VOLTARENACTIGO 1% GEL TUBE 100G

1. WHAT IS VOLTARENACTIGO 1 PER CENT, gel AND WHAT IS IT USED FOR?

Pharmacotherapeutic class: M02AA15

This medication is an anti-inflammatory and analgesic (pain relieving) gel for application to the skin in the area of pain only.

This medicine is indicated for adults (from 15 years of age) as a short-term local treatment for minor trauma: sprains, bruises.

You should contact your doctor if you do not feel any improvement or if you feel less well after 4 days.

2. WHAT YOU SHOULD KNOW BEFORE USING VOLTARENACTIGO 1 PER CENT, gel

Never use VOLTARENACTIGO 1 PER CENT, gel:

fromthe25th week of amenorrhea (beginning of the 6th month of pregnancy).

Ifyou are allergic to this drug or any related drug, including other non-steroidal anti-inflammatory drugs, aspirin;

incase of allergy to one of the excipients;

oninjured skin, whatever the lesion: oozing lesions, eczema, infected lesions, burns or wounds;

inchildren under 15 years of age.

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

Warnings and precautions

Use caution with VOLTARENACTIGO 1 PER CENT, gel:

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

If a rash appears after application, discontinue use immediately.

Do not apply to a large area of skin or for a prolonged period without medical advice.

This medicine contains propylene glycol and may cause skin irritation.

Due to the presence of benzyl benzoate, this medicine may cause irritation to the skin, eyes and mucous membranes.

This drug should not be used under occlusive dressings.

IF THERE IS NO IMPROVEMENT after 4 days of treatment, CONSULT your PHYSICIAN.

In adolescents 15 years of age and older, if symptoms worsen, it is recommended that you seek the advice of your physician.

If you are pregnant or breastfeeding:

Do not use this medicine on your own. Ask your doctor or pharmacist for advice.

Children and adolescents (under 15 years of age) :

This medicine should not be used in children under 15 years of age (see "Never use VOLTARENACTIGO 1 PER CENT, gel in the following situations").

Other medicines and VOLTARENACTIGO 1 PER CENT, gel

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

VOLTARENACTIGO 1 PER CENT, gel with food, drink and alcohol

Not applicable.

Pregnancy and Lactation

Pregnancy

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

VOLTARENACTIGO 1 PER CENT, gel should not be used after the 25th week of amenorrhea (beginning of the 6th month of pregnancy) as it may cause harm to the fetus or problems at delivery. VOLTARENACTIGO 1 PER CENT, gel should be used only on the advice of a physician until the 24th week of amenorrhea (5 completed months of pregnancy) and the dose should be as low as possible and the duration of treatment as short as possible.

Breastfeeding

This medicine passes into breast milk in small quantities. During lactation, VOLTARENACTIGO 1 PER CENT, gel should be used only after medical advice. However, VOLTARENACTIGO 1 PER CENT, gel should not be applied to the breasts of nursing mothers, nor should it be applied to a large area of skin, or for a prolonged period of time.

If you are pregnant or nursing, ask your doctor or pharmacist for more information.

Sportsmen

Not applicable.

Driving and use of machinery

Not applicable.

VOLTARENACTIGO 1 PER CENT, gel contains propylene glycol and benzyl benzoate.

3. HOW TO USE VOLTARENACTIGO 1 PER CENT, Gel

Dosage and Duration of Treatment

For use in adults only (15 years and older).

The occurrence of adverse effects may be minimized by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms.

1 local application, 2 to 3 times daily, for a maximum of 4 days. If pain persists beyond this period, a physician should be consulted.

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

Method of administration

Local use.

EXTERNAL USE

Massage the gel gently into the painful or inflammatory area for a prolonged period of time.

Wash hands thoroughly after each use.

If you have used more VOLTARENACTIGO 1 PERCENT, gel than you should have :

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

If you forget to use VOLTARENACTIGO 1 PER CENT, gel:

If you accidentally miss a dose, wait until your next dose and continue your treatment as usual. Do not take a double dose to make up for the one you forgot to take.

If you stop using VOLTARENACTIGO 1 PER CENT, gel:

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, but they do not always occur in everyone.

Exceptionally, reactions may occur which may be severe:

Allergic skinreactions: rash (pimples), urticaria, bullae,

Respiratoryproblemsof the asthma attack type (noisy and shortness of breath, impression of reduced respiratory capacity),

general anaphylaxis-likesymptoms(swelling of the face, lips, tongue, throat).

Treatment should be stopped immediately and your doctor or pharmacist should be informed.

More frequently, undesirable effects may occur, generally mild and temporary:

-localskin effects such as redness, itching, skin irritation, local erosion or ulceration,

veryrarely, increased sensitivity to the sun,

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

Your doctor or pharmacist should be informed.

Reporting side effects

If you experience any side effects, tell your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres

By reporting adverse reactions, you are helping to provide more information about the safety of the medicine.

5. HOW DO I USE VOLTARENACTIGO 1 PER CENT, gel?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date 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 coated aluminium tube.

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

Do not dispose of any medicine in the sewage system or in the household waste. Ask your pharmacist to dispose of any medication you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What VOLTARENACTIGO 1 PER CENT, gel contains

The active substance is:

Diethylamine diclofenac ..................................................................................................... 1.16 g

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

Per 100 g of gel.

Other components are:

Diethylamine, Carbomer 974P, cetomacrogol 1000, caprylic and capric acid ester with C12 to C18 fatty alcohol, isopropyl alcohol, liquid paraffin, cream fragrance 45(containing benzyl benzoate), propylene glycol, purified water.

What VOLTARENACTIGO 1 PER CENT is and what it contains

This medicine is presented as a gel. Box of 1 tube of 10 g, 50 g, 60 g or 100 g.

Marketing authorisation holder

GLAXOSMITHKLINE SANTE GRAND PUBLIC

100, ROUTE DE VERSAILLES

78164 MARLY-LE-ROI CEDEX