IBUPAS*7CER 136MG

IBUPAS 136 mg medicated plaster
Ibuprofen

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

IBUPAS is indicated for the local treatment of pain and inflammation of a rheumatic and traumatic nature in joints, muscles, tendons and ligaments.

What you need to know before taking the medicine
Do not use IBUPAS
- If you are allergic to the active substance or to any of the excipients.
- On open wounds or lesions, but only on intact skin. Avoid contact with eyes and mucous membranes.
- If you have had a history of hypersensitivity (asthma, allergic rhinitis, skin rashes and anaphylactic reactions) or gastrointestinal bleeding from 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 renal or hepatic failure.

Warnings and precautions
Take special care with IBUPAS
Analgesics, antipyretics, non-steroidal anti-inflammatory drugs, including ibuprofen, can cause hypersensitivity reactions, potentially severe even in subjects not previously exposed to this type of medicine.
Severe skin reactions, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Stop using IBUPAS and contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in paragraph 4.

IBUPAS should be used with great caution and on medical advice:
• In the elderly,
• In patients with chronic bronchitis, allergic rhinitis or nasal mucous membrane inflammation (in whom asthmatic attacks or severe inflammatory skin and mucous membrane reactions are more frequent),
• In patients with a history of gastrointestinal diseases (such as gastrointestinal ulcer, 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 hepatic or renal dysfunction or heart failure,
• If you suffer or have suffered from high blood pressure.

Possible side effects
Like all medicines, IBUPAS can cause side effects, although not everyone gets them.

The frequency of the possible side effects listed below is established using the following convention:
Very common ≥1/10; Common ≥1/100 - <1/10; Uncommon ≥1/1,000 - <1/100; Rare ≥1/10,000 - <1/1,000; Very rare <1/10,000; Not known (cannot be estimated from the available data).

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

Nervous system disorders
Common: Dry mouth, headache, altered taste

Gastrointestinal disorders
Common: Nausea

Skin and subcutaneous tissue disorders
Common: Facial oedema, blisters
Not known: skin becomes sensitive to light

Musculoskeletal and connective tissue disorders
Common: General malaise

Systemic disorders and administration site conditions
Very Common: Mild skin redness or mild irritation at the application site, which quickly resolve after removing the medicated plaster.
Common: Itching, burning, obvious skin irritations with skin redness, skin exfoliation and small skin lesions.

All side effects found in clinical studies were mild and transient.

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

Immune system disorders
Not known: Local hypersensitivity

Systemic disorders and administration site conditions
Not known: Contact dermatitis, numbness and tingling at the application site

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

Stop using IBUPAS and consult your doctor immediately if you notice any of the following symptoms:
• Non-raised reddish spots, target-shaped or circular on the trunk, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These severe skin 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 increased 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 generalised exanthematous pustulosis).

Systemic undesirable reactions following topical use of ibuprofen are unlikely, as the plasma levels of ibuprofen detected after IBUPAS application are much lower than those detectable with systemic administration of ibuprofen-based drugs. However, after applications for long periods of time, beyond the recommended period and non-observance of contraindications and warnings, the appearance of systemic undesirable effects, especially at the gastrointestinal level, cannot be excluded.
Adherence to the instructions in the leaflet reduces the risk of side effects.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.