COSTI Tablet Ref.[28164] Active ingredients: Domperidone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Medochemie Ltd, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

For the relief of the symptoms of nausea and vomiting.

4.2. Posology and method of administration

Posology

Costi should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.

Adults and adolescents (12 years of age and older and weighing 35 kg or more)

One 10 mg tablet up to three times per day with a maximum dose of 30 mg per day.

Hepatic Impairment

Costi is contraindicated in moderate or severe hepatic impairment (see section 4.3). Dose modification in mild hepatic impairment is however not needed (see section 5.2).

Renal Impairment

Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Costi should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced.

Method of administration

It is recommended to take oral Costi before meals. If taken after meals, absorption of the drug is somewhat delayed.

Patients should try to take each dose at the scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose.

Usually, the maximum treatment duration should not exceed one week.

4.9. Overdose

Symptoms

Overdose has been reported primarily in infants and children. Symptoms of overdosage may include agitation, altered consciousness, convulsion, disorientation, somnolence and extrapyramidal reactions.

Management

In the event of overdose, standard symptomatic treatment should be given immediately. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.

Gastric lavage as well as the administration of activated charcoal may be useful. Close medical supervision and supportive therapy are recommended. Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Store below 25°C, in the original package, in order to protect from light and moisture.

6.5. Nature and contents of container

Packs of 30 tablets are available.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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