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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The advice of your pharmacist

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For warnings, precautions for use and contraindications, please consult the instructions for use.

Description of Omezelis (Vagostabyl) SLEEP DISORDER 40 TABLETS

VAGOSTABYL is recommended for adults and children over 6 years of age, in case of mild sleep disturbances . This medicine has changed its name and is called Omezelis.

Description of Omezelis (Vagostabyl)

Vagostabyl is a mild painkiller , recommended in adults to reduce nervousness in the event of exaggerated perception of heartbeat (palpitations) after any heart disease has been ruled out.

It is also recommended in adults and children over 6 years of age, in cases of mild sleep disturbances .

Reserved for adults and children over 6 years old.

Using advice from Omezelis (Vagostabyl)

Adults :
Palpitations, 2 tablets 1 to 3 times a day before meals.
Minor sleep disorders: 2 tablets at dinner, 2 tablets at bedtime
Children over 6 :
Minor sleep disorders: 1 tablet at dinner, 1 tablet at bedtime

Composition of Omezelis (Vagostabyl)

dry hydro-alcoholic extract of hawthorn 50mg, dry hydro-alcoholic extract of lemon balm 45mg, calcium lactate pentahydrate 50mg, magnesium thiosulfate 10mg, for one tablet
Excipients : povidone K 30, lactose monohydrate, microcrystalline cellulose, anhydrous colloidal silica, corn starch, talc, magnesium stearate, sepifilm SN ...

Precautions for using Omezelis OMEZELIS

Contraindications :

  • Allergy to one of the components.
  • If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.
  • Oral use

Read the instructions carefully

Presentation of OMEZELIS (Vagostabyl)

Tube of 40 coated tablets.

The Biocodex laboratory also distributes the drug Omezelis in an economical version of 120 tablets

advice

Insomnia affects the subject's ability to fall asleep or the continuity of their sleep.
It is characterized by difficulty finding sleep or numerous awakenings during the night or too early in the morning. Some people may, however, fall asleep late (phase delay) or get up early (phase advance) and have enough sleep for them.

Sleep is one of the pillars of our well-being. It will allow us to recharge our physiological and psychological batteries. Not only are we tired when the quality of our sleep is not optimal, but in addition, we quickly have low morale.
Sleep can be disturbed for many reasons: stress, worries, a sense of duty that pushes us to do more and more and make our days longer and longer ...

Massage 30 minutes before bed, gently rub your solar plexus with 2 drops of lavender or 1 drop of tangerine and 1 drop of ravintsara mixed with half a teaspoonful of sweet almond oil.

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.

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

Pharmacovigilance : Report an adverse effect (s) related to the use of a drug

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).

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