Leaflet: information for the user

Metoclopramide Kern Pharma 1 mg/ml oral solution EFG

Read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Metoclopramide Kern Pharma 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. Storage of Metoclopramide Kern Pharma

6. Contents of the pack and additional information

Metoclopramida Kern Pharma is an antiemetic. It contains an active ingredient called “metoclopramida”. It acts on an area of the brain that prevents nausea or vomiting.

Adult population

Metoclopramida Kern Pharma is used in adults:

• to prevent delayed nausea and vomiting that may appear after chemotherapy,
• to prevent nausea and vomiting caused by radiation therapy,
• to treat nausea and vomiting, including nausea and vomiting that may appear with a migraine.

Metoclopramida can be taken in combination with oral analgesics in the case of migraine so that the analgesics are more effective.

Pediatric population

Metoclopramida 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 appear after chemotherapy

Do not take Metoclopramida Kern Pharma

• if you are allergic to metoclopramide or any of the other components of this medication (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),

(pheochromocytoma),

• if you have ever had involuntary muscle spasms (tardive dyskinesia) when treated with a medication,
• if you have epilepsy,
• if you have Parkinson's disease,
• if you are taking levodopa (medication for Parkinson's disease) or dopamine agonists (see below “Use of Metoclopramida Kern Pharma with other medications”),
• if you have ever had abnormal levels of blood pigments (methemoglobinemia) or deficiency of NADH cytochrome b5 reductase.

Do not administer Metoclopramida Kern Pharma to children under 1 year (see below “Children and adolescents”).

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

Warnings and precautions

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

• you have a history of abnormal heartbeats (prolongation of the QT interval) or any other heart problem

• you have problems with the levels of salts in your blood, such as potassium, sodium, and magnesium
• you are taking other medications known to affect the way your heart beats
• you have any neurological problem (brain)
• you have problems in the liver or kidneys. The dose may be reduced (see section 3).

Your doctor may perform blood tests to monitor your levels of blood pigments. In cases of abnormal levels (methemoglobinemia), treatment should be stopped 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

Uncontrolled movements (extrapyramidal disorders) may appear in children and young adults.

This medication should not be used in children under 1 year due to the high risk of uncontrolled movements (see above “Do not take Metoclopramida Kern Pharma”).

Use of Metoclopramida Kern Pharma with other medications

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication. This is because some medications may affect the way metoclopramide works or metoclopramide may affect the way other medications work. These medications include:

• levodopa or other medications used to treat Parkinson's disease (see above “Do not take Metoclopramida Kern Pharma”).

• anticholinergics (medications used to relieve stomach spasms or cramps),
• opioid derivatives (medications used to treat intense pain),
• sedatives,
• any medication used to treat mental health problems,
• digoxin (medication used to treat heart failure),
• ciclosporin (medication used to treat some immune system problems),
• mivacurium and suxamethonium (medications used to relax muscles),
• fluoxetine and paroxetine (medications used to treat depression).

Taking Metoclopramida Kern Pharma with food, drink, and alcohol

Do not consume alcohol during treatment with metoclopramide as it increases the sedative effect of Metoclopramida 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 medication.

Metoclopramida Kern Pharma may be taken during pregnancy if necessary. Your doctor will decide whether to administer this medication.

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

Driving and operating machinery

After taking Metoclopramida Kern Pharma, you may feel drowsy, dizzy, or have uncontrolled movements of tics, tremors, or muscle tone that cause body distortion. This may affect your vision and also interfere with your ability to drive and operate machinery.

Metoclopramida Kern Pharma contains propylparaben and methylparaben

It may cause allergic reactions (possibly delayed) because it contains propylparaben (E-216) and methylparaben (E-218).

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, 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 daily recommended 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 appear after chemotherapy (children aged 1-18 years)

The recommended dose is 0.1 to 0.15 mg/kg of 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 of body weight.

Dose table

Use the dosing plug included in the oral solution container to administer the appropriate dose of metoclopramide.

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

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

Administration form

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.

Geriatric population

It may be necessary to reduce the dose depending on kidney problems, liver problems, and general health problems.

Adults with renal problems

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

Adults with liver problems

Inform 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 (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), feel drowsy, have some consciousness problems, be confused, have hallucinations, and heart problems. Your doctor may prescribe 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 medication and the amount ingested.

If you forgot to take Metoclopramide Kern Pharma

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor, nurse, or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop treatment and immediately inform your doctor, pharmacist, or nurse if

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

• uncontrollable movements (which often affect the head and neck). These may appear normally at the beginning of treatment and may even occur after a single administration. These movements will cease when properly treated.

• high fever, high blood pressure, convulsions, sweating, salivation. These may be signs of a condition called malignant neuroleptic syndrome.
• itching and skin rash, facial, lip, or throat inflammation, 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 drowsy

Common(may affect up to 1 in 10 people)

• depression
• uncontrollable movements such as tics, tremors, twisting movements, or muscle contractions (rigidity, stiffness)
• symptoms similar to Parkinson's disease (rigidity, tremor)
• feeling restless
• decreased blood pressure (particularly with intravenous administration)
• diarrhea
• feeling weak

Uncommon(may affect up to 1 in 100 people)

• elevated levels of a hormone called prolactin in the blood that 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
• convulsions (especially in patients with epilepsy)

Frequency not known(frequency that cannot be estimated from available data)

• abnormal levels of blood pigments: which may 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, salivation. These may be signs of a condition called malignant neuroleptic syndrome
• changes in heartbeats, which may be seen on an ECG (electrocardiogram)
• cardiac arrest (particularly with intravenous administration)
• shock (intense drop in blood pressure) (particularly with intravenous administration)
• syncope (fainting) (particularly with intravenous administration)
• severe allergic reaction (particularly with intravenous administration)
• very high blood pressure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for human use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use Metoclopramida Kern Pharma after the expiration date that appears on the packaging and in the bottle. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and the

medicines that you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Metoclopramida Kern Pharma 1 mg/ml oral solution

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

Appearance of the product and content of the container

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

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus 72,

08228 Terrassa (Barcelona)

Spain

Last review date of this leaflet: November 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/