Dicloreum skin foam 3% - topical anti-inflammatory 50g

Product Description

Anti-inflammatory skin foam based on the active ingredient diclofenac.

Indications

Dicloreum Skin Foam 3% is used in the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

Excipients

Sodium hydroxide, macroglycerols caprylocaprates, phospholipon 80 H, polysorbate 80, benzyl alcohol, potassium sorbate, disodium phosphate dodecahydrate, tocopheryl acetate, mint/eucalyptus fragrance, purified water. Each pressurized container (50 g) contains: 47.5 g of solution and 2.5 g of propellant (isobutane, n-butane, propane).

Dosage

Adults: Apply the medicine 1-3 times a day or as prescribed by your doctor. For each application, spray a circular mass of foam 3-5 centimeters in diameter (equal to approximately 0.75-1.5 g in weight) into the palm of your hand, depending on the size of the area to be treated, massaging gently until completely absorbed. In case of iontophoresis treatment, the product must be applied to the negative pole. The medicine can also be used in combination with ultrasound therapy. After application, wash your hands, otherwise they will also be treated with the skin foam. Caution: Use only for short-term treatment.

Adolescents (14-18 years): Apply the medicine 1-3 times a day or as prescribed by your doctor. For each application, spray a circular mass of foam 3-5 centimeters in diameter (equal to approximately 0.75-1.5 g in weight) into the palm of your hand, depending on the size of the area to be treated, massaging gently until completely absorbed. In case of iontophoresis treatment, the product must be applied to the negative pole. The medicine can also be used in combination with ultrasound therapy. Wash your hands after application, otherwise they will also be treated with the skin foam. If this medicine is necessary for more than 7 days to relieve pain or if symptoms worsen, consult your doctor. Children and adolescents

Warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be ruled out if the preparation is used on large areas of skin and for a prolonged period (see the summary of product characteristics for systemic forms of diclofenac). Topical diclofenac should be applied only to intact, non-diseased skin, and not to skin wounds or open lesions. It should not be allowed to come into contact with eyes or mucous membranes and should not be ingested. In elderly patients and/or patients with gastric problems, the concomitant use of systemic anti-inflammatory drugs is not recommended. The drug should be used with caution in patients who have had a hypersensitivity reaction to NSAIDs or analgesics in the past, e.g., asthma attacks, skin rashes, or acute allergic rhinitis. Patients with asthma, chronic obstructive bronchial disease, allergic rhinitis, or inflammation of the nasal mucosa (nasal polyps) react more frequently than other patients with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema), or urticaria to antirheumatic treatment with NSAIDs. The use of other topical products, especially if prolonged, may result in sensitization. In this case, treatment should be discontinued and appropriate therapy instituted. Discontinue treatment if a skin rash develops after application of the product. Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that prevents air from entering. The medicine contains potassium sorbate, which may cause local skin reactions (e.g., contact dermatitis). To reduce possible photosensitivity phenomena, it is advisable not to expose yourself excessively to the sun during use.

Interactions

Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely. However, in high-dose and prolonged treatments, the possibility of competition between absorbed diclofenac and other drugs highly bound to plasma proteins should be kept in mind.

Undesirable Effects

Immune system disorders. Very rare: hypersensitivity (including urticaria), angioneurotic edema. Infections and infestations. Very rare: asthma. Skin and subcutaneous tissue disorders. Common: rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus; rare: bullous dermatitis; very rare: photosensitivity reaction.

Pregnancy

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 and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. 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. Additionally, 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 the newborn, at the end of pregnancy, may experience a prolongation of bleeding time, an antiplatelet effect that may occur even at very low doses, and inhibition of uterine contractions resulting in delayed or prolonged labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses, 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, the drug should not be applied to the breasts of nursing mothers, nor elsewhere on large areas of skin or for a prolonged period.

Format

50 g