Leaflet: Information for the user

Metoclopramide Kern Pharma 10 mg/2 ml injectable solution EFG

Metoclopramide hydrochloride

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.

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

Pediatric population

Metoclopramida Kern Pharma is used in children (1-18 years of age) only if other treatments do not work or cannot be used:

• to prevent delayed nausea and vomiting that may appear after chemotherapy
• to treat nausea and vomiting that may appear after an operation.

Do not use Metoclopramida Kern Pharma

• if you are allergic to metoclopramide or any of the other ingredients 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)
• if you have ever had involuntary muscle spasms (tardive dyskinesia) when treated with this medication
• if you have epilepsy
• if you have Parkinson's disease
• if you are taking levodopa (medication for treating 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 NADH cytochrome b5 deficiency.

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

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.

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 use 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 the following:

• 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)
• derivative morphine (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)
• mivacurio and suxametonio (medications used to relax muscles)
• fluoxetina and paroxetina (medications used to treat depression)

Use of Metoclopramida Kern Pharma with food, drink, and alcoholand alcohol

Do not consume 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

If necessary, Metoclopramida Kern Pharma may be used during pregnancy. Your doctor will decide whether or not to administer this medication.

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

Driving and operating machinery

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

Metoclopramida Kern Pharma contains sodium

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

This medication will be administered by a doctor or nurse. It will be given as a slow injection into a vein (for at least 3 minutes) or as a muscle injection.

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 radiation therapy: 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 of body weight.

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

All indications (pediatric patients 1-18 years old)

The recommended dose is 0.1 to 0.15 mg/kg of body weight, which can be repeated up to 3 times a day, administered slowly into a vein.

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

Dose table

Treatment should not exceed 48 hours for nausea and vomiting that occur after surgery.

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

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 Kern Pharma should not be used in children under 1 year (see section 2).

If you use more Metoclopramide Kern Pharma than you should

Contact your doctor or pharmacist immediately. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have some problems with consciousness, 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Metoclopramide Kern Pharma

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

If you have any other questions 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, inflammation 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 drowsy

Common(may affect up to 1 in 10 people)

• depression
• uncontrollable movements such as tics, jerks, 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 blood levels of a hormone called prolactin 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.

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side 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: https://www.notificaram.es. By reporting side 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.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of packaging and medications you no longer need if you are unsure. By doing so, you will help protect the environment.

Composition of Metoclopramida Kern Pharma

• The active ingredient is metoclopramide hydrochloride. Each ampule of 2 ml contains 10 mg of metoclopramide hydrochloride.
• The other components are: sodium chloride and water for injectable preparations.

Appearance of the product and content of the container

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

Each container contains 6 or 12 ampules of 2 ml.

Some container sizes may only be marketed.

Other presentations:

Metoclopramida Kern Pharma 1 mg/ml oral solution: Bottle of 250 ml

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Colón II Industrial Estate, 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 (AEMP S)http://www.aemps.gob.es/