IBUPAS 7CER 136MG

IBUPAS 136 MG MEDICAL CERTO

active ingredients

A medicated patch contains: active ingredient: ibuprofene 136 mg. For the full list of excipients see paragraph 6.1

Excellent

Potassium salt of the copolymer of 2-ethylsilacrilate, methylacrylate, acrylic acid, glycydylmethacrylate; oleic acid; Al⁺³. . Support matrix: PETS Protective film: Silicone PET

Therapeutic indications

IBUPAS is indicated for the treatment of joint and peri-articular disorders caused by inflammatory and rheumatic pathologies (e.g.: tendonitis, borsiti, epicondiliti, peri-artriti) and for the treatment of inflammatory and rheumatic disorders (e.g.: fibrositis, myosites).

Contraindications

Hypersensitivity to the active ingredient (ibuprofen) or to any of the excipients. The use of IBUPAS in subjects where an earlier hypersensitivity to acetylsalicylic acid or other non-steroidal analgesic or anti-inflammatory, in patients with early episodes of bronchospasm, angioedema or anaphylactoid reactions. The administration of IBUPAS is to be avoided in patients suffering from peptic ulcer in active phase, bronchial asthma or suffering from severe kidney and liver failure. It is also to avoid the use of IBUPAS in patients with history of gastrointestinal hemorrhage or perforation related to previous active treatments or history of hemorrhage/peptic recurring ulcer (two or more separate episodes of proven ulceration or bleeding), in therapy with anticoagulants (see paragraph 4.5) and finally in cases of severe heart failure. Also avoid the application of the medicated patch on skin or in areas that present dermatosis or infections. Avoid contact with eyes and mucosa. The use of IBUPAS is contraindicated during the third trimester of pregnancy and nursing (see paragraph 4.6) and in children under 12 years.

Population

Use only one medicated patch 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 the skin integral. It is recommended to thoroughly wash and dry the sore area, before applying the medicated plaster. In case the medicated plaster should be placed on joints subject to wide mobility, such as elbow or knee, it is recommended to apply longitudinally and not transversely, taking care to attack the medicated patch while holding 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 to adhere this part on the skin of the central zone of the sore point. Slowly detach one after another the two protective films, paying attention to prevent the medicated patch from making folds or sticking on itself. Immediately after attacking the medicated patch, slightly massage the skin for about 20 seconds so as to ensure a perfect adhesion of the medicated patch. Do not exceed the recommended doses. Pediatric patients There is no experience on using IBUPAS in children and therefore it is not recommended to use it in persons under the age of 12 (see paragraphs 4.3 and 4.4).

Conservation

No particular condition of conservation.

Warnings

The plasma levels of ibuprofen achieved after the administration of the medicated patch are much lower than those obtained by systemic administration and therefore the occurrence of systemic side effects is likely to be very reduced compared to systemic use. However, if medicated patches are used for a prolonged period of time it is not possible to exclude the possibility of systemic adverse events. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Non-steroidal antipyretic and anti-inflammatory analgesics (non-elective NSAIDs and selective COX-2 inhibitors), including ibuprofen, can cause hypersensitivity reactions, potentially serious, in subjects not previously exposed to this type of medication. These reactions include asthma attacks, skin rashes, allergic rhinitis and anaphylactic type reactions. Like other NSAIDs, ibuprofen can mask signs of infection. Seniors: caution should be used in the treatment of elderly patients who are generally more prepared for adverse events. Asthmatic patients, with obstructive diseases of bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasium) react more often than other patients to the treatment performed with NSAIDs, with asthmatic attacks, local inflammation of the skin and mucosa ( Quincke edema) or hives. During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of serious gastrointestinal events, gastrointestinal hemorrhage, ulceration and perforation, which may be fatal. Use caution in administering IBUPAS in patients with peptic ulcer anamnesis or gastrointestinal hemorrhage not secondary to the administration of NSAIDs and in cases of ulcerative colitis and Crohn's disease. Patients with history of gastrointestinal toxicity, especially elderly, must report any unusual gastrointestinal symptoms (especially gastrointestinal hemorrhage) in particular in the early stages of treatment. Caute should be lent to patients taking concomitant drugs that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-aggregating agents such as aspirin (see paragraph 4.5). When bleeding or gastrointestinal ulcer occurs in patients taking IBUPAS, the treatment must be suspended. It is also not recommended in case of hemorrhagic diathesis, severe liver or kidney dysfunctions and in cases of heart failure. Caution should be lent in patients with positive anamnesis for hypertension and/or congestive heart failure from mild to moderate since in association with the treatment with the NSAIDs fluid retention and edema were found. NSAIDs can reduce the effect of diuretics, and other antihypertensive drugs (see paragraph 4.5). Ibuprofen can cause water and sodium retention, potassium in patients who have never suffered kidney disorders due to its effects on kidney perfusion. This can cause edema or heart failure or hypertension in predisposed patients. Long-term use of ibuprofen, as with other NSAIDs, has led to kidney papillar necrosis and other kidney pathological alterations. Ibuprofen, like other NSAIDs, can inhibit piastrinic aggregation and has given evidence to prolong bleeding time in healthy subjects. Therefore, patients with clotting defects or anticoagulant therapy should be carefully observed. On rare occasions in patients with ibuprofen has been observed aseptic meningitis. Prolonged or repeated use of skin products can give rise to local sensitization phenomena. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause hypersensitivity reactions, potentially serious (anaphylactoid reactions), even in subjects not previously exposed to this type of medication. The risk of hypersensitivity reactions after hiring ibuprofen is greater in individuals who have presented such reactions after the use of other analgesic, antipyretic, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposes or chronic obstructive respiratory diseases or previous episodes of angioedema. In the early stages of therapy patients seem to be at higher risk: the onset of reaction occurs in most cases within the first month of treatment. Reactions of severe hypersensitivity (e.g. anaphylactic shock) have rarely been observed. In the presence of important adverse reactions (cutaneous reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and epidermal toxic necrolysis) and hypersensitivity reactions it is necessary to immediately stop therapy and consult the doctor for the purpose of establishing a suitable therapy. After short therapy without appreciable results, consult your doctor. There is no experience on using IBUPAS in children and therefore it is not recommended to use it in persons under the age of 12.

Interactions

It is unlikely that the use of patches based on ibuprofen has interactions with other medicines. It is not however to exclude the possibility of competition between absorbed ibuprofen and other high-linked drugs with plasma proteins. Do not use the product along with other oral or local medicines containing ibuprofen or other NSAIDs.

Effects

Undesirable effects can be minimized by reducing the duration of treatment as soon as possible to control symptoms. To determine the frequency of adverse reactions, data from clinical studies on the product were used. The following convention was adopted for the classification of frequencies: Very common ≥1/10; Municipalities ≥1/100 - Table 1: Impact of side effects associated with treatment in controlled clinical trials

Classification for systems and organs and frequency	Undesirable reaction
Diseases of the nervous system
Municipalities	Buckets, headache, dysgeusia
Gastrointestinal diseases
Municipalities	Nausea
Pathologies of skin and subcutaneous tissue
Municipalities	Facial edema, vesicles
Notable	Drug reaction with heosinophilia and systemic symptoms (DrESS syndrome)
Diseases of musculoskeletal system and connective tissue
Municipalities	General malaise
Systemic pathologies and conditions for administration
Very common	Yeast erythema
Municipalities	Prurito, bruciore, clear erythematose manifestation, skin exfoliation and cracking

All adverse events in clinical trials were mild and transitory. Undesirable effects reported by literature data

Classification for systems and organs and frequency	Undesirable reaction
Immunity system pathologies
Not known	Local hypersensitivity
Pathologies of skin and subcutaneous tissue
Not known	Photosensitivity reactions
Systemic pathologies and conditions for administration
Not known	Contact dermatitis
Not known	Torping and formicolii on the application site

With this type of medicines, cases of extensive and severe dermatological lesions such as multiform erythema, Quincke edema have been reported and, very rarely, bollose reactions including Stevens-Johnson Syndrome and Epidermal Toxic Necrolysis. Systemic undesirable reactions as a result of the topical use of ibuprofen are unlikely as 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 non-compliance with contraindications and warnings, it is not possible to exclude the appearance of systemic unwanted effects, especially at gastroenteric level (see paragraphs 4.4 and 5.2). Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

Overdosing

No overdose cases have been reported. In cases of severe poisoning, it is possible that metabolic acidosis occurs. Should systemic side effects occur due to incorrect use or accidental overdose with the product, general support measures are recommended to be taken in case of intoxication with non-steroidal anti-inflammatory drugs.

The systemic concentration of ibuprofene, compared with oral formulations, is lower after topical administration. Referring to the experience of treatment with NSAIDs for systemic administration, we recommend the following: Pregnancy The inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Data obtained from epidemiological studies suggest an increase in the risk of abortion, heart malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during the first period of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It is believed that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre- and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, ibuprofen should not be administered if not in strictly necessary cases. If used by women in conception or during the first and second trimester of pregnancy, the dose and duration of treatment must be the lowest and the shortest possible respectively. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of arterial duct and pulmonary hypertension); - kidney dysfunction that can progress to kidney failure with oligoidroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can also occur at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy. Food Ibuprofen is excreted in breast milk: at therapeutic doses during short-term treatment the risk of flu on the newborn seems unlikely, while in case of long-term treatment it should be considered premature weaning. NSAIDs must be avoided during breastfeeding. Fertility The use of Ibuprofen can compromise female fertility and is not recommended in women waiting for conception. This effect is reversible with the suspension of treatment. In women who have difficulty in conceiving or who are being investigated on infertility, it should be considered the interruption of treatment with ibuprofen.

Source: Farmadati