METOCLOPRAMIDE KERN PHARMA 10mg/2ml INJECTABLE SOLUTION

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, 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 pack:

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

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

Metoclopramide Kern Pharma is an antiemetic. It contains the active substance metoclopramide. It works in an area of the brain that prevents nausea or vomiting.

Adult population

Metoclopramide Kern Pharma 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

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 an operation.

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

Do not use Metoclopramide Kern Pharma

• 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 you have been 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 "Using Metoclopramide Kern Pharma with other medicines") if you have ever had abnormal blood pigment levels (methemoglobinemia) or NADH cytochrome b5 deficiency.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Metoclopramide Kern Pharma 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.

Children and adolescents

Uncontrolled 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 uncontrolled movements (see above "Do not use Metoclopramide Kern Pharma").

Using Metoclopramide Kern Pharma 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 metoclopramide works or metoclopramide may affect the way 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)
• 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 problems of the immune system)
• mivacurium and suxamethonium (medicines used to relax muscles)
• fluoxetine and paroxetine (medicines used to treat depression)

Using Metoclopramide Kern Pharma with food, drinkand alcohol

Do not drink alcohol during treatment with metoclopramide because it increases its sedative effect.

Pregnancy, breastfeeding and fertility

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.

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

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

Driving and using machines

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

Metoclopramide Kern Pharma contains sodium

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

3. How to take Metoclopramide Kern Pharma

This medicine will be administered 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 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 body weight, which can be repeated up to three times a day, administered slowly into a vein.

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

Dosing 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.

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 Metoclopramide Kern Pharma than you should

Contact your doctor or pharmacist immediately. You may experience uncontrolled movements (extrapyramidal disorders), drowsiness, some problems with consciousness, confusion, 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 Metoclopramide Kern Pharma

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.

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

• uncontrolled movements (which often affect the head and neck). These can occur normally at the start of treatment and can even occur after a single administration. These movements will stop when treated properly
• high fever, high blood pressure, seizures, sweating, saliva production. These can be signs of a condition called malignant neuroleptic syndrome
• itching and skin rash, facial swelling, lips or throat, 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
• uncontrolled movements such as tics, twitches, or torsion and muscle tone (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
• reduced 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)

• confusional state
• seizures (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, seizures, 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)
• severe allergic reaction (particularly with intravenous administration)
• very high blood pressure.

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through 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 Metoclopramide Kern Pharma

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

No special storage conditions are required.

Store in the original package to protect from light.

Do not use this medicine after the expiry date which is stated on the carton 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 Metoclopramide Kern Pharma

• 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 and packaging

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

Each pack contains 6 or 12 ampoules of 2 ml.

Not all 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 last revision of this leaflet:November 2019

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