Flector - 10 medicated plasters 180 mg for joint and muscle pain

Product Description

Flector® is a self-adhesive medicated plaster with analgesic and anti-inflammatory properties, providing a constant release of the active ingredient for up to 12 hours.

Indications

Flector® is a self-adhesive medicated plaster: Thanks to its hydrogel technology, it eliminates the need for organic solvents (such as toluene, hexane, and isopropanol) to make the plaster adhesive. Furthermore, thanks to the hydrogel's high water content, the medicated plaster provides a cooling effect upon application and continuous hydration of the skin. It acts locally, directly on the area affected by inflammation.

Flector® medicated plaster, when applied to the area where pain is felt, provides rapid and targeted action against pain and inflammation, thanks to a gradual and constant release of the active ingredient for up to 12 hours.

Flector® is a medicated plaster based on Diclofenac, a nonsteroidal anti-inflammatory active ingredient for cutaneous use. The combination of diclofenac with epolamine salt facilitates the absorption and concentration of the active ingredient in the area affected by pain and inflammation, promoting a rapid but prolonged anti-inflammatory and analgesic pharmacological action.

Composition

Active ingredients

A 180 mg medicated plaster contains: active ingredient: diclofenac hydroxyethylpyrrolidine 180 mg (equivalent to 140 mg of diclofenac sodium); excipients with known effects: propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate. For a full list of excipients, see section 6.1.

Excipients

Gelatin, polyvinylpyrrolidone, sorbitol 70% solution, kaolin, titanium dioxide, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, tartaric acid, dihydroxyaluminium aminoacetate, sodium carboxymethylcellulose, sodium polyacrylate, 1-3-butylene glycol, polysorbate 80, perfume, purified water, synthetic felt, plastic film.

Directions for use and Dosage

For cutaneous use only. Dosage: The medicine should be applied only to intact, healthy skin and should not be used while bathing or showering. Diclofenac medicated plaster should be used for the shortest possible duration in relation to the indication for use. Adults: The usual dosage regimen is 1 or 2 patches per day (one application every 12 or 24 hours) for a period of up to 14 days. The patient should be advised to consult a doctor if no improvement is seen following the recommended treatment period (see section 4.4). Paediatric population: Children and adolescents under 16 years: The use of this medicated plaster is not recommended because there are insufficient data to evaluate the safety and efficacy of the medicinal product (see section 4.3). In adolescents aged 16 years and over: If the medicinal product is required for a treatment period longer than 7 days for pain relief or if symptoms worsen, a re-evaluation is necessary. The patient or the adolescent's relatives should be advised to consult a doctor. Elderly: This medicinal product should be used with caution in elderly patients as they are more susceptible to adverse effects (see section 4.4). Patients with hepatic or renal impairment: For the use of diclofenac medicated plasters in patients with hepatic or renal impairment, see section 4.4. Method of administration: Cut the pouch containing the medicated plaster as indicated. Remove a medicated plaster, remove the plastic film used to protect the adhesive surface, and apply the plaster to the painful joint or area. If necessary, the plaster can be held in place with an elastic band (the package contains a tubular net). Carefully reseal the pouch. The plaster must be used in its entirety. Avoid contact with eyes or mucous membranes.

Warnings

If diclofenac medicated plasters are used on large areas of skin and for a prolonged period, the possibility of systemic adverse events cannot be ruled out (consult the Summary of Product Characteristics for systemic diclofenac formulations). The medicated plaster should be applied only to intact, healthy skin and should not be applied to broken skin or open wounds. The plaster should not come into contact with the eyes or mucous membranes. Patients with asthma, chronic obstructive bronchial disease, allergic rhinitis, or inflammation of the nasal mucosa (nasal polyps) react more frequently to treatment with NSAIDs than other patients with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema), or urticaria. Use, especially if prolonged, of this and other topical products may result in sensitization. In this case, treatment should be discontinued and appropriate therapy instituted. Although systemic absorption is minimal, the use of FLECTOR, as with any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women attempting to conceive. FLECTOR should be discontinued in women who have fertility problems or who are undergoing investigation of infertility. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

• Do not use with an occlusive dressing that does not allow air to pass through.
• Treatment should be discontinued immediately if a skin rash develops after applying the medicated plaster.
• Do not administer another diclofenac-containing medicinal product or other NSAIDs topically or systemically at the same time.
• Although systemic effects are expected to be low, the medicated plaster should be used with caution in patients with renal, cardiac, or hepatic impairment, a history of peptic ulcer disease or inflammatory bowel disease, or bleeding diathesis. Nonsteroidal anti-inflammatory drugs should be used with particular caution in elderly patients, who are more susceptible to side effects.
• Patients should be advised not to expose themselves to direct sunlight or sunlamps for approximately one day after removing the medicated plaster to reduce the risk of photosensitivity. Important information about some of the excipients. FLECTOR contains: - methyl parahydroxybenzoate, propyl parahydroxybenzoate: may cause allergic reactions (possibly delayed); - Propylene glycol: may cause skin irritation.

Contraindications

• Hypersensitivity to the active substance or to acetylsalicylic acid, other analgesics, other nonsteroidal anti-inflammatory drugs (NSAIDs), or to any of the excipients listed in section 6.1;
• Patients who have experienced asthma attacks, urticaria, or acute rhinitis after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns, or wounds.
• Third trimester of pregnancy (see section 4.6);
• Patients with active peptic ulcer. Children and adolescents: Use in children and adolescents under 16 years of age is contraindicated.

Undesirable effects

Adverse reactions (Table 1) are listed by frequency, the most frequent first, using the following convention: common (≥ 1/100, <1/10); uncommon (≥ 1/1,000, <1/100); rare (≥ 1/10,000, <1/1,000); very rare (<1/10,000); not known: cannot be estimated from the available data.

Following prolonged application to large areas of skin, the occurrence of systemic side effects, especially gastrointestinal, cannot be ruled out due to the amount of active ingredient absorbed. Use of the product in combination with other drugs containing diclofenac may result in hypersensitivity to light, skin rash with vesicle formation, eczema, erythema, and, in rare cases, severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome) (see section 4.5). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Overdose

No cases of overdose have been reported with diclofenac medicated plasters. If systemic side effects occur due to incorrect use or accidental overdose (e.g., in children), the general supportive measures for intoxication with nonsteroidal anti-inflammatory drugs are recommended.

Pregnancy and breastfeeding

Pregnancy The systemic concentration of diclofenac, compared to oral formulations, is lower after topical administration. Based on experience with systemic NSAID treatment, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development. Epidemiological studies suggest an increased risk of miscarriage, 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 is 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-fetal mortality. Furthermore, 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 trimesters of pregnancy, diclofenac should not be administered unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters 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 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 oligohydramnios; 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.

Breastfeeding 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 breastfeeding women, the product should be used during breastfeeding only under the advice of a healthcare professional. Under these circumstances, 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).

Storage

No special storage conditions are required.

Size

10 plasters