NOTICE
ANSM - Last updated: 01/06/2017
Name of the medicinal product
VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame
Metopimazine.
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Please read this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· 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 experience no improvement or feel less well after 2 days.
What is in this leaflet?
1. What is VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartam and in which cases it is used?
2. What should I know before taking VOGALIB 7.5 mg WITHOUT SUGAR, oral lyophilisate sweetened with aspartame?
3. How to take VOGALIB 7.5 mg WITHOUT SUGAR, oral lyophilisate sweetened with aspartame?
4. What are the possible side effects?
5. How to store VOGALIB 7.5 mg WITHOUT SUGAR, oral lyophilisate sweetened with aspartame?
6. Package contents and other information.
1. WHAT VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartam AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group: OTHER ANTIEMETICS. ATC code: A04AD05.
This medication is an anti-emetic.
VOGALIB 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. BEFORE YOU TAKE VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame?
Do not take VOGALIB 7.5 mg WITHOUT SUGAR, oral lyophilisate sweetened with aspartame:
· glaucoma (an eye condition characterized by increased pressure in the eye),
· difficulty urinating with prostatic origin,
· if you are allergic (hypersensitive) to metopimazine or any of the excipients in this medication mentioned in section 6,
· phenylketonuria (a rare disease detected at birth), due to the presence of aspartame.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking VOGALIB 7.5 mg WITHOUT SUGAR, oral lyophilisate sweetened with aspartame .
DO NOT LEAVE TO CHILDREN
This medicine contains metopimazine. Do not combine it with other medicines containing it so as not to exceed the maximum recommended daily dose ( see section Dosage ).
In the elderly, or in severe liver or kidney disease, drowsiness or dizziness may indicate overdose: stop taking the medication, and consult your doctor.
· Alcoholic beverages during treatment are discouraged.
· In children under 6 years of age, use the gout form.
If nausea and vomiting persist for more than 2 days, or if there is insufficient efficacy or other symptoms, do not continue treatment without the advice of your doctor or pharmacist.
IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
NEVER LEAVE TO CHILDREN.
Children and Youth
Not applicable.
Other medicines and VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame
Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
IN ORDER TO AVOID INTERACTIONS BETWEEN SEVERAL MEDICINAL PRODUCTS, YOU MUST SIGNAL SYSTEMATICALLY ANY OTHER TREATMENT IN PROGRESS TO YOUR DOCTOR OR TO YOUR PHARMACIST: in particular to avoid the association with dopaminergic drugs (used in particular in the treatment of the symptoms of the disease of Parkinson), or even alcohol because of the increased sedative effect of their association.
VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame with food, drink and alcohol
Alcoholic beverages during treatment are not recommended.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
This medication should be used with caution in pregnant or lactating women. In general, you should seek advice from your doctor or pharmacist before taking any medication.
Driving and using machines
Patients' attention is drawn to the risk of drowsiness, particularly among vehicle drivers and machine users.
VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartam contains aspartam (source of phenylalanine).
3. HOW TO TAKE VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame?
Always take this medication exactly as prescribed in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
The dosage should be adapted according to the schedule and intensity of digestive disorders.
Discontinue treatment as soon as the 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, with a daily dose of 4 lyophilisates at most divided into 4 doses per day, ie taking oral lyophilisate at the time of symptoms, possibly renewed if the symptoms persist or reappear, up to 4 times per day maximum.
Child over 6 years:
The maximum recommended dose is 15 mg / day, ie a daily dose of 2 lyophilisates at most divided into 2 doses per day, ie taking 1 oral lyophilisate at the time of the symptoms, to be renewed if the symptoms persist or reappear, up to 2 per day maximum.
Administration mode
This medication is administered orally.
Preparation is preferably 15 minutes before meals with a minimum interval of 4 to 6 hours between 2 administrations.
The oral lyophilisate is taken:
· or after depositing on the language where its disintegration is quasi- immediate (do not chew),
· or after dissolution in half a glass of water, where its dispersion is instantaneous.
If you take more than VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartam you should:
Immediately consult your doctor or pharmacist.
If you forget to take VOGALIB 7.5 mg WITHOUT SUGAR, oral lyophilisate sweetened with aspartame:
Do not take a double dose to make up for a missed dose.
If you stop taking VOGALIB 7.5 mg WITHOUT SUGAR, oral lyophilisate sweetened with aspartame:
Not applicable.
If you have any further questions on the use of this medication, ask your doctor, pharmacist or nurse for more information.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine may cause side effects, although not everybody gets them.
Effects rarely seen 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;
· somnolence;
· hypotension-like discomfort when changing positions (elongated / standing) observed in particular with the injectable form;
· dry mouth;
· abnormal milk flow, breast development in humans, excess prolactin (hormone causing lactation);
· rash of the skin, redness of the skin;
· impotence, frigidity.
Very rarely seen in less than 1 in 10,000 patients:
· muscular contractions, which can lead to difficulties in performing certain movements (walking, writing, speech, ...) or abnormal movements;
· constipation;
· visual accommodation disorders;
· urinary retention.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame?
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
No special storage conditions.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What VOGALIB contains 7,5 mg WITHOUT SUGAR, oral lyophilisate sweetened with aspartame
· The active substance is:
Metopimazine ................................................. .................................................. 7.5 mg
For an oral lyophilisate.
The other components are: xanthan gum (Rhodigel 23), aspartame, sodium docusate, dextran 70, mannitol.
What is VOGALIB 7.5 mg SANS SUGAR, oral lyophilisate sweetened with aspartame and contents of the pack
This medication is in the form of an oral lyophilisate in a box of 8.
Marketing Authorization Holder
TEVA HEALTH
100-110, ESPLANADE DU GENERAL DE GAULLE
92931 PARIS LA DEFENSE CEDEX
Marketing Authorization Operator
PROCTER & GAMBLE PHARMACEUTICALS FRANCE
163-165, QUAI AULAGNIER
92600 ASNIERES-SUR-SEINE
Maker
GALIEN LPS
22 RUE EDME LABORDE
Business Park Nevers Saint Eloi
58000 NEVERS
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Advice
Nausea and vomiting are common symptoms: they correspond to a defensive reflex of the organism.
They generally disappear within 1 to 2 days, following simple hygiene rules: do not remove drinks, if their intake does not trigger vomiting, re-feed gradually according to the tolerance.
If nausea and vomiting are too troublesome, you can take this medicine at the recommended dosage.
However, if other symptoms appear (especially pains and fever), if nausea and vomiting are very common, worsen or persist beyond 2 days, CONSULT YOUR DOCTOR.