DICLOREUM ANT LOC*10CER MED180

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

Therapeutic indications

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

Dosage and method of use

For cutaneous use only. Posology 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 possible time in relation to the indication for use. Adults The usual dosage regimen is 1 or 2 patches (or any other frequency evaluated in clinical trials for a specific product) per day (one application every 12 or 24 hours) for up to 14 days (or any other number of days the use has been evaluated in clinical trials for a specific product). If there is no improvement after the recommended treatment period, a doctor should be consulted Children and adolescents under 16 years : The use of this medicated plaster is not recommended in children and adolescents under 16 years of age because there are insufficient data to evaluate the safety and efficacy of the medicinal product (see section 4.3). In adolescents 16 years of age and older, if the product is required for a treatment period longer than 7 days for pain relief or if symptoms worsen, the patient or the adolescent's relatives are advised to consult a doctor . Elderly This medicinal product should be used with caution in elderly patients as they are more prone to undesirable 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 see section 4.4. Method of administration Cut the envelope 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 joint or painful area. If necessary, the patch can be held in place with an elastic band. Close the bag carefully by pressing the edge where the drawstring is located. The patch must be used whole.

Contraindications

• 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 who experienced asthma attacks, urticaria or acute rhinitis 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 lactation (see section 4.6). • Patients with active peptic ulcer disease. Children and adolescents : Use in children and adolescents under the age of 16 is contraindicated .

Side effects

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

Special 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 diclofenac systemic formulations). The medicated plaster should only be applied to intact, healthy skin and should not be applied to broken skin or open wounds. The patches should not come into contact with the eyes or mucous membranes. Undesirable effects may 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 pass air. • Treatment must be stopped immediately if a skin rash develops after applying the medicated plaster. • Do not administer another diclofenac-based medicine or other NSAIDs topically or systemically at the same time. • 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 prone to side effects. • This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. They can cause allergic reactions (possibly delayed). Also contains propylene glycol, which can cause skin irritation. • Patients should be advised not to expose themselves to direct sunlight or sunlamp light 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 : Local anti-inflammatory Dicloreum contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

Pregnancy and breastfeeding

pregnancy and lactation Pregnancy The systemic concentration of diclofenac, compared with 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 can have negative effects on pregnancy and/or on the embryo/foetal development. Results of epidemiological studies suggest an increased risk of miscarriage and of 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 considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given 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 prostaglandin synthesis inhibitors may 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 antiplatelet effect which may occur even at very low doses; • inhibition of uterine contractions resulting in delayed or prolonged labour. 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 suckling child are anticipated. Due to the lack of controlled studies in lactating women, the product should only be used during lactation 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).

Expiration and conservation

Store at a temperature not exceeding 30°C.

Interactions with other drugs

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.

Overdose

No cases of overdose with diclofenac medicated plasters have been reported. Should systemic undesirable 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.

Active principles

One 180 mg medicated plaster contains: Active ingredient: 180 mg diclofenac hydroxyethylpyrrolidine (equal to 140 mg of sodium diclofenac) Excipients with known effects: Methyl parahydroxybenzoate, Propyl parahydroxybenzoate For the complete list of excipients, see section 6.1

Excipients

Gelatin, Povidone, D–Sorbitol 70% solution, Kaolin, Titanium dioxide, Propylene glycol, Methyl parahydroxybenzoate, Propyl parahydroxybenzoate, Edetate disodium, Tartaric acid, Dihydroxyaluminium aminoacetate, Carmellose sodium, Polyacrylate sodium, 1,3–butylene glycol, Polysorbate 80 , Perfume, Purified water, Synthetic felt, Plastic film.