Patient Information Leaflet

Metoclopramide 5 mg/ml Injection

metoclopramide hydrochloride

What is in this leaflet

1.    What Metoclopramide 5 mg/ml Injection is and what it is used for

2.    What you need to know before you use Metoclopramide 5 mg/ml Injection

3.    How to use Metoclopramide 5 mg/ml Injection

4.    Possible side effects

5.    How to store Metoclopramide 5 mg/ml Injection

6.    Contents of the pack and other information

1.    What Metoclopramide 5 mg/ml Injection is and what it is used for

Metoclopramide 5 mg/ml 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

Metoclopramide 5 mg/ml 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

Metoclopramide 5 mg/ml Injection is used in children (aged 1-18 years) 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 use Metoclopramide 5 mg/ml Injection

Do NOT use Metoclopramide 5 mg/ml Injection if:

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

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

•    you have or may have a rare tumour of the adrenal gland, which sits near the kidney (phaeochromocytoma).

•    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 below “Other medicines and Metoclopramide 5 mg/ml Injection).

•    you have ever had an abnormal blood pigment level (methaemoglobinaemia) or NADH cytochrome-b5 deficiency.

Do not give Metoclopramide 5 mg/ml injection to a child less than one year of age (see below “Children and adolescents”).

You should not use Metoclopramide 5 mg/ml injection if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before you use Metoclopramide 5 mg/ml injection.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Metoclopramide 5 mg/ml Injection if:

•    you have a history of abnormal heart beats (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 (see section 3).

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.

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 use Metoclopramide 5 mg/ml Injection if”).

Other medicines and Metoclopramide 5 mg/ml Injection:

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Metoclopramide 5 mg/ml Injection works or Metoclopramide 5 mg/ ml 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 use Metoclopramide 5 mg/ml 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)

Metoclopramide 5 mg/ml Injection with alcohol

Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of Metoclopramide 5 mg/ml Injection.

Pregnancy and breast feeding:

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before being given this medicine. If necessary, Metoclopramide 5 mg/ml Injection may be given during pregnancy. Your doctor will decide whether or not you should be given this medicine.

Metoclopramide 5 mg/ml 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 using Metoclopramide 5 mg/ml Injection. This may affect your vision and also interfere with your ability to drive and use machines

3. How to use Metoclopramide 5 mg/ml Injection

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 patients

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: a single dose of 10 mg is recommended.

All indications (paediatric patients aged 1-18 years)

The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, given by slow injection into a vein.

The maximum dose in 24 hours is 0.5 mg/kg body weight.

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.

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

Talk to your doctor if you have liver problems. The dose should be reduced if you have severe liver problems.

Children and adolescents

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

If you receive more Metoclopramide 5 mg/ml Injection than you should

Contact your doctor or pharmacist straight away. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have a reduced level of consciousness, be confused, have hallucinations and cardiorespiratory arrest (your heart and breathing stop). Your doctor may prescribe you a treatment for these if necessary.

If you forget to use Metoclopramide 5 mg/ml Injection:

Do not have 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, nurse or pharmacist.

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, pharmacist 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'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 in women who are not breast-feeding

•    irregular periods

•    hallucination

•    decreased level of consciousness

•    slow heartbeat (particularly with intravenous route)

•    allergy

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

•    confusional state

•    convulsion (especially in patients with epilepsy). Not known (frequency cannot be estimated from the available data)

•    abnormal blood pigment levels: which may change the colour of your skin

•    abnormal development of breasts (gynaecomastia)

•    involuntary muscle spasms after prolonged use, particularly in elderly patients

•    high fever, high blood pressure, convulsions, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome

•    changes in heart beat, which may be shown on an ECG test

•    cardiac arrest (particularly with the injectable route)

•    shock (severe decrease of heart pressure) (particularly with the injectable route)

•    fainting (particularly with the intravenous route)

•    allergic reaction which may be severe (particularly with the intravenous route)

•    very high blood pressure.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - website: www.mhra.gov. uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Metoclopramide 5 mg/ml Injection

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label/ carton after “EXP:” The expiry date refers to the last day of that month.

Your injection will be stored at less than 25°C and protected from light.

6.    Contents of the pack and other information

What Metoclopramide 5 mg/ml Injection contains:

This injection contains the active ingredient metoclopramide hydrochloride. Each 1 ml of solution contains metoclopramide hydrochloride equivalent to 5 mg of anhydrous metoclopramide hydrochloride in a sterile solution for injection. This injection contains the following inactive ingredients: sodium chloride, citric acid monohydrate, sodium citrate, hydrochloric acid, sodium hydroxide, nitrogen and sterile water for injections.

What Metoclopramide 5 mg/ml Injection looks like and contents of the pack:

The injection is supplied in 2 ml, 10 ml and 20 ml clear glass ampoules. 10 ampoules supplied in each carton. Not all pack sizes may be marketed. The marketing authorisation number of this medicine is: PL 01502/0044

Marketing Authorisation Holder:

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturers:

hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

hameln rds a.s. Horna 36 900 01 Modra Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved September 2014

43887/40/14