Dizinel 20 mg/40 mg comprimidos

Contents of the leaflet

1. Introduction
2. What Dizinel is and what it is used for
3. What you need to know before taking Dizinel
5. How to take Dizinel
7. Possible side effects
8. Storage of Dizinel
10. Package contents and additional information

Introduction

Package Leaflet: Information for theuser

Dizinel 20 mg/40 mg tablets EFG

cinarizine/dimethydinate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What Dizinel is and what it is used for
2. What you need to know before taking Dizinel
3. How to take Dizinel
4. Possible side effects
5. Storage of Dizinel
6. Package contents and additional information

1. What Dizinel is and what it is used for

This medication contains two active ingredients. One of them is cinarizine, the other is dimethydinate. These two substances belong to two different groups of medications. Cinarizine is part of a group called calcium antagonists. Dimethydinate belongs to a group called antihistamines.

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

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

2. What you need to know before taking Dizinel

Do not take Dizinel:

• if you are allergic to cinarizine, dimethydinate, or diphenhydramine, or to any of the other components of this medication (listed in section 6).
• if you are allergic to any other antihistamine (such as astemizole, chlorpheniramine, and terfenadine, used as anti-allergic medications). Do not take this medication unless your doctor has prescribed it for you;
• 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 tumor);
• if you have an alcohol abuse problem;
• if you have prostate problems that make urination difficult;
• if you have liver or kidney failure.

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 heart disease;
• Parkinson's disease.

The use of this medication may worsen the condition of these diseases. Nevertheless, this medication may be suitable for you, but your doctor should take these facts into account.

Other medications and Dizinel

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

Cinarizine/dimethydinate may interact with other medications you are using.

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

• barbiturates (medications frequently used 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 frequently used to examine the eyes);
• ephedrine (may be used to treat cough and decongest the nose);
• medications taken to lower blood pressure.

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

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 cinarizine/dimethydinate in combination with medications used to treat heart rhythm disorders (antiarrhythmics).

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

Taking Dizinel with food and drinks

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

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 and using machines

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 unit dose; it is essentially "sodium-free".

3. How to take Dizinel

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet three times a day. Swallow the tablet with a little liquid after meals.

This medication is usually taken for a period of up to 4 weeks. Your doctor will indicate if you need to extend 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 very tired, dizzy, or shaky. Your pupils may dilate, and you may be unable to urinate. You may feel dry mouth, red face, and your heart rate may increase. You may also have 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 Toxicology Information Service, phone 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 make up for the missed doses.

If you stop taking Dizinel

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

• drowsiness
• dry mouth
• headache
• stomach pain

These side effects are usually mild and disappear within a couple of days, even if you continue taking this medication.

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

• sweating
• redness of the skin
• indigestion
• nausea (feeling of wanting to vomit)
• diarrhea
• nervousness
• cramps
• memory loss
• tinnitus (ringing in the ear)
• paresthesia (tingling in the hands or feet)
• tremor

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

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

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

• the count of white blood cells and platelets may be reduced, and the number of red blood cells may decrease drastically, which can cause weakness, bruising, or increase the susceptibility to infections.

If you suffer from 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 medication are:

• weight gain
• constipation
• feeling of chest pressure
• jaundice (yellowing of the skin or the white of the eye caused by liver or blood problems)
• worsening of narrow-angle glaucoma (an eye disease with increased intraocular pressure), uncontrolled movements
• unusual excitement and agitation (especially in children)
• severe skin reactions

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Dizinel

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

Do not use this medication after the expiration date stated on the blister pack and carton after EXP. 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 wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Dizinel

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

Appearance of Dizinel and package contents

Dizinel tablets are round, biconvex, white or almost white, 8 mm in diameter.

They are available in packs of 20, 50, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

ITALFARMACO, S.A.

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

Manufacturer

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

Date of the last revision of this package leaflet: September 2019

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