Dicloreum 3% Cutaneous Foam 50g | Buy Online at Farmaclick

What is Dicloreum Cutaneous Foam 3% 50g

Dicloreum cutaneous foam is a non-steroidal anti-inflammatory drug for topical use based on Diclofenac for the treatment of painful conditions and inflammations of a rheumatic nature affecting the joints, muscles, tendons, and ligaments.

ACTIVE INGREDIENTS

Diclofenac 3 g.

EXCIPIENTS

sodium hydroxide; caprylocaproyl macrogolglycerides; Phospholipon 80 H; polysorbate 80; benzyl alcohol; potassium sorbate; dibasic sodium phosphate dodecahydrate; tocopheryl acetate; mint/eucalyptus fragrance; purified water.

Each pressurized container (50 g) contains: 47.5 g of solution and 2.5 g of propellant (isobutane, n-butane, propane).

What Dicloreum Foam is used for

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

CONTRAINDICATIONS/SIDE EFFECTS

Hypersensitivity to diclofenac, to any of the excipients, to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, as well as to isopropanol; patients in whom asthma attacks, urticaria, or acute rhinitis have occurred after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) and isopropanol; third trimester of pregnancy; children and adolescents under 14 years of age.

DOSAGE

Adults: apply the medicine 1-3 times a day or according to medical prescription.

For each application, spray a circular mass of foam 3-5 centimeters in diameter (equal to approximately 0.75-1.5 g by weight) onto the palm of your hand, depending on the size of the area to be treated, massaging gently until fully absorbed.

In case of iontophoresis treatment, the product must be applied to the negative pole.

The drug can also be used in combination with ultrasound therapy.

After application, wash your hands, otherwise they will also be treated with the cutaneous foam.

Attention: use only for short periods of treatment.

Adolescents (14-18 years): apply the medicine 1-3 times a day or according to medical prescription.

For each application, spray a circular mass of foam 3-5 centimeters in diameter (equal to approximately 0.75-1.5 g by weight) onto the palm of your hand, depending on the size of the area to be treated, massaging gently until fully absorbed.

In case of iontophoresis treatment, the product must be applied to the negative pole.

The drug can also be used in combination with ultrasound therapy.

After application, wash your hands, otherwise they will also be treated with the cutaneous foam.

If this medicine is needed for more than 7 days to treat pain or if symptoms worsen, consult a doctor.

Children and adolescents <14 years: there is insufficient data on efficacy and safety.

Therefore, the use of the medicine is contraindicated.

Elderly: the usual dosage for adults can be used.

HOW TO USE DICLOREUM

Shake before use. Holding the canister upside down, dispense the desired amount by pressing the appropriate nozzle.

STORAGE

Store at a temperature not exceeding 30 degrees C.

Contains flammable propellant.

Protect from sunlight and do not expose to temperatures above 50 degrees C.

Store away from any source of combustion.

WARNINGS

The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large areas and for a prolonged period (see the summary of product characteristics for systemic forms of diclofenac).

Topical diclofenac should only be applied to intact, non-diseased skin, and not to open wounds or lesions.

It must not be allowed to come into contact with the eyes or mucous membranes and must not be ingested.

In elderly patients and/or those with gastric issues, the concomitant use of systemic anti-inflammatory drugs is not recommended.

The drug should be used with caution in patients who have had a past hypersensitivity reaction to NSAIDs or analgesics, e.g., asthma attacks, skin rashes, or acute allergic rhinitis.

Asthmatic patients, those with chronic obstructive bronchial diseases, allergic rhinitis, or inflammation of the nasal mucosa (nasal polyps) or urticaria respond to rheumatic treatment with NSAIDs more often than other patients.

The use, especially if prolonged, of other topical products can give rise to sensitization phenomena.

In such cases, it is necessary to discontinue treatment and establish appropriate therapy.

Discontinue treatment if a skin rash develops after applying the product.

Topical diclofenac can be used with non-occlusive bandages, but must not be used with an occlusive bandage that does not allow air to pass through.

The medicine contains potassium, which can cause local skin reactions (e.g., contact dermatitis).

To reduce potential photosensitivity phenomena, it is advisable not to overexpose yourself to the sun during use.

INTERACTIONS

Since systemic absorption of diclofenac following topical application is very low, such interactions are highly unlikely.

However, in high-dose and prolonged treatments, the possibility of competition between absorbed diclofenac and other drugs highly bound to plasma proteins should be kept in mind.

SIDE EFFECTS

Immune system disorders.

Very rare: hypersensitivity (including urticaria), angioedema.

Infections and infestations.

Very rare: asthma.

Skin and subcutaneous tissue disorders.

Common: rash, eczema, erythema, dermatitis (including contact dermatitis), pruritus; rare: bullous dermatitis; very rare: photosensitivity reaction.

PREGNANCY AND BREASTFEEDING

The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration.

Referring to experience with systemic NSAID treatment, the following is recommended: inhibition of prostaglandin synthesis may have negative effects on pregnancy and/or embryo/fetal 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 about 1.5%.

It is believed that the risk increases with the dose and duration of therapy.

In animals, administration of prostaglandin synthesis inhibitors has been shown to result in an increase in pre- and post-implantation loss and embryo-fetal mortality.

Furthermore, an increased incidence of various malformations, including cardiovascular, has been reported in animals that were administered prostaglandin synthesis inhibitors during the organogenetic period.

During the first and second trimesters 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 trimesters of pregnancy, the dose should be 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 ductus arteriosus and pulmonary hypertension); renal dysfunction (which may progress to renal failure with oligohydramnios); the mother and the newborn, at the end of pregnancy, to a possible prolongation of bleeding time and anti-aggregating effect that 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 quantities.

However, at therapeutic doses, 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, the drug should not be applied to the breasts of breastfeeding mothers, nor elsewhere on large areas of skin or for a prolonged period of time.

OTC Medicine - AIC 042685040