Metoclopramide Kern Pharma 10 mg/2 ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Metoclopramide Kern Pharma 10 mg/2 ml solution for injection EFG

Metoclopramide hydrochloride

Read all of this leaflet carefully before you start using 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.

Contents of this leaflet:

1. What Metoclopramide Kern Pharma is and what it is used for
2. What you need to know before you use Metoclopramide Kern Pharma
3. How to use Metoclopramide Kern Pharma
4. Possible adverse effects
5. How to store Metoclopramide Kern Pharma
6. Contents of the pack and other information

1. What Metoclopramide Kern Pharma is and what it is used for

Metoclopramide Kern Pharma is an antiemetic. It contains an active substance called "metoclopramide". It acts on an area of the brain that controls nausea and vomiting.

Adult population

Metoclopramide Kern Pharma is used in adults:

• to prevent nausea and vomiting that may occur after surgery
• to treat nausea and vomiting, including nausea and vomiting associated with migraine
• to prevent nausea and vomiting caused by radiotherapy

Paediatric population

Metoclopramide Kern Pharma is used in children (1–18 years of age) only if other treatments have not worked or cannot be used:

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

2. What you need to know before starting to take Metoclopramide Kern Pharma

Do not use Metoclopramide Kern Pharma

• 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) when treated with this medicine
• if you have epilepsy
• if you have Parkinson's disease
• if you are taking levodopa (a medicine used to treat Parkinson's disease) or dopaminergic agonists (see below "Use of Metoclopramide Kern Pharma with other medicines")
• if you have ever had abnormal levels of blood pigments (methemoglobinemia) or deficiency of NADH-cytochrome b5 reductase.

Do not administer Metoclopramide Kern Pharma to children under 1 year of age (see below "Children and adolescents").

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Metoclopramide Kern Pharma if:

• you have a history of abnormal heartbeats (QT interval prolongation) or any other heart problems
• you have problems with blood electrolyte levels 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.

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 Metoclopramide Kern Pharma").

Use of Metoclopramide Kern Pharma 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 metoclopramide works, or metoclopramide may affect how other medicines work. These medicines include:

• levodopa or other medicines used to treat Parkinson's disease (see above "Do not take Metoclopramide Kern Pharma")
• 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)

Use of Metoclopramide Kern Pharma with food, drink, and alcohol

You should not consume alcohol during treatment with metoclopramide, as it increases its sedative effect.

Pregnancy, breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Metoclopramide Kern Pharma may be used during pregnancy if necessary. Your doctor will decide whether or not this medicine should be administered.

Metoclopramide Kern Pharma is not recommended during breastfeeding because metoclopramide passes into breast milk and may affect your baby.

Driving and using machines

After taking Metoclopramide, you may feel drowsy, dizzy, or experience uncontrollable movements such as tics, jerks, or muscle twisting and unusual muscle tone causing body distortion. These effects may impair your vision and may also interfere with your ability to drive or operate machinery.

Metoclopramide Kern Pharma contains sodium

Patients on low-sodium diets should be aware that this medicine contains 5.90 mg (0.25 mmol) of sodium per vial.

3. How to take Metoclopramide Kern Pharma

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

In adult patients

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

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

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

All indications (paediatric patients 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 daily, administered slowly into a vein.

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

Dosing table

The treatment should not exceed 48 hours for the treatment of nausea and vomiting occurring after surgery.

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

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

If you use more Metoclopramida Kern Pharma than you should

Contact your doctor or pharmacist immediately. You may experience uncontrollable movements (extrapyramidal disorders), drowsiness, altered consciousness, confusion, hallucinations, and 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 use Metoclopramida Kern Pharma

Do not use 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.

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 usually appear at the beginning of treatment and may even occur after a single dose. These movements will cease when properly treated
• high fever, high blood pressure, seizures, sweating, salivation. These may be signs of a condition called neuroleptic malignant syndrome
• itching and skin rash, swelling of the face, lips or throat, difficulty breathing. These may be signs of an allergic reaction, which can 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, jerking, twisting movements or muscle contractures (stiffness, rigidity)
• symptoms similar to Parkinson's disease (stiffness, tremor)
• feeling restless
• decreased blood pressure (particularly with intravenous administration)
• diarrhoea
• 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)
• 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, 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)
• allergic reaction which may be severe (particularly via intravenous route)
• very high blood pressure.

If you experience any kind of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effects, 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 Metoclopramide Kern Pharma

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container after "EXP". The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are 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 Metoclopramide Kern Pharma

• The active substance is metoclopramide hydrochloride. Each 2 ml ampoule contains 10 mg of metoclopramide hydrochloride.
• The other components are: sodium chloride and water for injections.

Nature of the product and pack contents

Injectable solution packed in 2 ml ampoules for parenteral administration (intramuscular or intravenous).

Each pack contains 6 or 12 ampoules of 2 ml.

Only certain pack sizes may be marketed.

Other presentations:

Metoclopramide Kern Pharma 1 mg/ml oral solution: 250 ml bottle

Marketing Authorisation Holder and Manufacturer

Kern Pharma, S.L.

Pol. Ind. Colón II, C/ Venus 72

08228 Terrassa (Barcelona)

Spain

Date of the most recent review of this leaflet: November 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http:// www.aemps.gob.es /