ELITAN Tablet Ref.[50390] Active ingredients: Metoclopramide

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

4.1. Therapeutic indications

Adult population

Elitan is indicated in adults for:

  • Prevention of delayed chemotherapy induced nausea and vomiting (CINV)
  • Prevention of radiotherapy induced nausea and vomiting (RINV).
  • Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting. Metoclopramide can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine.

Paediatric population

Elitan is indicated in children (aged 1-18 years) for:

  • Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option.

4.2. Posology and method of administration

Posology

All indications (adult patients)

The recommended single dose is 10 mg, repeated up to three times daily.

The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight.

The maximum recommended treatment duration is 5 days.

Prevention of delayed chemotherapy induced nausea and vomiting (CINV) (paediatric patients aged 1-18 years)

The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by oral route. The maximum dose in 24 hours is 0.5 mg/kg body weight.

Dosing table:

AgeBody WeightDoseFrequency
1-3 years10-14 kg1 mgUp to 3 times daily
3-5 years15-19 kg2 mgUp to 3 times daily
5-9 years20-29 kg2.5 mgUp to 3 times daily
9-18 years30-60 kg5 mgUp to 3 times daily
15-18 yearsOver 60kg10 mgUp to 3 times daily

The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).

Tablets are not suitable for use in children weighing less than 30 kg.

Other pharmaceutical forms/strengths may be more appropriate for administration to this population.

Method of administration

A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose (see section 4.4).

Special population

Elderly

In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

Renal impairment

In patients with end stage renal disease (Creatinine clearance ≤15 ml/min), the daily dose should be reduced by 75%.

In patients with moderate to severe renal impairment (Creatinine clearance 15-60 ml/min), the dose should be reduced by 50% (see section 5.2).

Hepatic impairment

In patients with severe hepatic impairment, the dose should be reduced by 50% (see section 5.2).

Paediatric population

Metoclopramide is contraindicated in children aged less than 1 year (see section 4.3).

4.9. Overdose

Symptoms

Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.

Management

In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).

A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.

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.

6.5. Nature and contents of container

Combined PVC-Al blisters. Boxes of 10, 40, 100 and 1000 tablets.

Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

None.

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

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