ITAMI UNIDIE*5CER MEDIC 140MG

Itami Unidie 140 mg medicated plaster
diclofenac sodium

What it is and what it is used for
Itami Unidie is a pain-relieving medicine. It belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs).

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

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Itami Unidie
• if you suffer or have suffered in the past from bronchial asthma or allergies, you might experience bronchial muscle cramps (bronchospasm), which manifest as difficulty breathing;
• if you notice a skin rash that appears after applying the medicated plaster. If this happens, immediately remove the medicated plaster and stop the treatment;
• if you suffer from kidney, heart or liver dysfunction or have suffered in the past from gastrointestinal ulcer, 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 must not come into contact with or be applied to eyes or mucous membranes.
• Elderly patients should use Itami Unidie with caution, as they are 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 photosensitivity.

Do not use Itami Unidie simultaneously with any other medicine containing diclofenac or other non-steroidal anti-inflammatory and pain-relieving drugs, regardless of whether they are used externally or taken orally.

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

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

If you experience the following symptoms, tell your doctor immediately and stop using the plaster:
sudden itchy 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):
rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), itching, reactions at the application site of the plaster.

Rare (may affect up to 1 in 1,000 people):
Bullous dermatitis (e.g., bullous erythema), dry skin.

Very rare (may affect up to 1 in 10,000 people):
hypersensitivity (including urticaria), anaphylactoid reaction, sudden swelling of the face, hands and feet, lips, tongue, throat and/or larynx (angioneurotic edema), rash with blisters, asthma, skin photosensitivity (photosensitivity reaction).

Frequency unknown:
Burning sensation at the application site.

In patients who topically used active ingredients belonging to the same class of medicines as diclofenac, isolated cases of generalized skin rash, hypersensitivity reactions, such as swelling of the skin and mucous membranes and anaphylactic reactions with acute circulatory dysregulation and photosensitivity have been reported.

The absorption of diclofenac into the body through the skin is very low compared to the concentration of active substance in the blood measured after oral intake of diclofenac. Therefore, the likelihood of general side effects (such as gastrointestinal or kidney disorders or breathing difficulties) is very low.

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.