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SPC, Portugal: ESPERAL Tablets

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ESPERAL.

Qualitative and quantitative composition

Disulfiram (INN). 500 mg per tab. 10 g per pack.

Pharmaceutical form

Scored tablet (cream white): pack of 20.

Therapeutic indications

Prevention of relapse during treatment of chronic alcoholism.

Posology and method of administration

The standard dose is 1 tablet daily at the beginning of treatment. It is gradually reduced to one-half or one-quarter tablet daily. To be taken free of alcohol in the morning with breakfast.

Contraindications

Hypersensitivity to disulfiram or to any other ingredients of the drug Liver failure Diabetes Neuropsychiatric disorders Epilepsy Coronary artery disease Intake of alcohol or alcoholic beverages in the ...

Special warnings and precautions for use

Liver function tests (including transaminases) should be performed before disulfiram initiation (cf §4.3Contra-indications) and then periodically, in particular during the first 3 months. Should transaminases ...

Interaction with other medicinal products and other forms of interaction

Contraindicated combinations: Alcohol: antabuse effect (flushing, erythema, nausea, vomiting, hypotension, tachycardia, malaise or more severe reactions (cf. §4.8 Undesirable Effects). Avoid the intake ...

Pregnancy and lactation

Pregnancy: In view of the lack of existing clinical data on administration of this medication during pregnancy, disulfiram is contraindicated in pregnant women (§4.3. Contra-indications). Lactation: The ...

Effects on ability to drive and use machines

Attention should be drawn, in particular in vehicle drivers and machine operators, to the risk of somnolence associated with the use of this drug.

Undesirable effects

Due to disulfiram alone: Gastro-intestinal disorders: Metallic taste in the mouth Unpleasant odour in patients with colostomies (attributed to carbon sulphide) Liver disorders: Rare cases of hepatitis, ...

Overdose

Ingestion of disulfiram alone may produce various CNS disorders such as extrapyramidal symptoms consciousness disorders including coma, confusion, encephalopathy. Treatment is symptomatic. Combination ...

Pharmacodynamic properties

Disulfiram is an inhibitor of numerous enzymes. Inhibition of acetaldehyde dehydrogenase causes a rise in the concentration of acetaldehyde, a metabolite of ethyl alcohol which has a number of unpleasant ...

Pharmacokinetic properties

After oral intake, absorption of disulfiram is rapid but incomplete at 70 to 90%. It is rapidly metabolized, being reduced to diethyl dithiocarbamate which is itself eliminated as its glucuronoconjugate ...

List of excipients

Magnesium stearate, sodium carboxymethylcellulose, povidone, cellulose microcrystalline.

Incompatibilities

None.

Shelf life

Three years in normal storage conditions.

Special precautions for storage

None.

Nature and contents of container

Shelf life and precautions for storage are mentionned for a primary packaging as polyethylene container closed with polyethylene stopper containing 20 tablets.

Special precautions for disposal and other handling

None.

Marketing authorization holder

SOFARIMEX INDUSTRIA QUIMICA E FARMACEUTICA Lda, 2735 CACEM, Portugal

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