DICLOFENAC EG*GEL 100G 20MG/G

Diclofenac EG STADA Italia 20 mg/g Gel
Diclofenac, corresponding to diclofenac sodium (as diclofenac diethylammonium)

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

For adults and adolescents aged 14 and over
For short-term local symptomatic treatment of mild to moderate pain associated with acute muscle strains, sprains, or bruises resulting from impact injuries.

What you need to know before taking the medicine
Do NOT use Diclofenac EG STADA Italia
• if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if in the past, after taking/using acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (e.g. ibuprofen), you developed respiratory problems (asthma, bronchospasm), hives, runny nose, or swelling of the face or tongue;
• on open wounds, skin inflammations or infections, or on eczema and mucous membranes;
• if you are in the last 3 months of pregnancy;
• in children and adolescents under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Diclofenac EG STADA Italia.
• If Diclofenac EG STADA Italia is applied to extensive skin areas for a prolonged period, the possibility of systemic adverse events cannot be excluded. The gel should therefore be used with caution by patients with reduced kidney function, reduced heart function, or reduced liver function, as well as by patients with active peptic ulcers in the stomach or duodenum.
• Apply Diclofenac EG STADA Italia only to intact, healthy, and wound-free skin. Avoid contact of the gel with eyes or mucous membranes. The gel must not be ingested.
• After applying the gel to the skin, a permeable (non-occlusive) dressing can be used. However, the gel should be allowed to dry on the skin for a few minutes. Do not use an occlusive dressing that does not allow air to pass through.
• If symptoms worsen or do not improve after 3-5 days of treatment, consult a doctor.
• If you suffer from asthma, hay fever, swelling of the nasal mucous membranes (so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory infections (particularly associated with hay fever-like symptoms) and are hypersensitive to other painkillers and anti-rheumatic medicines of any kind, you are at a higher risk of developing asthma attacks (so-called analgesic intolerance/analgesic asthma), local swelling of the skin or mucous membranes (so-called angioedema) or hives - compared to other patients. In this case, Diclofenac EG STADA Italia should only be used taking certain precautions (preparation of emergency measures) and under direct medical supervision. The same applies to patients who are also allergic to other substances and exhibit, for example, skin reactions, itching or hives.
• Treatment with Diclofenac EG STADA Italia should be discontinued if a rash develops.
• If exposed to direct sunlight or artificial sun, there is a risk of skin reactions. Do not expose yourself to direct or artificial sunlight during treatment and for two weeks after stopping treatment.
• Precautions should be taken to ensure that children do not touch the area where the gel has been applied.

Children and adolescents
Do not use Diclofenac EG STADA Italia 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 have serious consequences. Stop using Diclofenac EG STADA Italia and contact your doctor or pharmacist immediately.

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

Very rare side effects (may affect up to 1 in 10,000 people)
• wheezing, shortness of breath, or chest tightness (asthma);
• swelling of the face, lips, tongue, or throat (angioedema).

Other possible side effects:

Common side effects (may affect up to 1 in 10 people)
• rash;
• itching;
• skin redness (erythema);
• eczema;
• dermatitis (skin inflammation), including contact dermatitis.

Uncommon side effects (may affect up to 1 in 100 people)
• peeling;
• dry skin;
• swelling (edema).

Very rare side effects (may affect up to 1 in 10,000 people)
• rash with pustules;
• gastrointestinal disorders;
• hypersensitivity reactions (including hives);
• photosensitivity with skin reactions following exposure to sunlight.

Side effects with unknown frequency (frequency cannot be estimated from the available data):
• burning sensation at the application site;
• dry skin.

When Diclofenac EG STADA Italia is applied to extensive skin areas for a prolonged period, the possible occurrence of systemic side effects (e.g. side effects affecting the liver, kidneys, or gastrointestinal tract, systemic hypersensitivity reactions) cannot be completely excluded - as their occurrence is possible after systemic administration of medicines containing diclofenac.

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.