Ibupas 136mg Alfasigma 7 Medicated Patches
- Brand:ALFASIGMA SpA
- Product Code: 036439026
- Availability: In Stock
- Purchase 3 items for 13.88€ each
- Purchase 4 items for 13.59€ each
- Purchase 5 items for 13.31€ each
Ibupas 136mg Alfasigma - Medical Device
IBUPAS is indicated for the treatment of joint and peri-articular disorders caused by inflammatory and rheumatic diseases (e.g. tendinitis, bursitis, epicondylitis, peri-arthritis) and for the treatment of inflammatory and extra rheumatic disorders. articular (e.g. fibrositis, myositis).
A medicated plaster contains: active ingredient: ibuprofen 136 mg. For the full list of excipients see section 6.1.
Potassium salt of the copolymer of 2 – ethylhexyl acrylate, methyl acrylate, acrylic acid, glycidyl methacrylate; oleic acid; At + 3. Support matrix: PET Protective film: silicone-coated PET.
Hypersensitivity to the active substance (ibuprofen) or to any of the excipients. The use of IBUPAS is contraindicated in subjects in whom a previous hypersensitivity to acetylsalicylic acid or to other analgesics or non-steroidal anti-inflammatory drugs has occurred, in patients with previous episodes of bronchospasm, angioedema or anaphylactoid reactions. Administration of IBUPAS is to be avoided in patients with active peptic ulcer, bronchial asthma or severe renal and hepatic insufficiency. The use of IBUPAS should also be avoided in patients with a history of gastrointestinal haemorrhage or perforation related to previous active treatments or a history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding), on anticoagulant therapy (see paragraph 4.5) and finally in cases of severe heart failure. Also avoid applying the medicated plaster on damaged skin or in areas with dermatosis or infections. Avoid contact with eyes and mucous membranes. The use of IBUPAS is contraindicated in pregnancy and lactation (see section 4.6) and in children below 12 years.
How is an ibupas medical patch applied?
Use only one medicated plaster at a time and replace it every 24 hours for a period not exceeding 14 days. IBUPAS is to be used exclusively for applications on intact skin. It is advisable to wash and dry the painful area carefully before applying the medicated plaster. If the medicated plaster is to be placed on joints subject to wide mobility, such as the elbow or knee, it is recommended to apply it longitudinally and not transversally, taking care to attach the medicated plaster keeping the joint partially flexed. To apply the medicated plaster, partially detach the two parts of transparent protective film in the central area of the medicated plaster so as to have a free adhesive surface of 2 - 3 cm and adhere this part to the skin of the central area of the painful spot. Slowly peel off the two protective films one after the other, taking care to prevent the medicated plaster from creasing or sticking to itself. Immediately after attaching the medicated plaster, lightly massage the skin for about 20 seconds to ensure perfect adhesion of the medicated plaster. Do not exceed the recommended doses. Pediatric patients There is no experience with the use of IBUPAS in children and therefore its use in subjects below 12 years of age is not recommended (see sections 4.3 and 4.4).
Warnings and Precautions
The plasma levels of ibuprofen achieved after administration of the medicated plaster are much lower than those obtained by systemic administration and therefore the onset of systemic side effects is likely to be very low compared to systemic use. Non-steroidal analgesics, antipyretics and anti-inflammatory drugs (non-selective NSAIDs and selective COX-2 inhibitors), including ibuprofen, can cause potentially serious hypersensitivity reactions in subjects not previously exposed to this type of drug. These reactions include asthma attacks, skin rashes, allergic rhinitis and anaphylactic-type reactions.Patients with asthma, obstructive bronchial disease, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react more often than other patients to treatment with NSAIDs, with asthma attacks, local inflammation of the skin and mucosa (Quincke's edema) or urticaria. Use caution when administering IBUPAS to patients with a history of peptic ulcer or gastrointestinal haemorrhage not secondary to NSAID administration and in cases of ulcerative colitis and Crohn's disease. It is also not recommended in case of haemorrhagic diathesis, severe hepatic or renal dysfunction and in cases of heart failure. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). Prolonged or repeated use of products for cutaneous use can give rise to local sensitization phenomena. In the presence of hypersensitivity reactions, it is necessary to stop the therapy immediately and consult the doctor in order to establish a suitable therapy. After a short therapy without noticeable results, consult your doctor. Caution should be exercised when treating elderly patients who are generally more predisposed to adverse events. There is no experience on the use of IBUPAS in children and therefore it is not recommended for use in subjects under 12 years of age.
The use of ibuprofen patches is unlikely to have interactions with other medicinal products. However, the possibility of competition between absorbed ibuprofen and other drugs with a high plasma protein binding cannot be excluded. Do not use the product together with other drugs for oral or local use containing ibuprofen or other NSAIDs.
Possible side effects from using the patch
Side effects can be minimized by reducing the duration of treatment to the shortest possible time it takes to control symptoms. Data from clinical studies on the product were used to determine the frequency of adverse reactions. The following convention has been used for the classification of frequencies: 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 Table 1: Incidence of treatment-associated undesirable effects in controlled clinical trials
System Organ Class and Frequency Undesirable Reaction
Nervous system disorders
Common Dry mouth, headache, dysgeusia
Skin and subcutaneous tissue disorders
Common Face edema, vesicles
Musculoskeletal and connective tissue disorders
Common General malaise
General disorders and administration site conditions
Very Common Mild erythema
Common Itching, burning, clear erythematous manifestation, skin exfoliation and cracking
All adverse events encountered in clinical trials were mild and transient in nature. From literature data, as with other NSAIDs, local hypersensitivity reactions, contact dermatitis, numbness and tingling at the application site may rarely occur. Cases of extensive and severe dermatological lesions such as erythema multiforme, Quincke's edema and, very rarely, bullous reactions including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been reported with this type of medicinal product. Systemic adverse reactions following the topical use of ibuprofen are unlikely as the plasma levels of ibuprofen detected following the application of IBUPAS are much lower than those detectable with systemic administration of ibuprofen-based drugs. However, following applications for long periods of time, beyond the recommended term and the non-observance of contraindications and warnings, the occurrence of systemic undesirable effects, especially gastrointestinal, cannot be excluded (see sections 4.4 and 5.2).
Pregnancy and breastfeeding
IBUPAS is contraindicated during pregnancy and lactation. Use should also be avoided if pregnancy is suspected or if you wish to plan a maternity leave.
Pack of 7 medicated plasters.