Leaflet: information for the useruser

Dizinel 20 mg/40 mg film-coated tablets

cinarizina/dimenhidrinato

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Dizinel is and what it is used for

2. What you need to know before you start taking Dizinel

3. How to take Dizinel

4. Possible side effects

5. Storage of Dizinel

6. Contents of the pack and additional information

This medication contains two active principles. One of them is cinnarizine, the other, dimenhydrinate. These two substances belong to two different groups of medications. Cinnarizine is part of a group called calcium antagonists. Dimenhydrinate belongs to a group called antihistamines.

Both substances act by reducing the symptoms of vertigo (a sensation of dizziness or feeling of spinning) and nausea (sensation of wanting to vomit). When these two substances are combined, they are more effective than each one used separately.

This medication is used for the treatment of different types of vertigo in adults. Vertigo can have different causes. The use of this medication may help you perform daily activities that are difficult for you when you have vertigo.

Do not take Dizinel:

-if you are allergic to cinnarizine, dimenhydrinate, or diphenhydramine, or to any of the other ingredients of this medication (listed in section 6).

-if you are allergic to any other antihistamine (such as astemizole, chlorpheniramine, and terfenadine, used as allergy medications). Do not take this medication unless it has been prescribed by your doctor;

- if you have angle-closure glaucoma (a specific type of eye disease);

- if you have epilepsy;

- if you have increased intracranial pressure (e.g., due to a tumor);

- if you have a problem with alcohol abuse;

- if you have prostate problems that make urination difficult;

- if you have liver or kidney insufficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication if you have:

- high or low blood pressure;

- increased intraocular pressure;

- intestinal obstruction;

- enlarged prostate;

- hyperthyroidism;

- severe coronary disease;

- Parkinson's disease.

This medication may worsen the condition of these diseases. However, this medication may be suitable for you, but your doctor must take these facts into account.

Other medications and Dizinel

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication

Cinnarizine/dimenhydrinate may interact with other medications you are using.

This medication may cause drowsiness and drowsiness when taken with one of the following medications:

- barbiturates (medications used frequently to calm you);

- narcotic analgesics (strong pain relievers, such as morphine);

- tranquilizers (a type of medication used to treat depression and anxiety);

- monoamine oxidase inhibitors (used to treat depression and anxiety).

This medication may increase the effects of the following medications:

- tricyclic antidepressants (used to treat depression and anxiety);

- atropine (a medication that relaxes muscles and is used frequently to examine the eyes);

- ephedrine (may be used to treat cough and nasal congestion);

- medications taken to lower blood pressure.

Procarbazine (a medication used to treat certain types of cancer) may increase the effect of cinnarizine/dimenhydrinate.

Aminoglycosides (a type of antibiotic) may damage the inner ear. When taking this medication, you may not notice that this damage is occurring.

Do not take cinnarizine/dimenhydrinate in combination with medications used to treat arrhythmias.

This medication may also alter the way your skin reacts to allergy tests.

Taking Dizinel with food and drinks

This medicationmay cause indigestion, which can be reduced by taking the tablets after meals. Do not take alcohol during treatment with this medication as it may cause drowsiness or drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication

Dizinel should not be used during pregnancy or breastfeeding.

Driving vehicles and operating machinery

Dizinel may cause drowsiness. If you feel drowsy, do not drive or operate machinery

This medication contains less than 23 mg of sodium (1 mmol) per dose; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet taken three times a day. Swallow the tablet with a small amount of liquid after meals.

This medication is usually taken for a period of up to 4 weeks. Your doctor will inform you if you need to extend the treatment with Dizinel.

If you take more Dizinel than you should

If you accidentally take too many tablets or a child ingests them, consult a doctor immediately.

If you take too much of this medication, you may feel extremely tired, dizzy, or shaky. Your pupils may dilate, and you may have difficulty urinating. You may experience a dry mouth, a red face, and an increased heart rate. You may also have a fever, headache, or sweating.

If you have taken a large amount of this medication, you may experience seizures, hallucinations, high blood pressure, feel shaky or excited, and have difficulty breathing. You may fall into a coma.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Dizinel

If you forget to take a Dizinel tablet, simply forget about that dose. Take the next Dizinel tablet at the time you usually take it. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Dizinel

Do not stop taking Dizinel before your doctor tells you to. If you stop treatment too soon, you are likely to experience symptoms of vertigo (dizziness and the sensation of 'spinning') again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Frequent side effects(affect up to 1 in 10 patients):

• drowsiness
• dry mouth
• headache
• stomach pain

These side effects are usually mild and may disappear within a couple of days even if you continue to take this medicine.

Less frequent side effects(affect up to 1 in 100 patients):

• sweating
• skin redness
• indigestion
• nausea (feeling of wanting to vomit)
• diarrhea,
• anxiety
• muscle cramps
• memory loss,
• tinnitus (ringing in the ear)
• paresthesia (tingling in the hands or feet)
• shakiness.

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

• vision problems
• allergic reactions (e.g. skin reactions)
• light sensitivity
• difficulty urinating.

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

• the white blood cell and platelet count may be reduced and the red blood cell count may be drastically reduced, which may cause weakness, bruising or increase susceptibility to infections.

If you experience infections with fever and a serious deterioration of your general health, consult your doctor.

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

• weight gain
• constipation
• sensation of chest oppression
• jaundice (yellow discoloration of the skin or white of the eye caused by liver or blood problems)
• worsening of angle-closure glaucoma (a eye disease with increased intraocular pressure), involuntary movements
• unusual excitement and agitation (especially in children)
• severe skin reactions.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister packaging and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dizinel

• The active principles are: cinnarizine 20 mg and dimenhydrinate 40 mg.
• The other components are: microcrystalline cellulose, sodium croscarmellose, cornstarch, hypromellose, anhydrous colloidal silica, talc, and magnesium stearate.

Appearance of Dizinel and content of the packaging

Dizinel tablets are round, biconvex, white or off-white tablets with a diameter of 8 mm.

They are presented in packaging of 20, 50, and 100 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

ITALFARMACO, S.A.

San Rafael, 3, 28108 Alcobendas (Madrid). Spain

Responsible for manufacturing

Medochemie Ltd, Central Factory, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus

Or

Medochemie Ltd,Factory AZ, 2 Michael Erakleous Street, Agios Athanassios Industrial Area, Agios Athanassios, 4101 Limassol, Cyprus

Last revision date of this leaflet: September2019

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.