DICLOREUM ACTIGEL GEL 100G 1%

DICLOREUM ACTIGEL 1% GEL

active principles

100g of gel contain: Active principle: diclofenac hydroxyethylpyrrolidine 1.32 g - equal to 1.0 g of diclofenac sodium. For the complete list of excipients, see section 6.1.

Exceptions

macrogols, macrogol stearate, cetyl stearyl-2-ethylhexanoate, carbomers, trolamine, isopropyl alcohol, fragrance, purified water.

Therapeutic indications

For the local treatment of painful and inflammatory states of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.

Contraindications

Individual hypersensitivity ascertained towards the components of the product. Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as well as isopropanol. Contraindicated in the third trimester of pregnancy (see section 4.6 Fertility, pregnancy and breastfeeding). Children and adolescents It is contraindicated for use in children and adolescents under the age of 14.

Posology

Adults over the age of 18: To apply DICLOREUM ACTIGEL 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2–4 g of DICLOREUM ACTIGEL (amount ranging in size from a cherry to a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel. Warning: use only for short periods of treatment. Teenagers aged 14 to 18: To apply DICLOREUM ACTIGEL 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example 2–4 g of DICLOREUM ACTIGEL (amount ranging in size from a cherry to a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated with the gel. If this product is needed for more than 7 days for pain relief or if symptoms worsen, consult a doctor. Children under the age of 14: There are insufficient data on efficacy and safety in children and adolescents under 14 years of age (see also section 4.3 Contraindications). Therefore, the use of DICLOREUM ACTIGEL is contraindicated in children under 14 years of age. Elderly people: The usual adult dosage can be used

Storage

Do not store above 30°C

Warnings

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period (see the summary of product characteristics of the systemic forms of diclofenac). DICLOREUM ACTIGEL should not be applied to skin wounds or open lesions, but only to intact skin. Avoid that the preparation comes into contact with the eyes and mucous membranes. The gel must not be swallowed. Concomitant use of systemic anti-inflammatory drugs is not recommended in elderly and/or gastric-suffering patients. Patients with asthma, chronic obstructive bronchial disease, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthmatic attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to antirheumatic treatment with NSAIDs more often than other patients. The use, especially if prolonged, of other products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy. Discontinue treatment if skin rash develops after application of the product. Topical diclofenac can be used with non-occlusive dressings, but should not be used with an air-tight occlusive dressing. Keep the medicine out of the sight and reach of children.

Interactions

Although bioavailability studies show unlikely interaction with other drugs, in high-dose and protracted treatments, the possibility of competition between the absorbed diclofenac and other drugs with high plasma protein binding should be kept in mind.

Effects

Adverse reactions (Table 1) are listed by frequency, the most frequent first, using the following convention: common (≥ 1 / 100, Table 1

Immune system disorders
Very rare	Hypersensitivity (including urticaria), angioneurotic oedema.
Infections and infestations
Very rare	Rash with pustules
Respiratory, thoracic and mediastinal disorders
Very rare	Asthma
Skin and subcutaneous tissue disorders
Common	Rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus.
Rare	Bullous dermatitis
Very rare	Photosensitivity reaction.

The use of the product in combination with other drugs containing diclofenac can give rise to phenomena of hypersensitivity to light, skin rash with the formation of vesicles, eczema, erythema and severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome).

Overdose

The low systemic absorption of topical diclofenac makes an overdose very unlikely. However, undesirable effects similar to those observed after an overdose of diclofenac tablets can be expected if topical diclofenac is inadvertently ingested (1 tube of 50 g contains the equivalent of 500 mg of diclofenac sodium). In case of accidental ingestion, which gives rise to significant systemic undesirable effects, the general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory drugs should be undertaken. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time after ingestion.

Pregnancy The systemic concentration of diclofenac compared with oral formulations is lower after topical administration. Referring to the experience with treatment with NSAIDs for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis can negatively affect pregnancy and/or 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 about 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. Feeding time Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of DICLOREUM ACTIGEL no effects on the infant are expected. 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, DICLOREUM ACTIGEL must 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).

Source: Farmadati