DICLOREUM UNIDIE 5CER 136MG24H

DICLOREUM UNIDIE 136 MG MEDICATED PATCH

active principles

A medicated plaster contains: active principle: ibuprofen 136 mg. For the full list of excipients see section 6.1

Exceptions

Potassium salt of the copolymer of 2-ethylhexyl acrylate, methyl acrylate, acrylic acid, glycidylmethacrylate; oleic acid; To the³. . Support matrix: Pet extension. Protective film: Siliconized PET.

Therapeutic indications

DICLOREUM UNIDIE is indicated for the local treatment of painful and inflammatory rheumatic or traumatic conditions of joints, muscles, tendons and ligaments.

Contraindications

Hypersensitivity to the active substance (ibuprofen) or to any of the excipients. The use of is contraindicated DICLOREUM UNIDIE in subjects in which 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. The administration of DICLOREUM UNIDIE is to be avoided in patients suffering from active peptic ulcer, bronchial asthma or suffering from severe renal and hepatic insufficiency. It is also to avoid the use of DICLOREUM UNIDIE in patients with a history of gastrointestinal haemorrhage or perforation related to previous active treatments or a history of recurrent peptic haemorrhage/ulcer (two or more distinct episodes of proven ulceration or bleeding), on anticoagulant therapy (see section 4.5) and finally in cases of severe heart failure. Also avoid applying the medicated plaster on damaged skin or in areas with dermatoses or infections. Avoid contact with eyes and mucous membranes. The use of DICLOREUM UNIDIE is contraindicated during the third trimester of pregnancy and lactation (see section 4.6) and in children below 12 years.

Posology

Use only one medicated plaster at a time and replace it every 24 hours for a maximum duration of 7-10 days. DICLOREUM UNIDIE is to be used exclusively for applications on intact skin. It is advisable to thoroughly wash and dry the painful area 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 the transparent protective film in the central area of the medicated plaster so as to have a free adhesive surface of 2 - 3 centimeters 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 population: There is no experience on the use of DICLOREUM UNIDIE in children and therefore it is not recommended for use in subjects under the age of 12 (see sections 4.3 and 4.4).

Storage

No special storage conditions.

Warnings

The plasma levels of ibuprofen achieved after administration of the medicated plaster are much lower than those obtained by systemic administration and therefore the occurrence of systemic side effects is likely to be much reduced compared to systemic use. However, if the medicated plasters are used for an extended period of time, the possibility of systemic adverse events cannot be excluded. Side effects may be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. Analgesics, antipyretics and non-steroidal anti-inflammatory drugs (non-selective NSAIDs and selective COX-2 inhibitors), including ibuprofen, can cause potentially serious hypersensitivity reactions in individuals not previously exposed to this type of drug. These reactions include asthma attacks, skin rashes, allergic rhinitis and anaphylactic-type reactions. Like other NSAIDs, ibuprofen can mask signs of infection. Elderly: Caution should be exercised in treating elderly patients who are generally more prone to adverse events. Asthmatic patients, with obstructive bronchial diseases, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react more often than other patients to treatment with NSAIDs, with asthmatic attacks, local inflammation of the skin and mucosa (Quincke's oedema) or urticaria . Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported at any time during treatment with all NSAIDs, with or without warning symptoms or a previous history of serious gastrointestinal events. Use caution when administering DICLOREUM UNIDIE in patients with a history of peptic ulcer or gastrointestinal haemorrhage not secondary to the administration of NSAIDs and in cases of ulcerative colitis and Crohn's disease. Patients with a history of GI toxicity, particularly the elderly, should report any unusual GI symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution should be exercised in patients receiving concomitant medications which could increase the risk of ulceration or haemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5). When gastrointestinal bleeding or ulceration occurs in patients taking DICLOREUM UNIDIE, treatment should be discontinued. It is also not recommended in case of bleeding diathesis, severe liver or kidney dysfunction and in cases of heart failure. Caution should be exercised in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment. NSAIDs can reduce the effect of diuretics and other antihypertensive drugs (see section 4.5). Ibuprofen can cause sodium, potassium and water retention in patients who have never suffered from renal disorders due to its effects on renal 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 renal papillary necrosis and other renal pathological changes. Ibuprofen, like other NSAIDs, can inhibit platelet aggregation and has been shown to prolong bleeding time in healthy subjects. Therefore, patients with coagulation defects or on anticoagulant therapy should be observed carefully. Aseptic meningitis has been observed on rare occasions in patients receiving ibuprofen. Prolonged or repeated use of products for cutaneous use can give rise to local sensitization phenomena. Analgesics, antipyretics, non-steroidal anti-inflammatory drugs can cause potentially serious hypersensitivity reactions (anaphylactoid reactions), even in subjects not previously exposed to this type of drug. The risk of hypersensitivity reactions after taking ibuprofen is greater in subjects who have experienced such reactions after the use of other analgesics, antipyretics, non-steroidal anti-inflammatory drugs and in subjects with bronchial hyperreactivity (asthma), hay fever, nasal polyposis or chronic obstructive respiratory disease or previous episodes of angioedema. In the early stages of therapy, patients appear to be at higher risk: the onset of the reaction occurs in most cases within the first month of treatment. Serious hypersensitivity reactions (e.g. anaphylactic shock) have been rarely observed. In the presence of important adverse reactions (skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) and hypersensitivity reactions, it is necessary to interrupt the therapy immediately and consult the doctor for the establishment of a suitable therapy. After brief therapy without appreciable results, consult your doctor. There is no experience on using DICLOREUM UNIDIE in children and therefore it is not recommended for use in subjects under the age of 12.

Interactions

The use of ibuprofen patches is unlikely to have interactions with other medicines. However, the possibility of competition between absorbed ibuprofen and other drugs with 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.

Effects

Undesirable effects can be minimized by reducing the duration of treatment to the shortest possible time needed to control symptoms. Data from clinical studies of 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 - Table 1: Incidence of treatment-related undesirable effects in controlled clinical trials.

System organ class and frequency	Unwanted reaction
Pathologies of the nervous system
Common	Dry mouth, headache, dysgeusia
Gastrointestinal pathologies
Common	Nausea
Skin and subcutaneous tissue disorders
Common	Facial edema, vesicles
Not known	Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome)
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 peeling and cracking

All adverse events seen in clinical trials were mild and transient in nature. Undesirable effects reported from literature data

System organ class and frequency	Unwanted reaction
Pathologies of the immune system
Not notes	Local hypersensitivity
Skin and subcutaneous tissue disorders
Not notes	Photosensitivity reactions
General disorders and administration site conditions
Not notes	Contact dermatitis
Not notes	Numbness and tingling at the application site

Cases of extensive and serious 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 undesirable reactions following topical use of ibuprofen are unlikely as the plasma levels of ibuprofen detected following the application of DICLOREUM UNIDIE are much lower than those detectable with the 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 side effects, especially at the gastrointestinal level (see sections 4.4 and 5.2). Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.

Overdose

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

The systemic concentration of ibuprofen, compared with oral formulations, is lower after topical administration. Referring to the experience of treatment with NSAIDs for systemic administration, the following is recommended:

Pregnancy

: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/foetal development. Data obtained from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor during the first period of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to about 1.5%. The risk is thought to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, ibuprofen should not be administered unless strictly necessary. When used by women attempting to conceive or during the first and second trimester of pregnancy, the dose and duration of treatment should be as low and as short as possible, respectively. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction which may progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an antiplatelet effect which can occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.

Feeding time

: Ibuprofen is excreted in breast milk: at therapeutic doses during short-term treatment the risk of influence on the newborn seems unlikely, while in case of long-term treatment early weaning should be considered NSAIDs should be avoided during breastfeeding.

Fertility

: The use of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. This effect is reversible upon discontinuation of treatment. In women who are having difficulty conceiving or who are undergoing investigation of infertility, discontinuation of ibuprofen treatment should be considered.

Source: Farmadati