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.