Read all of this leaflet carefully before you start using this medicine because it contains important information for you

-    Keep this leaflet. You may need to read it again.

furtherques doctor or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Maxolon Injection is and what it is used for

2.    What you need to know before you are given Maxolon Injection

3.    How you will be given Maxolon Injection

4.    Possible side effects

5.    Howto store Maxolon Injection

6.    Contents of the pack and other information

1.    WHAT MAXOLON INJECTION IS AND WHAT IT IS USED FOR

The name of your medicine is Maxolon Injection. Maxolon Injection is an antiemetic. It contains a medicine called “metoclopramide”. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting).

Adult population

Maxolon Injection is used in adults:

-    to prevent nausea and vomiting that may occur after surgery

-    to treat nausea and vomiting including nausea and vomiting which may occur with a migraine

-    to prevent nausea and vomiting caused by radiotherapy.

Paediatric population

Maxolon Injection is used in children (aged 1-18 years) only if other treatment does not work or cannot be used:

-    to prevent delayed nausea and vomiting that may occur after chemotherapy

-    to treat nausea and vomiting that has occurred after surgery.

2.    WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN MAXOLON INJECTION

Do not use Maxolon Injection:

-    if you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6).

-    if you have bleeding, obstruction or a tear in your stomach or gut.

-    if you have or may have a rare tumour of the adrenal gland, which sits near the kidney (pheochromocytoma).

-    if you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine.

-    if you have epilepsy

-    if you have Parkinson’s disease

-    if you are taking levodopa (a medicine for Parkinson’s disease) or dopaminergic agonists (see below “Other medicines and Maxolon Injection”)

-    if you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochrome-b5 deficiency.

Do not give Maxolon Injection to a child less than 1 year of age (see below “Children and adolescents”).

Warnings and precautions

Talk to your doctor or nurse before taking Maxolon Injection:

-    if you have a history of abnormal heart beats (QT interval prolongation) or any other heart problems

-    if you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium

-    if you are using other medicines known to affect the way your heart beats

-    if you have any neurological (brain) problems

-    if you have liver or kidney problems. The dose may be reduced (see section 3).

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

Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.

Children and adolescents

Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults. This medicine must not be used in children below 1 year of age because of the increased risk of the uncontrollable movements (see above “Do not take Maxolon Injection if”).

Other medicines and Maxolon Injection

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Maxolon Injection works or Maxolon Injection can affect how other medicines work. These medicines include the following:

-    levodopa or other medicines used to treat Parkinson’s disease (see above “Do not take Maxolon Injection if”)

-    anticholinergics (medicines used to relieve stomach cramps or spasms)

-    morphine derivatives (medicines used to treat severe pain)

-    sedative medicines

-    any medicines used to treat mental health problems

-    digoxin (medicine used to treat heart failure)

-    cyclosporine (medicine used to treat certain problems with the immune system)

-    mivacurium and suxamethonium (medicines used to relax muscles)

-    fluoxetine and paroxetine (medicine used to treat depression).

Maxolon Injection with food, drink and alcohol

Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of Maxolon Injection.

Pregnancy, breast-feeding and fertility

Pregnancy:

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. If necessary, Maxolon Injection may be taken during pregnancy. Your doctor will decide whether or not you should be given this medicine.

Breast-feeding:

Maxolon Injection is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby.

Driving and using machines

You may feel drowsy, dizzy or have uncontrollable twitching, jerking or writhing movements and unusual muscle tone causing distortion of the body after taking Maxolon Injection. This may affect your vision and also interfere with your ability to drive and use machines.

Maxolon Injection contains Sodium metabisulphite and Sodium

•    sodium metabisulphite, may rarely cause severe hypersensitivity reactions and bronchospasm.

•    This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. is essentially “sodium free”.

3. HOW YOU WILL BE GIVEN MAXOLON INJECTION

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The medicine will normally be given to you by a doctor or a nurse. It will be given as a slow injection into a vein (over at least 3 minutes) or by injection into a muscle.

In adults population

For the treatment of nausea and vomiting including nausea and vomiting which may occur with a migraine and for the prevention of nausea and vomiting caused by radiotherapy: the recommended single dose is 10 mg, repeated up to 3 times daily.

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

For the prevention of nausea and vomiting that may occur after surgery prevention: a single dose of 10mg is recommended.

The treatment should not exceed 48 hours for treatment of nausea and vomiting that has occurred after surgery.

The treatment should not exceed 5 days for prevention of delayed nausea and vomiting that may occur after chemotherapy.

Method of administration

You must wait at least 6 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.

Older people

The dose may need to be reduced depending on kidney problems, liver problems and overall health.

Adults with kidney problems

Talk to your doctor if you have kidney problems. The dose should be reduced if you have moderate or severe kidney problems.

Adults with liver problems

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Metoclopramide must not be used in children aged less than 1 year (see section 2).

If you use more Maxolon Injection than you should:

Contact your doctor straight away. You may experience uncontrollab lemovements (extrapyramidal disorders), feel drowsy, have some troubles of consciousness, be confused, have hallucination and heart problems. Your doctor may prescribe you a treatment for these signs if necessary.

If you forget to use Maxolon Injection

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop the treatment and talk straight away to your doctor or nurse if you experience one of the following signs while having 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, convulsions, sweating, production 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 an allergic reaction, which may be severe.

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

•    feeling drowsy.

Common (may affect up to 1 in 10 people)

•    depression

•    uncontrollable movements such as tics, shaking, twisting movements or muscle contracture (stiffness, rigidity)

•    symptoms similar to Parkinson disease (rigidity, tremor)