Dicloreum - topical anti-inflammatory - 10 medicated patches 180 mg

Product Description

Dicloreum Local Anti-Inflammatory 180mg: Medicated Plasters

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. The medicated plaster should be applied only to intact, healthy skin and should not be applied to broken skin or open wounds. The plasters should not come into contact with the eyes or mucous membranes. Undesirable effects can be minimized 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 through. Treatment should be discontinued immediately if a skin rash develops after applying the medicated plaster. Do not administer another diclofenac-containing 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, a history of peptic ulcer disease or inflammatory bowel disease, or bleeding tendencies. Nonsteroidal anti-inflammatory drugs should be used with particular caution in elderly patients, who are more susceptible to side effects. This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate. They may cause allergic reactions (possibly delayed). It also contains propylene glycol, which may cause skin irritation. Patients should be advised not to expose themselves to direct sunlight or sunlamps for approximately one day after removing the medicated plaster in order to reduce the risk of photosensitivity.

Pharmacotherapeutic category

Medicines for topical use for joint and muscle pain.

Storage

Store at a temperature not exceeding 30 degrees C.

Contraindications/Secondary effects

hypersensitivity to diclofenac, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (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 nonsteroidal 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; patients with active peptic ulcer. Children and adolescents: Use in children and adolescents under 16 years of age is contraindicated.

Excipients

Gelatin, povidone, D-Sorbitol 70% solution, kaolin, titanium dioxide, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, disodium edetate, tartaric acid, dihydroxyaluminium aminoacetate, sodium caramel, sodium polyacrylate, 1,3-butylene glycol, polysorbate 80, perfume, purified water, synthetic felt, plastic film.

Undesirable effects

Adverse reactions 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. Infections and infestations. Very rare: rash with pustules. Immune system disorders. Very rare: hypersensitivity (including urticaria), angioneurotic oedema, anaphylactoid reaction. Respiratory, thoracic and mediastinal disorders. Very rare: asthma. Skin and subcutaneous tissue disorders. Common: rash, eczema, erythema, dermatitis (including allergic dermatitis and contact dermatitis), pruritus; rare: bullous dermatitis (e.g., erythema bullosa), dry skin; very rare: photosensitivity reactions. General disorders and administration site conditions. Common: reactions at the administration site.

Pregnancy and breastfeeding

The systemic concentration of diclofenac, compared to oral formulations, is lower after topical administration. Based on experience with treatment with systemically administered NSAIDs, the following is recommended: inhibition of prostaglandin synthesis may have adverse effects on pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of miscarriage, cardiac malformation, and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is 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-fetal mortality. Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period. During the first and second trimesters of pregnancy, diclofenac should not be administered unless clearly necessary. If diclofenac is used by a woman attempting to conceive, or during the first and second trimesters 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 may progress to renal failure with oligohydramnios; the mother and newborn, at the end of pregnancy, to: possible prolongation of bleeding time, and an antiplatelet effect that 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. 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.

Indications

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

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.

Dosage

For cutaneous use only. The product should be applied only to intact, healthy skin and should not be applied while bathing or showering. The 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 (or any other frequency evaluated in clinical trials for a specific product) per day (one application every 12 or 24 hours) for a period of up to 14 days (or any other number of days evaluated in clinical trials for a specific product). 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 insufficient data are available to evaluate the safety and efficacy of the medicine. 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 or the adolescent's relatives are advised to consult a doctor. Elderly: This medicine should be used with caution in elderly patients as they are more susceptible to adverse effects. Method of administration: Cut the sachet containing the medicated plaster as directed. Remove a medicated plaster, remove the plastic film protecting the adhesive surface, and apply the plaster to the painful joint or area. If necessary, the plaster can be held in place with an elastic band. Carefully close the pouch by pressing the edge where the drawstring is located. The plaster must be used whole.

Active ingredients

Diclofenac hydroxyethylpyrrolidine.