DICLOFENAC SAND*GEL 100G 1%

Diclofenac Sandoz Gel
Diclofenac sodium
Equivalent medicinal product

What it is and what it is used for
Diclofenac Sandoz Gel contains the active ingredient diclofenac sodium. Diclofenac belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation.

Diclofenac Sandoz Gel is indicated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic origin affecting:
• joints;
• muscles;
• tendons and ligaments.

Consult your doctor if you do not feel better or if you feel worse after 7 days.

What you need to know before taking the medicine
Do not use Diclofenac Sandoz Gel
• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6);
• if you have previously experienced symptoms of an allergic reaction such as asthma (e.g., wheezing and shortness of breath), angioedema (swelling of the face, lips, tongue, and/or throat with difficulty swallowing and/or breathing), urticaria (skin rash), or acute forms of nasal inflammation (acute rhinitis) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you are in the third trimester of pregnancy (see section Pregnancy and breastfeeding);
• if the patient is a child or adolescent under 14 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Diclofenac Sandoz Gel.

Pay particular attention:
• do not swallow Diclofenac Sandoz Gel; wash your hands after use;
• do not apply Diclofenac Sandoz Gel to broken, diseased, or open-wound skin;
• avoid Diclofenac Sandoz Gel coming into contact with eyes or mucous membranes, such as in the mouth or vagina. If this occurs, wash the area immediately with running water and contact your doctor;
• do not use Diclofenac Sandoz Gel with an occlusive dressing, i.e., covering the affected area with a plastic film that does not allow air to pass through. However, you can use Diclofenac Sandoz Gel with a gauze that allows air to pass through;
• if you experience skin rashes, discontinue treatment with Diclofenac Sandoz Gel;
• if you use diclofenac on large areas of skin and for long periods of time, it is possible that you may experience side effects affecting the entire body; do not use Diclofenac Sandoz Gel in larger quantities or for a longer period of time than stated in this leaflet, unless otherwise advised by your doctor.

Children and adolescents
Diclofenac Sandoz Gel should not be used 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.

Common side effects (may affect up to 1 in 10 people)
• various types of skin reactions characterized by rash, redness, skin irritation, itching, and swelling (dermatitis, eczema).

Rare side effects (may affect up to 1 in 1,000 people)
• inflammation of the skin with the appearance of blisters (bullous dermatitis).

Very rare side effects (may affect up to 1 in 10,000 people)
• allergic reactions including urticaria;
• angioedema (swelling of the face, lips, tongue and/or throat with difficulty swallowing and/or breathing);
• skin eruption with the appearance of pustules;
• asthma (e.g., wheezing and shortness of breath);
• appearance of spots or redness on the skin after exposure to sunlight or sunlamps.

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

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.