Medicinal Products

ANTALCALM 140 mg Powder box of 1 sachet of 5

Generic Drug Therapeutic Class: Diagnostic Products or Other Therapeutic Products
Active ingredients: Diclofenac
laboratory: Pierre Fabre Medicament

Medicated plaster
All forms

Indication

Short treatment (max 7 days).

Short-term symptomatic local treatment of pain associated with sprains, strains and sharp bruising of limbs following abrupt trauma, such as sports injury in adults and adolescents from 16 years of age.

Dosage ANTALCALM 140 mg Plaster box of 1 sachet of 5

Short treatment (max 7 days).

Short-term symptomatic local treatment of pain associated with sprains, strains and sharp bruising of limbs following abrupt trauma, such as sports injury in adults and adolescents from 16 years of age.

Against indications

· Hypersensitivity to the active substance or to any of the excipients listed under Composition ;

· Hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drug (NSAID);

· History of asthma, urticaria or acute rhinitis after taking acetylsalicylic acid or any other nonsteroidal anti-inflammatory drug (NSAID);

· Patient suffering from a peptic ulcer;

· Damaged skin irrespective of the lesion: oozing dermatitis, eczema, infected lesion, burn or wound;

· Last trimester of pregnancy.

Children and adolescents:

Use is contraindicated in children and adolescents under 16 years of age.

Antalcalm side effects

The following frequency categories are used to evaluate adverse effects:

Very common

≥ 1/10

Frequent

≥ 1/100 to <1/10

Rare

≥ 1/1000 to <1/100

Rare

≥ 1/10 000 to <1/1000

Very rare

<1/10 000

Not known frequency

can not be estimated on the basis of available data

Infections and infestations

Very rare

Pustular eruption

Immune system disorders

Very rare

Hypersensitivity (including urticaria), angioneurotic edema, anaphylactic reaction

Respiratory, thoracic and mediastinal disorders

Very rare

Asthma

Skin and subcutaneous tissue disorders

Frequent

Skin rash, eczema, erythema, dermatitis (including allergic dermatitis and contact), pruritus

Rare

Bullous dermatitis (eg bullous erythema), dry skin

Very rare

Photosensitivity reaction

General disorders and administration site conditions

Frequent

Reactions to the application site

The plasma levels of diclofenac measured during the use of the drug plaster are very low compared to those obtained after oral intake of diclofenac. The risk of developing adverse effects induced by systemic treatment (such as gastrointestinal, hepatic and renal disorders) during the use of the plaster seems low. However, in special cases where the medicinal plaster is applied to a relatively large area of ​​skin and for a prolonged period, the possibility of systemic adverse effects can not be ruled out.

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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