FASTUFLEX 5CER MEDIC 180MG

FASTUFLEX 180 MG MEDICAL CERTO

active ingredients

Each 10 cm x 14 cm medicated patch contains a total of 180 mg of epolamine diclofenac, equivalent to 140 mg of sodium diclofenac. Excipients with known effects: methyl parahydroxybenzoate (E218): 14 mg; propile parahydroxybenzoate (E216): 7 mg; propylene glycol: 420 mg. The quantities indicated refer to a single patch. For the full list of excipients, see paragraph 6.1.

Excellent

Support layer: nonwoven polyester support. Adhesive layer (gel active): gelatin, povidone (K90), liquid sorbitol (not crystallized), heavy kaolin, titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propile parahydroxybenzoate (E216), bisodium edetate, tartaric acid, aluminum glycinate, carmellosa sodium, polyacrylatelen. Protective layer: polypropylene film.

Therapeutic indications

Local symptomatic treatment of pains and inflammations of rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

Contraindications

This medicine is contraindicated in the following cases: - hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAID) or any of the excipients of the medicinal product listed in paragraph 6.1; patients who have had asthmatic, urticaria or acute rhinitis triggered by acetylsalicylic acid or other non-steroidal inflammatory drugs (FANS). - damaged skin, whatever the type of injury: excessive dermatitis, eczema, infected lesion, burn or injury; - from the beginning of the 6th month of pregnancy (see paragraph 4.6 Pregnancy and nursing); - patients with active peptic ulcer; - children and adolescents under the age of 16.

Population

Only for skin use. Population: One (1) patch on the most painful area once or twice a day. Duration of treatment: FASTUFLEX must be used as soon as possible. The maximum duration of treatment is 14 consecutive days. Seniors: This medicine must be used with caution in elderly patients, as it is more prepared for the side effects (see paragraph 4.4). Children and teenagers under 16: There is no sufficient data on effectiveness and safety in children and adolescents under 16 (see also paragraph 4.3 Contraindications). In adolescents aged 16 or over, if this product is necessary for more than 7 days for pain attenuation or in case of aggravation of symptoms, it is recommended for the patient/parents of the teenager to consult a doctor. Patients with liver or kidney failure: For use of FASTUFLEX in patients with liver or kidney failure see paragraph 4.4. Method of administration: Cut the bag containing the medicated plaster as indicated. Take a medicated plaster, remove the plastic film used to protect the adhesive surface and apply it on the jointing or the sore body area. If necessary, the plaster can be held in place with an elastic net. Carefully remove the envelope with sliding closure. The plaster must be used whole.

Conservation

This medicine does not require any special storage temperature.

Warnings

- The medicated plaster must be applied exclusively on intact and healthy skin and not on skin injured or open wounds and should not be worn during the bath or shower. - The medicated patch should not get in touch or be applied on mucosa or eyes. - It should not be used with occlusive bandages. - Immediately interrupt the treatment where, following the application of the medicated patch, a rash develops. - Do not administer at the same time any medicine containing diclofenac or other NSAIDs, either by topical or by systemic means. - The possibility of systemic adverse events arising from the application of diclofenac for topical use cannot be excluded in case of use of the preparation for a prolonged period of time (see product information of systemic forms of diclofenac). Although the expected systemic effects are of limited entity, the patch must be used with caution in patients with kidney, heart or liver impairment, peptic ulcer anamnesi or intestinal inflammatory disease or hemorrhagic diathesis. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients, as they are more susceptible to the occurrence of unwanted effects. - This medicine contains methylparahydroxybenzoate and propylparahydroxybenzoate. They can cause allergic reactions (also delayed). It also contains propylene glycol, which can cause skin irritation. - Patients should be advised to avoid exposure to direct sunlight and tanning lamps to reduce the risk of photosensitivity. - In patients currently affected, or who have been affected in the past, by bronchial asthma, allergic diseases or allergy to acetylsalicylic acid or other NSAIDs, bronchospasm may occur. The medicated patch should be used with caution in patients with or without chronic asthma where acetylsalicylic acid or other non-steroidal anti-inflammatory drugs can trigger asthma, urticaria or acute rhinitis (see 4.3 Contraindications). To minimize the possibility of undesirable effects, it is recommended to use the minimum effective dose for the shortest time necessary to control symptoms, without exceeding the maximum approved limit of 14 days (see paragraphs 4.2 and 4.8).

Interactions

Since systemic absorption of diclofenac with use according to indication of medicated patches is very low, the risk of developing clinically significant drug interactions is negligible.

Effects

Adverse reactions (Table 1) are listed according to the frequency, with the most frequent first, using the following convention: very common: (>1/10), common (≥1/100, Infections and infestations   Very rare Pustolose exantema Immune system disorders   Very rare Hypersensitivity (including hives), angioedema, anaphylactoid reaction Respiratory, chest and mediastinic pathologies   Very rare Asthma Pathologies of skin and subcutaneous tissue   Municipalities Rash, eczema, erythema, dermatitis (including allergic and contact dermatitis*), itching Not common Petecchi 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   Municipalities Reactions in the scope Not common Feeling warm Systemic absorption of diclofenac is very low when compared to plasma levels obtained following the administration of oral forms of diclofenac and the probability of systemic side effects (such as gastric, hepatic and kidney disorders) with the use of topical diclofenac is very limited compared to the frequency of unwanted effects associated with oral use of diclofenac. However, the possibility of systemic side effects cannot be excluded in the case of application of FASTUFLEX on a relatively large area of skin and for a prolonged period. 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 professionals are required to report any suspected adverse reaction via the national reporting system at the web address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported with diclofenac-based medicated patches. Where incorrect use or accidental overdose (e.g. in children) of this product cause undesirable systemic effects, the recommended general measures should be taken for intoxication by non-steroidal anti-inflammatory drugs.

Pregnancy:

Systemic concentration of diclofenac is lower due to topical administration than oral formulations. Referring to the experience gained from the treatment with NSAIDs for systemic administration, we recommend the following: Inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryo/fetal development. Data resulting from epidemiological studies suggest an increase in the risk of abortion and heart and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of cardiovascular malformations was increased by a percentage of less than 1% and about 1.5%. The risk is believed to increase dose and duration of therapy. In animals it has been shown that the administration of an inhibitor of the synthesis of prostaglandine determines an increase of pre- and post-system losses and embryo-fetal lethal. In addition, there was an increase in the incidence of various malformations, including cardiovascular malformations, in animals which had been given an inhibitor of prostaglandin synthesis during the organogenetic period. During the first and second quarter of pregnancy, diclofenac should not be administered unless strictly necessary. 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 to kidney failure with oligoidramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, an anti-aggregating effect that can occur even 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-based medicated plaster, there are no effects on the infant. Due to the lack of controlled studies conducted on nursing women, the product must be used during breast milk lactation only on the advice of a healthcare provider. In this circumstances, FASTUFLEX 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