Verizina

Package Leaflet: Information for the User

Verizina 20 mg/40 mg tablets

Cinnarizine/dimenhydrinate
Equivalent medicine
Please read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What VERIZINA is and what it is used for

VERIZINA contains two active substances. One is cinnarizine and the other is dimenhydrinate.
These two substances belong to different groups of medicines. Cinnarizine belongs to the group of calcium antagonists,
while dimenhydrinate belongs to a group of medicines called antihistamines.
Both substances work by reducing 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.
VERIZINA is used to treat various types of vertigo in adults. Vertigo can have a number of different causes. The use of VERIZINA may help in carrying out daily activities that are made difficult by vertigo.

2. What you need to know before taking VERIZINA

Do not take VERIZINA:

• if you are under 18 years of age
• if you are allergic to cinnarizine, dimenhydrinate, diphenhydramine, or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to any other antihistamine (such as astemizole, chlorpheniramine, or terfenadine, used as antiallergic medicines). You must not take this medicine unless prescribed by your doctor
• if you have narrow-angle glaucoma (a specific type of eye disease)
• if you have epilepsy
• if you have increased intracranial pressure (e.g. due to a tumour)
• if you have a history of alcohol abuse
• if you have prostate problems causing difficulty in urinating
• if you have liver or kidney impairment.

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

• high or low blood pressure
• high intraocular pressure
• intestinal obstruction
• enlarged prostate
• overactive thyroid
• severe heart problems
• Parkinson's disease.

Use of VERIZINA may worsen these conditions. VERIZINA may still be suitable for you, but your doctor must take these factors into account.
Other medicines and VERIZINA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
VERIZINA may interact with other medicines you are taking.
Taking VERIZINA together with the following listed medicines may make you tired or drowsy:

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

VERIZINA 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 during 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 VERIZINA, you may not notice this damage.
Do not take VERIZINA with medicines used to correct heart rhythm problems (antiarrhythmics).
VERIZINA may also alter the skin's response to allergy tests.
VERIZINA with food, drinks and alcohol
VERIZINA may cause indigestion, which can be reduced by taking the tablets after meals.
Do not drink alcohol during treatment with VERIZINA, as it may cause tiredness or drowsiness.
Pregnancy, breastfeeding and fertility
Do not take VERIZINA if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding.
Driving and using machines
VERIZINA may cause drowsiness. If affected, do not drive or operate machinery.

3. How to use VERIZINA

Always take VERIZINA 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, taken after meals with some liquid.
Swallow the tablet whole without chewing it.
You will generally take VERIZINA for up to 4 weeks. Your doctor will tell you if you need to take VERIZINA for a longer period.

If you take more VERIZINA than you should
If you accidentally take too many tablets or if a child has ingested any, consult a doctor urgently.
Taking an excessive amount of VERIZINA may make you feel very tired, drowsy and unsteady. Your pupils may become dilated 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 VERIZINA, you may develop seizures, hallucinations, high blood pressure, tremors, agitation and breathing difficulties. You may go into a coma.

If you forget to take VERIZINA
If you forget to take a dose of VERIZINA, skip that dose. Take the next tablet at your usual time.
Do not take a double dose to make up for the forgotten tablet.

If you stop taking VERIZINA
Do not stop taking VERIZINA unless your doctor tells you to. If you stop treatment too early, your vertigo symptoms (sensation of dizziness and spinning) are likely to return.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Common side effects (may affect up to 1 in 10 people):

• drowsiness,
• dry mouth,
• headache,
• stomach ache. These are usually mild and disappear within a few days, even while continuing treatment with VERIZINA.

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 and/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,
• difficulty in urination.

Very rare side effects (may affect less than 1 in 10,000 people):

• reduction in the number of white blood cells and platelets,
• marked reduction in the number of red blood cells, which may cause weakness, bruising, or increased risk of developing infections. If you suffer from infections with fever and a serious worsening of your general health condition, consult your doctor and inform him/her about the medicine you are taking.

Other possible reactions (whose frequency cannot be estimated from the available data) that may occur with this type of medicine include:

• weight gain,
• constipation,
• feeling of 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 disease characterised by increased pressure inside the eye),
• uncontrolled movements,
• unusual excitement and restlessness (particularly in children),
• severe skin reactions.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VERIZINA

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
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 VERIZINA 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, pregelatinized starch, hypromellose, sodium croscarmellose, talc and magnesium stearate.

Description of the appearance of VERIZINA and package contents
VERIZINA tablets are white, round and convex in shape.
VERIZINA is available in packages containing 20 or 50 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Stewart Italia S.r.l., Via Larga, 15, 20122 Milan, Italy
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A. - Rua da Tapada Grande, n. 2, Abrunheira –2710-228
Sintra – Portugal
This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Italy: VERIZINA