Flector 180mg 5 medicated plasters

Flector 180mg 5 medicated plasters is a topical treatment designed to relieve pain and inflammation associated with rheumatic or traumatic conditions involving joints , muscles , tendons and ligaments . Each plaster contains diclofenac hydroxyethylpyrrolidine , an active ingredient known for its anti-inflammatory and analgesic properties. The formulation is designed to ensure a controlled release of the active ingredient directly to the affected area, offering targeted and prolonged relief. Ideal for those looking for a local treatment option, Flector medicated plasters are easy to apply and adhere well to the skin, allowing for convenient daily application. Thanks to its composition, it is particularly suitable for those who need an effective intervention against painful symptoms without resorting to systemic treatments.

ACTIVE INGREDIENTS

Active ingredients contained in Flector 180mg 5 medicated patches - What is the active ingredient in Flector 180mg 5 medicated patches?

One 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, perfume containing amyl cinnamal, amyl cinnamal alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamal, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, hexyl cinnamic aldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptin carbonate. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Flector 180mg 5 medicated plasters - What does Flector 180mg 5 medicated plasters contain?

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

Therapeutic indications Flector 180mg 5 medicated plasters - Why is Flector 180mg 5 medicated plasters used? What is it used for?

Local treatment of painful and inflammatory conditions of rheumatic or traumatic nature of: • Joints; • Muscles; • Tendons; • Ligaments.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Flector 180mg 5 medicated patches - When should Flector 180mg 5 medicated patches not be used?

• Hypersensitivity to the active substance or to acetylsalicylic acid or to other analgesics or other nonsteroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1. • Patients who have experienced asthmatic 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.

DOSAGE

Quantity and method of taking Flector 180mg 5 medicated patches - How to take Flector 180mg 5 medicated patches?

For cutaneous use only. Dosage : The medicinal product should only be applied to intact, healthy skin and should not be applied while bathing or showering. Diclofenac medicated plaster should be used for the shortest possible time 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 up to 14 days. The patient should be advised to consult their doctor if they experience no improvement 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 as 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. Advise the patient or relatives of the adolescent to consult their doctor. Elderly : This medicinal product should be used with caution in elderly patients as they are more susceptible to undesirable 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 sachet containing the medicated plaster as indicated. Take out a medicated plaster, remove the plastic film used to protect the adhesive surface and apply the plaster to the painful joint or surface. If necessary, the plaster can be held in place with an elastic band (the pack contains a tubular net). Carefully reseal the sachet. The plaster should be used in its entirety. Avoid contact with eyes or mucous membranes.

CONSERVATION

Storage Flector 180mg 5 medicated plasters - How to store Flector 180mg 5 medicated plasters?

No special storage conditions are required.

WARNINGS

Warnings Flector 180mg 5 medicated patches - About Flector 180mg 5 medicated patches it is important to know that:

If diclofenac medicated plasters are used on large areas of skin and for a prolonged period of time, the possibility of systemic adverse events cannot be excluded (see the Summary of Product Characteristics of the systemic formulations of diclofenac). The medicated plaster should only be applied to intact, healthy skin and should not be applied to damaged skin or open wounds. The plasters 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 polyp) react to treatment with NSAIDs more often than other patients with asthma attacks, local inflammation of the skin or mucosa (Quincke's oedema) or urticaria. The use, especially if prolonged, of this and other products for topical use may give rise to sensitization phenomena. In this case, treatment should be discontinued and appropriate therapy instituted. Although systemic absorption is minimal, the use of FLECTOR, as with any drug inhibiting the synthesis of prostaglandins and cyclooxygenase, is not recommended in women attempting to conceive. Administration of FLECTOR should be discontinued in women who have problems conceiving or who are undergoing investigation of infertility. Undesirable effects may be minimised 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. • Treatment should be discontinued immediately if a skin rash develops after application of the medicated plaster. • Do not administer another medicinal product containing diclofenac or other NSAIDs topically or systemically at the same time. • Although systemic effects should be low, the medicated plaster should be used with caution in patients with renal, cardiac or hepatic impairment, a history of peptic ulcer or inflammatory bowel disease or haemorrhagic 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 removal of the medicated plaster in order 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); - 420 mg of propylene glycol in each plaster: may cause skin irritation; - a flavouring (perfume) containing amyl cinnamal, amyl cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnamal, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farnesol, geraniol, hexyl cinnamic aldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptine carbonate: may cause allergic reactions

INTERACTIONS

Interactions Flector 180mg 5 medicated patches - Which medicines or foods can modify the effect of Flector 180mg 5 medicated patches?

Since the systemic absorption of diclofenac following the use of medicated plasters is very low, the risk of developing clinically significant interactions with other medicinal products is negligible. Clinical investigations performed with FLECTOR medicated plaster used concomitantly with other steroidal and non-steroidal anti-inflammatory drugs (salazopyrine, hydroxyquinoline, etc.) have not highlighted any interaction phenomena. However, the possibility of competition between absorbed diclofenac and other drugs with high plasma protein binding cannot be excluded. The concomitant topical or systemic use of other drugs containing diclofenac or other NSAIDs is not recommended (see section 4.8).

SIDE EFFECTS

Like all medicines, Flector 180mg 5 medicated plasters can cause side effects - What are the side effects of Flector 180mg 5 medicated plasters?

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. Table 1

Following applications for long periods of time on large skin surfaces, the appearance of systemic side effects, especially at the gastrointestinal level, cannot be excluded due to the amount of active ingredient that is absorbed. The use of the product in combination with other drugs containing diclofenac may give rise to phenomena of hypersensitivity to light, skin rash with the formation of vesicles, eczema, erythema and, in rare cases, severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome) (see section 4.5). Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important, as it allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Flector 180mg 5 medicated patches Overdose - What are the risks of Flector 180mg 5 medicated patches in case of overdose?

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

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Flector 180mg 5 medicated plasters.

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. 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. 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).

DRIVING AND USE OF MACHINERY

Taking Flector 180mg 5 medicated patches before driving or using machines - Does Flector 180mg 5 medicated patches affect driving or using machines?

The application of diclofenac medicated plasters does not alter the ability to drive vehicles or use machinery.