Metoclopramide hydrochloride 5mg/5ml Oral Solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

The name of the medicine is Metoclopramide hydrochloride 5mg/5ml Oral Solution but it will be referred to as Metoclopramide throughout this leaflet.

1. What Metoclopramide is and what it is used for
2. What you need to know before you take Metoclopramide
3. How to take Metoclopramide
4. Possible side effects
5. How to store Metoclopramide
6. Contents of the pack and other information

• 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 “Other medicines and Metoclopramide”)
• you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochrome-b5 deficiency.

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

Do not take Metoclopramide if any of the above statements apply to you, or that have applied to you in the past. If in doubt, consult your doctor or pharmacist before taking Metoclopramide.

Talk to your doctor, pharmacist or nurse before taking Metoclopramide 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 (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.

Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults. This solution 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 Metoclopramide if”).

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 works or Metoclopramide 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 Metoclopramide 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).
• rifampicin, a medicine used to treat tuberculosis or other infections, may reduce the amount of metoclopramide in the blood if administered at the same time.

Alcohol should not be consumed during treatment with metoclopramide because it increases the effect of drowsiness and sleepiness.

Pregnancy:

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

Breast-feeding:

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

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. This may affect your vision and also interfere with your ability to drive and use machines.

Sodium benzoate (E211): This medicine contains 1.25mg sodium benzoate in each 5ml which is equivalent to 0.25mg/ml.

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially “sodium-free” .

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

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

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

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

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

This medicine must be taken orally.

Use the measuring syringe provided in the pack to deliver the required dose.

Instructions for the use of syringe:

a) Open the bottle: press the cap and turn it anticlockwise (Figure 1).

b) Separate the adaptor from the syringe (Figure 2). Insert the adaptor into the bottle neck (Figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (Figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (Figure 5A), then push the piston upwards in order to remove any possible air bubbles (Figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 5C).

d) Turn the bottle the right way up (Figure 6A). Remove the syringe from the adaptor (Figure 6B).

e) Empty the contents of the syringe into the patient’s mouth by pushing the piston to the bottom of the syringe (Figure 7). The contents of the syringe should be emptied into the side cheek of the patient’s mouth to avoid a choking hazard. Leave the syringe adaptor in place after first use. Close the bottle with the plastic screw cap. Wash the syringe with water (Figure 8). Repeat the above steps if required dose is more than 5ml.

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

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

Each 5ml of oral solution contains 5mg metoclopramide hydrochloride (anhydrous).

The other ingredients are: sodium benzoate (E211), citric acid monohydrate (E330), sodium citrate (E331), saccharin sodium (E954), lemon flavour 13499 (containing propylene glycol (E1520), natural flavouring substances and flavouring preparation) and purified water.

Metoclopramide is a clear, colourless oral solution with lemon flavour supplied in an amber glass bottle with a tamper evident, child resistant plastic cap. The pack also comes with a 5ml oral syringe with 0.2ml graduation for measuring the dose and a syringe adaptor for bottle.

Metoclopramide hydrochloride oral solution is supplied in a bottle containing 150ml solution.