PRIMPERAN 10 mg /2 ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Primperan 10 mg/2 ml Solution for Injection

Metoclopramide Hydrochloride

Read all of this leaflet carefully before you start using 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.

Contents of the package leaflet:

1. What is Primperan and what is it used for
2. What you need to know before you use Primperan
3. How to use Primperan
4. Possible side effects
5. Storage of Primperan

1. Contents of the pack and other information

1. What is Primperan and what is it used for

Primperan is an antiemetic. It contains a medicine called “metoclopramide”. It works in an area of the brain that prevents nausea or vomiting.

Adult Population

Primperan is used in adults:

• to prevent nausea and vomiting that may occur after an operation
• to treat nausea and vomiting, including nausea and vomiting that may occur with migraine
• to prevent nausea and vomiting caused by radiotherapy.

Pediatric Population

Primperan is used in children (1-18 years of age) only if other treatments do not work or cannot be used:

• to prevent delayed nausea and vomiting that may occur after chemotherapy
• to treat nausea and vomiting that may occur after an operation.

2. What you need to know before you use Primperan

Do not use 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, which is near the kidney (pheochromocytoma)
• if you have ever had involuntary muscle spasms (tardive dyskinesia) when 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 “Using Primperan with other medicines”)
• if you have ever had abnormal blood pigment levels (methemoglobinemia) or NADH cytochrome b5 reductase deficiency.

Do not give Primperan to children under 1 year of age (see below “Children and adolescents”).

Do not use Primperan if any of the above applies to you. If you are not sure, consult your doctor, pharmacist or nurse before using Primperan.

Warnings and precautions

Consult your doctor, pharmacist or nurse before using Primperan if:

• you have a history of abnormal heartbeats (prolonged QT interval) or any other heart problem
• you have problems with salt levels 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 problem (brain)
• you have liver or kidney problems. The dose may need to be reduced (see section 3).

Your doctor may perform blood tests to check your blood pigment levels. In cases of abnormal levels (methemoglobinemia), treatment should be stopped immediately and permanently.

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 use Primperan”).

Using Primperan with 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 may affect the way Primperan works or Primperan may affect the way other medicines work. These medicines include:

• levodopa or other medicines used to treat Parkinson's disease (see above “Do not use Primperan”)
• anticholinergics (medicines used to relieve stomach spasms or cramps)
• opioid derivatives (medicines used to treat severe pain)
• sedatives
• any medicine used to treat mental health problems
• digoxin (a medicine used to treat heart failure)
• cyclosporin (a medicine used to treat some immune system problems)
• 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), may reduce the amount of metoclopramide in the blood if given at the same time.

Using Primperan with alcohol

Do not drink alcohol during treatment with metoclopramide because it increases the sedative effect of Primperan.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Primperan may be used during pregnancy if necessary. Your doctor will decide whether or not to prescribe this medicine.

Primperan is not recommended if you are breastfeeding because metoclopramide passes into breast milk and may affect your baby.

Driving and using machines

After using Primperan, you may feel drowsy, dizzy or have uncontrollable movements of tics, twitches or muscle tone that can cause body distortion. This may affect your vision and also interfere with your ability to drive and use machines.

Primperan 10 mg/2 ml Solution for Injection contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 1 ml of solution for injection; this is essentially “sodium-free”.

3. How to use Primperan

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, consult your doctor, pharmacist or nurse again.

This medicine will normally be given to you by a doctor or nurse. It will be given as a slow injection into a vein (at least over 3 minutes) or by injection into a muscle.

In adult patients

For the treatment of nausea and vomiting, including nausea and vomiting that may occur with migraine, and for the prevention of nausea and vomiting caused by radiotherapy: a single dose of 10 mg is recommended, which can be repeated up to 3 times a day.

The maximum recommended daily dose is 30 mg or 0.5 mg/kg of body weight.

For the prevention of nausea and vomiting that may occur after an operation: a single dose of 10 mg is recommended.

All indications (pediatric patients 1-18 years of age)

The recommended dose is 0.1 to 0.15 mg/kg of body weight, which can be repeated up to 3 times a day, given slowly into a vein.

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

Dose Table

Treatment should not exceed 48 hours for the treatment of nausea and vomiting that occurs after an operation.

Treatment should not exceed 5 days for the prevention of nausea and vomiting that may occur after chemotherapy.

Special populations

Elderly population

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

Adults with kidney problems

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

Adults with liver problems

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

Children and adolescents

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

If you use more Primperan than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Primperan

Do not use a double dose to make up for forgotten doses.

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.

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, sweaty skin, palpitations, dizziness, weakness or fainting.

Contact your doctor or another healthcare professional or go to the emergency department of the nearest hospital immediately.

Stop treatment and inform your doctor, pharmacist or nurse immediately if you experience one of the following signs while using this medicine:

• uncontrollable movements (which often affect the head and neck). These can occur in children and young adults and particularly when high doses are used. These signs usually appear at the beginning of treatment and can even occur after a single administration. These movements will stop when treated properly.
• high fever, high blood pressure, convulsions, sweating, saliva production. These can be signs of a condition called malignant neuroleptic syndrome.
• itching and skin rashes, facial swelling, lip or throat swelling, difficulty breathing. These can be signs of an allergic reaction, which can 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, twitches, torsion movements or muscle contractions (stiffness, rigidity)
• symptoms similar to Parkinson's disease (stiffness, tremor)
• feeling restless
• decreased blood pressure (particularly with intravenous administration)
• diarrhea
• feeling weak.

Uncommon(may affect up to 1 in 100 people)

• high levels of a hormone called prolactin in the blood, which can 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
• convulsions (especially in patients with epilepsy).

Frequency not known(frequency cannot be estimated from the available data)

• abnormal blood pigment levels: which can change the color of your skin
• abnormal development of the breasts (gynecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• high fever, high blood pressure, convulsions, sweating, saliva production. These can be signs of a condition called malignant neuroleptic syndrome
• changes in heartbeats, which can 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 side effects

If you experience 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 Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 temperature conditions are required, store in the original package to protect from light.

Do not use Primperan after the expiry date which is stated on the package after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Primperan 10 mg/2 ml Solution for Injection

• The active substance is metoclopramide hydrochloride. Each 2 ml ampoule contains 10 mg of metoclopramide hydrochloride.

• The other ingredients are: sodium chloride and water for injections.

Appearance of the product and pack contents

It is a solution for injection in 2 ml ampoules for intramuscular or intravenous administration.

Each pack contains 12 ampoules of 2 ml.

Other presentations:

Primperan 10 mg tablets: Packs of 30 and 60 tablets

Primperan 1 mg/ml Oral Solution: Bottle with 200 ml

Marketing Authorisation Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

Delpharm Dijon

6, Boulevard de l’Europe

21800 Quetigny

France

Date of last revision of this leaflet: February 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/