Metoclopramide 5 mg/5 ml Oral Solution Sugar-Free

• 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.

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

• to prevent delayed nausea and delayed vomiting that may occur after chemotherapy;
• to prevent nausea and vomiting caused by radiation therapy;
• to treat nausea and vomiting, including nausea and vomiting that can occur with a migraine. This medicine can, in case of migraine, be taken with oral painkillers to increase the analgesic effect.

Metoclopramide oral solution is used in children and adolescents (aged 1 to 18 years) to prevent delayed nausea and delayed vomiting when other treatments fail or cannot be used.

• if you are allergic to metoclopramide hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you have bleeding, narrowing (obstruction) or a tear (perforation) in your stomach or bowel;
• if you have or may have a rare tumour of the adrenal gland which sits near the kidney (phaeochromocytoma);
• if you have certain hormone-dependent tumors (prolactin-dependent tumors)
• if you have or have ever had involuntary muscle spasms (tardive dyskinesia) which were medically treated;
• if you suffer from epilepsy;
• if you suffer from Parkinson’s disease;
• if you suffer from movement disorders (extrapyramidal disorders);
• if you are taking levodopa (an active substance used in Parkinson's disease) or dopaminergic agents (see “Other medicines and Metoclopramide oral solution”);
• if you have or have ever had abnormal haemoglobin levels (methaemoglobinaemia) or NADH-cytochrome B5 reductase deficiency.

Metoclopramide oral solution must not be administered to children under 1 year of age (see below “Children and adolescents”).

Do not take Metoclopramide oral solution if any of the above situations applies to you. If you are not sure, talk to your doctor or pharmacist before taking Metoclopramide oral solution.

Talk to your doctor or pharmacist before taking Metoclopramide oral solution if:

• you have ever had an abnormal heartbeat (QT interval prolongation) or any other heart problems;
• you have problems with salt levels (potassium, sodium and magnesium) in your blood;
• you are taking or using other medicines known to affect the way your heart beats;
• you suffer from a neurological (brain) problem;
• you have problems with your liver or kidneys. It may be necessary to reduce the dose (see section 3).

Your doctor may do blood tests to check levels of haemoglobin (blood pigment) in your blood. In cases of abnormal levels (methaemoglobinaemia), treatment must be stopped immediately and permanently.

You must wait at least 6 hours after each metoclopramide dose, even if you vomit and eject the medicine, before you take your next dose, in order to prevent an overdose.

In children and young adults, uncontrollable movements (extrapyramidal disorders) may occur. This medicine must not be used in children under 1 year of age, due to the increased risk of uncontrollable movements (see above “Do not take Metoclopramide oral solution”).

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This is because other medicines may affect the way in which Metoclopramide oral solution works or Metoclopramide oral solution can impact on the effect of other medicines. These include:

• levodopa and other medicines used to treat Parkinson's disease (see above “Do not take Metoclopramide oral solution”);
• medicines used to relieve stomach cramps or spasms (anticholinergics);
• medicines used to treat severe pain (morphine derivatives);
• medicines with a depressant effect on the nervous system (sedative medicines);
• all other medicines to treat mental and psychiatric disorders;
• medicines used to treat heart failure (digoxin);
• medicines used to treat certain disorders of the immune system (ciclosporin);
• medicines used to relax the muscles (mivacurium and suxamethonium);
• medicines to treat depression (fluoxetine and paroxetine).

Metoclopramide may additionally affect the absorption (uptake from the gastrointestinal tract) of oral contraceptives (additional contraceptive measures are recommended) and other substances, e.g. reduce the absorption of cimetidine, and accelerate or increase the absorption of paracetamol, different antibiotics (proven for tetracycline, pivampicillin) and lithium.

You must refrain from consuming alcohol during treatment with metoclopramide, as this increases the depressant effect of Metoclopramide oral solution.

Pregnancy

If you are pregnant or breast-feeding, 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 oral solution can be taken during pregnancy. Your doctor will decide whether or not you should take this medicine.

Breast-feeding

Metoclopramide oral solution is not recommended if you are breast-feeding, as metoclopramide is excreted into human milk and may affect your baby.

Warning: This medicine may affect your responsiveness and ability to drive.

After taking Metoclopramide oral solution, you may feel drowsy, dizzy, or uncontrollable movement disorders (dyskinesia) may occur, such as tremors, twitches and curvature, as well as unusual muscle tone with abnormal body posture (dystonia). This can affect your vision and impair your ability to drive and use machines.

as preservatives, which may cause allergic reactions (possibly delayed).

The recommended single dose is 10 mg (10 ml) and can be given up to three times a day.

The maximum recommended daily dose is 30 mg (30 ml) or 0.5 mg (0.5 ml)/kg body weight.

The maximum recommended duration of treatment is 5 days.

Metoclopramide oral solution must not be used in children under 1 year of age (see section 2).

The recommended single dose is 0.1 to 0.15 mg (0.1 to 0.15 ml)/kg body weight and can be taken up to three times a day.

The maximum dose within 24 hours is 0.5 mg (0.5 ml)/kg body weight.

The maximum recommended duration of treatment is 5 days.

Dosage

Children from 1-3 years (10-14 kg body weight): 1 mg (corresponding to 1 ml) up to three times daily

Children from 3-5 years (15-19 kg body weight): 2 mg (corresponding to 2 ml) up to three times daily

Children from 5-9 years (20-29 kg body weight): 2.5 mg (corresponding to 2.5 ml) up to three times daily

Children and adolescents from 9-18 years (30-60 kg body weight): 5 mg (corresponding to 5 ml) up to three times daily

Adolescents from 15-18 years (more than 60 kg body weight): 10 mg (corresponding to 10 ml) up to three times daily

A dose reduction may be necessary depending on kidney and liver function, as well as your general state of health.

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

Talk to your doctor if you have liver problems. The dose must be reduced if you have a severe liver dysfunction.

You must wait at least 6 hours after each metoclopramide dose, even if you vomit and eject the medicine, before you take your next dose, in order to prevent an overdose.

Metoclopramide oral solution is an oral solution. It is dosed with a dosing syringe. The solution is squirted directly into the mouth.

1. Open the bottle.
2. Take the syringe and insert it into the opening of the adapter.
3. Turn the bottle upside down. Pull out the plunger up to the mark in millilitres (ml) corresponding to the dose prescribed by your doctor.
4. Turn the bottle the right way up. Remove the syringe from the adapter.
5. Empty the contents of the syringe directly into the patient's mouth, by pushing the plunger all the way into the syringe.
6. Close the bottle with the plastic cap.
7. Rinse the syringe using water only.

Contact your doctor or pharmacist immediately. You may suffer from uncontrollable movements (extrapyramidal disorders), drowsiness, impaired consciousness, confusion and hallucinations, as well as heart problems. If necessary, your doctor can treat these symptoms.

Information for the physician: Advice for management of overdose is at the end of this leaflet.

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

If you get any side effects, talk to your doctor or pharmacist. 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.

• The active substance is metoclopramide hydrochloride. 1 ml contains 1 mg metoclopramide hydrochloride.
• The other ingredients are methylhydroxybenzoate, propylhydroxybenzoate, sucralose, orange flavouring and purified water.

Clear, colourless to yellowish oral solution with orange flavouring.

Metoclopramide oral solution is available in amber glass bottles with 30 ml, 50 ml, 120 ml, 150 ml (in 180 or 200 ml bottles) and 200 ml solution, with a white screw cap, an adapter allowing inverted withdrawal of the solution and a 3 ml dosing syringe (for 30 and 50 ml bottles) or a 5 ml syringe (for 120, 150 and 50 ml bottles), with 0.5 ml markings.

Not all pack sizes or bottle sizes may be marketed.