NOTICE
ANSM - Updated on : 31/08/2024
Product name
VOLTARENSPE 1%, gel
Diethylamine diclofenac
Box
Please read this leaflet carefully before using this medicine, as it contains important information for you.
You must always use this medicine in strict accordance with the information given in this leaflet or by your doctor or pharmacist.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any of the unwanted effects, 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.
Keep out of the reach of children.
What does this leaflet contain?
1. What is VOLTARENSPE 1% gel and what is it used for?
2. What do I need to know before using VOLTARENSPE 1%, gel?
3. How do I use VOLTARENSPE 1%, gel?
4. What are the possible side effects?
5. How should VOLTARENSPE 1% gel be stored?
6. Package contents and other information.
1. WHAT IS VOLTARENSPE 1%, gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: NON-STEROIDIC ANTI-INFLAMMATORY FOR TOPICAL USE.
ATC code: M02AA15
This medicine is an anti-inflammatory and analgesic (pain reliever), in the form of a gel for application to the skin, over the painful area only.
It is intended for adults (15 years and over), for short periods, in :
- local treatment of minor trauma: sprains, contusions;
- local treatment of pain of muscular and tendino-ligamentary origin;
- symptomatic treatment of painful attacks of arthrosis, after at least one medical opinion.
2. WHAT DO I HAVE TO KNOW BEFORE USING VOLTARENSPE 1%, gel?
Never use VOLTARENSPE 1%, gel:
- if you are allergic to the active substance or to any of the other ingredients of this product, as listed in section 6.
- If you are pregnant, from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea).
- On injured skin, whatever the lesion: oozing lesions, eczema, infected lesions, burns or wounds.
- In the event of a history of allergy or hypersensitivity (onset of asthma, angioedema, urticaria or acute rhinitis) triggered by a drug containing diclofen.diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
- In children under 15 years of age.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Warnings and precautions
Take special care with VOLTARENSPE 1%, gel:
Special warnings
- 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, rashes or eczema.
- Rinse eyes thoroughly with water if product comes into contact with eyes. Consult your doctor or pharmacist if discomfort persists.
- After application
o Hands should be wiped with absorbent paper (for example), then washed, except if the site to be treated is involved. Absorbent paper should be disposed of in the garbage can after use.
o Wait for VOLTARENSPE 1% gel to dry before showering or bathing.
- If a rash appears after application, discontinue treatment immediately. If this occurs, contact your doctor or pharmacist.
- Do not apply to a large area of skin, at a higher dosage than recommended, or for a prolonged period without medical advice.
- This medicine contains propylene glycol (50 mg/g gel) and may cause skin irritation.
- Due to the presence of benzyl benzoate (1 mg/g gel), this drug may cause irritation of the skin, eyes and mucous membranes.
- This product contains perfume with benzyl alcohol, geraniol, citral, citronellol, coumarin, d-limonene, leugenol, farnesol and linalool, which may cause allergic reactions.
The gel form is reserved for adults (15 years and over).
For adolescents aged 15 and over, if symptoms worsen, it is advisable to seek your doctor's advice.
For intensive use, the physiotherapist should wear gloves.
IF IN DOUBT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
If you are pregnant or breast-feeding
Do not use this product on your own initiative. Ask your doctor or pharmacist for advice.
Children under 15 years of age
This medicine must not be used in children under 15 years of age (see "Never use VOLTARENSPE 1%, gel in the following cases").
Other medicines and VOLTARENSPE 1%, gel
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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This medicine contains diclofenac. Other medicines contain diclofenac, in particular certain oral medicines. Do not combine them, so as not to exceed the maximum recommended doses (see Dosage and Administration).
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VOLTARENSPE 1%, gel with food, drink and alcohol
Not applicable.
Pregnancy, breast-feeding and fertility
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 any medicine.
Pregnancy
Before the beginning of the 6th month of pregnancy (up to the 24th week of amenorrhea), you should not take this medicine unless absolutely necessary, as determined by your doctor, due to the potential risk of miscarriage or malformations. In such cases, the dose should be kept as low as possible and the duration of treatment as short as possible.
From the beginning of the 6th month to the end of pregnancy (beyond the 24th week of amenorrhea), this medicine is contraindicated.If you are pregnant, you must NEVER take this medicine, as its effects on your child may be serious or even fatal, particularly in terms of the heart, lungs and/or kidneys, even after a single dose.
If you have taken this medicine when you were pregnant, tell your obstetrician-gynecologist immediately, so that suitable monitoring can be offered to you if necessary.
Breast-feeding
As this drug passes into breast milk, it is not recommended to use it while breast-feeding.
If you are breast-feeding, do not apply this product to your breasts.
Fertility
This drug, like all non-steroidal anti-inflammatory drugs (NSAIDs), may impair fertility in women, leading to difficulties in becoming pregnant, which may be reversible on discontinuation of treatment. Inform your doctor if you are planning a pregnancy or have difficulty conceiving.
Sportsmen
Not applicable.
Driving and use of machinery
Not applicable.
VOLTARENSPE 1%, gel contains :
- propylene glycol
- benzyl benzoate
- fragrance with benzyl alcohol, geraniol, citral, citronellol, coumarin, d-limonene, leugenol, farnesol and linalool.
3. HOW TO USE VOLTARENSPE 1%, gel?
Dosage and duration of treatment
For adults only (15 years and over).
Dosage depends on indication.
The occurrence of adverse 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 to 3 times a day, 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, 3 to 4 times a day, 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, 3 to 4 times a day, 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 1% 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
Local application.
Gently massage the gel into the painful or inflammatory area.
After application:
- Hands should be wiped dry with absorbent paper (for example), then washed (except in the case of a painful flare-up of osteoarthritis of the fingers, if you apply the product to yourself). Absorbent paper should be disposed of in the garbage can after use.
- Wait for VOLTARENSPE 1% gel to dry before taking a shower or bath.
If you have used more VOLTARENSPE 1%, gel than you should have :
In case of overdose or accidental poisoning, wipe off excess gel with paper towels, then rinse thoroughly with water and consult your doctor or pharmacist immediately.
If you forget to use VOLTARENSPE 1%, 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 1%, 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.
In exceptional cases, reactions which may be severe may occur:
- allergic skin reactions: rash (with or without pimples), urticaria, bullae,
- asthma-like respiratory problems (short, noisy breath, impression of reduced respiratory capacity),
- general anaphylaxis-like symptoms (swelling of face, lips, tongue, throat).
Discontinue treatment immediately and inform your doctor or pharmacist.
More frequently, adverse reactions, generally mild and transient, may occur:
- local skin effects such as redness, itching, skin irritation, erosion or local ulceration,
Very exceptionally, 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.
Your doctor or pharmacist should be informed.
Reporting side effects
If you experience any side effects, please tell your doctor or pharmacist. This also applies to any side effect 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 1%, gel?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the packaging after EXP. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C for the varnished aluminum tube.
Store at a temperature not exceeding 30°C for the aluminum laminate tube. After opening, maximum shelf-life is 6 months.
Do not dispose of any medicine down the drain or with 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 1% 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-C18 fatty alcohol, isopropyl alcohol, liquid kerosene, parfum crème 45 (containing benzyl benzoate), propylene glycol, purified water.
What VOLTARENSPE 1% gel is and what it contains
This medicine comes in the form of a gel. Tube of 50 g or 100 g.
Marketing authorization holder
HALEON FRANCE
23 RUE FRANÇOIS JACOB
92500 RUEIL-MALMAISON
Marketing authorization holder
HALEON FRANCE
23 RUE FRANÇOIS JACOB
92500 RUEIL-MALMAISON
Manufacturer
NOVARTIS PHARMA S.A.S
26 RUE DE LA CHAPELLE
68330 HUNINGUE
or
CENTER SPECIALITES PHARMACEUTIQUES
Z.A.C. DE LA BAROGNE
77230 MOUSSY-LE-NEUF
or
GLAXOSMITHKLINE SANTE GRAND PUBLIC
23 RUE FRANCOIS JACOB
92500 RUEIL MALMAISON
Drug names in member states of the European Economic Area
Not applicable.
The last date on which this leaflet was revised was :
[To be completed later by the holder].
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 must 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 decide 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 decide whether an X-ray and orthopedic treatment are necessary:
- in case of severe knee swelling, with or without hematoma,
- and/or if you are unable 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 immediately:
- if the pain lasts for more than 14 days,
- or if the pain tends to appear at night
- or if it is accompanied by redness, rash, severe swelling, fever, malaise or if the pain is diffuse.