Dicloreum Actigel 1% 100 g gel

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

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

ACTIVE INGREDIENTS

100 g of gel contain: Active ingredient: diclofenac hydroxyethylpyrrolidine 1.32 g – equal to 1.0 g of diclofenac sodium. For the full list of excipients, see section 6.1.

EXCIPIENTS

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

CONTRAINDICATIONS AND SIDE EFFECTS

Individual hypersensitivity confirmed towards the components of the product. Patients in whom asthma attacks, urticaria or acute rhinitis have occurred 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 Use in children and adolescents under 14 years of age is contraindicated.

DOSAGE

Adults over 18 years old: Apply DICLOREUM ACTIGEL 3 or 4 times a day on the area to be treated, rubbing lightly. The quantity to be applied depends on the size of the affected part. For example, 2–4 g of DICLOREUM ACTIGEL (a quantity varying in size between a cherry and 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 treatment periods. Adolescents aged 14 to 18: Apply DICLOREUM ACTIGEL 3 or 4 times a day on the area to be treated, rubbing lightly. The quantity to be applied depends on the size of the affected part. For example, 2–4 g of DICLOREUM ACTIGEL (a quantity varying in size between a cherry and 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 to relieve pain or if symptoms worsen, consult a doctor. Children under 14 years old: Insufficient data are available 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: The usual dosage for adults can be used

CONSERVATION

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 systemic forms of diclofenac). DICLOREUM ACTIGEL must not be applied to skin wounds or open lesions, but only to intact skin. Avoid the preparation coming into contact with the eyes and mucous membranes. The gel should not be swallowed. In elderly patients and/or with gastric problems, the concomitant use of systemic anti-inflammatory drugs is not recommended. Asthmatic patients, with chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to antirheumatic treatment carried out 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 treatment and institute appropriate 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 occlusive dressing that does not allow air to pass through. Keep the medicine out of the sight and reach of children.

INTERACTIONS

Although bioavailability studies show that an interaction with other drugs is unlikely, in high-dose and prolonged treatments the possibility of competition between the absorbed diclofenac and other drugs with high binding to plasma proteins should be kept in mind.

SIDE EFFECTS

Adverse reactions (Table 1) are listed by frequency, 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. Table 1

Immune system disorders.

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

Infections and infestations.

Very rare: Rash with pustules.

Respiratory, thoracic and mediastinal disorders.

Very rare: Asthma.

Pathologies of the skin and subcutaneous tissue.

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 skin reactions with severe evolution (Stevens-Johnson syndrome, Lyell syndrome).

OVERDOSE

The low systemic absorption of topical diclofenac makes overdose very unlikely. However, side effects similar to those seen after an overdose of diclofenac tablets can be expected if topical diclofenac is inadvertently ingested (1 50 g tube contains the equivalent of 500 mg of diclofenac sodium). In case of accidental ingestion, which gives rise to significant systemic side 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 taken into consideration, especially within a short time after ingestion.

PREGNANCY AND BREASTFEEDING

Pregnancy The systemic concentration of diclofenac compared to oral formulations is lower after topical administration. Referring to experience with treatment with NSAIDs for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis may negatively affect 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 to which prostaglandin synthesis inhibitors were administered 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 DICLOREUM ACTIGEL 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, DICLOREUM ACTIGEL must 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

It does not interfere with the ability to drive and use machines.