VOLTADOL UNIDIE 140 MG MEDICATED PATCHES 10 PATCHES IN PAPER/PE/AL/EAA SACHET

Name
Voltadol Unidie 140 mg medicated patch
Diclofenac sodium
Equivalent medicine


What is it and what is it for?
Voltadol Unidie is a pain-reducing medicine. It belongs to the group of nonsteroidal anti-inflammatory drugs (NSAIDs).

Voltadol Unidie is used for the short-term (up to 7 days) local treatment of pain associated with muscle strains, sprains or bruises of the arms and legs due to blunt trauma in adolescents from 16 years of age and in adults.


What you need to know before taking the medicine
Do not use Voltadol Unidie
- if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to any other non-steroidal anti-inflammatory drugs (NSAIDs, e.g. acetylsalicylic acid, ibuprofen);
- if you have experienced asthma attacks , hives or swelling and irritation inside your nose after taking acetylsalicylic acid or other NSAIDs;
- if you suffer from active gastric or duodenal ulcer ;
- on damaged skin (e.g. skin abrasions, cuts, burns), infected or inflamed (exudative dermatitis) or eczema ;
- if she is in the last three months of pregnancy;
- in children and adolescents under 16 years of age.


Warnings and precautions
Talk to your doctor or pharmacist before taking Voltadol Unidie if you suffer or have suffered in the past from bronchial asthma or allergies, you may experience a cramp in the bronchial muscles (bronchospasm), which manifests itself with difficulty in breathing;
• if you notice a skin rash , which appears after applying the medicated plaster. If this happens, remove the medicated plaster immediately and stop treatment;
• if you suffer from kidney , heart or liver problems or have suffered in the past from gastrointestinal ulcers, intestinal inflammation or a tendency to bleed.

Side effects can be reduced by using the lowest effective dose for the shortest possible time.

Important precautions
• The medicated plaster should not come into contact with or be applied to eyes or mucous membranes.
• Elderly patients should use Voltadol Unidie with caution, as they may be more likely to develop side effects.

Avoid exposing the treated area to direct sunlight or sunlamps after removing the medicated plaster, to reduce the risk of light sensitivity.

Do not use Voltadol Unidie at the same time as any other medicine containing diclofenac or other non-steroidal anti-inflammatory and painkillers, regardless of whether they are used externally or taken orally.

Children and adolescents
Diclofenac is contraindicated in children and adolescents under 16 years of age.
There are insufficient data on efficacy and safety for children and adolescents under 16 years of age (see section Do not use Voltadol Unidie ).


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the following symptoms appear, tell your doctor immediately and stop using the patch:
sudden itchy skin rash (hives); swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing; drop in blood pressure or weakness.

The following side effects may also occur:

Common (may affect up to 1 in 10 people):
local skin reactions, such as redness of the skin, burning sensation, itching, red and inflamed skin, skin rash sometimes with pustules or wheals.

Very rare (may affect up to 1 in 10,000 people):
hypersensitivity reactions or local allergic reactions (contact dermatitis).

In patients using topical active substances belonging to the same class of medicinal products as diclofenac, isolated cases of generalized skin rash, hypersensitivity reactions such as swelling of the skin and mucous membranes, and anaphylactic-type reactions with acute disturbances of circulatory regulation and sensitivity to light have been reported.

Diclofenac is absorbed into the body through the skin very slowly compared to the concentration of the active ingredient in the blood measured after oral administration. Therefore, the likelihood of general side effects (such as gastrointestinal or kidney problems or difficulty breathing) is very low.

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.