Primperan 1 mg/ml oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Primperan 1 mg/ml oral solution
Metoclopramide hydrochloride
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
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What Primperan is and what it is used for
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What you need to know before taking Primperan
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How to take Primperan
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Possible side effects
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How to store Primperan
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Contents of the pack and other information
1. What Primperan is and what it is used for
Primperan is an antiemetic. It contains a medicine called “metoclopramide”. It acts on a part of the brain that controls nausea and vomiting.
Adult population
Primperan is 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 associated with migraine
Metoclopramide may be taken in combination with oral analgesics during migraine episodes to increase the effectiveness of the analgesics.
Pediatric population
Primperan is indicated in children (1–18 years of age) when other treatments are ineffective or cannot be used, for the prevention of delayed nausea and vomiting that may occur after chemotherapy.
2. What you need to know before taking Primperan
Do not take Primperan
- if you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6)
- if you have bleeding, obstruction, or perforation in the stomach or intestine
- if you have or may have a rare tumor of the adrenal gland near the kidney (pheochromocytoma)
- if you have ever experienced involuntary muscle spasms (tardive dyskinesia) while being treated with a medicine
- if you have epilepsy
- if you have Parkinson's disease
- if you are taking levodopa (a medicine for Parkinson's disease) or dopaminergic agonists (see below “Other medicines and Primperan”)
- if you have ever had abnormal levels of blood pigments (methemoglobinemia) or deficiency of NADH cytochrome b5 reductase.
Do not administer Primperan to children under 1 year of age (see below “Children and adolescents”).
Do not take Primperan if any of the above apply to you. If you are unsure, consult your doctor, pharmacist, or nurse before taking Primperan.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Primperan if:
- you have a history of abnormal heartbeats (QT interval prolongation) or any other heart problems
- you have problems with electrolyte levels in your blood, such as potassium, sodium, or magnesium
- you are taking other medicines known to affect your heart rhythm
- you have any neurological (brain) disorders
- you have liver or kidney problems. Your dose may need to be reduced (see section 3).
Your doctor may perform blood tests to monitor your blood pigment levels. If abnormal levels (methemoglobinemia) occur, treatment must be stopped immediately and permanently.
You should wait at least 6 hours between each dose of metoclopramide, even if you vomit or reject the dose, to avoid overdose.
Do not exceed 3 months of treatment due to the risk of involuntary muscle spasms.
Children and adolescents
Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults. This medicine should not be used in children under 1 year of age due to the high risk of uncontrollable movements (see above “Do not take Primperan”).
Other medicines and Primperan
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because some medicines may affect how Primperan works, or Primperan may affect how other medicines work. These medicines include:
- levodopa or other medicines used to treat Parkinson's disease (see above “Do not take Primperan”)
- anticholinergics (medicines used to relieve stomach spasms or cramps)
- morphine derivatives (medicines used to treat severe pain)
- sedative medicines
- any medicines used to treat mental health conditions
- digoxin (a medicine used to treat heart failure)
- cyclosporine (a medicine used to treat certain immune system disorders)
- mivacurium and suxamethonium (medicines used to relax muscles)
- fluoxetine and paroxetine (medicines used to treat depression)
- rifampicin (a medicine used to treat tuberculosis or other infections), which may reduce the amount of metoclopramide in the blood if taken at the same time.
Use of Primperan with alcohol
Alcohol should not be consumed during treatment with metoclopramide, as it increases the sedative effect of Primperan.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Primperan may be taken during pregnancy if necessary. Your doctor will decide whether this medicine should be administered.
Primperan is not recommended during breastfeeding because metoclopramide passes into breast milk and may affect your baby.
Driving and using machines
After taking Primperan, you may feel drowsy, dizzy, or experience uncontrollable movements such as tics, jerks, or unusual twisting and muscle tone causing body distortion. These effects may impair your vision and may also interfere with your ability to drive or operate machinery.
Primperan 1 mg/ml oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
It may cause allergic reactions (possibly delayed) as it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Primperan 1 mg/ml oral solution contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per 1 ml of oral solution; hence, it is essentially “sodium-free”.
Primperan 1 mg/ml oral solution contains alcohol
This medicine contains 4.9 mg of alcohol (ethanol) in each ml of oral solution, equivalent to 0.49 % (w/v). The amount in 1 ml of this medicine is equivalent to less than 0.12 ml of beer or 0.05 ml of wine.
The small amount of alcohol contained in this medicine does not produce any noticeable effect.
3. How to take Primperan
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
All indications (adult patients)
A single dose of 10 mg is recommended, which may be repeated up to three times a day.
The recommended maximum daily dose is 30 mg or 0.5 mg/kg body weight.
The maximum duration of treatment is 5 days.
For prevention of 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, which may be repeated up to three times a day, taken by mouth (orally).
The maximum dose in 24 hours is 0.5 mg/kg body weight.
Dosing table
Age | Body weight | Dosage | Frequency |
1-3 years | 10-14 kg | 1 mg | Up to 3 times a day |
3-5 years | 15-19 kg | 2 mg | Up to 3 times a day |
5-9 years | 20-29 kg | 2.5 mg | Up to 3 times a day |
9-18 years | 30-60 kg | 5 mg | Up to 3 times a day |
15-18 years | Over 60 kg | 10 mg | Up to 3 times a day |
Use the oral dosing syringe supplied in the oral solution pack to administer the correct dose of metoclopramide.
The oral dosing syringe is graduated in mg. The correlation with body weight is detailed in the dosing table. The dose is drawn by pulling the plunger to the corresponding mg graduation.
The use of the oral dosing syringe is restricted to the administration of this solution only.
The oral dosing syringe should be rinsed after each use.
Do not immerse the oral dosing syringe into the bottle.
Do not take this medicine for longer than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.
Method of administration
Wait at least 6 hours between each dose of metoclopramide, even in case of vomiting or dose rejection, to avoid overdose.
Special populations
Elderly population
Dose reduction may be necessary depending on kidney problems, liver problems, and general health status.
Adults with renal impairment
Inform your doctor if you have kidney problems. The dose should be reduced if you have moderate to severe renal impairment.
Adults with hepatic impairment
Inform your doctor if you have liver problems. The dose should be reduced if you have severe hepatic impairment.
Children and adolescents
Metoclopramide must not be used in children under 1 year of age (see section 2).
If you take more Primperan than you should
Contact your doctor or pharmacist immediately. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have disturbances in consciousness, confusion, hallucinations, or heart problems. Your doctor may prescribe treatment for these effects if necessary.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Primperan
Do not take a double dose to make up for forgotten doses.
If you have any further questions about the use of this medicine, ask your doctor, nurse, or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Frequency not known (frequency cannot be estimated from the available data)
- allergic reactions (such as anaphylaxis, angioedema, and urticaria).
Symptoms may include rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat or tongue, cold, clammy skin, palpitations, dizziness, weakness or fainting. Contact your doctor or other healthcare professional immediately or go to the nearest hospital emergency department straight away.
Stop treatment and inform your doctor, pharmacist or nurse immediately if you experience any of the following signs while taking this medicine:
- uncontrollable movements (often affecting the head and neck). These may occur in children and young adults, particularly when high doses are used. These signs usually appear at the beginning of treatment and may even occur after a single dose. These movements will cease when appropriately treated.
- high fever, high blood pressure, seizures, sweating, excessive salivation. These may be signs of a condition called neuroleptic malignant syndrome.
- itching and skin rashes, swelling of the face, lips or throat, difficulty 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, jerks, twisting movements or muscle contractures (stiffness, rigidity)
- Parkinson-like symptoms (stiffness, tremor)
- feeling restless
- low blood pressure (particularly with intravenous administration)
- diarrhoea
- feeling weak.
Uncommon (may affect up to 1 in 100 people)
- elevated levels in the blood of a hormone called prolactin which may cause: milk production in men and women who are not breastfeeding
- irregular periods
- hallucinations
- decreased level of consciousness
- slow heart rate (particularly with intravenous administration)
- allergy
- visual disturbances and involuntary deviation of the eyeball.
Rare (may affect up to 1 in 1,000 people)
- confusion
- seizures (especially in patients with epilepsy).
Frequency not known (frequency cannot be estimated from the available data)
- abnormal levels of blood pigments: which may change the colour of your skin
- abnormal breast development (gynaecomastia)
- involuntary muscle spasms after prolonged use, particularly in elderly patients
- high fever, high blood pressure, seizures, sweating, excessive salivation. These may be signs of a condition called neuroleptic malignant syndrome
- changes in heart rhythm, which may be seen on an ECG (electrocardiogram)
- cardiac arrest (particularly with intravenous administration)
- shock (severe drop in blood pressure) (particularly with intravenous administration)
- fainting (particularly with intravenous administration)
- very high blood pressure
- suicidal thoughts.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Primperan
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use Primperan after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Primperan 1 mg/ml oral solution
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The active substance is metoclopramide hydrochloride. Each ml of oral solution contains 1 mg of metoclopramide hydrochloride.
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The other components are: hydroxyethylcellulose, sodium cyclamate, sodium saccharin, methyl 4-hydroxybenzoate (E218), propyl 4-hydroxybenzoate (E216), citric acid monohydrate, apricot-orange flavour (contains ethanol), purified water.
Appearance of the product and contents of the pack
It is a colourless to slightly amber, viscous, transparent liquid with an aromatic orange and apricot odour.
This oral solution is packaged in a 200 ml bottle with a child-resistant cap and includes an oral dosing syringe.
Other presentations:
Primperan 10 mg tablets: Packs of 30 and 60 tablets
Primperan 10 mg/2 ml injectable solution: Pack containing 12 ampoules of 2 ml
Marketing Authorization Holder
sanofi-aventis, S.A.
C/ Rosselló i Porcel, 21
08016 Barcelona
Spain
Manufacturer
- Nattermann & Cie. GmbH
Nattermannallee, 1
50829 Cologne
Germany
or
Unither Liquid Manufacturing
Entrée 1, 3 Allée de la Neste
Zone Industrielle D’En Sigal
31770 Colomiers
France
Date of the most recent revision of this leaflet: September 2023
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/