Dicloreum Actigel 1% Diclofenac Gel Joint Pain 100 g

Gel for topical use based on diclofenac.

Therapeutic indications

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

Dosage and Posology

The drug should be taken according to the following doses and methods:

• Adults: 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 from 14 to 18 years: 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 below 14 years: Insufficient data on efficacy and safety are available 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: The usual adult dosage may be used

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 50 g contains the equivalent of 500 mg 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.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients
• 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
• 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 to <1/10); uncommon (≥ 1 / 1,000 to <1/100); rare (≥ 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000); not known: cannot be estimated from the available data.

- Disorders of the immune system

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

- 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, rash with blistering, eczema, erythema and skin reactions with severe evolution (Stevens-Johnson syndrome, Lyell's syndrome.

Pregnancy and breastfeeding

The 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 exhibit:

- 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 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.

Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, no effects on the suckling child are anticipated at therapeutic doses of Dicloreum Actigel. 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.

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 summary of product characteristics of 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.

Expiry and retention

Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. After the first opening of the tube, the gel can be used for a period of time not exceeding 12 months.

Warning : do not use the medicine after the expiry date indicated on the package.

Composition

100 gr of Dicloreum Actigel contain:

Active principle

Diclofenac hydroxyethylpyrrolidine 1.32 g - equal to 1.0 g of diclofenac sodium.

Excipients

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