DICLOREUM ANT LOC 10CER MED180

DICLOREUM ANTINFIAMMATORIAL 180 MG MEDICAL CEROTTS

active ingredients

A 180 mg medical patch contains: Active ingredient: Diclofenac hydroxyetylpyrrolidine mg 180 (equal to 140 mg of Diclofenac sodium) Excipients with known effects: 14 mg of parahydroxybenzoate methyl (E218), 7 mg of propile parahydroxybenzoate (E216), 420 mg of propylene glycol and 2,8 mg of perfume (containing amile cinnamal, amylcynnamilic alcohol, benzyl benzoate, benzil salicylate, cinnamon, cinnamonol. For the full list of excipients, see paragraph 6.1

Excellent

Gelatin, Povidone, D-Sorbitol 70% solution, Caolino, Titanium dioxide, propylene glycol, Metile parahydroxybenzoate (E218), Propile parahydroxybenzoato (E216), Disodium edetate, Tartaric acid, Dihydroxyaluminium aminotate, Caramellosa sodium, Polyacrylate.

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 of the finished product, as well as isopropanol. • Patients in which asthmatic accesses, hives or acute rhinitis occurred after intake of acetylsalicylic acid or other nonsteroidal inflammatory drugs (NSAIDs). • Damaged Cute, regardless of the type of injury: exudatory dermatitis, eczema, infected lesion, burns or wounds. • Third quarter of pregnancy and nursing (see paragraph 4.6). • Patients with active peptic ulcer. Children and teenagers: 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 The usual posological regime is of 1 or 2 patches (or any other frequency evaluated in clinical studies for a specific product) per day (an application every 12 or 24 hours) for a period of up to 14 days (or for any other number of days it has been evaluated the use in clinical studies for a specific product). If there is no improvement after the recommended treatment period, you will have to consult a doctor Children and teenagers under 16: 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 Cut the bag containing the medicated plaster as indicated. Extract a medicated plaster, remove the plastic film used to protect the adhesive surface and apply the plaster on the joint or the sore surface. If necessary, the plaster can be held on the spot by means of an elastic band. Close the envelope carefully by pressing the edge where the closing cord is located. The plaster must be used whole.

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. 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. - Do not administer another medicine with diclofenac or other NANS at the same time. - Although systemic effects should be limited, 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. Local anti-inflammatory dicloreum contains: - methyl parahydroxybenzoate (E218) and propile parahydroxybenzoate (E216) which can cause allergic reactions (also delayed). - 420 mg of propylene glycol for patch that can cause skin irritation. - a perfume containing allergens (amile cinnamal, amylcinnamilic alcohol, benzil benzoato, benzil salicylate, cinnammale, cinnamilic alcohol, citronellol, d-Limonene, eugenol, foliage, geranium, aldehyde exil cinnamica, hydroxycitronellal, isoeugenato.

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.

Effects

Adverse reactions (Table 1) are listed by frequency, first the most frequent, using the following convention: common (≥ 1/100, 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 Bold dermatitis (p.es. bollous erythema), dry skin Very rare Photosensitivity reactions Systemic pathologies and conditions for administration Town Reactions in the administration 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 case 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 can have negative effects on 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 pre- and post-system loss 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 inhibitors of prostaglandin synthesis 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.

Food

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 should 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