DICLOREUM UNIDIE 136 MG MEDICATED PATCH 5 PATCHES

Name
Dicloreum Unidie 136 mg medicated plaster
Ibuprofen


What is it and what is it for?
Dicloreum Unidie is a medicated patch containing ibuprofen as the active ingredient, a nonsteroidal anti-inflammatory drug (NSAID) with anti-inflammatory and analgesic action, which is released transdermally.

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


What you need to know before taking the 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 had a hypersensitivity episode (asthma, allergic rhinitis, skin rashes and anaphylactic reactions) or gastrointestinal bleeding from anti-inflammatory drugs in the past.
- In the presence of an active peptic ulcer, if you have bronchial asthma or are on anticoagulant therapy.
- If you are in the last 3 months of pregnancy and are breastfeeding.
- In children under 12 years of age.
- In case of severe heart failure.
- In case of severe renal or hepatic insufficiency.


Warnings and precautions
Analgesics, antipyretics, and nonsteroidal anti-inflammatory drugs, including ibuprofen, can cause hypersensitivity reactions, potentially serious even in subjects not previously exposed to this type of drug.
Serious skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and 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 serious skin reactions described in section 4.
Dicloreum Unidie must be used with great caution and on the advice of a doctor:
• In the elderly.
• In patients with chronic bronchitis, allergic rhinitis or inflammation of the nasal mucosa (polyps) in whom asthma attacks or severe inflammatory reactions of the skin and mucosa are more frequent.
• In patients with a history of gastrointestinal disease (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 the administration of NSAIDs or with other bleeding disorders.
• In patients with liver or kidney dysfunction or 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 adverse effects have been observed:

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

Common side effects (may affect up to 1 in 10 people):
• dry mouth
• heachache
• alteration of taste
• nausea
• facial edema (swelling)
• blisters on the skin
• general malaise
• itching
• burning
• obvious skin irritation with redness
• skin exfoliations
• small lesions on the skin

These side effects were mild and transient in nature.

In the literature, the following adverse 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
• the skin becomes sensitive to light

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

Stop using ibuprofen and see your doctor immediately if you notice any of the following symptoms:
• flat, target-shaped or circular reddish spots on the trunk, often with central blisters, peeling skin, and 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 skin rash, high body temperature, swollen lymph nodes and increased numbers of eosinophils, a type of white blood cell (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
Systemic adverse reactions following topical use of ibuprofen are unlikely because the plasma ibuprofen levels detected following the application of Dicloreum Unidie are much lower than those detected with systemic administration of ibuprofen-based drugs. However, following prolonged use beyond the recommended duration and failure to comply with contraindications and warnings, the occurrence of systemic adverse effects, especially gastrointestinal, cannot be ruled out.
Following the instructions in the package leaflet reduces the risk of side effects.

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.