VOLTARENE EMULGEL 1% GEL TUBE 50G

VOLTARENE EMULGEL 1% GEL TUBE 50G View larger

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Voltarène Emulgel 1% Gel 50 g Tube in our online pharmacy is an anti-inflammatory and analgesic (it relieves pain) as a gel for application to the skin only at the painful area.

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VOLTARENE EMULGEL 1% GEL TUBE 50G

 

For warnings, precautions for use and cons-indications, see the instructions for use.

 

Voltarène description Emulgel 1% Gel 50 g Tube

 

Voltaren Emulgel 1% Gel 50 g tube contains a non-steroidal anti-inflammatory drug (NSAID). He fights against local inflammation and pain.
It is used in the treatment of tendinitis, sprains, swelling occurring after chirugicale operation and pain in the fingers and knees in OA.

 

Using advice from Voltarène Emulgel 1% Gel 50 g Tube

 

Applying a gel tape (6 to 10 cm depending on the case) and extended by gentle massage to the painful area. Wash your hands after application (except when used for osteoarthritis of the fingers).
General dose:
Adults: 2-4 applications per day.

 

Voltaren Emulgel composition 1% Gel 50 g Tube

 

Alcohol benzyliquediclofénac diéthylamineparaffine liquidecétomacrogol 1000lavande essencelavandin essencecrème 45 parfumcarbomère 974 Ppropylèneglycolbois pink essenceeau purifiéegéraniolterpényle acétatealcool isopropyliquediéthylamine

 

Precaution of use

 

Do not use Voltarène Emulgel 1% Gel Tube 50g, in the following cases:
- From the 25th week of gestation (beginning of the 6th month of pregnancy);
- If you are allergic to it or a related drug, including other non-steroidal anti-inflammatory drugs, aspirin;
- If you are allergic to any of the excipients;
- On damaged skin, whatever the lesion oozing lesions, eczema, infected lesion, burn or wound.
When in doubt, it is essential to seek the advice of your doctor or pharmacist on our online pharmacy.

Special warnings:
- Do not apply to mucous membranes or the eyes.
- The appearance of a rash after application requires immediate discontinuation of treatment.
Precautions:
- The gel form is reserved for adults.
- The use of gloves by the physiotherapist in case of intensive use, is recommended.
If in doubt do not hesitate to ask your doctor or pharmacist on our online pharmacy.

 

If you are pregnant or breastfeeding:
Do not use this medicine on your own initiative. Talk to your doctor or pharmacist on our online pharmacy.

 

Introducing Voltarène Emulgel 1% Gel 50 g Tube

 

Tube of 50 g.

 

Warning, the drug is not a product like any other. Read the package leaflet before ordering. Do not leave medicines within reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

VIDAL OF THE FAMILY

VOLTARENE EMULGEL

Anti-inflammatory local action

diclofenac

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

PRESENTATIONS (summary)

VOLTARENE EMULGEL 1%: gel for local application; 50 g tube.
Refunded at 30%. - price: 1,82 euro (s).

VOLTARENE EMULGEL 1%: gel for local application; pressurized bottle of 100 ml.
Refunded at 30%. - price: 2,81 euro (s).

Laboratory GlaxoSmithKline Consumer Healthcare

COMPOSITION (summary)
p 100 g
Diclofenac diethylamine 1.16 g
Either Diclofenac sodium 1 g
Propylene glycol +

INDICATIONS (summary)
This gel contains a non- steroidal anti-inflammatory drug ( NSAID ). It locally fights against inflammation and pain.
It is used in:
  • short-term treatment of sprains and bruises;
  • supportive treatment of muscle, tendon and ligament pain;
  • the treatment of osteoarthritis after medical advice.
CONTRAINDICATIONS (summary)
This medication should not be used in the following cases:
  • allergy to aspirin or NSAIDs ;
  • in application to the injured skin ( eczema , burn, wound ...);
  • child under 15 years of age;
  • pregnancy (from the 6th month).
WARNING (Contents)
Do not apply this gel to the mucous membranes or under a waterproof (occlusive) dressing.
If a rash occurs, do not repeat the applications until you have taken the advice of your doctor.
Avoid exposing the treated area to sunlight or ultraviolet rays during treatment.
PREGNANCY AND BREAST-FEEDING (summary)
Pregnancy :
NSAIDs taken orally may be toxic to the fetus; their use is contraindicated during the last 4 months of pregnancy. NSAIDs for local application may pass through the skin, pass through the blood, and expose the fetus to the same risk, when applied over a large area of ​​skin or under an occlusive dressing. Do not use this medication during pregnancy without medical advice.

Breastfeeding:
This medication is low in breast milk: do not use it while breastfeeding without medical advice. It should not be applied to the breasts of a nursing woman.
DIRECTIONS FOR USE AND DOSAGE (summary)
Apply a gel ribbon in a gentle, prolonged massage over the painful area. Wash your hands after application (except when used for osteoarthritis of the fingers).

Usual dosage:

  • Adult and child over 15 years:
    • sprain, contusion: 1 application of a ribbon of 6 cm maximum, 2 to 3 times a day, for 1 to 4 days;
    • Tendinoligamentary pain: 1 application of a ribbon of 6 cm maximum, 2 to 4 times a day, for 1 to 7 days;
    • osteoarthritis: 1 application of a tape of 10 cm maximum, 3 to 4 times a day, for 7 to 14 days.
TIPS (summary)
If symptoms persist after the recommended treatment period, consult your doctor to re-evaluate the treatment.
This gel may be irritating to eyes or mucous membranes : in case of accidental contact with eyes, rinse thoroughly.
The tube must not be stored for more than 6 months after opening. Remember to note the date of first use on the box.
POSSIBLE ADVERSE EFFECTS (summary)
Most common: redness or irritation of the skin, itching.
Very rarely: allergic skin reaction ( urticaria , purpura ...) or general ( angioedema , asthma ) requiring discontinuation of treatment; photosensitization .


GLOSSARY (summary)


NSAIDs
Abbreviation for non-steroidal anti-inflammatory drug. Family of anti-inflammatory drugs that are not derived from cortisone (steroids), and the best known of which is aspirin.


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.


anti-inflammatory
Medicine that fights against inflammation. It can be either derived from cortisone (steroidal anti-inflammatory), or not derived from cortisone (nonsteroidal anti-inflammatory or NSAID).


osteoarthritis
Wear of cartilage, responsible for joint pain and limitation of movement.


asthma
Disease characterized by difficulty breathing, often resulting in wheezing. Asthma, permanent or occurring by crisis, is due to a narrowing and inflammation of the bronchi.


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).


skin rash
Appearance of pimples or plaques on the skin. These lesions can be due to a food, a drug, and translate an allergy or a toxic effect. Many viruses can also cause pimple eruptions: rubella, roseola and measles are the most common.


inflammation
Natural reaction of the organism against an element recognized as foreign. It manifests itself locally by redness, heat, pain or swelling.


mucous
Tissue (membrane) that lines the cavities and ducts of the body communicating with the outside (digestive tract, respiratory tract, urinary tract, etc.).


photosensitivity
Abnormal sensitivity of the skin to light or ultraviolet rays due to a drug or a natural or chemical substance.


purpura
Red or purplish skin patches due to small subcutaneous hemorrhages. Thrombocytopenic purpura is caused by a significant decrease in the number of platelets in the blood.


angioedema
Allergy edema usually affects the face. Quincke edema results in a sometimes spectacular swelling. Eyelids are often the first to be affected. In rare cases where edema affects the throat, respiratory problems may occur and urgent treatment is required.


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.


urticaria
Eruption of pimples on the skin, whose origin is mostly allergic. The buds look like nettles and their color varies from pale pink to red.

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: 10/03/2017

Name of the medicinal product

VOLTARENE EMULGEL 1%, gel

Diclofenac diethylamine

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 do not feel any improvement or feel less well:

· after 4 days in case of benign trauma: sprain (bruising), contusion,

· after 7 days in case of pain of muscular origin and tendino-ligamentary,

· after a maximum of 14 days in case of a painful outbreak of osteoarthritis.

Do not use this medication for children.

What is in this leaflet?

1. What is VOLTARENE EMULGEL 1%, gel and in which cases it is used?

2. What should I know before using VOLTARENE EMULGEL 1%, gel?

3. How to use VOLTARENE EMULGEL 1%, gel?

4. What are the possible side effects?

5. How to store VOLTARENE EMULGEL 1%, gel?

6. Package contents and other information.

1. WHAT VOLTARENE EMULGEL 1% GEL AND IN WHAT CASES IS IT USED?

Pharmacotherapeutic group: M02AA15

This medication is an anti-inflammatory and an analgesic (it calms the pain), in the form of gel for application on the skin, only in the region of pain.

This medication is intended for adults (from 15 years), for a short time, in:

· local treatment in case of benign trauma: sprain (bruising), contusion;

· local topical treatment of muscle and tendon-ligament pain;

· the symptomatic treatment of painful relapses of osteoarthritis, after at least a medical opinion.

2. BEFORE YOU USE VOLTARENE EMULGEL 1%, gel?

Never use VOLTARENE EMULGEL 1%, gel:

· from the 25th week of amenorrhea (beginning of the 6th month of pregnancy).

· in the event of an allergy to this or a related drug, including other non-steroidal anti-inflammatory drugs, aspirin;

· in case of allergy to any of the excipients;

· on injured skin, whatever the lesion: oozing lesions, eczema, infected lesion, burn or wound;

· in children under 15 years of age.

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

Warnings and Precautions

Take special care with VOLTARENE EMULGEL 1%, gel:

· Do not apply on mucous membranes or eyes.

· The appearance of a rash after application requires immediate cessation of treatment.

· Do not apply over large areas of skin and for prolonged periods without medical advice.

· This medicine contains propylene glycol and may cause skin irritation.

· Due to the presence of benzyl benzoate, this medicine may cause skin, eye and mucous membrane irritation.

The gel form is reserved for adults (from 15 years).

In adolescents aged 15 years and older, if symptoms worsen, it is recommended to seek the advice of your doctor.

The use of gloves by the masseur physiotherapist, in case of intensive use, is recommended.

IN CASE OF DOUBT DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.

If you are pregnant or breastfeeding:

Do not use this medication on your own. Seek advice from your doctor or pharmacist.

Children and adolescents (under 15 years of age):

This medication should not be used in children less than 15 years of age (see section "Never use VOLTARENE EMULGEL 1%, gel in the following cases").

Other medicines and VOLTARENE EMULGEL 1%, gel

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines obtained without a prescription.

This medicine contains Diclofenac. Other medicines contain certain medicines taken orally. Do not combine them, so as not to exceed the maximum recommended doses (see Dosage and Administration).

VOLTARENE EMULGEL 1%, gel with food, beverages and alcohol

Not applicable.

Pregnancy and breast feeding

Pregnancy

If you are pregnant, breast-feeding, or planning to become pregnant or planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

VOLTARENE EMULGEL 1%, gel should not be used from the 25th week of amenorrhea (beginning of the 6th month of pregnancy), as it may have harmful effects on the fetus or cause problems in childbirth. VOLTARENE EMULGEL 1%, gel should only be used after medical advice until the 24th week of amenorrhea (5 months of pregnancy) and the dose should be as low as possible and the duration of treatment as short as possible.

feeding

This drug passes into breast milk in small amounts. During breast-feeding, VOLTARENE EMULGEL 1%, gel should only be used after medical advice. However, VOLTARENE EMULGEL 1%, gel should not be applied to breasts in nursing mothers, on a large skin surface, or for extended periods of time.

If you are pregnant or breast-feeding, ask your doctor or pharmacist for more information.

Sport

Not applicable.

Driving and using machines

Not applicable.

VOLTARENE EMULGEL 1%, gel contains propylene glycol and benzyl benzoate.

3. HOW TO USE VOLTARENE EMULGEL 1%, gel?

Dosage and duration of treatment

Reserved for adults (from 15 years).

The dosage depends on the indication.

The occurrence of adverse reactions can be minimized by using the lowest dose possible during the shortest treatment time needed to relieve symptoms.

Benign trauma: sprain (bruising), contusion

1 local application, 2 to 3 times a day, for a maximum duration of 4 days. If the pain persists beyond that, a doctor should be consulted.

The dose administered to each application should not exceed 2.5 g of gel . This maximum dose corresponds to a tape of 6 cm of gel (see diagram of the scale).

http://afssaps-prd.afssaps.fr/php/ecodex/images/N0163103/image001.jpg

Pains of Muscular and Tendon-Ligament Origin

In supplementary treatment: 1 local application, 3 to 4 times per day, for a maximum duration of 7 days. If the pain persists beyond that, a doctor should be consulted.

The dose administered to each application should not exceed 2.5 g of gel. This maximum dose corresponds to a 6 cm ribbon (see scale drawing).
http://afssaps-prd.afssaps.fr/php/ecodex/images/N0163103/image001.jpg

Painful outbursts of osteoarthritis

Only after a first medical opinion.

Symptomatic treatment: 1 local application, 3 to 4 times per day, for a duration of 7 days. Treatment may be continued, if necessary, for up to 14 days. If the pain persists beyond that, a doctor should be consulted.

The dose administered to each application should not exceed 4 g of gel. This corresponds to a ribbon of about 10 cm (see diagram to scale).


http://afssaps-prd.afssaps.fr/php/ecodex/images/N0163103/image002.jpg

Special Populations

Children and adolescents under 15 years of age

This medication should not be used in children and adolescents under 15 years of age (see section "Never use VOLTARENE EMULGEL 1%, gel").

Elderly

This medication should be used with caution in elderly people who are more prone to adverse effects (see sections 4.4 and 4.8).

Administration mode

Local track.

Allow the gel to penetrate through a gentle and prolonged massage on the painful or inflammatory area.

Wash hands thoroughly after each use (except in the case of painful arthrosis of the fingers, if you apply the product to yourself).

If you have used more VOLTARENE EMULGEL 1%, you should not have:

In case of overdose or accidental poisoning, rinse thoroughly with water and consult your doctor or pharmacist immediately.

If you forget to use VOLTARENE EMULGEL 1%, gel:

If you have accidentally forgotten a dose, wait for the next dose and continue your treatment normally. Do not take a double dose to make up for a missed dose.

If you stop using VOLTARENE EMULGEL 1%, gel:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

Exceptionally severe reactions may occur:

· allergic skin reactions: rash, urticaria, bullae,

· respiratory problems such as asthma attack (noisy and short breath, decreased breathing ability);

· general manifestations of anaphylaxis (swelling of the face, lips, tongue, throat).

Immediately stop taking the medication and tell your doctor or pharmacist.

More commonly, adverse effects can occur, usually mild and transient:

· local skin effects such as redness, itching, skin irritation, local eruption or ulceration,

Very exceptionally, an increase in sensitivity to the sun.

Other general effects of non-steroidal anti-inflammatory agents, depending on the amount of gel applied, the surface area treated and its condition, duration of treatment and whether or not a closed dressing is used.

You should 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 VOLTARENE EMULGEL 1%, freezing?

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 package after EXP. The expiry date refers to the last day of that month.

Store at a temperature not exceeding 25 ° C for the painted aluminum tube.

Store at a temperature not exceeding 30 ° C for the aluminum laminate tube. After opening, the maximum shelf life is 6 months.

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 VOLTARENE EMULGEL contains 1%, gel

The active substance is:

Diclofenac diethylamine ............................................... .................................................. 1.16 g

Quantity corresponding to diclofenac sodium ............................................. .............................. 1.00 g

For 100 g of gel.

The other components are:

Diethylamine, Carbomer 974P, Ketomacrogol 1000, Caprylic and capric acid ester with C12 to C18 fatty alcohol, Isopropyl alcohol, Liquid paraffin, Cream 45 (containing benzyl benzoate), Propylene glycol, Purified water.

What is VOLTARENE EMULGEL 1%, gel and contents of the pack

This medication is in the form of a gel. Box of 1 tube of 50 g or 100 g.

Marketing Authorization Holder

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100, ROUTE DE VERSAILLES

78164 MARLY-LE-ROI CEDEX

Marketing Authorization Operator

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100, ROUTE DE VERSAILLES

78164 MARLY-LE-ROI CEDEX

Maker

NOVARTIS PHARMA SAS

26 RUE DE LA CHAPELLE

68330 HUNINGUE

or

CENTER PHARMACEUTICAL SPECIALTIES

ZAC DE LA BAROGNE

77230 MOUSSY-LE-NEUF

or

GLAXOSMITHKLINE HEALTH GRAND PUBLIC

100, ROUTE DE VERSAILLES

78164 MARLY-LE-ROI CEDEX

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 subsequently by the Contractor]

Other

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

ADVICE / HEALTH EDUCATION

Caution: Regardless of the indication for which you are using this medication, if there is a complete functional impotence, ie if you can not use the limb and in case of a significant "blue" hematoma, you should consult your doctor without delay .

Benign trauma: sprain (bruising), contusion

You just have trauma or bruising, you can use the gel for up to 4 days to relieve your pain. Do not resume a sporting activity or intense physical practice before the complete disappearance of the pain.

In addition, in case of:

Ankle sprain

You should consult your doctor who will judge the need for x-rays and orthopedic treatment:

· if you absolutely can not put yourself in support on the leg to make four steps,

· or if a hematoma (blue) appears within 24 to 48 hours,

· or if there is a considerable distortion or edema (swelling).

Injury of the knee

You should consult your doctor who will judge the need for x-rays and orthopedic treatment:

· in the event of severe swelling of the knee, with or without hematoma,

· and / or in case of impossibility of support.

Pains of Muscular and Tendon-Ligament Origin

If you can not use the limb that hurts you, or if the pain persists for more than 7 days, you should see a doctor.

Painful thrust of osteoarthritis

Osteoarthritis should be diagnosed by a doctor, who alone can make a difference with other diseases.

You can use this medicine to relieve the pain associated with a flare-up of osteoarthritis. However, you should consult your doctor without delay:

· if the pain lasts more than 14 days,

· or if the pain appears rather at night,

· or if it is accompanied by redness, rash, swelling, fever, discomfort or pain.

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