Dizinel 20 mg/40 mg tablets EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Dizinel 20 mg/40 mg tablets EFG
cinnarizine/dimenhydrinate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Dizinel is and what it is used for
- What you need to know before taking Dizinel
- How to take Dizinel
- Possible side effects
- How to store Dizinel
- Contents of the pack and other information
1. What Dizinel is and what it is used for
This medicine contains two active substances. One of them is cinnarizine, the other is dimenhydrinate. These two substances belong to two different groups of medicines. Cinnarizine belongs to a group called calcium antagonists. Dimenhydrinate belongs to a group known as antihistamines.
Both substances work by reducing symptoms of vertigo (a sensation of dizziness or of "spinning") and nausea (feeling the urge to vomit). When these two substances are combined, they are more effective than each one used separately.
This medicine is used for the treatment of different types of vertigo in adults. Vertigo may have various causes. Using this medicine may help you carry out daily activities that become difficult when you have vertigo.
2. What you need to know before starting to take Dizinel
Do not take Dizinel:
- if you are allergic to cinnarizine, dimenhydrinate, or diphenhydramine, or to any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to any other antihistamine (e.g., astemizole, chlorpheniramine, or terfenadine, used as antiallergic medicines). Do 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 tumor);
- if you have alcohol abuse problems;
- if you have prostate problems that make urination difficult;
- if you have liver or kidney failure.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take this medicine if you have:
- high or low blood pressure;
- increased intraocular pressure;
- intestinal obstruction;
- enlarged prostate;
- overactive thyroid;
- severe coronary artery disease;
- Parkinson's disease.
The use of this medicine may worsen these conditions. However, this medicine may still be suitable for you, but your doctor must take these factors into account.
Other medicines and Dizinel
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Cinnarizine/dimenhydrinate may interact with other medicines you are taking.
This medicine may cause tiredness and drowsiness when taken together with any of the following medicines:
- barbiturates (medicines frequently used to calm you);
- narcotic analgesics (strong pain relievers, such as morphine);
- tranquilizers (a type of medicine used to treat depression and anxiety);
- monoamine oxidase inhibitors (used to treat depression and anxiety).
This medicine may increase the effects of the following medicines:
- tricyclic antidepressants (used to treat depression and anxiety);
- atropine (a medicine that relaxes muscles and is frequently used for eye examinations);
- ephedrine (may be used to treat cough and nasal congestion);
- medicines taken to lower blood pressure.
Procarbazine (a medicine used to treat certain types of cancer) may increase the effect of cinnarizine/dimenhydrinate.
Aminoglycosides (a type of antibiotic) can damage the inner ear. While taking this medicine, you may not notice that this damage is occurring.
Do not take cinnarizine/dimenhydrinate in combination with medicines used to treat heart rhythm disorders (antiarrhythmics).
This medicine may also alter how your skin reacts to allergy tests.
Taking Dizinel with food and drinks
This medicine may cause indigestion, which can be reduced by taking the tablets after meals. Do not drink alcohol during treatment with this medicine, as it may cause tiredness or drowsiness.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
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 medicine contains less than 23 mg of sodium (1 mmol) per dose unit; therefore, it is essentially "sodium-free."
3. How to take Dizinel
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, 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 medicine is usually taken for a period of up to 4 weeks. Your doctor will inform you if treatment with Dizinel should be prolonged.
If you take more Dizinel than you should
If you accidentally take too many tablets or a child swallows them, consult a doctor immediately.
If you take too much of this medicine, you may feel very tired, dizzy, or shaky. Your pupils may become dilated and you may be unable to urinate. You may experience dry mouth, flushed face, and your heartbeat may become faster. You may also develop fever, headache, or sweating.
If you have taken a large amount of this medicine, you may experience seizures, hallucinations, high blood pressure, feel shaky or agitated, and have difficulty breathing. You may even fall into a coma.
In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, stating the name of the medicine and the amount ingested.
If you forget to take Dizinel
If you forget to take a Dizinel tablet, simply skip that dose. Take the next Dizinel tablet at your usual time. Do not take a double dose to make up for forgotten doses.
If you stop taking Dizinel
Do not stop taking Dizinel before your doctor tells you to do so. If you stop treatment too early, it is likely that your vertigo symptoms (dizziness and the sensation of 'spinning') will return.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets 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 few days, even if you continue taking this medicine.
Uncommon side effects (affect up to 1 in 100 patients):
- sweating
- skin redness
- indigestion
- nausea (feeling of needing to vomit)
- diarrhea
- nervousness
- cramps
- memory loss
- tinnitus (ringing in the ear)
- paresthesia (tingling in hands or feet)
- tremor
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):
- white blood cell and platelet counts may be reduced and red blood cell count may drop sharply, which could cause weakness, bruising, or increased susceptibility to infections.
If you develop infections with fever and a serious deterioration in your general health, consult your doctor.
Among the possible reactions (frequency cannot be estimated from available data) that may occur with this type of medicine are:
- weight gain
- constipation
- feeling of tightness in the chest
- jaundice (yellowing of the skin or whites of the eyes caused by liver or blood disorders)
- worsening of closed-angle glaucoma (an eye disease with increased intraocular pressure), uncontrolled movements
- unusual excitement and agitation (especially in children)
- severe skin reactions
Reporting of side effects
If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es
By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Dizinel
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and on the carton after EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Dizinel
- The active substances are: cinnarizine 20 mg and dimenhydrinate 40 mg.
- The other components are: microcrystalline cellulose, sodium croscarmellose, corn starch, hypromellose, anhydrous colloidal silica, talc, and magnesium stearate.
Appearance of Dizinel and contents of the pack
Dizinel tablets are round, biconvex, white or almost white tablets, 8 mm in diameter.
They are available in packs containing 20, 50, and 100 tablets.
Only certain 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 most recent review of this leaflet: September 2019
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.