Itami medicated plaster Diclofenac 140mg 10 plasters

ITAMI * 10CER MEDIC 140MG

Therapeutic indications

Local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

Dosage and method of use

For cutaneous use only.Dosage: The product should only be applied to intact and healthy skin and should not be applied when bathing or showering. The medicated plaster of diclofenac should be used for the shortest possible time in relation to the indication of use.Adults: Unless otherwise prescribed, apply a patch 2 times a day (one application every 12 hours) on the skin of the area to be treated, for a period of up to 14 days. If no improvement is seen following the recommended treatment period, a physician should be consulted (see section 4.4).Pediatric population: The use of this medicated plaster is not recommended in children and adolescents aged less than 16 years because there are insufficient data to evaluate the safety and efficacy of the medicinal product (see section 4.3). In adolescents aged 16 years and over, if the product is required for a treatment period exceeding 7 days for pain relief or if symptoms worsen, the patient or the adolescent's relatives are advised to consult a physician. .Elderly people: This medicinal product should be used with caution in elderly patients as they are more prone to side effects (see section 4.4).Patients with hepatic or renal insufficiency: For the use of diclofenac medicated plasters in patients with hepatic or renal insufficiency see section 4.4.Method of administration: See section 6.6.

Contraindications

- Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory preparations (NSAIDs) or to any of the excipients listed in section 6.1. - Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). - Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds. - Third trimester of pregnancy (see section 4.6). - Patients with active peptic ulcer. Pediatric population: Use in children and adolescents under the age of 16 is contraindicated.

Side effects

Following applications for long periods of time on large skin surfaces, the occurrence of systemic undesirable effects, especially at the gastrointestinal level, cannot be excluded due to the amount of active ingredient that is absorbed. listed by frequency, most frequent first, using the following convention: common (≥ 1/100, Table 1

The use of the product in combination with other drugs containing diclofenac can give rise to skin reactions with severe evolution (Stevens-Johnson syndrome, Lyell syndrome).Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

If diclofenac medicated plasters are used on large skin surfaces and for an extended period of time, the possibility of systemic adverse events cannot be excluded (see the Summary of Product Characteristics of systemic formulations of diclofenac). The medicated plaster should only be applied to intact and healthy skin and should not be applied to broken skin or open wounds. The patches should not come into contact with the eyes or mucous membranes and should not be swallowed. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. - Do not use with an occlusive dressing that does not allow air to pass. - Treatment should be stopped immediately if a skin rash develops after applying the medicated plaster. - ITAMI should be used with caution in patients who have had a hypersensitivity reaction to NSAIDs or analgesics in the past, eg. asthma attacks, skin rashes, acute allergic rhinitis and anaphylactoid reactions. Patients with asthma, chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to treatment with NSAIDs more often than others patients. Administration of ITAMI should be discontinued in women who have fertility problems or who are undergoing fertility investigations. The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. Treatment should be stopped immediately if a skin rash develops after applying the medicated plaster. After a short period of treatment without noticeable results, consult your doctor. - Do not administer topically or systemically another diclofenac-based medicine or other NSAIDs at the same time. - Although systemic effects are expected to be low, the medicated plaster should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulcer or inflammatory bowel disease or bleeding diathesis. Non-steroidal anti-inflammatory drugs should be used with particular care in elderly patients who are more prone to side effects. - Patients should be advised not to expose themselves to direct sunlight or sunlamps for approximately one day after removing the medicated plaster to reduce the risk of photosensitivity. Although systemic absorption is minimal, the use of ITAMI, as well as any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women intending to become pregnant. Keep this medicine out of the reach and sight of children.

Pregnancy and breastfeeding

Pregnancy:The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to the experience of treatment with NSAIDs for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered 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-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases. 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 as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy.Feeding time:Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of diclofenac medicated plasters no effects on the suckling child are anticipated. Due to the lack of controlled studies in breastfeeding women, the product should only be used during breastfeeding under the advice of a healthcare professional. In this circumstance, diclofenac medicated patches should not be applied to the breasts of nursing mothers, or elsewhere on large areas of skin or for an extended period of time (see section 4.4).

Expiration and retention

Store at a temperature not exceeding 30 ° C.

Interactions with other drugs

Since the systemic absorption of diclofenac following the use of medicated plasters is very low, the risk of developing clinically significant interactions with other medicinal products is negligible. However, the possibility of competition between absorbed diclofenac and other drugs with high plasma protein binding cannot be excluded. Concomitant topical or systemic use of other medications containing diclofenac or other NSAIDs is not recommended.

Overdose

There have been no reports of overdose with diclofenac medicated plasters. Should systemic side effects occur due to incorrect use or accidental overdose (eg in children) with the product, general supportive measures are recommended to be taken in cases of intoxication with non-steroidal anti-inflammatory drugs.

Active principles

One medicated plaster contains 140 mg of diclofenac sodium For a full list of excipients, see section 6.1

Excipients

Basic butyl methacrylate copolymer; Copolymer of acrylic acid; Polyethylene glycol 12 stearate, Sorbitan oleate; Non-woven fabric; Silicone paper.