Flector Unidie 14 mg 8 medicated plasters

Flector Unidie 14 mg 8 medicated patches is an effective and practical solution for the local treatment of pain and inflammation affecting joints, muscles, tendons and ligaments . Each medicated patch contains piroxicam 14 mg , an active ingredient belonging to the class of NSAIDs (nonsteroidal anti-inflammatory drugs), known for its targeted pain-relieving and anti-inflammatory action. Thanks to the transdermal patch technology, the active ingredient is released constantly and for a prolonged period directly onto the affected area, ensuring rapid and long-lasting relief from rheumatic pain, traumatic pain, rheumatism and muscle trauma .

The pack contains 8 medicated plasters , ideal for a complete treatment cycle. Flector Unidie is particularly suitable for those suffering from joint pain, muscle pain and inflammation due to trauma, strain or rheumatic diseases. The patch, easy to apply and discreet, adheres perfectly to the skin and can be used on different areas of the body, such as knees, elbows, shoulders and back, offering a targeted local treatment without the need to take oral medications. The formulation is designed to guarantee a controlled release of the active ingredient for 24 hours, thus ensuring continuous pain relief throughout the day.

Thanks to its effectiveness and practicality, Flector Unidie 14 mg pain-relieving patches represent an ideal choice for those who want a topical treatment against inflammation and musculoskeletal pain , with the convenience of a daily application and the safety of a product specifically for skin use.

ACTIVE INGREDIENTS

Active ingredients contained in Flector Unidie 14 mg 8 medicated plasters - What is the active ingredient in Flector Unidie 14 mg 8 medicated plasters?

One medicated plaster contains: • active substance: piroxicam 14 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Flector Unidie 14 mg 8 medicated plasters - What does Flector Unidie 14 mg 8 medicated plasters contain?

Acrylic copolymer, Eudragit E 100; non-woven fabric, siliconized polyester.

DIRECTIONS

Therapeutic indications Flector Unidie 14 mg 8 medicated plasters - Why is Flector Unidie 14 mg 8 medicated plasters used? What is it used for?

FLECTOR UNIDIE is indicated for the treatment of painful and inflammatory conditions of a rheumatic and traumatic nature of the joints, muscles, tendons and ligaments.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Flector Unidie 14 mg 8 medicated plasters - When should Flector Unidie 14 mg 8 medicated plasters not be used?

FLECTOR UNIDIE is contraindicated in the following cases: • hypersensitivity to the active substance (piroxicam) or to any of the excipients listed in paragraph 6.1; • patients in whom substances with a similar mechanism of action (NSAIDs) have caused hypersensitivity reactions (see paragraph 4.4); • patients with active peptic ulcer; • patients with bronchial asthma; • patients with a history of gastrointestinal bleeding from NSAIDs; • patients on anticoagulant therapy; • pregnancy and breastfeeding (see paragraph 4.6); • children under 12 years of age. FLECTOR UNIDIE patch must not be used on open wounds or lesions, but only on intact skin.

DOSAGE

Quantity and method of taking Flector Unidie 14 mg 8 medicated patches - How to take Flector Unidie 14 mg 8 medicated patches?

Dosage It is recommended to use only one medicated plaster at a time and replace it every 24 hours for a period not exceeding 8 days. Do not apply two plasters in the same day. FLECTOR UNIDIE is to be used exclusively on intact skin. Method of administration For cutaneous use only. After carefully washing and drying the painful area, rub one of the corners of FLECTOR UNIDIE between your fingers to remove the protective film and apply the adhesive part directly to the skin. If FLECTOR UNIDIE needs to be applied to joints with greater mobility, such as the elbow or knee, it is advisable to use a retention bandage to be applied to the flexed joint, in order to keep the plaster in place. Do not exceed the recommended doses. Avoid contact with eyes and mucous membranes.

CONSERVATION

Storage Flector Unidie 14 mg 8 medicated plasters - How should Flector Unidie 14 mg 8 medicated plasters be stored?

No special storage conditions are required.

WARNINGS

Warnings Flector Unidie 14 mg 8 medicated patches - About Flector Unidie 14 mg 8 medicated patches it is important to know that:

The serum levels achieved with FLECTOR UNIDIE were significantly lower than those obtained by oral administration but with strong individual variability, therefore the onset of systemic side effects, especially at the gastrointestinal level, cannot be excluded. Analgesics, antipyretics, nonsteroidal anti-inflammatory drugs, including piroxicam, can cause hypersensitivity reactions, potentially serious even in subjects not previously exposed to this type of drug. These include asthma attacks, skin rashes, allergic rhinitis and anaphylactic-type reactions. FLECTOR UNIDIE must be used with caution in subjects with chronic obstructive bronchial diseases, allergic rhinitis or inflammation of the nasal mucosa (nasal polyps) in whom asthmatic attacks or localized inflammatory reactions of the skin and mucosa (Quincke's edema) are more frequent. Use caution in patients with a history of peptic ulcer, in patients with a history of gastrointestinal bleeding not secondary to the administration of NSAIDs or with other bleeding disorders, in patients with Crohn's disease or ulcerative colitis, with severe hepatic or renal dysfunction or with heart failure. Prolonged or repeated use of products for cutaneous use may give rise to sensitization phenomena. In the presence of hypersensitivity reactions, it is necessary to discontinue therapy. Caution should be exercised in treating elderly patients who are generally more predisposed to adverse events. After a short therapy without results, consult your doctor. To avoid possible hypersensitivity or photosensitivity phenomena, avoid exposure to direct sunlight. Skin reactions Cases of fixed drug eruption (FDE) have been reported with piroxicam. Piroxicam should not be reintroduced in patients with a history of FDE related to piroxicam. A potential cross-reaction with other oxicams may occur. Paediatric population Keep this medicine out of the sight and reach of children.

INTERACTIONS

Interactions Flector Unidie 14 mg 8 medicated patches - Which medicines or foods can modify the effect of Flector Unidie 14 mg 8 medicated patches?

The use of piroxicam-based patches is unlikely to have interactions with other medicinal products. However, the possibility of competition between absorbed piroxicam and other drugs with high plasma protein binding cannot be excluded. Do not use the medicine together with other oral or local drugs containing piroxicam or other NSAIDs.

SIDE EFFECTS

Like all medicines, Flector Unidie 14 mg 8 medicated plasters can cause side effects - What are the side effects of Flector Unidie 14 mg 8 medicated plasters?

The use of the medicinal product may cause local skin reactions of an irritant or allergic nature such as erythema, itching, burning, contact dermatitis, numbness and tingling at the application site; with this type of medicinal product, cases of extensive and severe dermatological lesions such as urticaria, Quincke's edema, erythema multiforme have been reported. Photosensitivity reactions and more extensive and severe skin and mucosal reactions, including asthma attacks, are possible. Systemic adverse reactions following topical use of piroxicam are unlikely; since the plasma levels obtained are lower than those measured after systemic administration but are highly variable from individual to individual, it is not possible to exclude, especially in the case of prolonged therapies beyond the recommended term and failure to observe contraindications and warnings, the appearance of systemic adverse effects, especially at the gastrointestinal level (see paragraphs 4.4 and 5.2). The possible appearance of general or application site adverse effects requires suspension of therapy. Cases of fixed drug eruption have been reported with piroxicam with an unknown frequency (frequency cannot be estimated from the available data) (see section 4.4). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Flector Unidie 14 mg 8 medicated patches - What are the risks of Flector Unidie 14 mg 8 medicated patches in case of overdose?

There are no known cases of overdose. In case of overdose with evident clinical manifestations, immediately institute symptomatic therapy and apply the usual emergency measures.

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 Unidie 14 mg 8 medicated plasters.

Pregnancy and breastfeeding FLECTOR UNIDIE is contraindicated during pregnancy and breastfeeding and is not recommended in women intending to become pregnant. Fertility Administration should be suspended in women with fertility problems or who are undergoing fertility investigations.

DRIVING AND USE OF MACHINERY

Taking Flector Unidie 14 mg 8 medicated patches before driving or using machines - Does Flector Unidie 14 mg 8 medicated patches affect driving or using machines?

FLECTOR UNIDIE does not interfere with the ability to drive vehicles or use machines.