VOGALIB 7,5MG nausea vomiting LYOPHILISAT

VOGALIB 7,5MG LYOPHILISAT 8 View larger

3400936348288

Boehringer Boehringer

Vogalib is an anti-emetic drug (against nausea and vomiting). It is indicated for the treatment of acute nausea and vomiting without fever

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For warnings, precautions for use and contraindications, see the Vogalib Instructions for Use .

Description of the medication Vogalib Metopimazine

Vogalib is an anti-emetic drug (against nausea and vomiting). It is indicated in the short-term treatment of nausea and vomiting not accompanied by fever.

Reserved for adults and children over 6 years.

Composition

Metopimazine 7.5 mg for oral lyophilisate

Excipients: xanthan gum (Rhodigel 23), aspartame, sodium docusate, dextran 70, mannitol.

Excipient with a known effect: aspartam.

Dosage

Nausea and vomiting in children over 6 years of age : 1 to 2 lyophilisates per day.

Adults : 1 to 4 lyophilisates per day against nausea and vomiting .

Do not exceed 2 days of treatment without medical advice. Let melt on the tongue without chewing the mettopimazine tablets.

Cons-indications

Glaucoma, prostatic problems, phenylketonuria, allergy to one of the constituents, treatment with dopaminergic or levodopa

Oral use

Read attentively the notice of Vogalib

Capacity

Box of 8 oral lyophilisates.

Summary of Product Characteristics (ANSM)

Drug warnings

Be careful, the Vogalib over- the-counter medication is not a product like any other. Read the instructions for the Vogalib medication carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

Please inform your on-line pharmacist of ongoing treatments to identify any incompatibilities. The order validation form contains a custom message field provided for this purpose.

Click here to find the leaflet for this medicine on the website of the National Agency for the Safety of Medicines and Health Products.

Pharmacovigilance : Report an adverse reaction (s) associated with the use of a Vogalib drug

VIDAL OF THE FAMILY

VOGALIB

antiemetic

metopimazine

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS (summary)

VOGALIB without sugar: oral lyophilisate ; box of 8.
-

Laboratoire Procter and Gamble Pharmaceuticals France

COMPOSITION (summary)
p lyoph
metopimazine 7.5 mg
aspartame +

INDICATIONS (summary)
This drug is an antiemetic that belongs to the family of phenothiazines. It regulates the contraction of the muscles of the esophagus and of the stomach.
It is used in the short-term treatment of nausea and vomiting.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
This medication is prescribed for over-the-counter use and should not be used when severe pain or fever occurs simultaneously with vomiting.
Consult a physician if you have kidney failure, hepatic impairment and the elderly.
Avoid alcoholic beverages: increased risk of drowsiness.
This medication may induce somnolence, sometimes intense in some people. This drowsiness can be increased by taking alcohol or other sedative drugs. Driving and using hazardous machines are not recommended, especially within hours of taking the medication.
DRUG INTERACTIONS (summary)
This medication should not be combined with dopaminergic drugs.
Tell your doctor or pharmacist if you are taking an antihypertensive medication, a sedative, or a medication that may lower blood pressure.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
Only your doctor can appreciate the need for treatment during pregnancy.

Breastfeeding:
The occasional use of this medication during breastfeeding is possible in some cases. Consult your doctor.
DIRECTIONS FOR USE AND DOSAGE (summary)
This medication should be taken at the time of nausea.
The lyophilisate can be dissolved in half a glass of water or put directly on the tongue, without chewing it.

Usual dosage:

  • Adult: 1 lyophilisate, 1 to 4 times a day.
  • Children over 6 years: 1 lyophilisate, 1 or 2 times a day.
The duration of treatment is limited to 2 days without medical advice.
TIPS (summary)
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
During repeated vomiting, losses of water and mineral salts are important. They must be compensated by liquid foods (salted broths, soft drinks ...) taken in small quantities and regularly.
POSSIBLE ADVERSE EFFECTS (summary)
Rarely: somnolence, orthostatic hypotension , dry mouth, impotence , frigidity, stopping menstruation, nipple milk flow, increased breast volume (in both men and women), rash.
Exceptionally: spasm of the face, involuntary or inadequate movements, tremors, abnormal stiffness, disorders of accommodation , blockage of urine, constipation.


GLOSSARY (summary)


accommodation
"Focus" of the eye, allowing clear vision close up. Presbyopia is the most common disorder of accommodation; some drugs such as atropine may cause passenger accommodation problems.


adenoma of the prostate
Increase in the volume of the prostate gland located under the bladder of man. This increase in volume is benign, has no relationship to cancer, but can interfere with the passage of urine into the urethra through the gland.
Symptoms that suggest the presence of a prostate adenoma are:
  • difficulty urinating (slowness, weakness of the spray);
  • the need to get up several times at night to urinate;
  • urges to urinate imperiously and difficult to control.
Some drugs, especially atropinics, may have the undesirable effect of aggravating the discomfort and may lead to a total blockage of the bladder evacuation. They are therefore contraindicated or should be used cautiously in men with the symptoms described above.


alcohol
General name designating a family of substances that have the property of being able to be mixed with water and fatty substances. The most common alcohol is ethyl alcohol (ethanol), but there are many other alcohols: methanol, butanol, etc. The degree of alcoholic solution corresponds to the volume of pure alcohol present in 100 ml of solution, knowing that 1 glass of wine or 1/2 of beer (25 cl) contains about 8 g of alcohol.
When alcohol is used as an antiseptic, an unpleasant odor denaturant is often added to prevent drinking. Contrary to a widespread belief, alcohol at 70o (or even 60o) is a better antiseptic than alcohol at 90o.


antiemetic
Medication that combats vomiting.


antihypertensive
Medication that fights against excess blood pressure. The main ones are beta-blockers, diuretics, calcium channel blockers, ACE inhibitors, angiotensin II inhibitors and vasodilators.


dopaminergic
Drug that reproduces the effects of dopamine.
The main dopaminergic drugs are used in Parkinson's disease or in erectile dysfunction. They should not be associated with neuroleptics, which may nullify their effect.


glaucoma
Disease characterized by increased pressure of the fluids contained in the eye (intraocular hypertension).
This general term covers two totally different affections:
  • Open angle glaucoma or chronic glaucoma is the most common; it is generally symptom-free, detected by the measurement of intraocular tension in the ophthalmologist. It does not cause acute seizures, and treatment relies primarily on beta-blocking eye drops. People with open-angle glaucoma should not use cortisone derivatives without prior ophthalmologic advice.
  • Closed-angle glaucoma or acute glaucoma is more rare. Between seizures, intraocular tension is normal. But the inadvertent use of atropine medicines (especially eye drops) causes an acute crisis of intraocular hypertension which can permanently damage the retina in a few hours. It is an ophthalmological emergency that is recognized by a brutally red eye, horribly painful, hard as a glass ball, and whose vision becomes blurred.
The angle in question in these two affections is the irido-corneal angle. It is indeed between the iris and the cornea that is located the system of evacuation of the liquids of the eye. A slightly open (closed) angle exposes a total obstruction of the evacuation system. This obstruction can occur when the iris is opened to the maximum (mydriasis) under the effect of an atropinic drug: the iris then comes to be attached to the cornea.
Contraindications for atropine medicines are limited to those who have already had closed-angle glaucoma or have been detected by an ophthalmologist. Those who suffer from chronic open angle glaucoma are not affected by these contraindications.


orthostatic hypotension
Reduced blood pressure when changing from elongated to standing. Due mostly to drugs, orthostatic hypotension results in dizziness with risk of fall, especially in the elderly. These disturbances can be prevented by avoiding sudden changes of position: sit for a few moments at the edge of the bed before standing, slowly rising from a seat, keeping a support before moving.
Wearing compression stockings, which prevents blood from flowing back to the legs while standing, is also used to treat orthostatic hypotension.


incapacity
Erection impossible or insufficient for penetration.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.


lyophilisate
Powder resulting from rapid drying (at low temperature and under vacuum) of a substance dissolved in water (eg soluble coffee). As medicaments, lyophilisates may be dissolved in a solvent for the preparation of an injectable, atrial, nasal, etc. solution. or be presented as a tablet to be dissolved in a glass of water, sucked or allowed to melt under the tongue.


phenylketonuria
An inherited disease that is characterized by the absence of an enzyme and that leads to the accumulation in the blood of a toxic product. Screening is systematic at birth. Treatment is based on a specific diet during early childhood.


sedatives
  • Quiets, calms down.
  • Medication belonging to different families: anxiolytics, hypnotics, analgesics, antitussives, antiepileptics, neuroleptics, etc. but also antidepressants, antihistamines H1, antihypertensives. A sedative can be responsible for drowsiness and increase the effects of alcohol.

Cliquez ici pour retrouver la notice de ce médicament sur le site de l'Agence Nationale de Sécurité du Médicament et des produits de santé.

Pharmacovigilance : Déclarer un ou des effet(s) indésirable(s) lié(s) à l'utilisation d'un médicament

NOTICE

ANSM - Last updated: 01/06/2017

Name of the medicinal product

VOGALIB 7.5 mg SUGAR-FREE, oral lyophilisate sweetened with aspartame

Metopimazine.

framed

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.

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