VOLTADOL 140 MG MEDICATED PATCH 10 PATCHES

Name
Voltadol 140 mg medicated plaster
Diclofenac sodium


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

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

Contact your doctor if you do not feel better or if you feel worse after 7 days, if the disorder occurs repeatedly or you notice any recent changes in its characteristics.


What you need to know before taking the medicine
Do not use Voltadol
• if you are allergic to diclofenac sodium, acetylsalicylic acid, other non-steroidal anti-inflammatory drugs (NSAIDs) 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 manifested by 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 your skin has any kind of lesions, for example exudative dermatitis (irritation of the skin with exudate, a fluid that forms with inflammation), eczema (skin rash), infected lesion, burns or wounds;
• if you are in the third trimester of pregnancy (see section "Pregnancy, breastfeeding and fertility");
• if you have a lesion of the stomach mucosa or the first part of the intestine (peptic ulcer);
• if the subject to be treated is a child or an adolescent under 16 years of age.


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

Talk to your doctor before using Voltadol:
• if you have or have had asthma;
• if you have or have had chronic diseases with bronchial obstruction;
• if you have or have had allergic rhinitis (inflammation of the nose due to allergy);
• if you have or have had inflammation of the nasal mucosa (nasal polyp);
because he may experience asthma attacks, local inflammation of the skin, mucosa (Quincke's edema) or urticaria more easily than other patients.

Pay special attention:
• do not swallow Voltadol; wash your hands after use;
• do not apply Voltadol to broken, diseased or open wounds;
• avoid contact of Voltadol with your eyes or mucous membranes, for example in the mouth. If this occurs, wash the area immediately with running water and contact your doctor;
• do not use Voltadol with other anti-inflammatory medicines taken by mouth, by injection, rectally or applied to the skin;
• the use, especially if for long periods of time, of local medicines can cause allergic reactions. If this occurs, stop treatment with Voltadol immediately and consult your doctor who will give you suitable therapy;
• do not use Voltadol with an occlusive dressing, i.e. covering the affected area with a plastic film that does not allow air to pass through. Instead, you can use Voltadol with a gauze that allows air to pass through;
• avoid exposure to direct sunlight, including sunlamps, for about 1 day after removing the Voltadol patch, this will reduce the risk of having skin reactions due to the sun;
• if you use diclofenac for long periods of time, you may experience side effects that involve the whole body; do not exceed the recommended dose.

Talk to your doctor if:
• if he is elderly;
• if you have kidney, heart or liver problems;
• if you have had a peptic ulcer (lesion of the mucosa of the stomach and the first part of the intestine);
• if you are a woman and have fertility problems, if you are undergoing fertility tests or if you intend to start a pregnancy.

Stop treatment if you develop a skin rash after applying the medicated plaster.

If you use Voltadol with other medicines containing diclofenac you may experience skin reactions, including serious ones (Stevens-Johnson syndrome, Lyell syndrome).

Children and adolescents
Voltadol should not be used in children and adolescents under 16 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)
• rash (skin eruption), eczema (inflammation of the skin), erythema (redness of the skin), dermatitis (including allergic dermatitis and contact dermatitis), itching;
• reactions in the area where the patch is applied.

Rare side effects (may affect up to 1 in 1,000 people)
• bullous dermatitis (inflammation of the skin with the appearance of blisters);
• dry skin;
• burning sensation at the application site.

Very rare side effects (may affect up to 1 in 10,000 people)
• allergic reactions including urticaria, severe allergic reactions (anaphylactoid reactions and angioneurotic edema);
• 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, swelling or redness on the skin following exposure to sunlight or sunlamps.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.