DICLOREUM ACTIGEL GEL 50G 1%

DICLOREUM 1 % GEL

active ingredients

100 g of gel contain: Active ingredient: diclofenac hydroxyetylpyrrolidine 1,32 g – equal to 1.0 g sodium diclofenac. For the full list of excipients, see paragraph 6.1.

Excellent

macrogols, stearate macrogol, cetil stearil–2–ethyleneate, carbomers, trolamin, isopropyl alcohol, fragrance, purified water.

Therapeutic indications

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

Contraindications

Individual hypersensitivity ascertained towards the product components. Patients in which asthma, urticaria or acute strokes occurred after intake of acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs), as well as isopropanol. Contraindicated in the third trimester of pregnancy (see paragraph 4.6 Fertility, pregnancy and lactation). Children and teenagers It is contraindicated use in children and adolescents under the age of 14.

Population

Adults above 18 years old: Apply DICLOREUM ACTIGEL 3 or 4 times a day on the area to be treated, frying slightly. The quantity to be applied depends on the size of the party concerned. For example 2–4 g DICLOREUM ACTIGEL (quantitative of variable dimensions between a cherry and a walnut) is sufficient to treat an area of 400–800 cm2. After the application, wash your hands, otherwise they will also be treated with the gel. Teenagers from 14 years to 18 years: Apply DICLOREUM ACTIGEL 3 or 4 times a day on the area to be treated, frying slightly. The quantity to be applied depends on the size of the party concerned. For example 2–4 g DICLOREUM ACTIGEL (quantitative of variable dimensions between a cherry and a walnut) is sufficient to treat an area of 400–800 cm2. After the application, wash your hands, otherwise they will also be treated with the gel. If this product is necessary for more than 7 days to relieve pain or if symptoms worsen, consult a doctor. Children under 14 years: Insufficient data are available on effectiveness and safety in children and adolescents under 14 years (see also paragraph 4.3 Contraindications). Therefore, the use of DICLOREUM ACTIGEL is contraindicated in children under 14 years of age. Seniors: The usual dosage for adults can be used

Conservation

Do not store at temperature 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 extended skin areas and for a prolonged period (see the summary of the product characteristics of systemic forms of diclofenac). DICLOREUM ACTIGEL should not be applied on skin wounds or open injuries, but only on intact skin. Avoid the preparation from contacting your eyes and mucosa. The gel should not be ingested. In elderly and/or gastric patients we do not recommend the concomitant use of systemic anti-flogistic drugs. Asthmatic patients, with chronic obstructive diseases of bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasmal polipo) react with asthmatic attacks, local inflammation of the skin or mucosa (Quincke edema) or urticaria to the anti-rheumatic treatment performed with NSAIDs more often than other patients. The use, especially if prolonged, of other products for topical use may give rise to awareness-raising phenomena. In this case it is necessary to stop the treatment and establish suitable therapy. Stop the treatment if you develop skin rash after application of the product. The topical diclofenac can be used with non-occlusive bandages, but should not be used with an occlusive bandage that does not let air pass. Keep the medicine out of sight and reach of children.

Interactions

Although bioavailability studies are unlikely to interact with other drugs, high dose and protracted treatments over time include the possibility of competition between absorbed diclofenac and other high-binding drugs with plasma proteins.

Effects

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

Immune system disorders
Very rare	Hypersensitivity (including hives), angiourotic edema.
Infections and infestations
Very rare	Rash with pustles
Respiratory, chest and mediastinic pathologies
Very rare	Asthma
Pathologies of skin and subcutaneous tissue
Town	Rash, eczema, erythema, dermatitis (including contact dermatitis), itching.
Rare	Bold dermatitis
Very rare	Photosensitivity reaction.

The use of the product in association with other drugs containing diclofenac can give rise to phenomena of hypersensitivity to light, rash with formation of vesicles, eczema, erythema and severely evolving skin reactions ( Stevens–Johnson syndrome, Lyell syndrome).

Overdosing

The low systemic absorption of the topical diclofenac causes an overdose to be very unlikely. However side effects similar to those observed after overdosing diclofenac tablets, may be expected in case topical diclofenac was inadvertently ingested (1 50 g tube contains the equivalent of 500 mg sodium diclofenac). In case of accidental ingestion, which results in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs must be taken. They must be taken into account, especially within a short time of ingestion, gastric decontamination and the use of activated carbon.

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, we recommend the following: Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryo/fetal development. Results of epidemiological studies suggest an increased risk of abortion and cardiac malformation and gastroschisis after the use of an inhibitor of prostaglandin synthesis in the early stages of pregnancy. The absolute risk of heart failure increased from less than 1% to about 1.5%. It has been considered that the risk increases with dose and duration of therapy. In animals, the administration of prostaglandin synthesis inhibitors showed an increase in the loss of pre and post-plant and embryo-fetal mortality. In addition, an increase in the incidence of various malformations, including cardiovascular disorders, was reported in animals that had been given prostaglandin synthesis inhibitors during the organogenetic period. During the first and second quarter of pregnancy, diclofenac should not be administered if not in strictly necessary cases. If diclofenac is used by a woman waiting for conception, or during the first and second trimester of pregnancy, the dose must 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 arterial duct and pulmonary hypertension); • kidney dysfunction, which can progress in kidney failure with oligo-idroamnios; the mother and the newborn, at the end of pregnancy, to: • possible prolongation of the bleeding time, and anti-aggregating effect that can also be necessary at very low doses; • inhibition of uterine contractions resulting in delay or extension of labor. Consequently, diclofenac is contraindicated during the third trimester of pregnancy. Food Like other NSAIDs, diclofenac passes into breast milk in small quantities. However, at therapeutic doses of DICLOREUM ACTIGEL is not expected to affect the infant. Due to the lack of controlled studies in nursing women, the product must be used during breastfeeding only under the advice of a healthcare professional. In this circumstances, DICLOREUM ACTIGEL should not be applied on the breasts of nursing mothers, or elsewhere on extended areas of skin or for a prolonged period of time (see paragraph 4.4).

Source: Farmadati