VAGOSTABYL OMEZELIS TROUBLE SLEEPING TABLETS 120
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.
Vagostabyl, herbal medicinal balm, hawthorn, calcium and magnesium.
For warnings, precautions for use and contraindications, please consult the instructions for use of Omezelis (Vagostabyl).
OMEZELIS / VAGOSTABYL is recommended for adults and children over 6 years of age, in case of mild sleep disturbances.
Feeling that your heart is beating very hard or irregularly is not usually a sign of a heart problem if you are in good health.
Who has never felt his heart suddenly beat faster or faster, even without physical effort? These palpitations actually reflect a sudden change in heart rate. And while these heart runaways can cause fear of a heart problem, they are actually generally mild when they occur in healthy people. But if these episodes of palpitations are repeated or if they affect people with cardiovascular disease, they must alert and justify a consultation with a cardiologist.
OMEZELIS is a mild painkiller , recommended in adults to reduce nervousness in the event of excessive perception of heartbeat (palpitations) after all heart disease has been ruled out.
OMEZELIS is also recommended for adults and children over 6 years of age, in cases of mild sleep disturbances .
Reserved for adults and children over 6 years old
Adults :
Palpitations: 2 tablets of OMEZELIS 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
Insomnia is the reduction in the usual duration of sleep and / or the achievement of quality of sleep with repercussions on the quality of the next day's waking.
During the night the amount of sleep is reduced by difficulty falling asleep, night awakenings, too early awakening in the morning .
Sleep is experienced as light and not restful. The next day is difficult with complaints of fatigue, drowsiness, irritability, and is often accompanied by mood disorders.
There are various explanations for sleep disorders. Environmental causes (noise, heat, etc.), lifestyle errors (activity too intense in the evening, coffee or alcohol abuse), an inadequate imposed rhythm (night or team work), organic illness associated disturbing sleep (asthma, angina, peptic ulcer, gastroesophageal reflux ...) or even taking exciting drugs (theophylline, salbutamol, cortisone, beta blockers ...) are often with origin of the troubles.
This type of sleep disorder accounts for 15 to 20% of insomnia. It is insomnia that appears without obvious cause. It generally follows insomnia, the cause of which can be identified: after a surgical intervention, the birth of a child, significant psychological stress, shift work ...
There is a negative conditioning to insomnia which results in a paradoxical activation of the awakening systems as soon as the person goes to bed. It results in fear of not sleeping, tension or anxiety at bedtime, spontaneous falling asleep when sleep is not wanted (in front of the TV ...), the impossibility of taking a nap to recover .
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 ...
Contraindications :
Read the instructions carefully
tube of 120 coated tablets
Please note, the drug Omezelis (Vagostabyl) is not a product like the others. Read the package leaflet for Omezelis (Vagostabyl) 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 treatments.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 31/07/2017
Hawthorn (flower top of) (dry extract of), magnesium (thiosulfate), calcium (lactate of) pentahydrate, melissa (leaf of) (dry extract of).
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.
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?
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.
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?
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
7 AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
Marketing Authorization Operator
7, AVENUE GALLIENI
94250 GENTILLY
LA FRANCE
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]
Detailed information on this medicine is available on the ANSM website (France).
Phytotherapy and minerals
. Presentations . Composition . Indications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Lexicon
OMEZELIS: tablet (orange); box of 40.
-
OMEZELIS: tablet (orange); box of 120.
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Biocodex Laboratory
| p cp | |
| Hawthorn, extract | 50 mg |
| Melissa, extract | 45 mg |
| Calcium lactate | 50 mg |
| Magnesium thiosulfate | 10 mg |
| Lactose | + |
Usual dosage:
Sleeping troubles :
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