FLECTOR 10CER MEDIC 180MG

FLECTOR 180 MG MEDICAL CERTO

active ingredients

A 180 mg medical patch contains: • active ingredient: diclofenac hydroxyetylpyrrolidine 180 mg (equal to 140 mg of sodium diclofenac); • excipients with known effects: propylene glycol, methyl parahydroxybenzoate, propile parahydroxybenzoate, perfume in turn containing amile cinnamal, amylcinnamilic alcohol, benzil benzoato, benzil benzoato, benzil salicylate, cinnammal alcohol, cinnamilic alcohol, citronellol, d-Limonene, eugenol, folidium, exan. For the full list of excipients see paragraph 6.1.

Excellent

Gelatin, polyvinylpyrrolidone, sorbitol 70% solution, kaolin, titanium dioxide, propylene glycol, methyl parahydroxy-benzoate, propile parahydroxybenzoate, bisodium edetate, tartaric acid, dihydroxyaluminium aminoacetate, carbossimetilcellulose sodium, polyacrylate sodium, 1-3-butil.

Therapeutic indications

Local treatment of painful and inflammatory states of rheumatic or traumatic nature of: • Articulations; • Muscles; • Tensions; • Ligaments.

Contraindications

• Hypersensitivity to the active ingredient or acetylsalicylic acid or other analgesic or other nonsteroidal 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: exudative dermatitis, eczema, infected injury, burns, or wounds. • Third quarter of pregnancy (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 medicine 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 1 or 2 patches per day (an application every 12 or 24 hours) for a period of up to 14 days. Recommend the patient to consult the doctor if there is no improvement after the recommended treatment period (see paragraph 4.4). Pediatric population. . Children and teenagers under 16 years old: the use of this medicated patch is not recommended because sufficient data are not available to assess the safety and effectiveness of the medicinal product (see paragraph 4.3). In adolescents aged 16 or older: if the medicine is necessary for a treatment period of more than 7 days for pain relief or if symptoms worsen, a revaluation is necessary. Recommend the patient or relatives of the teenager to consult the 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 (the packaging contains a tubular mesh). Close the envelope carefully. The plaster must be used in full. Avoid contact with eyes or mucosa.

Conservation

Special conservation conditions are not necessary.

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. 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 use, especially if prolonged, of this kind as of other products for topical use can give rise to phenomena of sensitization. In this case it is necessary to stop the treatment and establish suitable therapy. Although systemic absorption is minimal, however the use of FLECTOR, as with any drug inhibiting the synthesis of prostaglandins and cycloxygenase is not recommended in women who intend to start a pregnancy. The administration of FLECTOR should be suspended in women who have fertility problems or who are subject to fertility surveys. 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 skin rash is developed 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 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 patch so as to reduce the risk of photosensitivity. Important information about some excipients. . FLECTOR contains: - methyl parahydroxybenzoate, propil parahydroxybenzoate: they can cause allergic reactions (also delayed); - 420 mg of glycol propylene in each patch: it can cause skin irritation; - an aroma (profume) in turn containing amile cinnamal, amylcinnamilic alcohol, benzil benzoato, benzil salicylate, cinnammale, cinnamilic alcohol, citronellol, d-Limonene, eugenol, foliage, geranium, aldehyde exil cinnamica, hydroxycitronellal, isoeugen can cause allergic reactions

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. Clinical surveys carried out with FLECTOR medicated patch used in conjunction with other steroid anti-inflammatory drugs and not (salazopyrin, hydroxychinoline, etc.) have not highlighted interaction phenomena. It is not however to exclude the possibility of competition between 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 (see paragraph 4.8).

Effects

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 reactions
Systemic pathologies and conditions for administration
Town	Reactions in the administration

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. The use of the product in association with other drugs containing diclofenac can give rise to phenomena of hypersensitivity to light, rash with formation of vesicles, eczema, erythema and, in rare cases, severe evolving skin reactions ( Stevens-Johnson syndrome, Lyell syndrome) (see paragraph 4.5). 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 benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported with medical patches of diclofenac. Should systemic side effects occur due to incorrect use or accidental overdose (e.g. in children) with the product, the general support measures to be taken in case of intoxication with non-steroidal anti-inflammatory drugs are recommended.

Pregnancy: The systemic concentration of diclofenac, compared to oral formulations, is lower after topical administration.Based on the experience of treatment with systemically administered NSAIDs, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development.Results of 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 of cardiac malformations increased from less than 1%, up 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 result in increased pre- and post-implantation loss and embryo-foetal mortality.Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors 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 fetus 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 neonate, at the end of pregnancy, to: - possible prolongation of bleeding time and anti-aggregating 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. Food: Like other NSAIDs, diclofenac passes into breast milk in small amounts.However, at therapeutic doses of diclofenac medicated plasters, no effects on the infant are anticipated.Due to the lack of controlled studies in breast-feeding women, the product should be used during breast-feeding only under the advice of a healthcare professional.In this circumstance, diclofenac medicated plasters should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).

Source: Farmadati