Metoclopramide Tablets

METOCLOPRAMIDE 10 OETHMAAN contains the active substance metoclopramide hydrochloride, belonging to a group of medicines called anti-emetics. It works on a part of your brain that prevents you from feeling sick (nausea) and being sick (vomiting).

METOCLOPRAMIDE 10 OETHMAAN is used:

• In conditions associated with slow stomach emptying or slow bowel movement. It is also useful in management of delayed stomach emptying occurring after surgery of the vagus nerve.
• For control of nausea and vomiting associated with intake of other medicines, with conditions in which urinary constituents are in the blood, after stomach operations and other digestive disorders including stomach upset, indigestion with wind.
• METOCLOPRAMIDE 10 OETHMAAN is also used during diagnostic procedures to increase passage of barium meal in radiology treatment, facilitate examination of stomach with delayed emptying and to prevent and control nausea and vomiting of barium in patient undergoing barium meal examination.
• It also makes it easier for the introduction of a tube in the stomach and intestines in medical procedures.
• Young adults and children The use of METOCLOPRAMIDE 10 OETHMAAN in patients under 20 years should be restricted to the following:

Do not take METOCLOPRAMIDE 10 OETHMAAN:

• If you are allergic to metoclopramide or any other ingredients of METOCLOPRAMIDE 10 OETHMAAN (listed in section 6)
• If you suffer from high blood pressure due to a tumour near the kidney (a condition known as phaeochromocytoma)
• If you have or have had bleeding, perforation or blockage of the stomach or small intestines
• If you have had an operation on your stomach or intestine within the last 3 – 4 days
• If you have a history of muscle disorders when using medicines with a similar action to METOCLOPRAMIDE 10 OETHMAAN tablets
• If you are taking medicines called “phenothiazines” (antipsychotic medicine).
• If you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with METOCLOPRAMIDE 10 OEHMAAN.
• If you suffer from epilepsy.
• If you suffer from a condition called “Parkinson’s disease”.
• If you are taking a medicine called levodopa (a medicine used to treat Parkinson’s disease).
• If you have ever had an abnormal blood pigment level (methaemoglobinaemia) or NADH cytochrome-b5 deficiency.
• Do not give METOCLOPRAMIDE 10 OETHMAAN to a child less than 1 (one) of age (see below “Children and adolescents”).
• if you are pregnant or breastfeeding.
• if you suffer from convulsive disorders.
• if you suffer from a condition called “porphyria”.

Warnings and precautions

Take special care with METOCLOPRAMIDE 10 OETHMAAN:

• Check with your doctor or pharmacist before taking METOCLOPRAMIDE 10 OETHMAAN if you:
• have epilepsy (METOCLOPRAMIDE 10 OETHMAAN may increase the risk of having a seizure)
• have liver impairment or severe kidney disease
• suffer from allergies, or asthma
• have Parkinson’s disease (METOCLOPRAMIDE 10 OETHMAAN may make your symptoms worse)
• suffer from metabolic condition called porphyria
• have a history of abnormal heart beats (QT interval prolongation) or any other heart problems.
• have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
• are taking any medicines known as serotonergic medicines, as taking these medicines with METOCLOPRAMIDE 10 OETHMAAN can cause side effects (such as restlessness, loss of coordination, fast heartbeat and increased body temperature).
• are taking medicines known as phenothiazines for mental disorders
• are taking any other medicine by mouth. It is possible that METOCLOPRAMIDE 10 OETHMAAN may change the amount of the other medicine that gets into your body.
• have high blood pressure (hypertension).
• Have any neurological (brain) problems

Do not share medicines prescribed for you with any other person. Always take METOCLOPRAMIDE 10 OETHMAAN exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is:

• Adults and children over 14 years: 10 mg (1 x 10 mg tablet) three times daily.
• Children 5 to 14 years: 5 mg (half a tablet) three times daily.

Swallow the tablets with water. If you have the impression that the effect of METOCLOPRAMIDE 10 OETHMAAN is too strong or too weak, talk to your doctor or pharmacist.

If you take more METOCLOPRAMIDE 10 OETHMAAN than you should

In the event of overdosage consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms that you took more could include restlessness, agitation, irritability, spasm of facial and neck muscles and the muscles of the tongue.

If you forget to take METOCLOPRAMIDE 10 OETHMAAN:

Do not take a double dose to make up for forgotten doses. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking METOCLOPRAMIDE 10 OETHMAAN

Talk to your doctor before you stop taking the tablets and follow their advice.

METOCLOPRAMIDE 10 OETHMAAN can have side effects. Not all side effects reported for METOCLOPRAMIDE 10 OETHMAAN are included in this leaflet. Should your general health worsen while taking METOCLOPRAMIDE 10 OETHMAAN, please consult your doctor, pharmacist or other health care professional for advice.

If any of the following happens, stop taking METOCLOPRAMIDE 10 OETHMAAN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Severe allergic reactions such as swelling of the face, lips, throat or tongue, difficulty breathing, very fast heart beat or even loss of unconsciousness
• Central Nervous System (CNS):
• Extrapyramidal or Parkinsonian effects (difficulty in speaking or swallowing, loss of balance control, mask-like face, shuffling walk, stiffness of arms or legs, trembling and shaking of hands and fingers)
• Dystonic effects (spasms of facial muscles and jaw muscles which prevent the jaw from opening, rhythmic protrusion of the tongue, difficulty speaking, spasms of muscles around the eye, involuntary arching of the head and neck)

These are very serious side effects. If you have them, you may have had a serious reaction to METOCLOPRAMIDE 10 OETHMAAN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Neuroleptic Malignant Syndrome: excessive temperature, drowsiness, rigid muscles, rapid breathing, restlessness and uncontrolled movements. This is more likely to occur if you are taking neuroleptic, medicines such as chlorpromazine
• Blood: Your medicines may alter the numbers and types of your blood cells; you may notice increased bruising or nose bleeds. Your doctor may want to give you a blood test
• 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
• Chest pain, angina, changes in the way your heart beats, for example, if you notice it beating faster, cardiac arrest (particularly with the injectable route)
• Shock (severe decrease of heart pressure)
• Sudden increase in blood pressure in patients with tumour of the adrenal gland (pheochromocytoma)
• Very high blood pressure

These are all serious side effects. You may need urgent medical attention.

Keep well-closed and store below 25 °C in a dry place and protect from light. Do not remove the blister from the carton until required for use. KEEP OUT OF REACH OF CHILDREN. Do not store in bathrooms. Do not use after the expiry date stated on the label or carton. Return all unused medicine to your pharmacy. Do not dispose of unused medicine in drains or sewerage systems e.g. toilets.