MUSCORIL DOLORE*GEL100G 20MG/G

MUSCORIL DOLORE 20 mg/g gel
Diclofenac, corresponding to diclofenac sodium (as diclofenac diethylamine)

What it is and what it is used for
MUSCORIL DOLORE contains the active ingredient diclofenac, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

MUSCORIL DOLORE is indicated for:
For adults and adolescents aged 14 years and over
For the local symptomatic treatment of pain associated with acute muscle strains, sprains or bruises following impact trauma, such as sports injuries and accidents.

For adolescents aged 14 years and over, the medicine is indicated for short-term treatment.

What you need to know before taking the medicine
Do not use MUSCORIL DOLORE:
- if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
- if you have developed asthma attacks, urticaria, runny nose (acute rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
- on open wounds, inflammation or skin infections, on eczema or on mucous membranes;
- if you are in the last 3 months of pregnancy (see Pregnancy and breastfeeding);
- in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using MUSCORIL DOLORE.

If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (the so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory tract infections (especially those associated with symptoms similar to allergic rhinitis), you are more susceptible than other patients to asthma attacks (the so-called analgesic intolerance/analgesic asthma), local swelling of the skin or mucous membranes (the so-called Quincke's oedema) and urticaria.
In these patients, MUSCORIL DOLORE can only be used with certain precautions (emergency preparedness) and under direct medical supervision. The same applies to patients who are also allergic to other substances and experience, for example, skin reactions, itching or urticaria.

When MUSCORIL DOLORE is applied to an extensive skin area and for a prolonged period, the possibility of systemic side effects associated with the application of MUSCORIL DOLORE cannot be excluded.

Apply MUSCORIL DOLORE only to intact, healthy and wound-free skin. Avoid contact with the eyes and oral mucous membranes. The gel must not be swallowed.

After applying the gel to the skin, a breathable (non-occlusive) dressing can be used, but the gel should first be allowed to dry on the skin for a few minutes. Do not use it with occlusive dressings that do not allow air to pass through.

Consult your doctor if symptoms worsen or do not improve within 3-5 days.

The use of MUSCORIL DOLORE should be discontinued if a skin rash develops.

Avoid exposure to sunlight, including sunlamps, while using this medicine.

The necessary precautions should be taken to prevent children from touching the area where the gel is applied.

Children and adolescents
MUSCORIL DOLORE is contraindicated in children and adolescents under 14 years of age.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects can be serious. Stop using MUSCORIL DOLORE and contact your doctor immediately:

Rare side effects (may affect up to 1 in 1,000 people)
• Skin inflammation with blisters (bullous dermatitis)

Very rare side effects (may affect up to 1 in 10,000 people)
• Asthma
• Swelling of the face, lips, tongue or throat (angioedema)

Other side effects may occur: Common (may affect up to 1 in 10 people)
• Skin rash, skin redness (erythema), dermatitis (including contact dermatitis), itching.

Uncommon (may affect up to 1 in 100 people)
• Peeling, skin dehydration, oedema.

Very rare (may affect up to 1 in 10,000 people)
• Rash with pustules;
• Gastrointestinal disorders;
• Hypersensitivity reactions, including urticaria;
• Skin spots or redness after exposure to sunlight or sunlamps (photosensitivity reaction).

Frequency not known (frequency cannot be estimated from the available data)
• Burning sensation at the application site.

When MUSCORIL DOLORE is applied to an extensive skin area and for a prolonged period, the possibility of systemic side effects (e.g., renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions) similar to those that may occur after systemic administration of medicines containing diclofenac cannot be excluded.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.