VAGOSTABYL OMEZELIS TROUBLE SLEEPING TABLETS 40

VAGOSTABYL TROUBLE SOMMEIL 40 COMPRIMES View larger

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VAGOSTABYL OMEZELIS TROUBLE SLEEPING TABLETS 40

Vagostabyl is a mild sedative, recommended in adults to reduce nervousness when exaggerated perception of heartbeats (palpitations) after any heart disease has been ruled out.

Vagostabyl, herbal medicinal balm, hawthorn, calcium and magnesium

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Partners with: VAGOSTABYL OMEZELIS TROUBLE SLEEPING TABLETS 120, Melatonin ChronoDorm 1 mg 30 Tablets sleep, Euphytose sleep better cp 120 / 180, PRANAROM AROMANOCTIS SLEEP - RELAXATION 30 capsules, Erbanuit Sleep Erbalab 30 Capsules

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For warnings, the precautions and cons-indications, please see the instructions.

Description VAGOSTABYL OMEZELIS SLEEP DISORDER 40 TABLETS

VAGOSTABYL is recommended for adults and children over 6 years, in mild sleep disorders.

Description Vagostabyl / OMEZELIS

Vagostabyl is a mild sedative, recommended in adults to reduce nervousness when exaggerated perception of heartbeats (palpitations) after any heart disease has been ruled out.

It is also recommended for adults and children over 6 years, in mild sleep disorders.

For adults and children over 6 years

Council use Vagostabyl / OMEZELIS

Adults:
Palpitations, 2 tablets 1-3 times daily before meals.
Minor disorders of sleep: 2 tablets at dinner, 2 tablets at bedtime
Children over 6 years:
Minor disorders of sleep: 1 tablet at dinner, 1 tablet at bedtime

Composition Vagostabyl / OMEZELIS

hydroalcoholic extract of hawthorn dry 50mg, dry extract hydro-alcoholic balm 45mg, 50mg calcium lactate pentahydrate, magnesium thiosulfate 10mg, for a tablet
Excipients povidone K 30, lactose monohydrate, microcrystalline cellulose, anhdre colloidal silica, cornstarch, talc, magnesium stearate, SEPIFILM SN ...

Carefully use Vagostabyl / OMEZELIS

Cons-indications:

Allergy to any component.
If in doubt, do not hesitate to ask your doctor or pharmacist.
Oral

Read carefully the instructions

Introducing Vagostabyl / OMEZELIS

40 tube 120 or coated tablets

Warnings on drugs

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines out of reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Attention to incompatibilities on your current medications.

Tell your pharmacist online treatments underway to identify possible incompatibilities. The checkout form contains a custom message field provided for this purpose.

Click here to find record of the drug at the site of the National Security Agency of Medicines and Health Products.

Pharmacovigilance : Report or a related adverse event (s) (s) (s) the use of a drug

VIDAL OF THE FAMILY

OMEZELIS

Phytotherapy and minerals

. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Lexicon

PRESENTATIONS (summary)

OMEZELIS: tablet (orange); box of 40.
-

OMEZELIS: tablet (orange); box of 120.
-

Biocodex Laboratory

COMPOSITION (summary)
p cp
Hawthorn, extract 50 mg
Melissa, extract 45 mg
Calcium lactate 50 mg
Magnesium thiosulfate 10 mg
Lactose +

INDICATIONS (summary)
This medicinal product contains extracts of plants for sedative purposes and mineral elements.
It is traditionally used in the symptomatic treatment of nervousness, especially in cases of mild sleep disorders, and in the treatment of palpitations in adults.
WARNING (Contents)
Palpitations may be the symptom of heart disease: do not use this medication for extended periods without your doctor's advice.
PREGNANCY AND BREAST-FEEDING (summary)
This medicine contains only presumed safe substances during pregnancy or lactation. However, do not use it prolonged without the advice of your pharmacist or doctor.
DIRECTIONS FOR USE AND DOSAGE (summary)
The tablets should be swallowed with a little water.

Usual dosage:

Sleeping troubles :
  • Adult: 2 tablets at dinner, 2 tablets at bedtime.
  • Children over 6 years: 1 tablet at dinner, 1 tablet at bedtime.
Palpitations:
  • Adult: 2 tablets, 1 to 3 times daily, before meals.
TIPS (summary)
Medicines are not the only response to stress: a better hygiene of life, a moderate consumption of excitants (coffee, tea, alcoholic beverages ...) also make it possible to fight against the excess of nervousness and its manifestations ( palpitations , sleeping troubles).


GLOSSARY (summary)


palpitations
Abnormal perception of irregular heartbeat.


sedative
  • 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.


symptom
Trouble felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all the patients.


symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without addressing its cause.

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: 31/07/2017

Name of the medicinal product

OMEZELIS, Coated tablet

Hawthorn (flower top of) (dry extract of), magnesium (thiosulfate), calcium (lactate of) pentahydrate, melissa (leaf of) (dry extract of).

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 talk to your doctor if you do not feel better or feel less well.

What is in this leaflet?

1. What is OMEZELIS, coated tablet and in which cases it is used?

2. What do you need to know before taking OMEZELIS, a coated tablet?

3. How to take OMEZELIS, coated tablet ?

4. What are the possible side effects?

5. How to store OMEZELIS, a coated tablet ?

6. Package contents and other information.

1. WHAT IS OMEZELIS, coated tablet AND WHAT CASES IS IT USED FOR?

Pharmacotherapeutic group: Phytotherapy and mineral elements for sedative purposes - ATC code: N05CM.

This medication is traditionally used in the disorders of cardiac erethism of the adult having a healthy heart as well as in the symptomatic treatment of the neurotonic states of the adult and of the child in particular in case of minor disorders of sleep.

2. BEFORE YOU TAKE OMEZELIS, coated tablet?

If your doctor has told you about an intolerance to some sugars, contact your doctor before taking this medicine.

Never take OMEZELIS, coated tablet:

· If you are allergic to any of the active ingredients or any of the other ingredients of this medication mentioned in section 6.

If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.

Warnings and Precautions

Talk to your doctor or pharmacist before taking OMEZELIS, a coated tablet .

- This medication contains an azo dye, Orange Yellow S (E110) and may cause allergic reactions.

- This medicine contains sucrose. Its use is not recommended in patients with intolerance to sucrose.

children

In children, a sleep disorder requires a consultation with your doctor.

Other medicines and OMEZELIS, coated tablet

Inform your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.

OMEZELIS, tablet coated with food and beverages

Not applicable.

Pregnancy and breast feeding

It is best not to use this medication during pregnancy. The use of this medication should be avoided during breastfeeding.

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.

Driving and using machines

Not applicable.

OMEZELIS, coated tablet contains an azo dye, orange yellow S (E110) and sucrose.

3. HOW TO TAKE OMEZELIS, coated tablet?

Always take this medication exactly as prescribed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

In adults :

- In case of palpitations: 2 tablets 1 to 3 times a day before meals.

- In case of minor sleep disturbances: 2 tablets at dinner, 2 tablets at bedtime.

In children over 6 years :

- In case of minor sleep disturbances: 1 tablet at dinner, 1 tablet at bedtime.

Compressed form is not suitable for children under 6 years of age.

Duration of treatment

Treatment should not be continued without medical advice.

If you take more OMEZELIS, coated tablet than you should have

A massive overdose may result in the following symptoms:

- nausea,

- vomiting,

- Abundant urine,

- Excessive thirst,

- Constipation,

- And in severe cases, heart rhythm disorders.

If you take more OMEZELIS tablets than you should, consult your doctor.

If you forget to take OMEZELIS, coated tablet

Not applicable.

If you stop taking OMEZELIS, coated tablet

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine may cause side effects, although not everybody gets them.

- Exceptionally, hypersensitivity reactions and digestive disorders.

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 OMEZELIS, coated tablet?

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 outer packaging. The expiry date refers to the last day of that month.

This medication should be stored away from moisture.

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 OMEZELIS contains, coated tablet

· The active substances are:

Hydroalcoholic dry hawthorn extract ............................................ ........................................ 50.00 mg

Hydroalcoholic dry extract of melissa ............................................. ........................................ 45.00 mg

Calcium lactate pentahydrate .............................................. ................................................ 50, 00 mg

Magnesium thiosulfate ............................................... .................................................. ....... 10.00 mg

For a coated tablet.

· The other components are:

Povidone K 30, lactose monohydrate, microcrystalline cellulose (Avicel PH 101), anhydrous colloidal silica, corn starch, talc, magnesium stearate.

Coating: SEPIFILM SN, talc, sucrose, gelatin, gum arabic, yellow orange S (E 110), OPAGLOSS 6000.

What is OMEZELIS, coated tablet and contents of the pack

This medication is in the form of a coated tablet. Box of 40 or 120 tablets.

Marketing Authorization Holder

BIOCODEX

7 AVENUE GALLIENI

94250 GENTILLY

LA FRANCE

Marketing Authorization Operator

BIOCODEX

7, AVENUE GALLIENI

94250 GENTILLY

LA FRANCE

Maker

BIOCODEX

1, AVENUE BLAISE PASCAL

60000 BEAUVAIS

LA FRANCE

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).

Sleep disorders can manifest themselves in several ways: difficulty falling asleep, nighttime awakenings, early awakenings. The causes can be diverse: psychological origin (stress, dark thoughts), changing habits (altitude, holidays), alcohol intake, insomnia in the elderly. We offer treatments to address these minor ailments. Most important disorders (sleepwalking, night terrors, bedwetting in children, REM sleep disorder, psychiatric disorders origin or linked to other pathologies) require consulting your doctor.

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