Dicloreum actigel gel 100g 1% 035450028

DICLOREUM ACTIGEL*GEL 100G 1%

Therapeutic indications

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

Dosage and method of use

Adults over the age of 18: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 (quantity of variable 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 periods of treatment. Teenagers aged 14 to 18: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 (quantity of variable 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 the age of 14:Insufficient data are available on efficacy and safety in children and adolescents below 14 years (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

Contraindications

Known individual hypersensitivity to 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 4.6Fertility, pregnancy and breastfeeding). Children and adolescents It is contraindicated for use in children and adolescents under the age of 14.

Side effects

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

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

Special 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 should not be ingested. The concomitant use of systemic anti-inflammatory drugs is not recommended in elderly and / or gastric patients. Patients with asthma, 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 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 occlusive dressing that does not allow air to pass.Keep this medicine out of the sight and reach of children.

Pregnancy and breastfeeding

PregnancyThe systemic concentration of diclofenac compared with oral formulations is lower after topical administration. Referring to experience with NSAID treatment for systemic administration, the following is recommended: Inhibition of prostaglandin synthesis may adversely affect 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 was believed to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause an increase in pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has 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 except in strictly necessary cases. 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 can expose the fetus to: • cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); • renal dysfunction, which can progress to renal failure with oligo – hydroamnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of the bleeding time, and antiplatelet effect which 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.Feeding timeLike other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of DICLOREUM ACTIGEL no effects on the suckling child are expected. Due to the lack of controlled studies in breastfeeding women, the product should only be used during breastfeeding under the advice of a healthcare professional. In this circumstance, DICLOREUM ACTIGEL should not be applied to the breasts of nursing mothers, or elsewhere on large areas of skin or for an extended period of time (see section 4.4).

Expiry and retention

Do not store above 30 ° C

Interactions with other drugs

Although an interaction with other drugs is unlikely from bioavailability studies, the possibility of competition between absorbed diclofenac and other drugs with high plasma protein binding should be taken into account in high-dose and long-term treatments.

Overdose

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

Active principles

100 g ofgelcontain:Active principle: 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.