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SYMPATHYL ESCHSCHOLTZIA AUBÉPINE 40 TABLETS

Nervousness, Sleep Disorders - Adults

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

Description of Sympathyl Eschscholtzia Hawthorn 40 Tablets

Sympathyl 40 film-coated tablets is a medication used as a calming agent. Sympathyl is recommended in adults to reduce nervousness or in case of exaggerated perception of heart beat (palpitations) after all heart disease has been ruled out; Sympathyl Eschscholtzia Hawthorn is used in cases of mild sleep disturbances .

using advice

P osology

Reserved for adults only.

The usual dose is 4 tablets per day in two doses, 2 tablets in the morning and 2 tablets in the evening, before the meal.

Method and route of administration

Oral use.

Swallow the tablets with a glass of water.

Frequency of Administration

Morning and evening before meals.

Duration of treatment

Treatment should not be continued without medical advice.

Composition

The active substances are:

Eschscholtzia (dry aqueous extract) ............................................ ............................... 20.00 mg

Hawthorn (dry hydroalcoholic extract of flowering head) 75.00 mg

Heavy magnesium oxide .............................................. ...................... 24.35 mg

Quantity corresponding to 75 mg of magnesium element, either ........................................ ..... 6.2 mEq

For a film-coated tablet.

The other components are:

Microcrystalline cellulose, sodium carboxymethyl starch (type A), micronized stearic acid, shellac, polyvidone, acetylated monoglyceride, hypromellose, titanium dioxide, macrogol 6000, carmine indigo lacquer, azorubine, yellow iron oxide

Presentation

Box of 40 tablets.

Our advice and expert advice in pharmacy

Among sleep disorders, insomnia is the disorder most commonly encountered. If the majority of insomnia is related to relatively mild problems, sleep disorders can sometimes be a sign of a disease. When sleep disorders persist, they have negative repercussions on physical and psychic health. Do not hesitate to consult a doctor.

When is the talk of insomnia?

One French man in three says he suffers from insomnia. But only those who feel the consequences of sleep deprivation such as fatigue, difficulty concentrating, irritability or memory problems suffer. The one who is in full form in the aftermath of short nights is probably a small sleeper who is unaware. Chronic insomnia affects nearly 20% of the French population. It is severe in 6 to 9% of cases. Different types of insomnia should be distinguished:

Sleep insomnia: this is the most frequent. The person goes to bed at a usual time, and one or two hours later she still has not found sleep.
- Mid-night insomnia: the person wakes up in the night, one or more times, and has difficulty falling asleep.
- Insomnia in the early morning: the person falls asleep without problem, but wakes up at four or five in the morning, and it is impossible for him to recover sleep.
- Total Insomnia: This type of insomnia is much rarer. The person stays awake all night.

Some people also observe a reversal of the rhythm of sleep: they sleep during the day, but not at night.

What Causes Sleep Disorders?

Anxiety and stress are the leading causes of poor sleep, as well as environmental factors (noise, moving, etc.). Sometimes other problems can cause sleep disorders, such as snoring, pain, poor bedding, excess caffeine or alcohol.

While the vast majority of insomnia are related to relatively benign psychological disturbances, sleep disorders can be a sign of a physical illness. They can alert on diabetes, for example, hyperthyroidism, an infectious disease, cardiovascular problems, neurological disorders or osteoarthritis. It is therefore necessary to look for these diseases when sleep is disrupted.

Some medications, such as corticosteroids or some decongestants, as well as nicotine, may be responsible for insomnia. Do not forget to report your current treatments. Finally, insomnia can turn out to be one of the symptoms of another psychic illness. Middle and late night insomnia are thus characteristic of depressions. Finally, disturbances in sleep-wake rhythm may occur in persons subject to jet lag, or who work at night (shift work, nursing staff).

Drug warnings

Beware, the drug is not a product like the others. Read the package leaflet 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 products.

Please inform your on-line pharmacist of ongoing treatments to identify any incompatibilities. The order validation form contains a custom message field provided for this purpose.

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

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NOTICE

ANSM - Last updated: 27/05/2010

Name of the medicinal product

SYMPATHYL, film-coated tablet

Eschscholtzia, Hawthorn, Heavy magnesium oxide

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 your doctor.

· 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 SYMPATHYL, film-coated tablet AND WHAT IT IS USED FOR?

2. BEFORE YOU TAKE SYMPATHYL, film-coated tablet?

3. HOW TO TAKE SYMPATHYL, film-coated tablet?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE SYMPATHYL, film-coated tablet?

6. ADDITIONAL INFORMATION

1. WHAT IS SYMPATHYL, film-coated tablet AND WHAT IT IS USED FOR?

Pharmacotherapeutic group

PHYTOTHERAPY AND MINERAL ELEMENTS WITH SEDATIVE.

Therapeutic indications

This medication is a mild calming agent.

It is recommended in adults:

· to reduce nervousness or in case of exaggerated perception of the heart beat (palpitations) after all heart disease has been ruled out.

· in case of mild sleep disturbances.

2. BEFORE YOU TAKE SYMPATHYL, film-coated tablet?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not take SYMPATHYL, film-coated tablets:

· if you are allergic (hypersensitive) to the active ingredients or to any of the constituents contained in SYMPATHYL, film-coated tablet.

· If you have severe renal impairment (kidney function failure).

This medication MUST NOT BE GENERALLY USED, unless otherwise instructed by your doctor, in the following cases:

· in case of treatment with quinidinics.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST

Precautions for use; special warnings

Take special care with SYMPATHYL, film-coated tablet:

This medication contains an azo dye (E122) and may cause allergic reactions.

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

Interaction with other medicines

Taking or using other medicines

You should not use this medication unless your doctor tells you otherwise, as well as certain medicines used to treat heart rhythm disorders (quinidine).

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

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

It is best not to use this medication during pregnancy.

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

The use of this medication should be avoided during breastfeeding.

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

Sport

Not applicable.

Effects on ability to drive or use machines

Not applicable.

List of excipients with known effect

Important information about some of the ingredients of SYMPATHYL, film-coated tablet:

List of excipients with known effect: Azorubine (E122).

3. HOW TO TAKE SYMPATHYL, film-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 only.

The usual dose is 4 tablets per day in two doses, that is 2 tablets in the morning and 2 tablets in the evening, before the meal.

Method and route of administration

Oral use.

Swallow the tablets with a glass of water.

Frequency of Administration

Morning and evening before meals.

Duration of treatment

Treatment should not be continued without medical advice.

Symptoms and Instructions for Overdose

Not applicable.

Instructions for omission of one or more doses

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, SYMPATHYL, film-coated tablets are likely to have side effects, although not everybody gets them.

Rare digestive disorders (diarrhea, abdominal pain).

If you notice any side effects not listed in this leaflet, or if certain side effects become serious, please tell your doctor or pharmacist.

5. HOW TO STORE SYMPATHYL, film-coated tablet?

Keep out of the reach and sight of children.

Expiration date

Do not use SYMPATHYL film-coated tablets after the expiry date which is stated on the outer packaging.

Storage conditions

This medication should be stored at a temperature below 25 ° C.

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 SYMPATHYL contain in film-coated tablets?

The active substances are:

Eschscholtzia (dry aqueous extract) ............................................ .................................................. ... 20.00 mg

Hawthorn (dry hydroalcoholic extract of flowered top) ......................................... 75 mg

Heavy magnesium oxide .............................................. .................................................. .......... 124.35 mg

Quantity corresponding to 75 mg of magnesium element, either ........................................ .................... 6.2 mEq

For a film-coated tablet.

The other components are:

Microcrystalline cellulose, sodium carboxymethyl starch (type A), micronized stearic acid, shellac, polyvidone, acetylated monoglyceride, hypromellose, titanium dioxide, macrogol 6000, carmine indigo lacquer, azorubine, yellow iron oxide.

Pharmaceutical form and content

What is SYMPATHYL film-coated tablets and contents of the pack?

This drug is in the form of film-coated tablet.

Box of 40, 60, 120 or 600 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

INNOTECH INTERNATIONAL LABORATORY

22, AVENUE ARISTIDE BRIAND

94110 ARCUEIL

exploiting

INNOTECH INTERNATIONAL LABORATORY

22, AVENUE ARISTIDE BRIAND

94110 ARCUEIL

Maker

INNOTHERA CHOUZY

RENE CHANTEREAU STREET

The GREEN ISLE

41150 CHOUZY SUR CISSE

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.

Vidal file

VIDAL OF THE FAMILY

SYMPATHYL

Phytotherapy and mineral element

eschscholtzia, hawthorn, magnesium

. Presentations . Composition . Indications . Contraindications . Warning . Drug Interactions . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon

PRESENTATIONS ^(summary)

SYMPATHYL: tablet (blue); box of 40.
-

Innotech International Laboratory

COMPOSITION ^(summary)

	p cp
Eschscholtzia, extract	20 mg
Hawthorn, flowered summit extract	75 mg
Magnesium oxide	124.35 mg

INDICATIONS ^(summary)

This medicinal product contains plant extracts for sedative purposes and magnesium.
It is traditionally used in the symptomatic treatment of nervousness, in particular in the case of mild sleep disorders, and in the treatment of palpitations in adults.

CONTRAINDICATIONS ^(summary)

This medication should not be used in patients with severe renal impairment .

WARNING ^(Contents)

Palpitations may be the symptom of heart disease: do not use this medication for extended periods without your doctor's advice.

DRUG INTERACTIONS ^(summary)

This drug may interact with drugs containing quinidine.

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 before meals.

Usual dosage:

Adult: 2 tablets, morning and evening.

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).

POSSIBLE ADVERSE EFFECTS ^(summary)

Rarely: diarrhea, abdominal pain.

GLOSSARY ^(summary)

renal failure
Inability of the kidneys to eliminate waste or medicinal substances. Advanced renal insufficiency does not necessarily result in a decrease in the amount of urine excreted. Only a blood test and creatinine dosage may reveal this disease.

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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