Metoclopramide Kern Pharma 1 mg/ml oral solution EFG

Package leaflet: Information for the user

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, 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 side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Metoclopramida Kern Pharma is an antiemetic. It contains an active substance called "metoclopramide". It acts on a region of the brain to prevent nausea or vomiting.

Adult population

Metoclopramida 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 associated with migraine.

Metoclopramide may be taken in combination with oral analgesics during migraine attacks to enhance the effectiveness of the analgesics.

Paediatric population

Metoclopramida Kern Pharma is indicated in children (1–18 years of age) when other treatments are ineffective or cannot be used, to prevent delayed nausea and vomiting that may occur after chemotherapy.

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

Do not take 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 tumour 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 Metoclopramide Kern Pharma with other medicines"),
• if you have ever had abnormal levels of blood pigments (methaemoglobinaemia) 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").

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

Warnings and precautions

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

• you have a history of abnormal heartbeats (prolongation of the QT interval) or any other heart problems,
• you have problems with levels of salts 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) problems,
• you have liver or kidney problems. Your dose may need to be reduced (see section 3).

Your doctor may carry out blood tests to monitor your blood pigment levels. If abnormal levels (methaemoglobinaemia) occur, treatment must be stopped immediately and permanently.

You should wait at least 6 hours between each dose of metoclopramide, even if you vomit or reject 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").

Use of Metoclopramide Kern Pharma with other medicines

Tell 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 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).

Taking Metoclopramide Kern Pharma with food, drink, and alcohol

Alcohol should not be consumed during treatment with metoclopramide, as it increases the sedative effect of Metoclopramide Kern Pharma.

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.

Metoclopramide Kern Pharma may be taken during pregnancy if considered necessary. Your doctor will decide whether this medicine should be administered.

Metoclopramide Kern Pharma is not recommended during breastfeeding, as 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 experience uncontrollable movements such as tics, jerks, or twisting and unusual muscle tone causing body distortion. This may affect your vision and may also impair your ability to drive or operate machinery.

Metoclopramide Kern Pharma contains propyl parahydroxybenzoate and methyl parahydroxybenzoate

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

3. How to take Metoclopramide Kern Pharma

Follow exactly the administration instructions for this medicine as indicated 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 daily.

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

The maximum duration of treatment is 5 days.

To prevent 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 of body weight, which may be repeated up to three times daily, taken by mouth (oral route).

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

Dosing table

Use the dosing cap provided in the oral solution pack 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 must wait at least 6 hours between each dose of metoclopramide, even in case of vomiting or dose rejection, to avoid overdose.

Elderly population

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

Adults with renal problems

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

Adults with hepatic problems

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 take more Metoclopramide 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 take Metoclopramide Kern Pharma

Do not take a double dose to make up for forgotten 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 occur at the beginning of treatment and may even appear after a single dose. These movements will cease when properly treated.

• high fever, high blood pressure, seizures, sweating, saliva production. 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 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 contractures (stiffness, rigidity)
• Parkinson-like symptoms (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 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, saliva production. 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 heart pressure) (particularly with intravenous administration)

• fainting (particularly with intravenous administration)

• allergic reaction which may be severe (particularly with intravenous administration)

• very high blood pressure

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. 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 components are: hydroxyethylcellulose, sodium saccharin, methyl p-hydroxybenzoate (E-218), propyl p-hydroxybenzoate (E-216), citric acid monohydrate, lemon flavour, lime flavour, purified water.

Appearance of the medicine and contents of the pack

Metoclopramide Kern Pharma is a solution packed in a 250 ml amber-coloured plastic bottle containing the solution and a 10 ml dosing cap for oral administration.

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 revision of this leaflet: November 2019

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