NOTICE
ANSM - Updated on : 13/12/2023
Name of medicinal product
METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam
Metopimazine
Box
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
You must always take this medicine exactly as instructed in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well after 2 days.
What does this leaflet contain?
1. What is METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam and what is it used for?
2. What do I need to know before taking METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, Laspartam-sweetened orodispersible tablet?
3. How do I take METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam?
4. What are the possible side effects?
5. How to store METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam?
6. Package contents and other information.
1. WHAT IS METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: OTHER ANTIEMETICS. ATC code: A04AD05.
This drug is an antiemetic.
METOPIMAZINE VIATRIS CONSEIL is indicated for the short-term treatment of nausea and vomiting not accompanied by fever, in adults and children over 6 years of age.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet, sweetened with laspartam?
Never take METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam:
- if you are allergic to metopimazine or any of the other ingredients listed in section 6,
- if you have glaucoma (an eye condition characterized by increased pressure in the eye),
- in case of urinary difficulties of prostatic origin.
Warnings and precautions
Ask your doctor, pharmacist or nurse before taking METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet, sweetened with laspartam.
This medicine contains metopimazine. Do not combine with other medicines containing metopimazine, so as not to exceed the maximum recommended daily dose(see Dosage section).
In elderly subjects, or in cases of serious liver or kidney disease, the appearance of drowsiness or dizziness may indicate an overdose: stop taking the drug and consult your doctor.
- The consumption of alcoholic beverages during treatment is not recommended.
- For children under 6, use the drop form.
If nausea and vomiting persist for more than 2 days, or in the event of insufficient efficacy or other symptoms, do not continue treatment without consulting your doctor or pharmacist.
Children and adolescents
Not applicable.
Other medicines and METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet, sweetened with laspartam
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
IN ORDER TO AVOID INTERACTIONS BETWEEN MEDICATIONS, IT IS ESSENTIAL TO REPORT ANY OTHER CURRENT TREATMENT TO YOUR DOCTOR OR PHARMACIST: in particular, avoid combining with alcohol, as this combination increases the sedative effect.
METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam with food, drink and alcohol
The consumption of alcoholic beverages during treatment is not recommended.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
This medicine should be used with caution by pregnant or breast-feeding women. In general, ask your doctor or pharmacist for advice before taking any medicine.
Driving vehicles and operating machinery
Patients' attention is drawn to the risk of drowsiness, particularly in drivers of vehicles and users of machines.
This medicine contains 2 mg daspartam per dose.
METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam contains laspartam, a source of phenylalanine°. May be dangerous for people with phenylketonuria (PKU), a rare genetic disorder characterized by accumulation of phenylalanine that cannot be eliminated properly.
3. HOW DO I TAKE METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet, sweetened with laspartam?
Always take this medicine exactly as instructed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Dosage should be adjusted according to the severity and timing of digestive disorders.
Discontinue treatment as soon as symptoms disappear.
In adults and children, the duration of treatment without medical advice should not exceed 2 days.
Adults:
The maximum recommended dose is 30 mg/day,i.e. a daily dose of up to 4 orodispersible tablets taken 4 times a day, i.e. take 1 orodispersible tablet at the onset of symptoms, and repeat if necessary if symptoms persist or reappear, up to a maximum of 4 times a day.
Children over 6 years of age:
The maximum recommended dose is 15 mg/day,i.e. a maximumdaily dose of 2 orodispersible tablets divided into 2 doses per day, i.e. take 1 orodispersible tablet at the time of symptoms, and repeat if necessary if symptoms persist or reappear, up to a maximum of 2 per day.
Method of administration
This drug is administered orally.
It should preferably be taken 15 minutes before meals, with a minimum interval of 4 to 6 hours between 2 administrations.
The orodispersible tablet is deposited on the tongue, where it disintegrates almost immediately (do not chew).
If you have taken more METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam than you should have :
Consult your doctor or pharmacist immediately.
If you forget to take METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam :
Do not take a double dose to make up for the one you forgot to take.
If you stop taking METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet, sweetened with laspartam :
Not applicable.
If you have any further questions about the use of this medicine, please ask your doctor, pharmacist or nurse.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Rarely observed in less than 1 in 1,000 patients and in more than 1 in 10,000 patients:
- allergic reactions, including generalized allergic reactions with respiratory discomfort;
- drowsiness;
- hypotension-like discomfort when changing position (lying/standing), particularly with the injectable form;
- dry mouth;
- cessation of menstruation, abnormal milk flow, breast development in men, excess prolactin (hormone causing lactation);
- eruption of pimples, redness of the skin;
- impotence, frigidity.
Very rarely observed in less than 1 in 10,000 patients:
- muscle contractures, which may lead to difficulty in performing certain movements (walking, writing, speaking, etc.) or to abnormal movements;
- constipation;
- visual disturbances;
- urinary retention.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you contribute to providing more information on drug safety.
5. HOW TO CONSERVE METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet, sweetened with laspartam?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging. The expiration date refers to the last day of that month.
No special storage precautions are required.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. This will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet sweetened with laspartam contains
- The active substance is :
Metopimazine................................................................................................................. 7.5 mg
per orodispersible tablet.
The other excipient components are : Glycerol dibehenate, Colloidal anhydrous silica, Mint flavor, Aspartam(E951), Crospovidone type A, Microcrystalline cellulose, Mannitol(E451), Magnesium stearate.
What is METOPIMAZINE VIATRIS CONSEIL 7.5 mg SUGAR-FREE, orodispersible tablet, sweetened with laspartam, and what does it contain?
This medicine takes the form of a pale yellow to off-white, flat, bevel-edgedorodispersible tablet , engraved with "MT" on one side.
Box of 8.
Marketing authorization holder
VIATRIS SANTE
1 Rue de Turin
69007 Lyon, France
Marketing authorization holder
VIATRIS SANTE
1 Rue de Turin
69007 Lyon
Manufacturer
CENTER SPECIALITES PHARMACEUTIQUES
ZAC DU SUZOT
35 RUE DE LA CHAPELLE
63450 SAINT AMANT TALLENDE
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
Health education advice
Nausea and vomiting are common symptoms: they correspond to the body's defense reflex.
They generally disappear within 1 to 2 days, if you follow simple hygiene rules: don't stop drinking, if taking a drink doesn't trigger vomiting, and eat gradually as tolerated.
If the symptoms of nausea and vomiting are too troublesome, you can continue to take the drug at the recommended dosage.
However, if other symptoms appear (pain and fever in particular), or if nausea and vomiting are very frequent, worsen or persist for more than 2 days, CONSULT YOUR DOCTOR.