DICLOFENAC TE*GEL 100G 20MG/G

DICLOFENAC TEVA ITALIA 20 mg/g gel
Diclofenac

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

DICLOFENAC TEVA ITALIA is indicated:

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 DICLOFENAC TEVA ITALIA
• 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, inflammations or infections of the skin, on eczema or on 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 DICLOFENAC TEVA ITALIA.

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 (especially associated with symptoms similar to allergic rhinitis), you are more exposed, compared to other patients, to asthma attacks (so-called analgesic intolerance/analgesic asthma), local swelling of the skin or mucous membranes (so-called Quincke's oedema) and hives.
In these patients, DICLOFENAC TEVA ITALIA can only be used with certain precautions (emergency preparation) 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 DICLOFENAC TEVA ITALIA is applied to an extensive skin area and for a prolonged period, the possibility of systemic undesirable effects associated with the application cannot be excluded.

Apply DICLOFENAC TEVA ITALIA only to intact, healthy, and wound-free skin. Avoid contact with 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 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 DICLOFENAC TEVA ITALIA should be discontinued if a rash develops.

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

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

Children and adolescents
DICLOFENAC TEVA ITALIA 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 DICLOFENAC TEVA ITALIA 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):
• 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 tightness or erythema following 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 DICLOFENAC TEVA ITALIA is applied to an extensive skin area and for a prolonged period, the possibility of systemic side effects (for example, 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, 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.