Itami 140 mg Diclofenac sodium Joint Pain 5 Medicated Plasters

Sodium diclofenac based patches.

Therapeutic indications

Itami Patch is used in the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

Dosage and Posology

The drug should be taken according to the following doses and methods: unless otherwise prescribed, apply a patch 2 times a day, in the morning and in the evening, on the skin of the area to be treated, for a period not exceeding 7-10 days. In children aged 16 and over, if this product is needed for more than 7 days to relieve pain or if symptoms worsen, the adolescent's patient / parents are / are advised to consult a physician.

Overdose

The low systemic absorption of topical diclofenac makes an overdose very unlikely. However, undesirable effects similar to those seen after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 pack of 10 patches contains the equivalent of 1.4 g diclofenac sodium). In the event of accidental ingestion resulting in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Gastric decontamination and the use of activated charcoal must be considered, especially within a short time of ingestion.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients or to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, as well as isopropanol.
• Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Third trimester of pregnancy.
• 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 appearance of systemic undesirable effects, especially at the gastrointestinal level, cannot be excluded due to the amount of active ingredient that is absorbed. Adverse reactions (Table 1) are listed by frequency, most frequent first, using the following convention: common (≥ 1/100 to <1/10); uncommon (≥ 1 / 1,000 to <1/100); rare (≥ 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); Not known: cannot be estimated from the available data.

- Disorders of the immune system

• Very rare: Hypersensitivity (including urticaria), angioneurotic edema

- Infections and infestations

• Very rare: Rash with pustules

- Respiratory, thoracic and mediastinal disorders

• Very rare: Asthma

- Skin and subcutaneous tissue disorders

• Common: Rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus.
• Rare: Bullous dermatitis.
• Very rare: Photosensitivity reaction

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).

Pregnancy and breastfeeding

The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to experience with NSAID treatment 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 believed 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 exhibit:

- the fetus to:

• cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
• renal dysfunction, which can progress to renal failure with oligohydroamnios;

- the mother and the newborn, at the end of pregnancy, to:

• possible prolongation of 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.

Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Itami 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, Itami should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for an extended period of time.

Special warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period (see summary of product characteristics of systemic forms of diclofenac). Topical diclofenac should only be applied to intact, non-diseased skin, and not to skin wounds or open lesions. It should not be allowed to come into contact with eyes or mucous membranes and should not be ingested. Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass. 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. 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. Discontinue treatment if skin rash develops after application of the product and consult your doctor in order to establish a suitable therapy. After a short period of treatment without noticeable results, consult your doctor. Although systemic absorption is minimal, the use of Itami, as well as any prostaglandin synthesis and cyclooxygenase inhibitor drug, is not recommended in women planning to become pregnant. Keep this medicine out of the reach and sight of children.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store at a temperature not exceeding 30 ° C.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

One Itami patch contains:

Active principle

Diclofenac sodium 140 mg

Excipients

Basic butyl methacrylate copolymer; Acrylate-vinyl acetate copolymer; Polyethylene glycol 12 stearate, Sorbitan oleate; Non-woven fabric; Silicone paper.