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METOCLOPRAMIDE 5MG/5ML ORAL SOLUTION SUGAR-FREE

Active substance(s): METOCLOPRAMIDE HYDROCHLORIDE

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Package leaflet: Information for the patient

Metoclopramide

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Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
– 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.
What is in this leaflet
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
1. What Metoclopramide oral solution is and what it is used for
Metoclopramide oral solution is a medicine to treat vomiting (antiemetic). It
contains the active substance metoclopramide hydrochloride. This acts in the
part of your brain that prevents you from feeling sick (nausea) or being sick
(vomiting).
Metoclopramide oral solution is used in adults:
– 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.
2. What you need to know before you take Metoclopramide oral
solution
Do not take Metoclopramide oral solution:
– 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 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 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.
Warnings and precautions
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.
Children and adolescents
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”).
Other medicines and 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.

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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 oral solution with alcohol
You must refrain from consuming alcohol during treatment with metoclopramide,
as this increases the depressant effect of Metoclopramide oral solution.
Pregnancy and breast-feeding
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.
Driving and using machines
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.
Metoclopramide oral solution contains methyl-parahydroxybenzoate
and propyl-parahydroxybenzoate as preservatives, which may cause
allergic reactions (possibly delayed).
3. How to take Metoclopramide oral solution
Always take this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
Adults
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.
Use in children and adolescents aged 1 to 18 years
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 table
Age

Body weight

Dosage

Amount
of fluid

1–3 years

10–14 kg

1 mg

1 ml

3–5 years

15–19 kg

2 mg

2 ml

5–9 years

20–29 kg

2.5 mg

2.5 ml

9–18 years

30–60 kg

5 mg

5 ml

15–18 years

more than 60 kg

10 mg

10 ml

Frequency

Up to three
times daily

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Metoclopramide hydrochloride

5mg/5ml Oral Solution Sugar-Free

Older people
A dose reduction may be necessary depending on kidney and liver function, as
well as your general state of health.
Patients with kidney dysfunction
Talk to your doctor if you have kidney problems. The dose must be reduced if
you have moderate to severe kidney dysfunction.
Patients with liver dysfunction
Talk to your doctor if you have liver problems. The dose must be reduced if you
have a severe liver dysfunction.
Method of administration
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.

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3.4.

If you take more Metoclopramide oral solution than you should
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.
If you forget to take Metoclopramide oral solution
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 pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop the treatment and talk to your doctor or pharmacist immediately if you
notice any of the following signs while taking this medicine:
– uncontrollable movements (often involving the head or neck). This can
occur in children and young adults, particularly when high dosages are
used. These signs normally occur at the start of treatment and may
occur even after a single dose. These movements are reversible if treated
properly;
– high fever, high blood pressure, seizures, sweating, increased salivation.
These may be signs of a condition known as neuroleptic malignant
syndrome;
– itching or rash, swelling of the face, lips or throat, difficulty in breathing.
These may be signs of an allergic reaction, which may be serious.
Very common (may affect more than 1 in 10 patients treated)
– drowsiness
Common (may affect up to 1 in 10 patients treated)
– depression
– uncontrollable movements such as tics, tremors, twisting movements or
muscle contractions (stiffness, rigidity)
– symptoms similar to Parkinson’s disease (rigidity, tremor)
– restlessness
– low blood pressure (especially after intravenous administration)
– diarrhoea
– weakness
Uncommon (may affect up to 1 in 100 patients treated)
– increased levels of a hormone known as prolactin, which can trigger milky
secretions from the breast glands in men and non-breastfeeding women

– menstruation disorders
– hallucinations
– impaired consciousness
– slow heartbeat (especially with intravenous administration)
– allergy
Rare (may affect up to 1 in 1,000 patients treated)
– confusion
– seizures (especially in epileptic patients)
Not known (cannot be estimated from the available data)
– abnormal haemoglobin (blood pigment) levels, which may result in
a change of skin colour
– abnormal breast growth (gynaecomastia)
– involuntary muscle spasms after prolonged use, especially in elderly
patients
– high fever, high blood pressure, seizures, sweating, increased salivation
– These may be signs of a condition known as neuroleptic malignant
syndrome.
– changes in heart rate, detectable on the electrocardiogram (ECG
examination)
– cardiac arrest (especially when used as an injection)
– shock (severe drop in blood pressure) (especially when used as an injection)
– fainting (especially when administered into a vein)
– allergic reaction that may be serious (especially when administered into
a vein)
– very high blood pressure
Reporting of side effects
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.
5. How to store Metoclopramide oral solution
Keep this medicine out of the sight and reach of children.
Keep the bottle in the outer carton.
Do not use this medicine after the expiry date which is stated on the label and
carton after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25°C.
After first opening, this medicine can be used for 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.
6. Contents of the pack and other information
What Metoclopramide oral solution contains
– 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.
What Metoclopramide oral solution looks like and contents of the pack
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.
Marketing Authorisation Holder and Manufacturer
Lannacher Heilmittel Ges.m.b.H., 8502 Lannach
For any information about this medicine, please contact the local representative
of the Marketing Authorisation Holder.
This leaflet was last revised in November 2016.
The following information is intended for healthcare professionals only:
Symptoms
Extrapyramidal disorders, drowsiness, decreased level of consciousness,
confusion, hallucination, and cardio-respiratory arrest may occur.
Management
In case of extrapyramidal symptoms related or not to overdose, the treatment
is only symptomatic (benzodiazepines in children and/or anticholinergic antiparkinsonian medicinal products in adults).
A symptomatic treatment and a continuous monitoring of the cardiovascular
and respiratory functions should be carried out according to clinical status.

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How do you use the dosing syringe?
1. Open the bottle (Fig. 1).
2. Take the syringe and insert it into the opening of the adapter (Fig. 2).
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 (Fig. 3).
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 (Fig. 4).
1.2.

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