NOTICE
ANSM - Updated on : 08/10/2025
Product name
DICLOFENAC URGO 2%, gel
Diclofenac (as diclofenac diethylamine)
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 provided 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 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 do not feel any improvement or if you feel less well after 4 days.
Keep out of the reach of children.
What does this leaflet contain?
1. What is DICLOFENAC URGO 2%, gel and what is it used for?
2. What do I need to know before using DICLOFENAC URGO 2%, gel?
3. How do I use DICLOFENAC URGO 2%, gel?
4. What are the possible side effects?
5. How do I keep DICLOFENAC URGO 2% gel?
6. Package contents and other information.
1. WHAT IS DICLOFENAC URGO 2%, gel AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: NON-STEROIDIC ANTI-INFLAMMATORY FOR TOPICAL USE - ATC code: M02AA15
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 indicated for short-term local treatment of mild trauma, sprains and contusions in adults and adolescents aged 15 and over.
You should consult your doctor if you do not feel any improvement or if you feel worse after 4 days.
2. WHAT DO I HAVE TO KNOW BEFORE USING DICLOFENAC URGO 2% gel?
Never use DICLOFENAC URGO 2%, gel:
- If you are allergic to the active substance or to any of the other ingredients of this medicine, as listed in section 6.
- If you are pregnant, from the beginning of the 6th month of pregnancy (beyond 24 weeks of amenorrhea).
- 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
Be careful with DICLOFENAC URGO :
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 or skin with a deczema rash.
After application:
- 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.
- Wait for DICLOFENAC URGO to dry before showering or bathing.
In case of contact with eyes, rinse thoroughly with water. If discomfort persists, talk to your doctor or pharmacist.
If you develop a rash after using this product, discontinue use immediately. If this occurs, contact your doctor or pharmacist.
DICLOFENAC URGO 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 cabins).
Do not use under an occlusive dressing, but a bandage or compress may be used. If there is no improvement after 4 days of treatment, 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 DICLOFENAC URGO 2% gel").
Other drugs and DICLOFENAC URGO 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, in particular certain oral medications. Do not combine them, so as not to exceed the maximum recommended doses (see Dosage and Administration).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, 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. You should NEVER take this medicine, as its effects on your child may have serious or even fatal consequences, particularly on the heart, lungs and/or kidneys, even with a single dose.
If you have taken this medicine while 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, this medicine should never be applied to the breasts.
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 and make it difficult for them to become 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
Topical application of diclofenac has no effect on the ability to drive or operate machinery.
DICLOFENAC URGO 2% gel contains propylene glycol (E1520).
This medicine contains 54 mg propylene glycol in 1 g of gel and may cause skin irritation.
DICLOFENAC URGO 2% gel contains butylated hydroxytoluene (E321).
Butylated hydroxytoluene may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.
DICLOFENAC URGO 2%, gel contains fragrances
This medicine contains perfume with benzyl alcohol (0.15 mg/g, E1519), citral, citronellol, coumarin, leugenol, farnesol, geraniol, d-limonene and linalool, which may cause allergic reactions.
Benzyl alcohol may also cause slight local irritation.
3. HOW DO I USE DICLOFENAC URGO 2% gel?
Do not use this gel on children (under 15 years of age).
Dosage
1 application, 2 times a day (preferably morning and evening) on the painful area. The quantity required depends on the size of the painful area: the dose administered for each application should not exceed 2.5 g of gel.
Method of administration
Local use.
EXTERNAL USE.
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. Absorbent paper should be disposed of in the garbage can after use.
- Wait for DICLOFENAC URGO to dry before showering or bathing.
Duration of treatment
Treatment is limited to 4 days. If pain persists beyond this period, a doctor should be consulted.
If you have used more DICLOFENAC URGO 2% gel than you should have :
In case of overdose or accidental intoxication, wipe off excess gel with absorbent paper, then rinse thoroughly with water and consult your doctor or pharmacist immediately.
If you forget to use DICLOFENAC URGO 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 DICLOFENAC URGO 2%, gel :
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
Some rare and very rare side effects may be severe.
If you experience any of the following signs of allergy, discontinue treatment 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 skin reactions such as redness, itching, skin irritation, erosion or local ulceration.
- 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, pharmacist or nurse. 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 CONSERVE DICLOFENAC URGO 2%, gel?
Keep out of sight and reach of children.
Do not use this medicine after the expiration date indicated on the box and tube. The expiration date refers to the last day of that month.
Store at a temperature not exceeding 25°C.
Store in original tube, protected from light.
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. Do not apply ointment shortly before taking a shower or bath. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What DICLOFENAC URGO 2% gel contains
- The active substance is :
Diclofenac diethylamine................................................................................................. 23.2 mg
Corresponding to diclofenac sodium................................................................................. 20 mg
For 1 g of gel.
Other ingredients are: isopropyl alcohol, propylene glycol (E1520), cocoyl caprylocaprate, liquid kerosene, carbomer, macrogol cetostearyl ether, diethylamine, oleic acid (E570), butylated hydroxytoluene (E321), fragrance, purified water.
What DICLOFENAC URGO 2% gel is and what it contains
Homogeneous, white to almost white gel, packaged in aluminum laminate tubes, closed with a PE ring and PP screw cap, available in the following presentations: 30 g, 50 g per tube.
Not all presentations may be marketed.
Marketing authorization holder
lABORATOIRES URGO HEALTHCARE
42 RUE DE longvic
21300 chenove
france
Marketing authorization holder
lABORATOIRES URGO HEALTHCARE
42 RUE DE longvic
21300 chenove
FRANCE
Manufacturer
MERCKLE GMBH
GRAF-ARCO-STR.3
ULM
89079, BADEN-WUERTTEMBERG
GERMANY
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 subsequently by the holder].
Other
Detailed information on this drug is available on the ANSM (France) website.
HEALTH ADVICE/EDUCATION
Caution: If you are completely functionally impotent, i.e. you cannot use your limb, or if you have a large hematoma ("bruise"), you should consult your doctor immediately.
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 the event 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 decide whether an X-ray and orthopedic treatment are necessary:
- in the event of severe knee swelling, with or without hematoma
- and/or if you are unable to bear weight.