Muscoridol 10 Medicated Patches for Muscle Pain 180 mg

INDICATIONS

Local symptomatic treatment of rheumatic or traumatic pain and inflammation of joints, muscles, tendons and ligaments.

ACTIVE INGREDIENTS

Each medicated plaster measuring 10 cm x 14 cm contains a total of 180 mg of diclofenac epolamine equivalent to 140 mg of diclofenac sodium. Excipients with known effects: methyl parahydroxybenzoate (E218): 14 mg; propyl parahydroxybenzoate (E216): 7 mg; propylene glycol: 420 mg; referring to the quantity per patch. For the full list of excipients, see section 6.1.

EXCIPIENTS

Backing layer: non-woven polyester backing. Adhesive layer (active gel): gelatin, povidone (K90), liquid sorbitol (non-crystallizable), heavy kaolin, titanium dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), disodium edetate, tartaric acid, aluminum glycinate, sodium carmellose, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, purified water. Protective layer: polypropylene film.

CONTRAINDICATIONS AND SIDE EFFECTS

This medicinal product is contraindicated in the following cases: - Hypersensitivity to diclofenac, acetylsalicylic acid, other analgesics or other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients listed in section 6.1. - Patients who have had asthma attacks, urticaria or acute rhinitis triggered by acetylsalicylic acid or other non-steroidal 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 under the age of 16.

DOSAGE

For cutaneous use only. Dosage One (1) patch on the most painful area once or twice a day. Duration of administration Zaranny should be used for the shortest time possible. The maximum duration of treatment is 14 consecutive days. Advise the patient to consult their doctor if they do not experience improvement following the recommended treatment period (see section 4.4). Elderly This medicine should be used with caution in elderly patients as they are more predisposed to side effects (see section 4.4). Pediatric population (Children and adolescents under 16 years old) The use of this medicated plaster is not recommended since there are insufficient data available on the safety and efficacy of the medicine in children and adolescents under 16 years of age (see section 4.3). In adolescents aged 16 years and older, if the product is needed for a treatment period longer than 7 days for pain relief or if symptoms worsen, the patient/parents of the adolescent are advised to consult a doctor, as re-evaluation is necessary. Patients with hepatic or renal insufficiency For the use of Zaranny in patients with hepatic or renal insufficiency see section 4.4. Method of administration Cut the bag 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 joint or painful surface. If necessary, the plaster can be held in place using an elastic mesh bandage. Carefully close the envelope with the sliding closure. The patch must be used whole.

CONSERVATION

This medicine does not require any particular storage temperature.

WARNINGS

- The medicated plaster must only be applied to intact and healthy skin and must not be applied to damaged skin or open wounds and must not be applied when bathing or showering. - The medicated plaster must not come into contact with or be applied to the mucous membranes or eyes. - Do not use with an occlusive dressing that does not let air pass. - Treatment must be stopped immediately if a rash develops after applying the medicated plaster. - Do not administer simultaneously, topically or systemically, another medicinal product based on diclofenac or other NSAIDs. - The possibility of systemic adverse events produced by the application of topical diclofenac cannot be excluded if the preparation is used on a large skin surface and for a prolonged period (see product information relating to other systemic forms of diclofenac). Although systemic effects may be minimal, the patch should be used with caution in patients with impaired renal, cardiac or hepatic function, a history of peptic ulcer, intestinal inflammation or haemorrhagic diathesis. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients, as they are more susceptible to the onset of side effects. - Patients should be advised not to expose themselves to direct sunlight or sun lamps for approximately one day after removing the medicated plaster in order to reduce the risk of photosensitivity. - The medicated plaster should be used with caution in patients with asthma, chronic bronchial obstructive disease, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) who may react with asthma attacks, local inflammation of the skin or mucous membranes (Quincke's edema), urticaria or acute rhinitis after treatment with acetylsalicylic acid or other non-steroidal anti-inflammatory agents more often than other patients (see section 4.3). - In order to minimize the occurrence of side effects, it is recommended to use the lowest effective dose for the shortest duration necessary to control symptoms, without exceeding the approved maximum of 14 days (see sections 4.2 and 4.8). - The use, especially if prolonged, of this as well as other products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt treatment and institute appropriate therapy. - Although systemic absorption is minimal, however the use of the medicated plaster, as of any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women intending to become pregnant (see section 4.6). - The administration of the diclofenac-based medicated plaster must be suspended in women who have fertility problems or who are undergoing fertility investigations (see section 4.6). This medicine contains methyl parahydroxybenzoate e propyl parahydroxybenzoate. They can cause allergic reactions (even delayed); This medicine contains 420 mg of propylene glycol per patch.

INTERACTIONS

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 carried out with the diclofenac-based medicated plaster, used in conjunction with other steroidal and non-steroidal anti-inflammatory drugs (salazopyrin, hydroxyquinoline, etc.), have not highlighted any interaction phenomena. However, the possibility of competition between the absorbed diclofenac and other drugs with high binding to plasma proteins cannot be excluded. Concomitant topical or systemic use of other drugs containing diclofenac or other NSAIDs (see section 4.8) is not recommended.

SIDE EFFECTS

Adverse reactions are listed by frequency, the most frequent first, using the following convention: very common (>1/10); 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: frequency cannot be estimated from the available data.

Infections and infestations.

Very rare: Pustular rash.

Immune system disorders.

Very rare: Hypersensitivity (including urticaria), angioedema, anaphylactic reaction.

Respiratory, thoracic and mediastinal disorders.

Very rare: Asthma.

Pathologies of the skin and subcutaneous tissue.

Common: Rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), pruritus.

Uncommon: Petechiae.

Rare: Bullous dermatitis (e.g. bullous erythema), dry skin.

Very rare: Photosensitivity reaction

Not known: Burning sensation at the application site.

Systemic pathologies and conditions relating to the administration site.

Common: Administration site reactions.

Uncommon: Feeling hot.

The systemic absorption of diclofenac is very low compared to the plasma levels measured after oral intake of diclofenac and the probability of systemic side effects (such as gastric, hepatic and renal disorders) is very low compared to the frequency of side effects associated with oral use of diclofenac. However, if Zaranny is used on large skin surfaces and for long periods of time, the appearance of systemic side effects is possible, especially at the gastrointestinal level due to the amount of active ingredient that is absorbed. The use of the product in combination with other drugs containing diclofenac must be avoided as it can give rise to phenomena of hypersensitivity to light, skin rash with vesicle formation, eczema, erythema and, in rare cases, severe skin reactions (Stevens-Johnson syndrome, Lyell syndrome) (see paragraphs 4.4 and 4.5). Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. 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

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

PREGNANCY AND BREASTFEEDING

Pregnancy The systemic concentration of diclofenac, compared to oral formulations, is lower after topical administration. Referring to the experience of treatment with NSAIDs for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis may have negative effects on pregnancy and/or embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in the early stages of pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been thought to increase with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-foetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular malformations, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimester of pregnancy diclofenac should not be administered unless strictly 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 as possible and the duration of treatment as short as possible. During the third trimester of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligohydramnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of bleeding time, and anti-aggregating effect which can 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 quantities. However, at therapeutic doses of diclofenac medicated plaster, no effects on the infant are expected. 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, Zaranny should not be applied to the breasts of breastfeeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time (see section 4.4). Fertility The administration of the medicated plaster must be suspended in women who have fertility problems or who are undergoing fertility investigations.

EFFECTS ON DRIVING ABILITY

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