METOCLOPRAMIDE KERN PHARMA 1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Metoclopramide Kern Pharma 1 mg/ml Oral Solution EFG

Read all of this leaflet carefully before you start taking 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 take Metoclopramide Kern Pharma
3. How to take Metoclopramide Kern Pharma
4. Possible side effects
5. Storage of Metoclopramide 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 acts on an area of the brain that prevents nausea or vomiting.

Adult population

Metoclopramide Kern Pharma 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 that may occur with migraine.

Metoclopramide can be taken in combination with oral painkillers in the case of migraine to make the painkillers more effective.

Pediatric population

Metoclopramide Kern Pharma is indicated in children (1-18 years of age) if 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 you take Metoclopramide Kern Pharma

Do not take 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 a medicine,
• if you have epilepsy,
• if you have Parkinson's disease,
• if you are taking levodopa (a medicine for Parkinson's disease) or dopamine agonists (see below “Using Metoclopramide Kern Pharma with other medicines”),
• if you have ever had abnormal blood pigment levels (methemoglobinemia) or NADH cytochrome b5 reductase deficiency.

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

Do not take Metoclopramide Kern Pharma if any of the above applies to you. If you are not sure, consult your doctor, pharmacist, or nurse before taking this medicine.

Warnings and precautions

Consult 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 problems

• you have problems with the levels of salts 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 problems (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 discontinued immediately and permanently.

You should wait at least 6 hours between each dose of metoclopramide, even in the case of vomiting or rejection of 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 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).

Taking Metoclopramide Kern Pharma with food, drink, and alcohol

Do not consume alcohol during treatment with metoclopramide because it increases the sedative effect of Metoclopramide Kern Pharma.

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 taking this medicine.

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

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 Kern Pharma, you may feel drowsy, dizzy, or have uncontrollable movements, such as tics, twitches, or muscle contractions, which can affect your vision and interfere with your ability to drive and use machines.

Metoclopramide Kern Pharma contains propyl parahydroxybenzoate and methyl parahydroxybenzoate

It may cause allergic reactions (possibly delayed) because it contains propyl parahydroxybenzoate (E-216) and methyl parahydroxybenzoate (E-218).

3. How to take Metoclopramide Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

All indications (adult patients)

A single dose of 10 mg is recommended, which can be repeated up to three times a day.

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

The maximum treatment duration is 5 days.

To prevent delayed nausea and vomiting that may occur after chemotherapy (children 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, taken orally.

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

Dosing Table

Use the dosing cap included in the package of the oral solution to administer the correct dose of metoclopramide.

The dosing cap is graduated in ml. The correspondence with body weight is detailed in the dosing table.

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

Method of administration

Metoclopramide Kern Pharma is administered orally.

You should wait at least 6 hours between each dose of metoclopramide, even in the case of vomiting or rejection of the dose, to avoid overdose.

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 take more Metoclopramide Kern Pharma than you should

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

Do not take 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 the treatment and inform your doctor, pharmacist, or nurse immediately if

you experience one of the following signs while taking this medicine:

• uncontrollable movements (which often affect the head and neck). These can occur normally 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 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
• uncontrollable movements such as tics, twitches, 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)
• severe allergic reaction (particularly with intravenous administration)
• very high blood pressure.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: 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.

Do not use Metoclopramide Kern Pharma after the expiry date stated on the packaging and on the bottle. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Metoclopramide Kern Pharma 1 mg/ml Oral Solution

• The active substance is metoclopramide. Each ml of solution contains 1 mg of metoclopramide hydrochloride.
• The other ingredients are: hydroxyethylcellulose, sodium saccharin, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), citric acid monohydrate, lemon essence, lime flavor, purified water.

Appearance of the product and packaging contents

Metoclopramide Kern Pharma is a solution packaged in a 250 ml topaz-colored plastic bottle with a 10 ml dosing cap for oral administration.

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