1. WHAT IS VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
This medicine is an anti-emetic.
Therapeutic indications
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. WHAT YOU SHOULD KNOW BEFORE TAKING VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartam
List of information needed before taking the medicine
Not applicable.
Contraindications
Do not take VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame in the following cases:
- - glaucoma (eye disease characterized by an increase in pressure in the eye),
- - difficulty in urinating due to prostate problems,
- - hypersensitivity to metopimazine or to any of the excipients,
- - phenylketonuria (a rare disease detected at birth), due to the presence of aspartame.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Be careful with VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartam:
Special warnings
KEEP OUT OF THE REACH OF CHILDREN
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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).
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In elderly people, or in cases of serious liver or kidney disease, the appearance of drowsiness or dizziness may indicate an overdose: stop taking the medicine and consult your doctor.
Precautions for use
- - The intake of alcoholic beverages during treatment is not recommended.
- - For children under 6 years of age, use the drop form.
If nausea and vomiting persist for more than 2 days, or in case of insufficient efficacy or occurrence of other symptoms, do not continue the treatment without the advice of your doctor or pharmacist.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
NEVER LEAVE WITHIN THE REACH OF CHILDREN.
Interactions with other drugs
Taking or using other medicines
TO AVOID POSSIBLE INTERACTIONS BETWEEN MEDICATIONS, IT IS NECESSARY TO REPORT ANY OTHER CURRENT TREATMENT TO YOUR DOCTOR OR PHARMACIST: in particular, avoid association with dopaminergic drugs (used in particular in the treatment of the symptoms of Parkinson's disease), or even alcohol because of the increased sedative effect of their association.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
This medicine should be used with caution by pregnant or breastfeeding women. In general, it is advisable to ask your doctor or pharmacist for advice before taking any medicine.
Sportsmen
Not applicable.
Effects on ability to drive and use machines
Driving and use of machines:
The attention of patients is drawn, particularly in drivers of vehicles and users of machines, to the risk of drowsiness.
List of excipients with a notorious effect
List of excipients with a notorious effect: aspartam (source of phenylalanine).
3. HOW TO TAKE VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartam
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Dosage
- - In adults:
1 oral lyophilisate at the time of symptoms, to be repeated if necessary if symptoms persist or reappear, without exceeding 4 lyophilisates per day (i.e. 30 mg of metopimazine).
- - In children over 6 years of age:
1 oral lyophilisate at the time of symptoms, to be repeated if necessary if symptoms persist or reappear, without exceeding 2 lyophilisates per day (i.e. 15 mg of metopimazine).
Method of administration
Oral administration
The oral lyophilisate is taken
- - either after depositing on the tongue where it disintegrates almost immediately (do not chew),
- - or after dissolution in half a glass of water, where its dispersion is instantaneous.
In adults and children, the duration of treatment without medical advice should not exceed 2 days.
Symptoms and instructions in case of overdose
If you have used more VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame than you should have: consult your doctor immediately.
Instructions in case of missed doses
Not applicable.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame is likely to have undesirable effects, although not everyone is subject to them:
- - drowsiness,
- - Muscle contractures, which may lead to difficulties in performing certain movements (walking, writing, speaking..), or abnormal movements.
- - Discomfort such as hypotension, when changing position (lying down/standing up) observed in particular with the injectable form,
- - dry mouth,
- - constipation,
- - visual accommodation disorders,
- - difficulty in urination,
- - impotence, frigidity,
- - cessation of menstruation, abnormal milk flow, breast development in men, excess of prolactin (hormone causing lactation),
- - rash, redness of the skin.
If you notice any side effects not listed in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.
5. HOW TO USE VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame?
Keep out of the reach and sight of children
Expiry date
Do not use VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame after the expiry date stated on the box.
Conditions of storage
No special storage precautions
If necessary, warnings against certain visible signs of deterioration
Do not dispose of the medicine in the sewer or with your household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.
6. ADDITIONAL INFORMATION
Complete list of active ingredients and excipients
What does VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartam, contain?
The active substance is:
Metopimazine ................................................................................................................................... 7.5 mg
For an oral lyophilisate.
The other components are: xanthan gum (Rhodigel 23), aspartam, docusate sodium, dextran 70, mannitol.
Pharmaceutical form and content
What is VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame and what does it contain?
This medicinal product comes in the form of an oral lyophilisate in a box of 8.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
TEVA SANTE
110, ESPLANADE DU GENERAL DE GAULLE
92931 PARIS LA DEFENSE CEDEX
Français
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