Dicloreum Local Anti-inflammatory 10 Medicated Patches 180 mg

INDICATIONS

Local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of joints, muscles, tendons and ligaments.

ACTIVE INGREDIENTS

A 180 mg medicated plaster contains: Active ingredient: Diclofenac hydroxyethylpyrrolidine 180 mg (equal to 140 mg of sodium Diclofenac) Excipients with known effects: 14 mg of methyl parahydroxybenzoate (E218), 7 mg of propyl parahydroxybenzoate (E216), 420 mg of propylene glycol and 2.8 mg of perfume (containing amyl cinnamale, amyl cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnammal, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farinasol, geraniol, hexyl cinnamic aldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptin carbonate). For the full list of excipients, see section 6.1

EXCIPIENTS

Gelatin, Povidone, D-Sorbitol 70% solution, Kaolin, Titanium dioxide, Propylene glycol, Methyl parahydroxybenzoate (E218), Propyl parahydroxybenzoate (E216), Disodium edetate, Tartaric acid, Dihydroxyaluminium aminoacetate, Sodium caramel, Sodium polyacrylate, 1,3-butylene glycol, Polysorbate 80, Perfume, Purified water, Synthetic felt, Plastic film.

CONTRAINDICATIONS AND SIDE EFFECTS

• Hypersensitivity to diclofenac, acetylsalicylic acid or other non-steroidal anti-inflammatory preparations (NSAIDs) or to any of the excipients of the finished product, as well as to isopropanol. • Patients in whom asthma attacks, urticaria or acute rhinitis have occurred after taking acetylsalicylic acid or other non-steroidal inflammatory drugs (NSAIDs). • Damaged skin, regardless of the type of lesion: exudative dermatitis, eczema, infected lesion, burns or wounds. • Third trimester of pregnancy and breastfeeding (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

For cutaneous use only. Dosage The product should only be applied to intact, healthy skin and should not be applied when bathing or showering. The diclofenac medicated plaster must be used for the shortest time possible in relation to the indication of use. Adults The usual dosing regimen is 1 or 2 patches (or any other frequency evaluated in clinical studies for a specific product) per day (one application every 12 or 24 hours) for a period of up to 14 days (or for any other number of days the use has been evaluated in clinical studies for a specific product). If there is no improvement following the recommended treatment period, you should consult a doctor Children and adolescents under 16 years of age: The use of this medicated plaster is not recommended in children and adolescents under 16 years of age because insufficient data are available to evaluate the safety and effectiveness of the medicine (see section 4.3). In adolescents aged 16 years and older, if the product is needed for a treatment period of more than 7 days for pain relief or if symptoms worsen, the patient or relatives of the adolescent are advised to consult a doctor. Elderly This medicine should be used with caution in elderly patients as they are more predisposed to side effects (see section 4.4). Patients with hepatic or renal insufficiency For the use of diclofenac medicated plasters in patients with hepatic or renal insufficiency, consult 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 patch can be held in place using an elastic band. Carefully close the envelope by pressing the edge where the closing cord is located. The patch must be used whole.

CONSERVATION

Store at a temperature not exceeding 30°C.

WARNINGS

If diclofenac medicated plasters are used on large skin surfaces 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 must be applied only to intact and healthy skin and must not be applied to damaged skin or open wounds. The patches should not come into contact with the eyes or mucous membranes. Side effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms. - Do not use with an occlusive dressing that does not allow air to pass through. - Treatment must be stopped immediately if a skin rash develops after application of the medicated plaster. - Do not simultaneously administer topically or systemically another medicinal product based on diclofenac or other NSAIDs. - Although systemic effects should be limited, the medicated plaster should be used with caution in patients with renal, cardiac or hepatic impairment, history of peptic ulcer or inflammatory bowel disease or bleeding diathesis. Non-steroidal anti-inflammatory drugs should be used with particular caution in elderly patients who are more predisposed to side effects. - Patients should be advised not to expose themselves to direct sunlight or light from sunlamps for approximately one day after removal of the medicated plaster in order to reduce the risk of photosensitivity. Local anti-inflammatory Dicloreum contains: - methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (even delayed). - 420 mg of propylene glycol per patch which may cause skin irritation. - a perfume containing allergens (amyl cinnamale, amyl cinnamyl alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, cinnammal, cinnamyl alcohol, citronellol, d-Limonene, eugenol, farinasol, geraniol, hexyl cinnamic aldehyde, hydroxycitronellal, isoeugenol, linalool, methyl heptin carbonate) which may cause reactions allergic.

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.

SIDE 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 available data.

Infections and infestations.

Very rare: Rash with pustules.

Immune system disorders.

Very rare: Hypersensitivity (including urticaria), angioneurotic edema, anaphylactoid 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.

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

Very rare: Photosensitivity reactions

Systemic pathologies and conditions relating to the administration site.

Common: Administration site reactions.

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 risk/benefit ratio 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 was thought to increase with the 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 oligo-hydramnios; 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 plasters, 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, diclofenac medicated plasters 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).

EFFECTS ON DRIVING ABILITY

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