VOLTAREN EMULGEL 2% GEL 60G TUBE IN LDPE/AL/LLDPE-HDPE MIXTURE ANTI-BLOCKING ADDITIVE MASTERBATCH

Name
Voltaren Emulgel 2% gel
Diclofenac diethylammonium


What is it and what is it for?
Voltaren Emulgel contains the active ingredient diclofenac diethylammonium. Diclofenac belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs) and is used to reduce pain and inflammation.
Voltaren Emulgel contains a component, oleic alcohol, which facilitates skin penetration.

Voltaren Emulgel is indicated for the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature affecting:
• joints, e.g. osteoarthritis and arthritis;
• muscles, e.g. contractures or injuries;
• tendons and ligaments, e.g. tendonitis.

Contact 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 Voltaren Emulgel
• if you are allergic to diclofenac diethylammonium or any of the other ingredients of this medicine (listed in section 6);
• if in the past after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) you have had an allergic reaction that manifested itself as asthma (difficulty breathing caused by inflammation and narrowing of the bronchi), angioedema (swelling of the face, lips, tongue and/or throat with difficulty swallowing and/or breathing), urticaria (itchy skin rash), or acute rhinitis (runny nose due to acute forms of inflammation of the nasal mucosa);
• if you are in the last 3 months of pregnancy (see section "Pregnancy, breastfeeding and fertility");
• if the patient is a child or adolescent under 14 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before using Voltaren Emulgel.

Pay particular attention:
• do not swallow Voltaren Emulgel; after use, clean your hands with absorbent paper and then wash them (see section 3);
• do not apply Voltaren Emulgel on broken, diseased or open wounds;
• avoid contact of Voltaren Emulgel with your eyes or mucous membranes, such as those of the mouth or vagina. If this occurs, wash the area immediately with running water and contact your doctor;
• Do not use Voltaren Emulgel with an occlusive dressing, i.e., covering the affected area with a non-breathable plastic film. Instead, you can use Voltaren Emulgel with a breathable gauze dressing;
• if you experience skin rashes, stop taking Voltaren Emulgel;
• If you use diclofenac on large areas of skin and for long periods of time, you may experience side effects that affect your whole body; do not exceed the recommended dose.

Children and adolescents
Voltaren Emulgel 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 characterised by rash, skin irritation, redness, 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 hives;
• angioedema (swelling of the face, lips, tongue and/or throat with difficulty swallowing and/or breathing);
• skin rash with the appearance of pustules;
• asthma (difficulty breathing caused by inflammation and narrowing of the bronchi);
• appearance of spots or redness on the skin following exposure to sunlight or sunlamps.

Side effects with unknown frequency
• burning sensation at the application site;
• dry skin.

Reporting of side effects
If you experience 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.