Package Insert: Information for the User

Primperan 1 mg/ml Oral Solution

Metoclopramide Hydrochloride

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

Primperan is an antiemetic. It contains a medication called “metoclopramide”. It acts on an area of the brain that prevents nausea or vomiting.

Adult population

Primperan 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

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

Pediatric population

Primperan 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 Primperan

• 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 treated with a medicine
• if you have epilepsy
• if you have Parkinson's disease
• if you are taking levodopa (medicine for Parkinson's disease) or dopamine agonists (see below "Other medicines and Primperan")
• if you have ever had abnormal levels of blood pigments (methemoglobinemia) or deficiency of NADH cytochrome b5 reductase.

Do not administer Primperan to children under 1 year (see below "Children and adolescents").

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before taking Primperan 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 using other medicines 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 control 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 medicine should not be used in children under 1 year due to the high risk of uncontrolled movements (see above "Do not take Primperan").

Other medicines and Primperan

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

• levodopa or other medicines used to treat Parkinson's disease (see above "Do not take Primperan")
• anticholinergics (medicines used to relieve stomach spasms or cramps)
• morphine derivatives (medicines used to treat intense pain)
• sedatives
• any medicine used to treat mental health problems
• digoxin (medicine used to treat heart failure)
• ciclosporin (medicine used to treat some immune system problems)
• mivacurium and suxamethonium (medicines used to relax muscles)
• fluoxetine and paroxetine (medicines used to treat depression)
• rifampicin (medicine used to treat tuberculosis or other infections), may reduce the amount of metoclopramide in the blood if taken at the same time.

Use of Primperan with alcohol

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Primperan may be taken during pregnancy if necessary. Your doctor will decide whether to administer this medicine.

Primperan is not recommended during breastfeeding because metoclopramide passes into breast milk and may affect your baby.

Driving and operating machinery

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

Primperan 1 mg/ml oral solution contains parahydroxybenzoate of methyl and parahydroxybenzoate of propyl

It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methyl and parahydroxybenzoate of propyl.

Primperan 1 mg/ml oral solution contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per 1 ml of oral solution; this is, essentially "sodium-free".

Primperan 1 mg/ml oral solution contains alcohol

This medicine contains 4.9 mg of alcohol (ethanol) per ml of oral solution, equivalent to 0.49% (p/v). The amount in 1 ml of oral solution of this medicine is equivalent to less than 0.12 ml of beer or 0.05 ml of wine.

The small amount of alcohol contained in this medicine does not produce any perceptible effect.

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 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 appear after chemotherapy (children 1-18 years old)

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 oral syringe for measurement provided in the oral solution container to administer the appropriate dose of metoclopramide.

The oral syringe for measurement is graduated in mg. The correspondence with body weight is detailed in the dose table. The dose is obtained by pulling the plunger until the corresponding mg graduation is reached.

The use of the oral syringe for measurement is restricted to the administration of this solution.

The oral syringe for measurement must be rinsed after each use.

The oral syringe for measurement must not be submerged in the bottle.

This medication should not be taken for more than 5 days to prevent delayed nausea and vomiting that may appear after chemotherapy.

Administration form

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

Special populations

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 Primperan than you should

Contact your doctor or pharmacist immediately. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsiness, 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 take Primperan

Do not take 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 can cause side effects, although not everyone will experience them.

Unknown frequency(frequency that cannot be estimated from available data)

• allergic reactions (such as anaphylaxis, angioedema, and urticaria).

The symptoms may include rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, coldness, moist skin, palpitations, dizziness, weakness, or fainting. Contact your doctor or another healthcare professional immediately or go to the nearest hospital emergency department immediately.

Discontinue treatment and immediately report to 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 in children and young adults and particularly when high doses are used. These signs usually appear 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 rashes, 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, torsion 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)

• high levels of a hormone called prolactin in the blood, 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
• convulsions (especially in patients with epilepsy).

Unknown frequency(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)
• fainting (particularly with intravenous administration)
• very high blood pressure
• suicidal thoughts.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://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 Primperan after the expiration date that appears on the packaging after CAD. 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 medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Primperan 1 mg/ml oral solution

• The active ingredient is metoclopramide hydrochloride. Each ml of oral solution contains 1 mg of metoclopramide hydrochloride.

• The other components are: hydroxyethylcellulose, sodium cyclamate, sodium saccharin, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), citric acid monohydrate, orange-apricot flavor (contains ethanol), purified water.

Appearance of the product and contents of the packaging

It is a transparent, viscous, colorless to slightly amber liquid with an aromatic orange and apricot odor.

This oral solution is packaged in a 200 ml bottle and includes an oral syringe for measurement.

Other presentations:

Primperan 10 mg tablets: Bottles with 30 and 60 tablets

Primperan 10 mg/2 ml injectable solution: Bottle with 12 ampoules of 2 ml

Marketing authorization holder

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing

A. Nattermann & Cie. GmbH

Nattermannallee, 1

50829 Cologne

Germany

Last review date of this leaflet: September 2023

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