrystalline cellulose, maize starch, sodium croscarmellose, hypromellose 2910 (6 mPa·s), colloidal anhydrous silica, magnesium stearate and talc.

Description of the appearance of Stabivert and pack sizes
Stabivert tablets are round, approximately 8 mm in diameter, and white to off-white in colour.
They are marked on one side with "V5" and are smooth on the other side.
Available in packs of 20, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
DMG Italia Srl
Via Laurentina Km 26.700
00071 Pomezia (RM)
Italy

Manufacturer
Torrent Pharma (Malta) Limited
Central Business Centre, Level 2,
Triq Hal Tarxien,
Gudja-GDJ 1907
Malta
Terapia SA
124 Fabricii Street
Cluj-Napoca, 400632
Romania

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Cinnarizin/Dimenhydrinat Torrent 20 mg/40 mg Tabletten
Italy: Stabivert
Poland: Aludran
Romania: LIVOSTIN 20 mg/40 mg tablets