
Ask a doctor about a prescription for DIZINEL 20 mg/40 mg TABLETS
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.
Contents of the package leaflet
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.
Do not take Dizinel:
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medication if you have:
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:
This medication may increase the effects of the following medications:
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".
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.
Like all medications, this medication can cause side effects, although not everyone experiences them.
Common side effects(affect up to 1 in 10 patients):
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):
Rare side effects(affect up to 1 in 1,000 patients):
Very rare side effects(affect up to 1 in 10,000 patients):
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:
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.
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.
Composition of Dizinel
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/.
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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for DIZINEL 20 mg/40 mg TABLETS – subject to medical assessment and local rules.