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Omezelis Sleep Disorders 120 Tablets
Over-the-counter medication

Omezelis Sleep Disorders 120 Tablets

Brand : Biocodex Biocodex
used for :
product contains :

OMEZELIS (Vagostabyl) is a mild sedative recommended for adults to reduce nervousness associated with sleep disorders. It is an over-the-counter medication containing lemon balm and magnesium.

€9.05 EXCL. VAT €9.96 INCL. VAT
This product is an over-the-counter medication. Please consult the package insert before ordering online.
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Reference : 3400930297780
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What is Omezelis (formerly Vagostabyl) used for?

Do you feel stressed, tense, or have trouble falling asleep? Omezelis could very well become your natural ally in everyday life. This supplement is a traditional herbal medicine recognized for its effectiveness in treating mild anxiety and difficulty falling asleep. Its formula is based on the long-standing and proven use of lemon balm (Melissa officinalis), a plant renowned for its soothing properties, and magnesium, a key mineral in regulating the nervous system.

Lemon balm (Melissa officinalis), the main ingredient in Omezelis, is widely used in herbal medicine for its calming and relaxing effects. It works gently yet effectively to relieve nervous tension, promote relaxation, and help the body achieve greater emotional balance. It also helps reduce stress-related palpitations and improves sleep quality.

Magnesium lactate, for its part, acts as a stress regulator. It supports the normal functioning of the nervous system, helps reduce nervous fatigue, and helps prevent cramps and spasms caused by nervousness. This natural combination works synergistically to promote a state of optimal relaxation, without causing dependence or addiction.

Omezelis is recommended for temporary stress,mild anxiety, sleep disturbances,irritability, or during periods of mental overload. It is suitable for both students during exam periods and adults facing professional or personal pressure.

Its effectiveness relies on a dosage schedule spread out over the evening and at bedtime, tonaturally guide the body toward nighttime relaxation. Its simple, well-tolerated formulation is suitable for daily use over a 1-month period, with a gradual effect that respects the body’s natural rhythms.

In summary, Omezelis is a natural solution—without the risk of dependence or excessive daytime drowsiness—that helps you regain your inner peace, reduce mental tension, and improve the quality of your sleep. Thanks to its gentle, plant-based approach, it meets the needs of those seeking natural solutions to stress, with no known side effects to date.

To enhance its effects, you can combine Omezelis with the Chronodorm Melatonin supplement for a combined effect on stress and falling asleep.

How should this product be used?

Recommended dosage and instructions for use

Take Omezelis orally with a large glass of water. For adults and adolescents 12 years and older, the recommended dose is 2 tablets with dinner and 2 tablets at bedtime, for a total of 4 tablets per day. This schedule promotes gradual relaxation in the evening, which is ideal for preparing the body for sleep.

Treatment is recommended for 1 month. If you do not notice any improvement after two weeks, it is recommended that you consult a healthcare professional.

Share your feedback on the usage instructions and dosage of Omezelis with our partner Avis Vérifiés after your purchase.

There are various explanations for sleep disorders. Environmental causes (noise, heat, etc.), poor lifestyle habits (excessive physical activity in the evening, excessive coffee or alcohol consumption), an unsuitable work schedule (night shifts or rotating shifts), an underlying medical condition that disrupts sleep (asthma, angina, gastro-duodenal ulcers, gastroesophageal reflux, etc.) or even the use of stimulant medications (theophylline, salbutamol, cortisone, beta-blockers, etc.) are often the root causes of these disorders.

Learn more about psychophysiological insomnia

This type ofsleepdisorder accounts for 15 to 20% of insomnia cases. It is a form of insomnia that occurs without any obvious cause. It generally follows a period of insomnia with an identifiable cause: after surgery, the birth of a child, significant psychological stress, shift work, etc.
There is a negative conditioning to insomnia that results in a paradoxical activation of the arousal systems as soon as the person goes to bed. This manifests as a fear of not being able to sleep, tension or anxiety at bedtime, falling asleep spontaneously when not trying to sleep (in front of the TV…), and the inability to take a nap to rest.

Precautions for Use

  • Do not use if you have a known allergy to any of the ingredients.
  • Not recommended for children under 12 years of age.
  • Do not use during pregnancy or while breastfeeding.
  • Risk of drowsiness: Avoid driving or operating machinery.
  • Do not combine with other medications without consulting a doctor.
  • Contains lactose: avoid if you have galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.
  • Follow the recommended doses.
  • Keep out of reach of children.

What are its ingredients?

Dried Lemon Balm Leaf Extract, Magnesium Lactate, Polyvinylpyrrolidone K30, Lactose Monohydrate, Microcrystalline Cellulose, Anhydrous Colloidal Silica, Corn Starch, Magnesium Stearate, Hypromellose, Calcium Carbonate, Polydextrose, Polyethylene Glycol 3350, Talc, Indigo Dye E132

Nutritional Values of Omezelis

Each tablet contains:

  • Lemon balm: 150 mg of dry extract (equivalent to 105 mg per tablet)
  • Magnesium (as lactate): 75 mg

Presentation

This product is available in film-coated tablets, in a bottle of120 tablets, sufficient for approximately one month’s use. Its formulation makes it easy to take and helps ensure adherence to the recommended dosage.

Expert Advice and Recommendations

To support the effects ofOmezelis, several lifestyle tips can help you naturally restore a healthy nervous system balance. Start by establishing a regular sleep routine: go to bed at set times, avoid screens in the evening, and prioritize calming rituals such as a passionflower or chamomile tea. Gentle physical activity, such as walking or yoga, is also an excellent way to manage stress.

When it comes to diet, focus on foods rich in natural magnesium (almonds, legumes, whole grains), and limit stimulants (coffee, tea, alcohol). In addition, consider aromatherapy: a few drops of true lavender essential oil on your pillow can help you relax.

Finally, mindfulness meditation, cardiac coherence, or warm baths with essential oils are excellent natural ways to restore lasting serenity, while supporting the effects of your treatment.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

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

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).

 

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.

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