DICLOREUM UNIDIE*8CER 136MG24H

Dicloreum Unidie 136 mg medicated plaster
Ibuprofen

What it is and what it is used for
Dicloreum Unidie is a medicated plaster containing ibuprofen as an active ingredient, a non-steroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic action, which is released transdermally.

Dicloreum Unidie is indicated for the local treatment of pain and inflammation of rheumatic and traumatic origin in joints, muscles, tendons and ligaments.

What you need to know before taking this medicine
Do not use Dicloreum Unidie
- If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
- On open wounds or lesions, but only on intact skin. Avoid contact with eyes and mucous membranes.
- If you have previously had an episode of hypersensitivity (asthma, allergic rhinitis, skin rashes and anaphylactic reactions) or gastrointestinal bleeding due to anti-inflammatory drugs.
- If you have an active peptic ulcer, bronchial asthma or are on anticoagulant therapy.
- If you are in the last 3 months of pregnancy and breastfeeding.
- In children under 12 years of age.
- In case of severe heart failure.
- In case of severe kidney or liver failure.

Warnings and precautions
Analgesics, antipyretics, non-steroidal anti-inflammatory drugs, including ibuprofen, can cause hypersensitivity reactions, potentially severe even in individuals not previously exposed to this type of drug.
Severe skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Dicloreum Unidie and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
Dicloreum Unidie should be used with great caution and on medical advice:
• In the elderly.
• In patients with chronic bronchitis, allergic rhinitis or inflammation of the nasal mucosa (polyps) in whom asthmatic attacks or severe inflammatory skin and mucosal reactions are more frequent.
• In patients with a history of gastrointestinal diseases (such as peptic ulcer, gastrointestinal bleeding, ulcerative colitis or Crohn's disease).
• In patients with a history of gastrointestinal bleeding even if not caused by NSAID administration or with other bleeding disorders.
• In patients with liver or kidney dysfunction or with heart failure.
• If you suffer or have suffered from high blood pressure.

Possible side effects
Like all medicines, Dicloreum Unidie can cause side effects, although not everybody gets them.

In controlled clinical studies conducted on this product, the following side effects were found:

Very common side effects (may affect more than 1 in 10 people):
• slight skin redness or moderate irritation at the application site

Common side effects (may affect up to 1 in 10 people):
• dry mouth
• headache
• altered taste
• nausea
• facial edema (swelling)
• skin blisters
• general malaise
• itching
• burning
• obvious skin irritation with redness
• skin exfoliation
• small skin lesions

These side effects were mild and transient.

In the literature data, the following side effects have been reported:

Frequency not known (frequency cannot be estimated from the available data):
• local hypersensitivity
• contact dermatitis
• numbness and tingling at the application site
• skin becomes sensitive to light

With this type of medicine, rare cases of extensive and severe skin lesions such as Quincke's edema and, very rarely, bullous reactions have also been reported.

Stop using ibuprofen and consult your doctor immediately if you notice any of the following symptoms:
• non-raised, reddish, target-shaped or circular patches on the torso, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature, enlarged lymph nodes and an increase in eosinophils, a type of white blood cell (DRESS syndrome).
• Widespread, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
Systemic undesirable effects following topical use of ibuprofen are unlikely, as plasma ibuprofen levels detected after Dicloreum Unidie application are much lower than those detectable with systemic administration of ibuprofen-based drugs. However, following prolonged application, beyond the recommended period and non-observance of contraindications and warnings, the occurrence of systemic undesirable effects cannot be excluded, especially at the gastrointestinal level.
Adhering to the instructions in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you get any side effects, including those 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.