DICLOREUMACT*GEL 100G 20MG/G

DIFLEX 20 mg/g gel
Diclofenac

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

DIFLEX 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 contusions following impact trauma, such as injuries and sports 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 DIFLEX:
• 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, hives, runny nose (acute rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• on open wounds, skin inflammations or infections, eczema, or mucous membranes;
• if you are in the last three 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 DIFLEX.

If you suffer from asthma, allergic rhinitis, swelling of the nasal mucosa (so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory tract infections (particularly associated with symptoms similar to allergic rhinitis), you are more exposed 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 hives.
In these patients, DIFLEX 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 show, for example, skin reactions, itching or hives.

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

Apply DIFLEX only to intact, healthy skin free of wounds. Avoid contact with eyes and oral mucous membranes. The gel should not be ingested.

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

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

The use of DIFLEX 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
DIFLEX 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 DIFLEX 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:

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)
• Skin rash with pustules
• Gastrointestinal disturbances
• Hypersensitivity reactions, including hives
• Skin tightness or erythema following exposure to sunlight or sunlamps (photosensitivity reaction).

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

When DIFLEX is applied to a large skin area 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 diclofenac-containing medicines cannot be excluded.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.