DICLOFENAC ZENTIVA*GEL 50G 1%

DICLOFENAC ZENTIVA 10 mg/g gel

What it is and what it is used for
DICLOFENAC ZENTIVA contains the active ingredient diclofenac sodium and belongs to the class of non-steroidal anti-inflammatory drugs for topical use.

DICLOFENAC ZENTIVA 10 mg/g gel is used for the local treatment of painful and inflammatory conditions of rheumatic or traumatic origin affecting joints, muscles, tendons or ligaments.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

What you need to know before taking the medicine
Do not use DICLOFENAC ZENTIVA
- if you are allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in paragraph 6);
- if you have had asthma attacks, urticaria (itchy skin rash) or acute rhinitis (runny nose) after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs);
- if you are in the last 3 months of pregnancy;
- in children and adolescents under 14 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using DICLOFENAC ZENTIVA.

• Pay particular attention to the following: Diclofenac Zentiva should only be applied to unbroken and healthy skin: do not apply it to skin wounds or open lesions;
• do not apply the gel to eyes and mucous membranes (e.g. mouth or vagina): if this happens, wash immediately with running water and contact your doctor; • do not swallow the gel; wash hands after use;
• stop using the medicine if you develop a skin rash after application;
• DICLOFENAC ZENTIVA can be used with non-occlusive dressings (such as a breathable gauze) but should not be used with an occlusive dressing (such as an airtight plastic film);
• if you use diclofenac gel on large areas of skin and for prolonged periods of time, you may experience side effects that could affect your entire body. Do not exceed the recommended dose.

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

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects are listed in order of frequency:

Common (may affect up to 1 in 10 patients)
- Rash
- Eczema
- Erythema
- Dermatitis (including contact dermatitis)
- Itching

Rare (may affect up to 1 in 1,000 patients)
- Skin inflammation with the appearance of blisters (bullous dermatitis)

Very rare (may affect up to 1 in 10,000 patients)
- Allergic reactions (including urticaria)
- Swelling of the face, lips, tongue and/or throat with difficulty swallowing (and/or breathing (angioneurotic oedema)
- Rash with pustules
- Asthma
- Photosensitivity reactions

Not known
- Burning sensation at the application site,
- Dry skin

In such cases, it is recommended to stop treatment immediately and contact your doctor.

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.