PRIMPERAN 10 MG TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Primperan 10 mg tablets

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 other people, 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:

1. What Primperan is and what it is used for

2. What you need to know before taking Primperan

3. How to take Primperan

4. Possible adverse effects

5. How to store Primperan

6. Contents of the container 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 an area of the brain to prevent nausea or 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 in the case of migraine to make the analgesics more effective.

Paediatric population

Primperan is indicated in children (1–18 years of age) when other treatments do not work or cannot be used, to prevent 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 to 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 “Use of Primperan with other medicines”)
• 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

Consult 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 salt 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-related) 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 in case of vomiting or missed 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”).

Use of Primperan with other medicines

Inform 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 medicine used to treat mental health conditions
• digoxin (a medicine used to treat heart failure)
• ciclosporin (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 when taken simultaneously.

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 plan 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 twisting and unusual muscle tone that may distort your body. These effects may impair your vision and interfere with your ability to drive or operate machinery.

Primperan 10 mg tablets contain lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Primperan

Follow exactly the instructions for administering this medicine as given by your doctor. 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 orally.

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

Dosing table

Do not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.

Primperan tablets are not suitable for use in children weighing less than 61 kg. Other pharmaceutical forms/doses may be more appropriate for administration (e.g. oral solution or injectable solution).

Method of administration

You must wait at least 6 hours between each dose of metoclopramide, even if vomiting or dose rejection occurs, to avoid overdose.

Special populations

Elderly population

Dose reduction may be necessary depending on kidney problems, liver problems, and general health status.

Other pharmaceutical forms/doses may be more suitable for administration (e.g. oral solution or injectable solution).

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.

This formulation is not suitable for administration. Other pharmaceutical forms/doses may be more appropriate for administration (e.g. oral solution or injectable solution).

Adults with hepatic impairment

Inform your doctor if you have liver problems. The dose should be reduced if you have severe hepatic impairment.

This formulation is not suitable for administration. Other pharmaceutical forms/doses may be more appropriate for administration (e.g. oral solution or injectable solution).

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 telephone number: 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 missed 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 will experience 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 stop 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 sleepy.

Common (may affect up to 1 in 10 people)

• Depression
• Uncontrollable movements such as tics, jerks, twisting movements or muscle spasms (stiffness, rigidity)
• Parkinsonism-like symptoms (stiffness, tremor)
• Feeling restless
• Low blood pressure (particularly with intravenous administration)
• Diarrhea
• Feeling weak.

Uncommon (may affect up to 1 in 100 people)

• Elevated blood levels 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)
• Allergic reaction
• 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 color of your skin
• Abnormal breast development (gynecomastia)
• 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 effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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.

Store below 25°C.

Do not use Primperan after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Primperan 10 mg tablets

• The active substance is metoclopramide hydrochloride. Each tablet contains 10 mg of metoclopramide hydrochloride.

• The other components are: monohydrate lactose, microcrystalline cellulose, corn starch, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

The tablets are flat, scored, white to off-white in colour.

They are packaged in a 60-tablet blister pack for oral administration.

Other presentations:

Primperan 1 mg/ml oral solution: 200 ml bottle

Primperan 10 mg/2 ml injectable solution: Pack containing 12 vials of 2 ml

Marketing Authorization Holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer

Famar Health Care Services Madrid, S.A.U.

Avda. de Leganés, 62

28923 - Alcorcón (Madrid)

Spain

or

Delpharm Dijon

6, Boulevard de l’Europe

21800 Quetigny

France

Date of latest revision of this leaflet: February 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/