Synthol MUSCLE PAIN GEL TUBE 75G

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SYNTHOL Gel to treat muscle pain 75G tube

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

You just hit your shin against your coffee table. And you tell yourself that a huge blue will appear. Bruises or bruises are caused by a broken or cracked small surface blood vessel. It hurts and it's not very pretty. Even if they end up disappearing, after having gone through almost all the colors of the rainbow, you can limit the damage by reacting quickly.

Description of Synthol Muscle Pain Gel

This medication is recommended, in adults and children over 7 years old, as a local adjunctive treatment for minor trauma (bruises, strokes).

using advice

Method of administration : Cutaneous use.

Dosage : 1 application to the painful area 2 to 3 times a day. Wash hands after application.

Duration of treatment : If there is no improvement after 5 days of treatment, consult your doctor.

Composition of SYNTHOL GEL muscle pain TUBE 75G

The active substances are : Levomenthol 0.520g; 0.250g veratrole; Resorcinol 0.030g; Salicylic acid 0.100g. Per 100g of gel.

The other ingredients are : Aromatic composition (linalyl acetate, lavender essential oil, linalool, coumarin, geraniol), benzyl alcohol, hydroxyethylcellulose, citric acid monohydrate, lauric macrogol ether, 96% ethanol, purified water.

Precautions for use

  • do not use in children under 7,
  • never apply a dose higher than that recommended
  • do not apply over a large area of the body,
  • respect the recommended frequency and duration of treatment.

After application, it is necessary to wash your hands to avoid any involuntary contact of the product with the eyes.

In case of breastfeeding, it is best not to use this medication and in no case should it be applied to the

Presentation

75g tube.

Fight muscle pain, and Osteoarthritis

The management of muscle pain, or Osteoarthritis (such as back pain, low back pain, arthritis, contracture, body aches) is done in 3 steps:

  1. Apply warmth with the Thermacare heating patches or the Thera-pearl warming bag (apply 15 to 20 minutes)
  2. Relieve pain, promote relaxation and recovery with Synthol gel, apply by gently massaging without penetrating.
  3. Maintain using a lumbar support or support belt , a neck brace or a cervical collar , which will protect the painful area during recovery.

These pathologies can be identified by the presence of pain-stiffness and mobility problems .

The heat therapy improves mobility, reduces the painful message (analgesic), promotes muscle relaxation, and reduces contractures, body aches.

Warnings on pain relievers

Attention, 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 online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
  • Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

VIDAL OF THE FAMILY

SYNTHOL gel

Analgesic of local action

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

PRESENTATIONS (summary)

SYNTHOL: gel; 75 g tube.
-

Laboratory GlaxoSmithKline Consumer Healthcare

COMPOSITION (summary)
p 100 g
levomenthol 520 mg
veratrole 250 mg
resorcinol 30 mg
Salicylic acid 100 mg
95 ° Alcohol +

INDICATIONS (summary)
It is an analgesic gel that contains a salicylic and substances that have a revulsive effect.
It is used in the adjunctive treatment of bruising and bruising.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
WARNING (Contents)
This medicine contains terpene (menthol) which can, in very rare cases, cause serious accidents in young children ( convulsions ...). It should only be used after medical advice in children under 7 years of age. The risk is increased when applied to large areas or in case of epilepsy .
PREGNANCY AND BREAST-FEEDING (summary)
The substances contained in this medication are little absorbed by the skin. However, do not use it prolonged during pregnancy or breastfeeding without the advice of your doctor or pharmacist.
DIRECTIONS FOR USE AND DOSAGE (summary)
Spread the gel over the painful area and let in a gentle and prolonged massage.

Usual dosage:

  • Adult and child over 7 years: 2 or 3 applications per day.
TIPS (summary)
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
Remember to wash your hands after application. In case of accidental contact with eyes, rinse thoroughly.
POSSIBLE ADVERSE EFFECTS (summary)
Allergic skin reaction , requiring discontinuation of treatment; not to be confused with redness normal to the point of application, due to the drug.
Related to the presence of terpenes (menthol), if the usual dosage is exceeded:
  • convulsions in children,
  • agitation, confusion of ideas (especially in the elderly).
The presence of alcohol can promote dryness and irritation of the skin, especially in case of repeated applications.


GLOSSARY (summary)


allergy
Skin reaction (itching, pimples, swelling) or general discomfort occurring after contact with a particular substance, use of a medication or ingestion of food. The main forms of allergy are eczema, urticaria, asthma, angioedema and allergic shock (anaphylactic shock). Food allergy can also result in digestive disorders.


analgesic
Medication that works against pain. Analgesics act either directly on the centers of pain in the brain or by blocking the transmission of pain to the brain.
Synonym: analgesic.


antecedents
Affection healed or always in evolution. The antecedent may be personal or family. The background is the history of a person's health.


convulsions
Involuntary contractions limited to a few muscles or generalized to the whole body. They are due to excessive pain or stimulation of the brain: fever, poisoning, lack of oxygen, brain damage. Convulsions may be due to an epileptic seizure or high fever in young children.


bruising
Infiltration of blood into the skin and mucous membranes that may occur spontaneously or, most often, after trauma. Bruises are commonly called blues.


eczema
Skin disease manifested by pimples and itching. Eczema may be due to contact with an allergic substance (contact eczema) or be linked to a genetic predisposition (atopic eczema).


epilepsy
A chronic seizure disorder associated with abnormal electrical activity of a group of brain cells. Its manifestations, varying in intensity, range from the sudden drop in attention (absences, or small evil) to loss of consciousness accompanied by abnormal muscle movements (convulsions, or great evil). Partial epilepsy, as its name implies, does not concern the whole body: the jerky movements only touch one or more muscle groups.


dosage
Quantity and distribution of the dose of a drug according to the age, weight and general condition of the patient.


Allergic reaction
Reaction due to hypersensitivity of the organism to a drug. Allergic reactions can take a wide variety of aspects: urticaria, angioedema, eczema, eruption of pimples resembling measles, etc. Anaphylactic shock is a generalized allergic reaction that causes discomfort due to a sudden drop in blood pressure.


repellent
Substance or technique intended to cause an influx of blood into the skin near a diseased organ in order to relieve it (suction cups, mustard poultice). Currently, these methods are less used and the term revulsive essentially concerns medicines for local use which cause dilation of the blood vessels of the skin.


salicylate
A family of drugs, the best known of which is acetylsalicylic acid (aspirin).


terpene
A general term for aromatic substances of vegetable origin. These are traditionally used for their respiratory properties (stimulating, expectorant, antiseptic) and their revulsive power when applied to the skin. The most used are camphor, menthol, eucalyptol, essential oils of mint, turpentine, niaouli, pine, anise, etc.
Some terpenes, and especially camphor, have been responsible for convulsions, respiratory pauses in the infant, in case of overdose. They can also cause behavioral problems in the elderly. These products should be used with caution at the extreme ages of life.


treatment
Treatment that complements the action of a specific treatment, but generally does not achieve healing on its own.

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: 05/04/2016

Name of the medicinal product

SYNTHOL gel

framed

Please read this leaflet carefully before you start using this medicine because it contains important information for you.

You should always use 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 of the 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 contact your doctor if you experience no improvement or feel less well after 5 days.

Do not use this medication for children.

Review summary

In this notice :

1. WHAT IS SYNTHOL, GEL AND IN WHAT CASES IS IT USED?

2. BEFORE YOU USE SYNTHOL, GEL?

3. HOW TO USE SYNTHOL, gel?

4. WHAT ARE POSSIBLE SIDE EFFECTS?

5. HOW TO STORE SYNTHOL, gel?

6. ADDITIONAL INFORMATION

1. WHAT IS SYNTHOL, GEL AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group

OTHER TOPICS FOR ARTICULAR AND MUSCULAR PAIN; ATC code: M02AX10.

Therapeutic indications

In adults and children over 7 years of age, this medication is recommended for local treatment of benign trauma (blues, strokes).

2. BEFORE YOU USE SYNTHOL, GEL?

List of information needed before taking the medication

Not applicable.

Cons-indications

Do not use SYNTHOL, gel:

· If you are allergic (hypersensitive) to levomenthol, veratrole, resorcinol, salicylic acid, near active substances or any of the other ingredients of this medication mentioned in section 6.

· If you have a history of allergies to salicylates, a related drug (NSAIDs, aspirin) or any of the other ingredients,

· In children and elderly subjects with a history of convulsions (febrile or not), due to the presence of terpene derivatives (levomenthol, lavandin essential oil and linalool).

Do not apply to the eyes, on damaged skin regardless of lesion: oozing lesions, eczema, infected lesion, burn or wound.

Precautions for use; special warnings

Warnings and Precautions

Talk to your doctor or pharmacist before using SYNTHOL, gel.

This medication is reserved for adults and children over 7 years of age.

This specialty contains terpenic derivatives (levomenthol, essential oil of lavandin and linalool) which can lead to excessive doses of seizure-type accidents in children. Observe the instructions for use:

· do not use in children under 7 years,

· never apply a dose higher than recommended (see section "3. How to use SYNTHOL gel"),

· do not apply over an extended surface of the body,

· respect the recommended frequency and duration of treatment.

In case of epilepsy old or recent, REQUEST ADVICE TO YOUR DOCTOR.

After application, it is necessary to wash your hands to avoid any involuntary contact of the product with the eyes.

Interaction with other medicines

Other medicines and SYNTHOL gel

Inform your doctor or pharmacist if you are using, have recently used or could use any other medicines.

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

In case of breast-feeding, it is preferable not to use this medication and in no case should it be applied to the breasts.

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

SYNTHOL, gel contains alcohol

3. HOW TO USE SYNTHOL, gel?

Instructions for proper use

Not applicable.

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

Dosage

1 application on the painful area 2 to 3 times a day.

Wash hands after application

Administration mode

Dermal

Duration of treatment

If there is no improvement after 5 days of treatment, consult your doctor.

Symptoms and Instructions for Overdose

If you used more SYNTHOL, freeze than you should:

Rinse thoroughly with water.

Immediately consult your doctor or pharmacist.

Instructions for omission of one or more doses

If you forget to use SYNTHOL, gel:

Do not take a double dose to make up for the single dose that you have forgotten to take.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

Description of adverse reactions

Like all medicines, this medicine may cause side effects, although not everybody gets them.

· Risk of local reaction.

· Rare cases of contact dermatitis requiring discontinuation of treatment have been reported.

· Possibility of skin redness at the point of application.

· Due to the presence of terpene derivatives and in case of non-respect of the recommended doses:

o risk of convulsions in children,

o possibility of agitation, confusion in the elderly

Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.

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

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 SYNTHOL, gel?

Keep out of the reach and sight of children.

Expiration date

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Storage conditions

This medication should be stored at a temperature not exceeding 25 ° C.

If necessary, warnings against visible signs of deterioration

Do not throw any medication into drains or household waste. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

Full list of active substances and excipients

What SYNTHOL contains, gel:

The active substances are:

Levomenthol ................................................. .................................................. .................................. 0.520 g

Veratrole ................................................. .................................................. ....................................... 0.250 g

Resorcinol ................................................. .................................................. ..................................... 0.030 g

Salicylic acid................................................ .................................................. ............................. 0.100 g

For 100g of gel

The other components are:

Aromatic composition (linalyl acetate, lavandin essential oil, linalol, coumarin, geraniol) benzyl alcohol, hydroxyethylcellulose, citric acid monohydrate, Macrogol lauryl ether, 96% ethanol, purified water.

Pharmaceutical form and content

Aspect of SYNTHOL, gel and contents of the pack

This medication is in the form of a gel. Tube of 75 g and 100 g.

Not all pack sizes may be marketed.

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

BOOTS COMPANY PLC

BEESTON SITE THANE ROAD

NOTTINGHAMSHIRE NG2 3AA

UK

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 revised is the MM / YYYY.

AMM under exceptional circumstances

Not applicable.

Internet Information

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

Information for health professionals only

Not applicable.

Other

ADVICE / HEALTH EDUCATION

OTHER TOPICS FOR ARTICULAR AND MUSCLE PAIN

You just have a mild trauma or a bruise, you can use the gel to relieve your pain.

However, if there is a complete functional impairment, ie if you can not use the upper limb or the lower limb and in case of a large (blue) hematoma, you should also consult without delay your doctor.

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