TRANQUITAL AUBEPINE VALERIANE SLEEP DISORDERS

TRANQUITAL AUBEPINE VALERIANE TROUBLES DU SOMMEIL View larger

3400934097355

Herbal Medicine.
Traditionally used to reduce nervousness, particularly in cases of sleep disorders.

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The advice of your pharmacist

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For warnings, precautions for use and cons-indications, please refer to the user guide.

Description

Herbal Medicine.
Traditionally used to reduce nervousness, particularly in cases of sleep disorders.

The active substances are:

Valerian (dry alcoholic extract): 34.6 mg of maltodextrin or lactose monohydrate,
Hawthorn (aqueous dry extract): 37.8 mg of maltodextrin.
For a coated tablet 500.0 mg.


The other ingredients are:  
Colloidal anhydrous silica, lactose monohydrate, corn starch, sodium carboxymethyl starch, talc, magnesium stearate, dewaxed bleached shellac, gum arabic, titanium dioxide, sucrose, white beeswax.


Excipients with known effect:   lactose, sucrose.

Dosage:

RESERVED FOR ADULTS.
4-6 tablets per day taken with a full glass of water.


Method of administration:
Orally.


Frequency of administration:
Distribute taken in the day.


If you have taken more TRANQUITAL, coated tablet you should:
In case of massive intake of compounds of valerian root medicines, mild symptoms may occur. They disappear within 24 hours.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Do not take TRANQUITAL, coated tablet:
If you are hypersensitive to the active substance or to any of the other ingredients in TRANQUITAL, coated tablet.


Be careful with TRANQUITAL, coated tablet:

  • Use of this medicine is not recommended in children under 12 years.
  • Use of this medicine is not recommended in patients with impaired galctose a deficit Lapp lactase or malabsorption of glucose or galactose (rare hereditary diseases).
  • Use of this medicine is not recommended in patients with fructose intolerance, malabsorption of glucose or galactose or deficit n sucrase / isomaltase (rare hereditary diseases).


Taking other medicines:
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your médeicn or pharmacist.
The combination of TRANQUITAL, coated tablet with synthetic sedatives is not recommended.


Pregnancy and lactation:
The use of this drug should be avoided during pregnancy and lactation.
If you discover that you are pregnant during treatment, consult your doctor as only he can judge the need to continue. Ask your doctor or pharmacist before taking any medicine.


Effects on ability to drive and use machines:
It should attract the attention of drivers or demachines users on the sedative effects of this medication may cause drowsiness events or changes in reflexes.


Excipients with known effect:   lactose, sucrose.

Packaging:   Box   100   coated tablets

Summary of Product Characteristics (MSNA)

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 products in your.

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

TRANQUITAL

Phytotherapy

Valerian hawthorn

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

PRESENTATIONS (summary)

TRANQUITAL: tablet (white); box of 100.
-

Laboratory GlaxoSmithKline Consumer Healthcare

COMPOSITION (summary)
p cp
Valerian, dry extract 34.6 mg
Hawthorn, dry extract 37.8 mg
Lactose +

INDICATIONS (summary)
This medicinal product contains plant extracts for sedative purposes .
It is traditionally used in the symptomatic treatment of nervousness, especially in cases of mild sleep disorders.
WARNING (Contents)
If you must drive or use a hazardous machine, make sure that this medication does not alter your vigilance.
PREGNANCY AND BREAST-FEEDING (summary)
This medicinal product contains safe presumed plants during pregnancy or lactation. Nevertheless, as a precaution, do not use it 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:

  • Adult: 4 to 6 tablets per day.
TIPS (summary)
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
Drugs are not the only answer to sleep disorders: a better hygiene of life, a moderate consumption of stimulants (including alcoholic beverages ...), soundproofing of the room or the wearing of earplugs Quies balls) also improve the quality of sleep.


GLOSSARY (summary)


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


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: 14/12/2015

Name of the medicinal product

TRANQUITAL, coated tablet

framed

Read this leaflet carefully before you start taking this medicine. It contains important information for your treatment.

If you have any further questions, ask your doctor or pharmacist.

· Keep this leaflet, you may need to read it again.

· If you need more information and advice, ask your pharmacist.

· If symptoms worsen or persist, consult a physician.

· If you notice any side effects not listed in this leaflet, or if you experience any of the effects listed as serious, please tell your doctor or pharmacist.

Review summary

In this notice :

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

2. BEFORE YOU TAKE TRANQUITAL, coated tablet?

3. HOW TO TAKE TRANQUITAL, coated tablet?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE TRANQUITAL, coated tablet?

6. ADDITIONAL INFORMATION

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

Pharmacotherapeutic group

Herbal medicines.

Therapeutic indications

Traditionally used to reduce nervousness, especially in the case of sleep disorders.

2. BEFORE YOU TAKE TRANQUITAL, coated tablet?

List of information needed before taking the medication

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

Cons-indications

Do not take TRANQUITAL, coated tablet:

· If you are hypersensitive to the active substance or any of the other ingredients of TRANQUITAL, coated tablet.

Precautions for use; special warnings

Take special care with TRANQUITAL, coated tablet:

· The use of this medication is not recommended in children under 12 years of age.

· The use of this medication is not recommended in patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome (rare hereditary diseases).

· Use of this medication is not recommended in patients with fructose intolerance, glucose or galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).

Interaction with other medicines

Taking other medicines

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

The combination of TRANQUITAL, a tablet coated with synthetic sedatives is not recommended.

Interactions with food and beverages

Not applicable.

Interactions with Herbal Medicines or Alternative Therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy and breast feeding

The use of this medication should be avoided during pregnancy and lactation.

If you discover that you are pregnant during treatment, consult your doctor as he alone can judge the need to continue.

Ask your doctor or pharmacist for advice before taking any medicine.

Sport

Not applicable.

Effects on ability to drive or use machines

Driving and using machines

Attention should be drawn to the sedative effects of this medication, which may cause drowsiness or changes in reflexes.

List of excipients with known effect

List of excipients with known effect:

Lactose, sucrose.

3. HOW TO TAKE TRANQUITAL, coated tablet?

Instructions for proper use

Not applicable.

Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment

Dosage

RESERVED FOR ADULTS.

4 to 6 tablets per day to take with a large glass of water.

Administration mode

Oral use.

Frequency of Administration

Distribute the catch in the day.

Symptoms and Instructions for Overdose

If you take more than TRANQUITAL, coated tablet you should:

In the case of a massive intake of medicines composed of valerian root, mild symptoms may appear. They disappear within 24 hours.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, TRANQUITAL, a coated tablet, is likely to have side effects, although not everybody gets them.

Digestive disorders such as nausea or abdominal cramps may occur.

If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.

5. HOW TO STORE TRANQUITAL, coated tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use TRANQUITAL, coated tablet after the expiry date which is stated on the carton. The expiry date refers to the last day of the month.

Storage conditions

No special storage conditions.

If necessary, warnings against visible signs of deterioration

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What does TRANQUITAL contain in a coated tablet?

The active substances are:

Valerian (hydroalcoholic solids content of) on maltodextrin or on lactose monohydrate 34.6 mg

Hawthorn (aqueous dry extract of) on maltodextrin ......................................... 37.8 mg

For a coated tablet of 500.0 mg.

The other components are:

Anhydrous colloidal silica, lactose monohydrate, corn starch, sodium carboxymethyl starch, talc, magnesium stearate, bleached bleached gum, gum arabic, titanium dioxide, sucrose, white beeswax.

Pharmaceutical form and content

What is TRANQUITAL, coated tablet and contents of the pack?

This medication is in the form of a coated tablet.

Box of 30, 80 or 100 tablets.

Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different

Holder

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100 ROUTE OF VERSAILLES

CS 80001

78164 MARLY-LE-ROI CEDEX

exploiting

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100 ROUTE OF VERSAILLES

CS 80001

78164 MARLY-LE-ROI CEDEX

Maker

SOPHARTEX LABORATORIES

21, RUE DU PRESSOIR

28500 VERNOUILLET

or

FAMAR FRANCE

AVENUE OF CHAMPS DE MARS

45072 ORLEANS CEDEX 02

Names of the medicinal product in the Member States of the European Economic Area

Not applicable.

Date of approval of the notice

The last date on which this leaflet was approved is {date}.

AMM under exceptional circumstances

Not applicable.

Internet Information

Detailed information on this medicine is available on the Afssaps website (France).

Information for health professionals only

Not applicable.

Other

Not applicable.

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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