VOLTALGAN*CUTANEOUS FOAM 50G 3%

Voltalgan 3% cutaneous foam
Diclofenac

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

Voltalgan is indicated for the local treatment of painful and inflammatory conditions of rheumatic or traumatic nature affecting:
• joints
• muscles
• tendons and ligaments.

Consult your doctor if you do not feel better or if you feel worse after 7 days, if the problem recurs, or if you notice any recent changes in its characteristics.

What you need to know before taking the medicine
Do not use Voltalgan
• if you are allergic to diclofenac, acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs) or any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), which manifested as asthma (difficult 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 rash), or acute rhinitis (runny nose due to acute inflammation of the nasal mucosa);
• if your skin has any kind of lesions, such as exudative dermatitis (skin irritation with exudate, a fluid that forms with inflammation), eczema (skin rash), lesions with infection, burns or wounds;
• if you are in the third trimester of pregnancy (see section Pregnancy, breastfeeding and fertility);
• if the patient is a child or adolescent under 14 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using Voltalgan.

Consult your doctor before using Voltalgan:
• if you suffer or have suffered from asthma
• if you suffer or have suffered from chronic obstructive pulmonary disease
• if you suffer or have suffered from allergic rhinitis (inflammation of the nose due to allergy)
• if you suffer or have suffered from an inflammation of the nasal mucosa (nasal polyp)
because you may more easily experience asthma attacks, local skin inflammation, mucosal inflammation (Quincke's edema) or urticaria than other patients.

Pay particular attention:
• do not swallow Voltalgan; wash your hands after use;
• do not apply Voltalgan to damaged, diseased skin or open wounds;
• avoid Voltalgan coming into contact with the eyes or mucous membranes, for example of the mouth. If this occurs, wash the area immediately with running water and contact your doctor;
• if you are an elderly patient and/or have stomach problems, do not use Voltalgan with other anti-inflammatory medicines taken orally, by injection or rectally;
• do not use Voltalgan with an occlusive dressing, i.e., by covering the affected area with a plastic film that does not allow air to pass through. However, you can use Voltalgan with an air-permeable gauze;
• use, particularly if for long periods of time, of medicines for local use can cause allergic reactions. If this occurs, discontinue treatment with Voltalgan and consult your doctor who will provide appropriate therapy;
• avoid excessive exposure to sunlight during the use of Voltalgan, this will reduce the risk of sun-related skin reactions;
• if you use diclofenac over large areas of skin and for long periods of time, you may experience side effects affecting the entire body; do not exceed the recommended dose.

Discontinue treatment if a rash develops after using Voltalgan.
If you use Voltalgan with other medicines containing diclofenac, you may experience skin reactions, even severe ones (Stevens-Johnson syndrome, Lyell's syndrome).

Children and adolescents
Voltalgan 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, such as irritation, redness, itching, scaling, swelling or blisters (dermatitis, eczema, erythema, rash).

Rare side effects (may affect up to 1 in 1,000 people)
• bullous dermatitis (skin inflammation with blister formation).

Very rare side effects (may affect up to 1 in 10,000 people)
• allergic reactions including urticaria
• angioedema (swelling of the skin, tissues and mucous membranes, e.g., swelling of the face or tongue with difficulty swallowing and/or breathing)
• skin rash with pustule formation
• asthma (difficult breathing caused by inflammation and narrowing of the bronchi)
• appearance of spots, swelling or redness on the skin following exposure to sunlight or sunlamps.

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

Following the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.