Vogalib 7.5mg sugar free 8 oral lyophilisats

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

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