Patient Information Leaflet

What is in your medicine?

Each orange/yellow capsule contains 30mg metoclopramide hydrochloride. The capsules also contain the inactive ingredients: colloidal silicon dioxide, ethyl cellulose, maize starch, shellac, sucrose and talc. The gelatin capsules are coloured with: erythrosine (E127), iron oxide, yellow and black (E172) and titanium dioxide (E171).

Gastromax capsules are in blister packs containing 28 capsules.

What type of medicine is Gastromax?

The medicine works on the muscles in the upper part of your digestive system to help control your symptoms. It also works within your brain to prevent you feeling and/or being sick.

What is your medicine for?

It is used in adults aged over 20 years:-

• For the relief of nausea and vomiting that can accompany digestive disorders or cancer chemotherapy.
• For the relief of symptoms including heartburn, indigestion and a feeling of fullness or trapped wind which may occur in digestive disorders.

Before you take your medicine.

You should not take Gastromax if:-

• You have previously had an allergic reaction to metoclopramide or any of the ingredients of Gastomax.
• You are under 20 years of age.
• You have phaeochromocytoma (a rare disorder due to an adrenaline producing tumour above the kidney).

Check with your doctor before starting treatment if you answer YES to the questions below.

• Are you pregnant or breast feeding? Gastromax is not recommended in the first three months (first trimester) of pregnancy or while breast feeding.
• Do you have liver or kidney problems? The doctor may wish to keep a careful check on you while you are receiving this treatment.
• Have you recently undergone stomach or bowel surgery?
• Do you have acute porphyria (a rare inherited blood disease)?
• Are you taking any of the following medicines?
  • Pain killers : aspirin, paracetamol or stronger pain killers called opioids.
  • Cough or cold remedies containing a decongestant.
  • Digoxin.
  • Lithium.
  • Medicines for the following conditions: asthma, depression, epilepsy, Parkinson's Disease, schizophrenia.
  • Medicines called 'antimuscarinics' which are used to treat stomach cramps, period pains or urinary incontinence. For example, hyosine or propantheline.

Elderly: If you are elderly and are taking Gastromax over a long period of time your doctor will want to review your treatment regularly.

How to take your medicine.

Patients over 20 years of age:

Your medicine should only be taken by mouth.

• It should be swallowed whole with liquid.
• Do not chew.
• It is best to take the capsule before a meal.

The label on the pack will tell you what dose YOU should take and how often to take it. If you are still not sure ask your doctor or pharmacist.

• The usual dose is one capsule daily.
• Do not exceed the stated dose.

You can take the capsule in the morning or evening depending on when your symptoms occur.

• If you have symptoms which occur at night take the capsule before your evening meal.
• If your symptoms are mainly associated with daytime activity, such as after meals, bending or stooping, take the capsule before breakfast.

Patients with kidney or liver disease:

• If you have kidney or liver disease, your body may eliminate Gastromax more slowly. Particular care should be taken to look for possible side-effects. If side effects occur, consult with your doctor so treatment may be stopped if necessary.

If your symptoms persist after you have taken Gastromax, consult your doctor.

Does this medicine cause undesirable effects?

The following undesirable effects have been reported:

Tiredness, drowsiness, sleepiness, dizziness, restlessness or diarrhoea may occur.

Rarely, breast swelling, tenderness or unusual breast milk production; confusion.

Very rarely, depression.

Gastromax can affect muscles. Muscles of the head, face and neck are most likely to be affected.

If this happens, you may find it difficult to control your muscles.

Face, mouth and tongue muscles may be affected causing slurred speech, facial twitching, chewing, spasm or a general increase in muscle tension or stiffness.

You may also find it difficult to control your arm and leg muscles. Arm and leg muscles may become tense, stiff or rigid.

"Tardive dyskinesia" may occur, where effects on muscles are pronounced and affect several areas of the body.

The effects of Gastromax on muscles are more likely to occur in elderly patients taking the medicine for a long time.

If this becomes a problem, your doctor may be able to give you another medicine to help.

Serious muscle reactions are very rare but have occured as part of a "syndrome" with medicines of this type. Effects associated with this syndrome include: significant muscle rigidity, fever and coma.

It is important to tell your doctor if any unwanted effect causes you concern, including those which may not be listed above.

Look after your medicine

This treatment is for YOU. Do not give it to others.

Do not take this medicine after the date stamped on the pack.

Further information

This leaflet does not contain all the information about this medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

The information in this leaflet is about Gastromax only.