Enzaver

PATIENT INFORMATION LEAFLET

CINNARIZINE AND DIMENHYDRINATE TECNIGEN 20 mg/40 mg tablets
cinnarizine/dimenhydrinate
Generic 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 may 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 Cinnarizine and Dimenhydrinate TecniGen is and what it is used for
2. What you need to know before taking Cinnarizine and Dimenhydrinate TecniGen
3. How to take Cinnarizine and Dimenhydrinate TecniGen
4. Possible side effects
5. How to store Cinnarizine and Dimenhydrinate TecniGen
6. Contents of the pack and other information

1. What Cinnarizine and Dimenhydrinate TecniGen is and what it is used for

Cinnarizine and Dimenhydrinate TecniGen contains two active substances, cinnarizine and dimenhydrinate.
These two substances belong to different groups of medicines. Cinnarizine belongs to the so-called
calcium channel blockers, while dimenhydrinate belongs to a group of medicines called
antihistamines.
Both substances act by reducing symptoms of vertigo (a sensation of dizziness or spinning) and nausea (feeling unwell). When these two substances are used together, they are more effective than either one used alone.
Cinnarizine and Dimenhydrinate TecniGen is used to treat various types of vertigo in adults. Vertigo may have a number of different causes. The use of Cinnarizine and Dimenhydrinate TecniGen can help you carry out daily activities that may be difficult due to vertigo.

2. What you need to know before taking Cinnarizine and Dimenhydrinate TecniGen

Do not take Cinnarizine and Dimenhydrinate TecniGen:

• 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)

1/6

• if you are allergic to any other antihistamines (such as astemizole, chlorpheniramine, or terfenadine, used as antiallergic medicines). You must not take this medicine unless prescribed by your doctor.
• if you have closed-angle glaucoma (a specific type of eye disease)
• if you have epilepsy
• if you have increased intracranial pressure (e.g. due to a brain tumour)
• if you have alcohol abuse problems
• if you have prostate problems causing difficulty in urinating
• • if you have hepatic or renal impairment.

Warnings and precautions
Talk to your doctor or pharmacist before taking Cinnarizine and Dimenhydrinate TecniGen if you have:

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

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

• barbiturates (medicines often taken to induce calmness)
• 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).

Cinnarizine and Dimenhydrinate TecniGen 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 Cinnarizine and Dimenhydrinate TecniGen, you may not notice such damage.
You must not take Cinnarizine and Dimenhydrinate TecniGen together with medicines used to correct heart rhythm problems (antiarrhythmics).
2/6
Cinnarizine and Dimenhydrinate TecniGen may also alter the skin's response to allergy tests.
Cinnarizine and Dimenhydrinate TecniGen with food, drinks and alcohol
Cinnarizine and Dimenhydrinate TecniGen may cause indigestion, which can be reduced by taking the tablets after meals. Do not drink alcohol during treatment with Cinnarizine and Dimenhydrinate TecniGen, as it may cause tiredness or drowsiness.
Pregnancy, breastfeeding and fertility
Do not take Cinnarizine and Dimenhydrinate TecniGen if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding.
Driving and using machines
Cinnarizine and Dimenhydrinate TecniGen may cause drowsiness. If this occurs, you must not drive or operate machinery.

3. How to take Cinnarizine and Dimenhydrinate TecniGen

Always take Cinnarizine and Dimenhydrinate TecniGen exactly as your doctor or pharmacist has instructed you.
If you are in any doubt, consult your doctor or pharmacist.
The recommended dose is 1 tablet three times a day, taken after meals with some liquid.
The tablet must be swallowed whole and not chewed.
You will usually take Cinnarizine and Dimenhydrinate TecniGen for no longer than 4 weeks. Your doctor will tell you if you need to take Cinnarizine and Dimenhydrinate TecniGen for a longer period.

If you take more Cinnarizine and Dimenhydrinate TecniGen than you should
If you accidentally take too many tablets or if a child has swallowed any, consult a doctor immediately.
Taking an excessive amount of Cinnarizine and Dimenhydrinate TecniGen 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 very large dose of Cinnarizine and Dimenhydrinate TecniGen, you may develop seizures, hallucinations, high blood pressure, feel shaky and agitated, and have difficulty breathing. You may fall into a coma.

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

3/6

If you stop taking Cinnarizine and Dimenhydrinate TecniGen
Do not stop taking Cinnarizine and Dimenhydrinate TecniGen 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 doubts about using 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 (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 Cinnarizina e Dimenidrinato TecniGen.

Uncommon side effects (affect up to 1 in 100 people):

• sweating,
• skin flushing,
• indigestion,
• nausea (feeling unwell),
• diarrhoea,
• nervousness,
• cramps,
• forgetfulness,
• tinnitus (ringing in the ears),
• paresthesia (tingling in hands and/or feet),
• tremor.

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

• visual disturbances,
• allergic reactions (e.g. skin rashes),
• light sensitivity,
• difficulty in urination.

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

• reduction in the number of white blood cells and platelets,
• a 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 severe worsening of your general health condition, consult your doctor and inform him/her about the medicines you are taking.

4/6

Other possible reactions (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 disease characterized by increased pressure within 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 or pharmacist. 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 Cinnarizine and Dimenhydrinate TecniGen

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 on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Cinnarizina e Dimenidrinato TecniGen contains
The active substances are: cinnarizine 20 mg and dimenhydrinate 40 mg.
The other components are: microcrystalline cellulose, pregelatinized starch, hypromellose,
sodium croscarmellose, talc and magnesium stearate.
Description of the appearance of Cinnarizina e Dimenidrinato TecniGen and pack contents
Cinnarizina e Dimenidrinato TecniGen tablets are white, round and convex.
They are available in packs of 20, 50 tablets.
Marketing Authorization Holder and Manufacturer
5/6
Marketing Authorization Holder: Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI)
Manufacturers
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra, Portugal
West Pharma – Produções de Especialidades Farmacêuticas, S.A.
Rua João de Deus, n.º 11, Venda Nova, 2700-486 Amadora, Portugal
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
Portugal: Cinarizina + Dimenidrinato Biofarmoz
Italy: Cinnarizina e Dimenidrinato TecniGen
6/6