ITAMI 10CER MEDIC 140MG

ITAMI 140 MG MEDICAL CERTO

active ingredients

A medicated patch contains 140 mg of sodium diclofenac For the complete list of excipients, see paragraph 6.1

Excellent

Butil methacrylate basic copolymer; Acrylic acid copolymer; Polyethyleneglycol 12 stearate, Sorbitano oleato; Nonwoven fabric; Silicone paper.

Therapeutic indications

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

Contraindications

- Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory preparations (NSAID) or any of the excipients listed in the paragraph 6.1. - Patients in which asthmatic accesses, hives or acute rhinitis occurred after intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs). - Damaged Cute, regardless of the type of injury: exudatory dermatitis, eczema, infected lesion, burns or wounds. - Third quarter of pregnancy (see paragraph 4.6). - Patients with active peptic ulcer. Pediatric population: Use in children and adolescents under the age of 16 is contraindicated.

Population

Only for skin use. Population: The product should be applied only on the intact and healthy skin and should not be applied when bathing or showering. The medical patch of diclofenac must be used as soon as possible in relation to the indication of use. Adults: Unless otherwise prescribed, apply a patch 2 times a day (an application every 12 hours) on the skin of the area to be treated, for a period of up to 14 days. If there is no improvement after the recommended treatment period, you will have to consult a doctor (see paragraph 4.4). Pediatric population: The use of this medicated patch is not recommended in children and adolescents under the age of 16 because sufficient data is not available to assess the safety and effectiveness of the medicinal product (see paragraph 4.3). In teenagers aged 16 or over, if the product is necessary for a treatment period of more than 7 days for pain relief or if symptoms worsen, it is recommended to the patient or the relatives of the teenager to consult a doctor. Seniors: This medicinal product must be used with caution in elderly patients as they are more prepared for unwanted effects (see paragraph 4.4). Patients with liver or kidney failure: For the use of diclofenac medicated patches in patients with liver or kidney failure, see the paragraph 4.4. Method of administration: See paragraph 6.6.

Conservation

Store at temperature not exceeding 30°C.

Warnings

If diclofenac medicated patches are used on extended cutaneous surfaces and for a prolonged period of time it is not possible to exclude the possibility of systemic adverse events (consulting the Summary of Features of the Product of Systemic formulations of diclofenac). The medicated patch should be applied only on the skin intact and healthy and should not be applied on the skin lesa or on open wounds. The patches should not get in touch with the mucous membranes or eyes and should not be ingested. Undesirable effects can be minimized with the use of the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. - Do not use with an occlusive bandage that does not let air pass. - Treatment should be stopped immediately if a rash develops after the application of the medicated patch. - ITAMI should be used with caution in patients who have previously had a reaction of hypersensitivity to NSAIDs or analgesics, e.g. asthma attacks, skin rashes, acute allergic rhinitis and anaphylactoid reactions. Asthmatic patients, with chronic obstructive diseases of bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasmal polipo) react with asthmatic attacks, local inflammation of the skin or mucosa (Quincke edema) or urticaria to treatment performed with NSAIDs more often than other patients. The administration of ITAMI should be suspended in women who have fertility problems or who are subject to fertility surveys. The use, especially if prolonged, of products for topical use can give rise to awareness-raising phenomena. The treatment should be interrupted immediately if a rash develops after the application of the medicated patch. After a short period of treatment without appreciable results, consult your doctor. - Do not administer another medicine with diclofenac or other NANS at the same time. - Although systemic effects should be low, the medicated patch should be used with caution in patients with kidney, heart or liver impairment, history of peptic ulcer or intestinal inflammatory disease or hemorrhagic diathesis. Non-steroidal anti-inflammatory drugs should be particularly used in elderly patients who are more prepared for unwanted effects. - Patients should be warned not to expose themselves to direct sunlight or sunlight for about a day after the removal of the medicated plaster so as to reduce the risk of photosensitivity. Although systemic absorption is minimal, however the use of ITAMI, as with any drug inhibiting the synthesis of prostaglandins and cycloxygenase is not recommended in women who intend to start a pregnancy. Keep the medicine out of reach and sight of children.

Interactions

Since systemic absorption of diclofenac as a result of the use of medicated patches is very low, the risk of developing clinically significant interactions with other medicines is negligible. It is not however to exclude the possibility of competition between the absorbed diclofenac and other high-linked drugs with plasma proteins. The topical or systemic use of other drugs containing diclofenac or other NSAIDs is not recommended.

Effects

As a result of applications for long periods of time on large skin surfaces, it is not possible to exclude, due to the active ingredient that is absorbed, the appearance of systemic unwanted effects, especially at gastroenteric level. Adverse reactions (Table 1) are listed by frequency, first the most frequent, using the following convention: common (≥ 1/100, Table 1

Infections and infestations
Very rare	Rash with pustles
Immune system disorders
Very rare	Hypersensitivity (including hives), angiourotic edema, anaphylactoid reaction
Respiratory, chest and mediastinic pathologies
Very rare	Asthma
Pathologies of skin and subcutaneous tissue
Town	Rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), itching.
Rare	Bollous dermatitis (e.g. bollous erythema), dry skin
Very rare	Photosensitivity reaction
Notable	Burning sensation in the application
Systemic pathologies and conditions for administration
Town	Reaction in administration

The use of the product in association with other drugs containing diclofenac can result in severe evolving skin reactions ( Stevens-Johnson syndrome, Lyell syndrome). 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 risk/benefit ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported with medical patches of diclofenac. If systemic side effects occur due to incorrect use or accidental overdose (p.es. in children) with the product, we recommend general support measures to be taken in cases of intoxication with non-steroidal anti-inflammatory drugs.

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, we recommend the following: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered 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 disease, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy diclofenac should not be administered if not in strictly necessary cases. If diclofenac is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose must 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 arterial duct and pulmonary hypertension); - kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; - inhibition of uterine contractions resulting in delay or extension of labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Nursing: Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of diclofenac medicated patches there are no effects on the infant. Due to the lack of controlled studies in nursing women, the product must be used during breastfeeding only under the advice of a healthcare professional. In this circumstance, medicated diclofenac patches should not be applied on the breasts of nursing mothers, or elsewhere on extended areas of skin or for a prolonged period of time (see paragraph 4.4).

Source: Farmadati