Metoclopramide

• For nausea and vomiting
• Also suitable for children of 12 months and above
• Can cause dizziness or uncontrollable movements
• Avoid alcohol

Metoclopramide is used to treat and prevent nausea and vomiting. The active ingredient metoclopramide stops nausea messages being sent to the vomiting centre in the brain, thereby preventing or reducing nausea and vomiting.

Metoclopramide tablets are used to:

• Prevent and treat nausea and vomiting caused by chemotherapy or radiotherapy in the treatment of cancer in adults and children aged 1-18 years.
• Treat nausea and vomiting which may occur with a migraine.
• Treat nausea and vomiting caused by other factors.

The tablets should be taken with a drink of water or some food. You must wait at least six hours between each dose, even in case of vomiting, in order to avoid overdose.

The maximum recommended treatment duration is five days unless otherwise advised by your doctor.

Dosage

Dosage varies per person and is determined by a doctor for each specific patient depending on the symptoms. The general guidelines for use are listed below.

To treat nausea and vomiting regardless of the cause (in adults)

• The recommended dose is 10 mg, repeated up to three times daily.
• The maximum dose in 24 hours is 30 mg or 0.5mg/kg body weight.
• The maximum recommended treatment duration is five days.

To prevent delayed nausea and vomiting that may occur after chemotherapy (in children and adolescents aged 1-18 years)

• The recommended dose is 0.1 to 0.15mg/kg body weight (see dosing chart in the package leaflet), repeated up to 3 times daily.
• The maximum dose in 24 hours is 0.5mg/kg body weight.
• The maximum recommended treatment duration is five days.

Metoclopramide tablets are not suitable for use in children weighing less than 30 kg. Other pharmaceutical forms/strengths may be more appropriate for administration.

Alcohol/driving

Metoclopramide can cause sleepiness or dizziness. Uncontrollable movements (extrapyramidal disorders) may also occur. This could affect your vision and ability to drive. Avoid potentially hazardous tasks such as driving and operating heavy machinery if you experience these symptoms.

Alcohol should be avoided whilst taking this medicine because it increases the sedative effect of Metoclopramide tablets.

If you take more Metoclopramide than you should or miss a dose

If you take more Metoclopramide tablets than you were told to, contact your doctor or pharmacist immediately. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have some troubles of consciousness, be confused, have hallucinations and heart problems. Your doctor may prescribe you a treatment for these signs if necessary.

If you forget to take your dose on time, do not take a double dose to make up for the forgotten dose. Skip the missed dose and take the next tablet at the usual time.

Metoclopramide is not suitable for everyone. Do not use this medicine if:

• You are allergic to any of the ingredients in this medicine (see section 'What Metoclopramide contains').
• You have bleeding, obstruction or a tear in your stomach or gut.
• You have or may have a rare tumour of the adrenal gland (pheochromocytoma).
• You have ever had involuntary muscle spasms (tardive dyskinesia) when you have been treated with a medicine.
• You have epilepsy.
• You have Parkinson’s disease.
• You are taking levodopa (a medicine for Parkinson’s disease) or dopaminergic agonists (see section 'Other medicines and Metoclopramide').
• You have ever had abnormal blood pigment level (methaemoglobinaemia) or NADH cytochrome-b5 deficiency.

When should this medicine be used with caution?

Talk to your doctor or pharmacist before taking Metoclopramide tablets if:

• You have a history of abnormal heartbeats (QT interval prolongation) or any other heart problems.
• You have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
• You are using other medicines known to affect the way your heart beats.
• You have any neurological (brain) problems.
• You have liver or kidney problems. The dose may be reduced.

Your doctor may perform blood tests to check your blood pigment levels. In cases of abnormal levels (methaemoglobinaemia), the treatment should be immediately and permanently stopped.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will decide whether or not you should be given this medicine.

Do not use this medicine without consulting your doctor if you are breastfeeding. Metoclopramide is not recommended if you are breastfeeding because metoclopramide passes into breast milk and may affect your baby.

Other medicines and Metoclopramide

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because some medicines can affect the way Metoclopramide tablets work or Metoclopramide tablets can affect how other medicines work. These medicines include:

• Levodopa or other medicines used to treat Parkinson’s disease.
• Anticholinergics (medicines used to relieve stomach cramps or spasms).
• Morphine derivatives (medicines used to treat severe pain).
• Sedative medicines.
• Medicines used to treat mental health problems.
• Digoxin (medicine used to treat heart failure).
• Ciclosporin (medicine used to treat certain problems with the immune system).
• Mivacurium and suxamethonium (medicines used to relax muscles).
• Fluoxetine and paroxetine (medicines used to treat depression).

Medicines can cause side effects, although some people may not experience any.

Stop the treatment and talk to your doctor or pharmacist immediately if you experience any of the following symptoms while taking this medicine:

• Uncontrollable movements (often involving head or neck). These may occur in children or young adults and particularly when high doses are used. These signs usually occur at the beginning of treatment and may even occur after one single administration. These movements will stop when treated appropriately.
• High fever, high blood pressure, fits/seizures (convulsions), sweating, overproduction of saliva. These may be signs of a condition called neuroleptic malignant syndrome.
• Itching or skin rashes, swelling of the face, lips or throat, difficulty in breathing. These may be signs of a severe, potentially life-threatening allergic reaction.

Other side effects that are known to be associated with Metoclopramide include:

Very common (may affect more than 1 in 10 people)

• Sleepiness.

Common (may affect up to 1 in 10 people)

• Feeling of dejection and despair (depression).
• Uncontrollable movements such as tics, shaking, twisting movements or muscle contracture (stiffness, rigidity).
• Symptoms similar to Parkinson’s disease (rigidity, tremor).
• Feeling restless.
• Blood pressure decrease (particularly with intravenous route).
• Diarrhoea.
• Feeling weak.

Uncommon (may affect up to 1 in 100 people)

• Raised levels of a hormone called prolactin in the blood which may cause milk production in men and women who are not breastfeeding.
• Irregular periods.
• Hallucinations.
• Decreased level of consciousness.
• Slow heartbeat (particularly with intravenous route).
• Allergy.

Rare (may affect up to 1 in 1,000 people)

• Confusion.
• Convulsion (especially in patients with epilepsy).

For a list of side effects with unknown frequency, please see the package leaflet. Consult a doctor if you experience side effects, also if the side effects are not listed in the package leaflet.

The active substance in Metoclopramide HCl Aurobindo is metoclopramide hydrochloride monohydrate, equivalent to 10 mg of anhydrous metoclopramide hydrochloride.

The other ingredients are: lactose, croscarmellose sodium, magnesium stearate.

The manufacturer of MetoclopramideHCl Aurobindo is:

Centrafarm Services B.V. Nieuwe Donk 9
4879 AC Etten-Leur
The Netherlands

Read the package leaflet before use.