VOLTAREN ACTIGO 2% INTENSE GEL NOVARTIS

VOLTAREN ACTIGO 2% INTENSE GEL NOVARTIS View larger

3400927407581

Diclofenac is a nonsteroidal anti-inflammatory derived from phenylacetic acid and the group of aryl carboxylic acids.
Gel form, it has a local anti-inflammatory and analgesic activity.
This medicine is indicated as local short-term treatment in adults and adolescents from 15 years in the case of Benin trauma, sprain (sprain), contusion.

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The advice of your pharmacist

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

Used for : sprain, contusion, strain, Benin trauma

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

Description

Diclofenac is a nonsteroidal anti-inflammatory derived from phenylacetic acid and the group of aryl carboxylic acids.
Gel form, it has a local anti-inflammatory and analgesic activity.
This medicine is indicated as local short-term treatment in adults and adolescents from 15 years in the case of Benin trauma, sprain (sprain), contusion.


The active substance is:  

Diclofenac diethylamine 2.32 g .....................
Amount corresponding to 2.00 g diclofenac sodium .......................
To 100 g of gel.

The other ingredients are:  
Butylated hydroxytoluene, carbomer, ester of caprylic and capric acids with fatty alcohol C12 to C18, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleyl alcohol, propylene glycol, eucalyptus fragrance, purified water.

List of excipients with known effects:   propylene and buthylhydroxytoluène.

Do not use this gel in children (under 15 years).

Dosage  
1 application, 2 times a day (morning and evening preferably) on the painful area.

Method and route of administration
Locally.
EXTERNAL USE.
Rub the gel by a gentle massage on the painful and prolonged inflammatory or region.
Wash hands after use.

Duration of treatment
The duration of treatment is limited to 4 days.

If you take more than 2% VoltarenActigo INTENSE gel that you should:
In case of overdose, rinse with water and optionally apply a symptomatic treatment.

If you forget to use VoltarenActigo INTENSE 2% gel:
If you have accidentally forgot to use your dose, use it when you remember and continue your regular dosing schedule. Do not use a double dose to make up for the dose you forgot to use.

Packaging:   tube   30 g

Never use VoltarenActigo INTENSE 2% gel in the following cases: in the following cases:

  • From the 25th week of gestation (early 6th month of pregnancy)
  • If you are allergic to this drug or related drugs, including other non-steroidal anti-inflammatory drugs, aspirin
  • If you are allergic to any of the excipients
  • On damaged skin, regardless of the injury: oozing lesions, eczema, infected lesion, burns or wounds
  • In children under 15 years

In case of doubt, it is essential to seek avisde your doctor or pharmacist.

Be careful with VoltarenActigo 2% INTENSE gel:

Special warnings
Do not apply to mucous membranes or the eyes.
The appearance of a rash after application requires immediate discontinuation of treatment.

  • If you are suffering from or have a history of bronchial asthma or allergic disease
  • If you are suffering from peptic ulcer history, renal or hepatic failure, hemorrhagic risk or inflammation of the intestine.
  • Do not expose yourself to sunlight or sunlamps during treatment.

This medication contains propylene glycol and may induce skin irritation.
This medicine contains butylated hydroxytoluene (E320) and may cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.

Precautions
Do not use under occlusive dressing, but a tape or gauze can be used.
No improvement after 4 days of treatment or if symptoms worsen, consult a doctor.
Gloves by the physiotherapist, e NCAS intensive use is recommended.

If you are pregnant or breastfeeding
Do not use this medication on your own initiative.
Seek advice from your doctor or pharmacist.

Children and adolescents (under 15 years)
There is little data on safety and efficacy in children and adolescents under 15 years.

Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if it is a drug Graduation USANS order.

This medicine contains   Diclofenac. Other drugs including some containing medications orally. Do not mix so as not to exceed the maximum recommended doses (see Dosage and method of administration).

Pregnancy
Until the 24th week of gestation (5 months of age pregnancy), your doctor may, if necessary, to prescribe this drug in a timely manner.
From the 25th week of gestation (early 6th month of pregnancy), you should IN NO EVENT OF YOURSELF take this medication because its effects on your child can have serious consequences, especially on a plane cardio- lung and kidney, even with a single dose.
Ask your doctor or pharmacist before taking any medicine.

Nursing
This medication passes into breast milk. As a precaution, you should avoid using it while breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
moot.

List of excipients with known effects   :   propylene and butylhydroxytoluene.

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

VOLTARENACTIGO INTENSE

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 INTENSE 2%: gel for local application; 30 g tube.
-

Laboratory GlaxoSmithKline Consumer Healthcare

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

INDICATIONS (summary)
This gel contains a non- steroidal anti-inflammatory drug ( NSAID ). It locally fights against inflammation and pain.
It is used in the local 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.
Precautions are necessary if there is a history of stomach ulcer or duodenal ulcer or digestive bleeding, liver failure or renal insufficiency .
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 medication while breastfeeding without medical advice. It should not be applied to the breasts of a nursing woman.
DIRECTIONS FOR USE AND DOSAGE (summary)
The gel should be applied in gentle and prolonged massage on the painful area.

Usual dosage:

  • Adult and child over 15 years: 1 application, morning and evening, for a maximum of 4 days. If symptoms persist after this time, consult your doctor to re-evaluate the treatment.
TIPS (summary)
This gel can be irritating to eyes or mucous membranes : wash your hands after application. In case of accidental contact with eyes, rinse thoroughly.
The tube should not be stored more than 1 month 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.


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


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.


duodenum
A part of the intestine into which food from the stomach penetrates.


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.


Hepatic insufficiency
Inability of the liver to perform its function, which is essentially the elimination of some waste, but also the synthesis of many biological substances essential to the body: albumin, cholesterol and coagulation factors (vitamin K, etc.).


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.


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.


ulcer
Injury of skin, mucous membranes or cornea.
  • Leg ulcer: chronic wound due to poor circulation of blood.
  • Gastroduodenal ulcer: a localized wound in the mucosa of the stomach or duodenum due to excess acidity and very often to the presence of a bacterium (Helicobacter pylori). The ulcer is favored by stress, alcohol, smoking and certain medications (aspirin, NSAIDs, etc.).


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.

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NOTICE

ANSM - Last updated: 15/12/2016

Name of the medicinal product

VOLTARENACTIGO 2% INTENSE, 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 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 2% INTENSE, gel and in which cases is it used?

2. What should I know before using VOLTARENACTIGO 2% INTENSE, gel?

3. How to use VOLTARENACTIGO 2% INTENSE, gel?

4. What are the possible side effects?

5. How to store VOLTARENACTIGO 2% INTENSE, gel?

6. Package contents and other information.

1. WHAT VOLTARENACTIGO 2% INTENSE, GEL AND WHAT CASES IS USED FOR?

Pharmacotherapeutic group : M02AA15

Diclofenac is a nonsteroidal anti-inflammatory drug derived from phenylacetic acid and the group of arylcarboxylic acids.

In the form of a gel, it has local anti-inflammatory and analgesic activity.

This drug is indicated as a short-term local treatment in adults and adolescents from 15 years of age, in case of benign trauma, sprains, bruising.

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

2. BEFORE YOU USE VOLTARENACTIGO 2% INTENSE, GEL?

Never use VOLTARENACTIGO 2% INTENSE, gel:

· from the 25th week of gestation (early 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 2% INTENSE, gel:

Special warnings

Do not apply on mucous membranes or eyes.

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

· If you have or have a history of bronchial asthma or allergic disease.

· If you have a history of peptic ulcer disease, kidney or liver failure, hemorrhage or inflammation of the intestine.

· Do not expose yourself to sunlight or tanning lamps during treatment.

This medicine contains propylene glycol and may cause skin irritation.

This medicinal product contains butylated hydroxytoluene (E320) and may cause local skin reactions (eg eczema) or irritation of the eyes and mucous membranes.

Precautions for use

Do not use under occlusive dressing, but a tape or compress may be used.

Without improvement after 4 days of treatment or if symptoms worsen, seek medical attention.

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

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)

There is little data on safety and efficacy in children and adolescents under 15 years of age (see "Never use VOLTARENACTIGO 2%, gel in pressurized vial in the following cases").

Other medicines and VOLTARENACTIGO 2% INTENSE, 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).

VOLTARENACTIGO 2% INTENSE, gel with food, drinks and alcohol

Not applicable.

Pregnancy and breast feeding

Pregnancy

Up to 24 weeks of amenorrhea (5 months of age pregnancy) your doctor may, if necessary, to prescribe this drug in a timely manner.

From the 25th week of gestation (early 6 th month of pregnancy), you should IN NO EVENT OF YOURSELF take this drug because its effect on your child may have serious consequences, especially on a plane cardio-pulmonary and renal, even with a single intake.

Ask your doctor or pharmacist for advice before taking any medicine

feeding

This drug passes into breast milk. As a precaution, it should be avoided during breastfeeding

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

Sport

Not applicable.

Driving and using machines

Not applicable.

VOLTARENACTIGO 2% INTENSE, gel contains propylene glycol and butylhydroxytoluene.

3. HOW TO USE VOLTARENACTIGO 2% INTENSE, gel?

Do not use this gel in children (under 15 years of age).

Dosage

1 application, twice a day (preferably morning and evening) on ​​the painful area.

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.

Duration of treatment

The duration of treatment is limited to 4 days.

If you used more VOLTARENACTIGO 2% INTENSE, 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 2% INTENSE, 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 2% INTENSE, gel:

Not applicable.

4. WHAT ARE POSSIBLE SIDE EFFECTS?

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

Some rare and very rare adverse effects can be severe.

If you experience any of the following signs of allergy, stop treatment immediately and tell your doctor or pharmacist.

· Skin allergic reactions: rash, urticaria, bullae.

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

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

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

· Local skin effects such as redness, itching, skin irritation, erosion or local ulceration.

· Very rarely, an increase in sensitivity to the sun.

· Other general effects of nonsteroidal anti-inflammatory drugs, 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 (digestive effects, kidney).

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 2% INTENSE, gel?

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.

To be used within 30 days after opening.

Store at a temperature not exceeding 30 ° C for the aluminum laminate tube.

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 2% INTENSE gel

The active substance is:

Diclofenac diethylamine ............................................... .................................................. 2.32 g

Quantity corresponding to diclofenac sodium ............................................. .............................. 2.00 g

For 100 g of gel.

The other components are:

Butylhydroxytoluene, carbomers, caprylic and capric acid esters with C12 to C18 fatty alcohol, diethylamine, isopropyl alcohol, liquid paraffin, macrogol cetostearyl ether, oleyl alcohol, propylene glycol, eucalyptus fragrance, purified water.

What is VOLTARENACTIGO 2% INTENSE, gel and contents of the pack

This medication is in the form of a gel. Box of 1 tube of 30 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

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 later by the holder]

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 should 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.

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.

How to manage joint pain (and those of osteoarthritis)?

EULAR recommendations *
1. hydiéno-dietary rules: weight loss, exercise
2. General management: use of analgesic, anti-arthritic slow-acting, and anti-inflammatory
3. Local ownership: joint injections (cortisone, hyaluronic acid)
4. Surgical Management
* European League Against Rheumatism

What advice micronutrition and herbal medicine for joint pain?

1 / Support for pain and inflammation daily

Stage 1: functional gene, morning stiffness, pain unlocking, blocking
Cartimotil Fort PILEJE the dosage of one capsule a day for 3 months
Food complementa combination of 3 excerpts: turmeric extract, boswellia and Laver
Stage 2: permanent pain, chronic, disabling
Fort Cartimotil the dosage of one capsule a day for 3 months and 4 capsules per day during inflammatory processes

+ Application CARTIMOSIL Gel on healthy skin, one to several times a day and massage with light circular movements. Massage Gel combines plant extracts and essential oils to target articular

2 / Treatment of protective cartilage background

Arthrobiane at a dose of 4 tablets per day for 3 months, renewable

Food complementa combination of drugs for osteoarthritis of slow action: glucosamine and chondroitin + Galangal

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