VoltarenActigo 1% GEL 50ML BOTTLE DICLOFENAC

3400935931474

VoltarenActigo 1% GEL 50ML BOTTLE DICLOFENAC: It is indicated as a local short-term treatment in adults and children over 15 years, in case of Benin trauma, sprain (sprain), contusion

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Partners with: Ibuprofen 400MG Spedifen 12 Bags, Muscles and Joints Friction Sileo 200ml, Dexsil Pharma Sports Body Gel. 100 ml tube

Used for : contusion, Benin trauma, sprain (sprain)

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VoltarenActigo 1% GEL DICLOFENAC BOTTLE 50ML

For warnings, precautions for use and against-indications, please refer to the user manual.

Description VoltarenActigo 1% GEL DICLOFENAC BOTTLE 50ML

It is indicated as a local short-term treatment in adults and children over 15 years, in case of Benin trauma, sprain (sprain), contusion

Using advice and opinion on VoltarenActigo 1% GEL DICLOFENAC BOTTLE 50ML

1 application, 3 times daily.

The duration of treatment is limited to 4 days.

Locally - For adults (from 15 years).

EXTERNAL USE.

Rub the gel with a gentle massage and extended to the painful inflammatory or region.

Wash hands after use.

The main types of muscle pain

Muscle pain is found in many cases cramps, aches, sprains, contractures, muscle tears, lumbago, torticollis.
A cramp is a severe muscle pain, unexpected and temporary.

Cramp causes lameness: the muscle or muscle group in question can no longer operate normally and play its role.
Aches are common after a major and unusual effort. Aches appear within 2 days of effort.
These muscle pain are not serious and will heal on their own in a week maximum: treat aches is relatively easy.

Sprains are sudden elongation of the muscle that cause significant pain and instantaneous. They can appear in case of violent effort afterwards or cold. The pain is localized hot but can become diffused thereafter, the pain being imperceptible at rest. To heal a strained, rest is essential: time is variable depending on the importance of stretching.

Contractures can cause a tear when, despite the pain, the muscle continues its effort. To treat contracture, stopping and laying up are in order.

Composition of VoltarenActigo 1% GEL DICLOFENAC BOTTLE 50ML

Active ingredients:
Diclofenac diethylamine ............................................ 1.16 g
Amount corresponding to 1.00 g diclofenac sodium ...................
Per 100 g of gel.

Other Materials: Diethylamine, Carbomer 974P, cetomacrogol 1000, ester of caprylic and capric acids with C12 to C18 fatty alcohol, isopropyl alcohol, liquid paraffin, perfume cream 45, propylene glycol, purified water.

Active ingredient: Diclofenac sodium

Storage: Pressurized container:
· To protect against sunlight and do not expose to temperatures exceeding 30 ° C
· Do not pierce or burn, even after use

Packaging: pressurized bottle of 50 ml gel

Use caution with VoltarenActigo 1% GEL DICLOFENAC BOTTLE 50ML

Special warnings

· Do not apply to mucous membranes or the eyes.
· The appearance of a rash after application requires immediate discontinuation.
This medicine contains propylene glycol and can induce skin irritation.
Precautions

This drug should not be used under occlusion.
THERE IS NO IMPROVEMENT after 4 days of treatment, consult your DOCTOR.
If you are pregnant or breastfeeding:
Do not use this medication on your own. Talk to your doctor or pharmacist.

VoltarenActigo Introducing 1% GEL DICLOFENAC BOTTLE 50ML

pressurized bottle 50ml

Warnings about medications

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

Tell your pharmacist Online ongoing treatment to identify any incompatibilities. The order confirmation form contains a custom message field provided for this purpose.

Click here to find the manual of this drug on the website of the National Agency of Drug Safety and health products.

Pharmacovigilance : Declare one or effect (s) undesirable (s) connected (s) to the use of a drug

VIDAL OF THE FAMILY

VoltarenActigo

Anti-inflammatory local action

diclofenac

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

PRESENTATIONS (summary)

VOLTARENACTIGO 1%: gel for local application; 60 g tube.
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VOLTARENACTIGO 1%: gel for local application; 100 g tube.
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VOLTARENACTIGO 1%: gel for local application; 50 ml pressurized bottle.
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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 the treatment of short sprains and bruises.
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)
This medication can be used on the advice of your pharmacist. Nevertheless, medical advice is preferable in cases of severe pain, severe edema or limb or joint mobility.
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:
NSAIDs are low in breast milk: do not use this gel during 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 (max. 6 cm) in a soft, prolonged massage on the painful area.

Usual dosage:

  • Adult and child over 15 years: 1 application, 2 or 3 times a day, for a maximum of 4 days. If symptoms persist after this time, consult your doctor to re-evaluate the treatment.
TIPS (summary)
This medicinal product may be freely available in certain pharmacies; nevertheless, do not hesitate to ask your pharmacist for advice.
This gel can be irritating to eyes or mucous membranes : wash your hands after application. In case of accidental contact with eyes, rinse thoroughly.
This gel should 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).


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

VOLTARENACTIGO 1%, gel in pressurized bottle

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 experience no improvement or feel less well after 4 days.

Do not use this medication for children.

What is in this leaflet?

1. What is VOLTARENACTIGO 1%, gel in pressurized vial and in which cases it is used?

2. What should I know before using VOLTARENACTIGO 1%, gel in a pressurized vial?

3. How to use VOLTARENACTIGO 1%, gel in a pressurized bottle?

4. What are the possible side effects?

5. How to store VOLTARENACTIGO 1%, gel in a pressurized bottle?

6. Package contents and other information.

1. WHAT VOLTARENACTIGO 1%, gel in pressurized vial 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 indicated in adults (from 15 years of age) as a short-term local treatment for benign trauma: sprain (sprain), bruising.

You should contact your doctor if you experience no improvement or feel less well after 4 days.

2. BEFORE YOU USE VOLTARENACTIGO 1%, gel in a pressurized vial?

Never use VOLTARENACTIGO 1%, gel in pressurized vial:

· 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 VOLTARENACTIGO 1%, gel in pressurized bottle

· Do not apply to the mucous membranes or the eyes only on the painful area.

· 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.

This medication should not be used as an occlusive dressing.

IN THE ABSENCE OF IMPROVEMENT after 4 days of treatment, CONSULT YOUR DOCTOR.

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

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 younger than 15 years of age (see "Never use VOLTARENACTIGO 1%, gel in pressurized vial in the following cases").

Other medicines and VOLTARENACTIGO 1%, gel in pressurized bottle

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).

VOLTARENACTIGO 1%, gel in pressurized bottle 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.

VOLTARENACTIGO 1%, pressurized bottle 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. VOLTARENACTIGO 1%, gel in pressurized vial 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 the shortest treatment possible.

feeding

This drug passes into breast milk in small amounts. During breast-feeding, VOLTARENACTIGO 1%, gel in pressurized vial should only be used after medical advice. However, VOLTARENACTIGO 1%, pressurized vial 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.

VOLTARENACTIGO 1%, pressurized bottle gel contains propylene glycol and benzyl benzoate.

3. HOW TO USE VOLTARENACTIGO 1%, gel in pressurized vial?

Dosage and duration of treatment

Reserved for adults (from 15 years).

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

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

Administration mode

Local track.

EXTERNAL USE

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

Wash hands thoroughly after each use.

If you used more VOLTARENACTIGO 1%, pressurized bottle gel than you should:

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

If you forget to use VOLTARENACTIGO 1%, pressurized bottle 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 VOLTARENACTIGO 1%, pressurized bottle 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 VOLTARENACTIGO 1%, gel in pressurized vial?

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.

Pressurized container:

· Protect from sunlight and do not expose to temperatures above 30 ° C.

· Do not pierce or burn even after use.

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 VOLTARENACTIGO contains 1%, gel in pressurized bottle

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 VOLTARENACTIGO 1%, gel in pressurized vial and contents of the pack

This medication is in the form of a gel in a 50 ml or 100 ml pressurized bottle.

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

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: if there is a complete functional impotence, ie if you can not use the limb and in case of a significant ("blue") hematoma, you must consult your doctor without delay .

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.

Otherwise :

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).

In case of knee injury

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.

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