ITAMI Medicated plaster Ref.[50023] Active ingredients: Diclofenac

The medicated plaster must not come into contact with or be applied to the eyes or mucous membranes. It should be applied only to intact non-diseased skin, and not to skin wounds or open injuries.

Undesirable effects can be reduced by using the lowest effective dose for the shortest possible period of time (see section 4.2).

Bronchospasm can occur in patients who suffer or have previously suffered from bronchial asthma or allergies.

Treatment must be stopped immediately if a skin rash develops after applying the medicated plaster.

Patients should be warned against exposure to sunlight or solarium radiation after removal of the medicated plaster in order to reduce the risk of photosensitisation.

The possibility of systemic adverse events from application of diclofenac medicated plaster cannot be excluded if the preparation is used on large areas of skin and over a prolonged period. Although the systemic effects are expected to be minimal, the medicated plasters should be used with caution in patients with impaired renal, cardiac or hepatic function, or a history of peptic ulcer, inflammatory bowel disease or haemorrhagic diathesis. Non-steroidal anti-inflammatory drugs should be used with caution in elderly patients as they are more likely to experience undesirable effects.

No other medicinal products containing diclofenac or any other non-steroidal anti-inflammatory drugs (NSAIDs) should be used concomitantly, neither topically nor systemically.

Since systemic absorption of diclofenac during labelled use of the medicated plasters is very low, the risk of developing clinically relevant drug-drug interactions is negligible.

Pregnancy

The systemic concentration of diclofenac is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in 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 a prostaglandin synthesis inhibitor during the organogenetic period.

During the first and second trimester of pregnancy, diclofenac should not be given unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
• renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to:
• possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses.
• inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, diclofenac is contraindicated during the third trimester of pregnancy.

Breastfeeding

Diclofenac passes into breast milk in small amounts. However, at therapeutic doses of diclofenac medicated plaster no effects on the suckling child are anticipated.

Because of a lack of controlled studies in lactating women, the medicinal product should only be used during lactation under advice from a healthcare professional. Under this circumstance,Itami should not be applied on the breasts of breast-feeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

Itami has no influence on the ability to drive and use machines.

The following frequency categories are used for reporting undesirable effects: Very common ≥1/10, Common ≥1/100 to <1/10, Uncommon ≥1/1,000 to <1/100, Rare ≥1/10,000 to <1/1,000, Very rare <1/10,000, Not known cannot be estimated from the available data.

Systemic plasma diclofenac levels measured during labelled use of the medicated plasters are very low compared to those obtained after oral intake of diclofenac. The risk of developing systemically induced undesirable effects (like gastric, hepatic and renal disorders, systemic hypersensitivity reactions) during use of the plaster therefore appears to be low. However, in particular when the medicated plaster is used on a large area of skin and over a prolonged period of time, systemic side effects may occur.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Not applicable.