NOTICE
ANSM - Updated on : 15/10/2025
Product name
VOLTARENSPE 2%, gel
Diethylamine diclofenac
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
Always use this medicine exactly as it is described in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for any advice or information you may need.
- If you experience any of the side effects listed above, please tell 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 if you feel less well:
- after 4 days in case of minor trauma: sprain, contusion,
- after 7 days for muscular and tendino-ligamentary pain,
- after a maximum of 14 days for painful arthrosis flare-ups.
Keep out of the reach of children.
What does this leaflet contain?
1. What is VOLTARENSPE 2% gel and what is it used for?
2. Whatdo I need to know before using VOLTARENSPE 2%, gel?
3. How do I use VOLTARENSPE 2%, gel?
4. What are the possible side effects?
5. How should VOLTARENSPE 2% gel be stored?
6. Package contents and other information.
1. WHAT IS VOLTARENSPE 2%, gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: NON-STEROIDIC ANTI-INFLAMMATORY FOR TOPICAL USE - ATC code: MO2AA15
Diclofenac is a non-steroidal anti-inflammatory, derived from phenylacetic acid of the arylcarboxylic acid group, with local, anti-inflammatory and analgesic activity.
This medicine is intended for adults (15 years and over), for short periods, in :
- local treatment of minor trauma: sprains, contusions;
- local treatment of muscular and tendino-ligamentary pain;
- symptomatic treatment of painful flare-ups of arthrosis, after at least one medical consultation.
2. WHAT DO I HAVE TO KNOW BEFORE USING VOLTARENSPE 2%, gel?
Never use VOLTARENSPE 2%, gel:
- From the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea),
- Hypersensitivity to diclofenac,
- Hypersensitivity to any of the excipients,
- Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds,
- History of allergy or hypersensitivity (occurrence of asthma, angioedema, urticaria or acute rhinitis) triggered by a drug containing diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
- In children and adolescents under 15 years of age.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Ask your doctor, pharmacist or nurse before using VOLTARENSPE 2%, gel.
Be careful with VOLTARENSPE 2%, gel:
Do not swallow.
Do not apply to mucous membranes or eyes.
Apply only to the painful area, on intact, healthy skin free of sores, open lesions or skin with a deczema rash.
In case of contact with eyes, rinse thoroughly with water. If discomfort persists, talk to your doctor or pharmacist.
If a rash appears after application, discontinue treatment immediately. If this occurs, contact your doctor or pharmacist.
VOLTARENSPE 2%, gel should be used with caution in patients with a history of :
- stomach or intestinal ulcer, intestinal inflammation, kidney or liver disease (renal or hepatic insufficiency) or blood coagulation disorder (bleeding diathesis),
- bronchial asthma or allergic disease.
Dosage should be kept as low as possible for the shortest time necessary to relieve pain.
To reduce the risk of photosensitization, avoid exposure to sunlight (even hazy sunlight or UV booths).
This medicine contains propylene glycol; do not use on open wounds or large areas of injured or damaged skin (burns) without telling your doctor or pharmacist.
This product contains butylated hydroxytoluene and may cause local skin reactions (contact dermatitis) or irritation of the eyes and mucous membranes.
Do not use under an occlusive dressing, but a bandage or compress may be used. If there is no improvement after the recommended treatment period, or if symptoms worsen, consult a doctor.
In the event of intensive use, gloves should be worn by the physiotherapist.
Children and adolescents (under 15)
There are limited data on safety and efficacy in children and adolescents under 15 years of age (see "Never use VOLTARENSPE 2% gel in the following situations").
Other drugs and VOLTARENSPE 2%, gel
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even if obtained without a prescription.
This medicine contains diclofenac. Other drugs contain diclofenac, particularly certain oral medications. Do not combine them, so as not to exceed the maximum recommended doses (see Dosage and Administration).
VOLTARENSPE 2%, gel with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
- Unless absolutely necessary, diclofenac should not be prescribed during the first 24 weeks of amenorrhea (5 months of pregnancy). If diclofenac is administered to a woman wishing to become pregnant or who is less than six months pregnant, the dose should be as low as possible and the duration of treatment as short as possible.
If you have taken this medicine while pregnant, talk to your obstetrician-gynecologist immediately, so that appropriate monitoring can be arranged.
Breast-feeding
This drug passes into breast milk. As a precautionary measure, it should not be used while breast-feeding.
Under no circumstances should this product be applied to the breasts of nursing mothers.
Ask your doctor or pharmacist for advice before taking any medication.
Fertility
This drug, like all non-steroidal anti-inflammatory drugs (NSAIDs), may impair fertility in women, making it difficult for them to become pregnant.
Tell your doctor if you are planning a pregnancy or have difficulty conceiving.
Driving vehicles and operating machinery
Topical application of diclofenac has no effect on the ability to drive or operate machinery.
VOLTARENSPE 2% gel contains propylene glycol and butylated hydroxytoluene, d-limonene and linalool:
This medicine contains 50 mg propylene glycol per g gel.
This medicine contains butylhydroxytoluene and may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous membranes.
This product contains perfume containing d-limonene and linalool, which may cause allergic reactions.
3. HOW TO USE VOLTARENSPE 2%, gel?
Always use this medicine exactly as instructed in this leaflet or as directed by your doctor, pharmacist or nurse. Check with your doctor, pharmacist or nurse if in doubt.
Dosage
For adults only (15 years and over).
Dosage depends on indication.
The occurrence of undesirable effects can be minimized by using the lowest possible dose for the shortest duration of treatment necessary to relieve symptoms.
Minor trauma: sprain, contusion
1 local application, 2 times a day (morning and evening), for a maximum of 4 days. If pain persists beyond this period, a doctor should be consulted.
The dose for each application should not exceed 2.5 g of gel. This maximum dose corresponds to a 6 cm ribbon of gel (see scale diagram).
Pain of muscular and tendino-ligamentary origin
As adjunctive treatment: 1 local application, 2 times a day (morning and evening), for a maximum of 7 days. If pain persists beyond this period, a doctor should be consulted.
The dose for each application should not exceed 2.5 g of gel. This maximum dose corresponds to a 6 cm ribbon (see scale diagram).
Painful flare-ups of arthrosis
Only after initial medical advice.
Symptomatic treatment: 1 local application, 2 times a day (morning and evening), for 7 days. Treatment may be continued, if necessary, for up to 14 days. If pain persists beyond this period, a doctor should be consulted.
The dose administered per application should not exceed 4 g of gel. This corresponds to a ribbon of approximately 10 cm (see scale diagram).
Special populations
Children under 15 years of age
This medicine must not be used in children under 15 years of age (see "Never use VOLTARENSPE 2% gel in the following cases").
Elderly subjects
This drug should be used with caution in the elderly, who are more prone to adverse reactions.
Method of administration
Apply to the skin.
Do not swallow. Do not apply to mucous membranes, eyes or damaged skin.
This drug must not be used under an occlusive dressing. However, a bandage or compress may be used.
Gently massage the gel into the painful or inflammatory area for a prolonged period.
After application:
- Hands should be wiped with absorbent paper (for example), then washed, except if the site to be treated is involved. After use, paper towels should be disposed of in the garbage can, not in the toilet, to prevent the product from entering the sewage system.
- Before dressing or applying a non-occlusive bandage, allow the gel to dry for a few minutes on the skin.
- If you need to shower or take a bath, apply the product afterwards.
If you have used more VOLTARENSPE 2% gel than you should have :
Wipe off excess gel with paper towel.
In case of accidental poisoning, consult your doctor or pharmacist immediately.
If you forget to use VOLTARENSPE 2%, 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 VOLTARENSPE 2%, gel :
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, VOLTARENSPE may cause undesirable effects, but these do not always occur in everyone.
Some rare and very rare side effects may be severe.
If you experience any of the following signs of allergy, discontinue use immediately and inform your doctor or pharmacist.
- Allergic skin reactions: rash (with or without pimples), urticaria, bullae.
- Respiratory problems such as asthma attacks (short, noisy breath, impression of reduced respiratory capacity).
- General manifestations of anaphylaxis (swelling of face, lips, tongue, throat).
- More frequently, adverse reactions, generally mild and transient, may occur:
- Local cutaneous effects such as redness, itching, skin irritation, erosion or local ulceration.
- Indeterminate: burning sensation at the application site, dry skin.
- Very rarely, increased sensitivity to sunlight.
- Other general effects of non-steroidal anti-inflammatory drugs, depending on the amount of gel applied, the surface treated and its condition, the duration of treatment and whether or not a closed dressing is used (digestive, renal effects).
Reporting side effects
If you experience any side effects, please tell 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: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https: //signalement.social-sante.gouv.fr/.
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO USE VOLTARENSPE 2%, gel
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging and on the tube after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 30°C. After opening, maximum shelf-life is 6 months.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to dispose of any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What VOLTARENSPE 2% gel contains
- The active substance is :
Diethylamine diclofenac .............................................................................................. 2.32 g
Quantity corresponding to diclofenac sodium ................................................................... 2.00 g
For 100 g of gel.
- The other components are :
Carbomers, caprylic and capric esters with C12-C18 fatty alcohols, diethylamine, isopropyl alcohol, liquid kerosene, macrogol cetostearyl ether, oleic alcohol, eucalyptus* fragrance, purified water, propylene glycol, butylhydroxytoluene.
*composition of eucalyptus fragrance : cineole, methyl dihydrojasmonate, racemic camphor, essential oil of deucalyptus (eucalyptus globulus), linalool, cetalox, racemic rose oxide, dipropylene glycol, borneol laevo, caryophyllene, essential oil of pine, terpineol, dorange terpenes (D-limonene), alpha-pinene, essential oil of elemi, camphene, acetate C-9, linalool oxide.
What VOLTARENSPE 2% gel is and what it contains
This medicine comes in the form of a homogeneous, white to almost white gel, in 50 gtubes ().
Marketing authorization holder
HALEON FRANCE
23 RUE FRANCOIS JACOB
92500 RUEIL-MALMAISON
Marketing authorization holder
HALEON France
23 RUE FRANCOIS JACOB
92500 RUEIL-MALMAISON
Manufacturer
HALEON France
23 RUE FRANCOIS JACOB
92500 RUEIL-MALMAISON
Product names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[to be completed subsequently by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.
HEALTH EDUCATION ADVICE
Caution: whatever the indication for which you are using this medicine, if there is complete functional impotence, i.e. if you cannot use the limb, and in the event of a significant haematoma ("bruise"), you should consult your doctor without delay.
Minor trauma: sprain, contusion
If you have just suffered a trauma or contusion, you can use the gel for up to 4 days to relieve your pain. Do not resume sports or strenuous exercise until the pain has completely disappeared.
In addition, in case of :
Ankle sprain :
You should consult your doctor, who will determine whether an X-ray and orthopedic treatment are necessary:
- if you can't stand on your leg at all to take four steps,
- or if a hematoma (bruise) appears within 24 to 48 hours,
- or if there is very significant deformity or swelling.
Knee injury:
You should consult your doctor, who will determine whether an X-ray and orthopedic treatment are necessary:
- in case of significant knee swelling, with or without hematoma,
- and/or inability to bear weight.
Pain of muscular and tendino-ligamentary origin
If you are unable to use the painful limb, or if the pain persists for more than 7 days, you should consult a doctor.
Painful flare-up of arthrosis
Arthrosis must be diagnosed by a doctor, who alone can distinguish it from other diseases.
You can use this medicine to relieve the pain associated with a flare-up of arthrosis. However, you should consult your doctor without delay:
- if the pain lasts for more than 14 days,
- or if the pain tends to occur at night,
- or if accompanied by redness, rash, severe swelling, fever, discomfort or if pain is diffuse.