Document: leaflet MAH GENERIC_PL 20416-0103 change

• leaflet MAH GENERIC_PL 20416-0103
• leaflet MAH GENERIC_PL 40147-0058

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PATIENT INFORMATION LEAFLET

METOCLOPRAMIDE Tablets lOmg

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This medicine has been prescribed for you. 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

1.    What Metoclopramide Tablets are and what they are used for

2.    Before you take Metoclopramide Tablets

3.    How to take Metoclopramide Tablets

4.    Possible side effects

5.    How to store Metoclopramide Tablets

6.    Further information

1.    What Metoclopramide Tablets are and what they are used for

Metoclopramide tablets are an antiemetic. They contain a medicine called “metoclopramide”. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting). Adults

Metoclopramide tablets are used in adults:

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

-    to prevent nausea and vomiting caused by radiotherapy

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

Metoclopramide can be taken with oral painkillers in case of migraine to help painkillers work more effectively.

Paediatric population fchildren and adolescents)

Metoclopramide tablets are indicated 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.

2.    Before you take Metoclopramide Tablets

Do not take these tablets 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 (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 below “Taking other medicines”)

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

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

Do not take Metoclopramide tablets if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist or nurse before you take Metoclopramide tablets.

Check with your doctor, pharmacist or nurse before taking these tablets 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).

Blood Tests

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.

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.

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 these tablets”).

Taking other medicines:

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 tablets works or Metoclopramide tablets 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 these tablets 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)

•    ciclosporin (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 Tablets with alcohol

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

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 Tablets may be taken during pregnancy. Your doctor will decide whether or not you should be given this medicine.

Metoclopramide Tablets are not recommended if you are breastfeeding 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 Metoclopramide Tablets. This may affect your vision and also interfere with your ability to drive and use machines.

Important information about one of the ingredients of this medicine

Metoclopramide Tablets contain lactose. If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Metoclopramide Tablets

Swallow the tablets with water.

Your doctor will decide the dose that is best for you. Always follow your doctor’s instructions. The pharmacist’s label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.

Adults

The recommended single dose is 10 mg, repeated up to three times daily.

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

The maximum recommended treatment duration is 5 days.

Children and Adolescents

To prevent delayed nausea and vomiting that may occur after chemotherapy (children aged 1-18 years). The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken by mouth (oral route).

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

You should not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy. Metoclopramide Tablets are not suitable for use in children weighing less than 61 kg. Other pharmaceutical forms/strengths may be more appropriate for administration.

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

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

Other pharmaceutical forms/strengths may be more appropriate for administration of reduced doses of less than 10 mg.

Children and adolescents

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

If you take more tablets than you should

Contact your doctor or pharmacist straight away. You may experience uncontrollable movements (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 take a dose

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, 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 disease (rigidity, tremor)

•    feel 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 injection route)

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

•    fainting (particularly with intravenous route)

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

•    very high blood pressure.

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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Metoclopramide Tablets

Keep this medicine in the original package and protect from heat, light and moisture.

Do not take the tablets if the expiry date on the pack has passed.

If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN

6.    Further information

Ingredients: Each 10mg tablet contains 10mg anhydrous metoclopramide hydrochloride as the active ingredient.

They also contain the following other ingredients: lactose, pregelatinised starch, magnesium stearate, maize starch and sodium starch glycollate.

What the medicine looks like:

Metoclopramide Tablets are white tablets engraved with company logo on one side and scored on the other, engraved with “A” above and “306” below the score.

This medicine is available in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed).

Who makes this medicine and holds the Product Licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK

Date leaflet revised: November 2014

If you would like this leaflet in a different format please contact the licence holder at the above address.