Metoclopramide Salf

Package leaflet: Information for the user

METOCLOPRAMIDE S.A.L.F. 10 mg/2 ml injectable solution

Metoclopramide hydrochloride monohydrate
Equivalent medicine
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What METOCLOPRAMIDE S.A.L.F. is and what it is used for
2. What you need to know before using METOCLOPRAMIDE S.A.L.F.
3. How to use METOCLOPRAMIDE S.A.L.F.
4. Possible side effects
5. How to store METOCLOPRAMIDE S.A.L.F.
6. Contents of the pack and other information

1. What METOCLOPRAMIDE S.A.L.F. is and what it is used for

This medicine contains the active substance metoclopramide hydrochloride monohydrate, which belongs to a group of medicines called "prokinetics" (antiemetics), used to prevent the sensation of nausea or vomiting.

METOCLOPRAMIDE S.A.L.F. is indicated in adults for:

• prevention of nausea and vomiting that may occur after surgical procedures;
• symptomatic treatment of nausea and vomiting, including nausea and vomiting caused by acute headache (acute migraine);
• prevention of nausea and vomiting induced by radiotherapy.

METOCLOPRAMIDE S.A.L.F. is indicated in children (aged between 1 and 18 years) only if other
treatments are not effective or cannot be used, for:

• prevention of nausea and vomiting that may occur after chemotherapy;
• treatment of nausea and vomiting that may occur after surgical procedures.

2. What you should know before using METOCLOPRAMIDE S.A.L.F.

Do not use METOCLOPRAMIDE S.A.L.F.

• if you are allergic to metoclopramide hydrochloride monohydrate or to any of the other ingredients of this medicine (listed in section 6);
• if you have bleeding, obstruction, or perforation of the stomach or intestine;
• if you have a confirmed or suspected tumour of the adrenal glands located near the kidneys (pheochromocytoma);
• if you have previously experienced involuntary muscle contractions (tardive dyskinesia) after taking medicines used for mental disorders (neuroleptics) or metoclopramide;
• if you suffer from epilepsy (with increased frequency and intensity of seizures);
• if you suffer from Parkinson's disease;
• if you are taking medicines for the treatment of Parkinson's disease (levodopa and dopaminergic agonists);
• if you have previously had blood disorders (methemoglobinemia, NADH cytochrome b5 reductase deficiency);
• if you suffer from glaucoma (increased pressure within the eyeball);
• in children under 1 year of age (see below "Children and adolescents").

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using METOCLOPRAMIDE S.A.L.F.
This medicine must be administered with great caution and under strict medical supervision:

• if you have neurological disorders or are taking medicines acting on the central nervous system. This medicine may worsen symptoms of Parkinson's disease and is therefore contraindicated in such cases (see section "Do not use METOCLOPRAMIDE S.A.L.F.");
• if you have heart problems (QT interval prolongation, bradycardia) or if you are taking medicines to regulate heart rhythm (which prolong the QT interval);
• if you have altered levels of salts in the blood such as potassium, sodium, and magnesium (electrolyte imbalance). Inform your doctor before using this medicine, as serious heart problems (circulatory collapse, severe bradycardia, cardiac arrest, and QT interval prolongation) may occur, especially if the medicine is administered intravenously;
• if you have kidney problems (renal impairment) or severe liver problems (hepatic impairment) (see section "Use in patients with kidney or liver problems").

Stop treatment with this medicine and consult your doctor in the following cases:

• if you develop muscle problems and uncontrolled movements (extrapyramidal disorders). These are particularly likely to occur in children and young adults. These effects usually occur at the beginning of treatment, after a single dose, or with high doses; they are generally reversible after discontinuation of the medicine;
• if movement disorders appear (tardive dyskinesia). This may occur especially after prolonged use and particularly in elderly patients. To reduce the risk of such effects, avoid using this medicine for longer than 3 months;
• if you experience muscle rigidity, high fever, changes in heart rhythm, seizures, sweating, or excessive salivation (neuroleptic malignant syndrome). Your doctor will determine appropriate treatment in such cases;
• if a blood disorder occurs (methemoglobinemia possibly related to NADH cytochrome b5 reductase deficiency). In this case, your doctor will determine appropriate treatment (such as methylene blue therapy).

Respect a minimum interval of at least 6 hours between two administrations (see section "How to use METOCLOPRAMIDE S.A.L.F."), even in case of vomiting and dose rejection, to avoid overdose.
This medicine must be administered slowly intravenously (slow bolus over at least 3 minutes) to reduce the occurrence of adverse effects such as low blood pressure (hypotension) or motor restlessness (akathisia).
Your doctor may perform blood tests. If a blood haemoglobin disorder (methaemoglobinaemia) occurs, treatment must be immediately and permanently discontinued.
Treatment should not exceed 3 months due to the risk of involuntary muscle spasms. If such symptoms occur, discontinue treatment.
Use of METOCLOPRAMIDE S.A.L.F. may lead to an increase in a substance called "prolactin". Your doctor will consider this possibility, especially if you have breast cancer or a benign tumour of the gland called "pituitary" (pituitary adenoma) causing prolactin production.

Children and adolescents
METOCLOPRAMIDE S.A.L.F. must not be administered to children under 1 year of age due to the higher risk of uncontrolled movements.
In children and adolescents, movement disorders (extrapyramidal disorders) may occur more frequently.

Other medicines and METOCLOPRAMIDE S.A.L.F.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
Do not use this medicine if you are taking:

• levodopa and dopaminergic agonists, medicines used for the treatment of Parkinson's disease.

If you are taking any of the following medicines, inform your doctor as they may interact with METOCLOPRAMIDE S.A.L.F:

• anticholinergics, medicines used to relieve stomach cramps or contractions;
• morphine derivatives, medicines used to relieve severe pain, as they may alter the effect of METOCLOPRAMIDE S.A.L.F;
• anxiolytics, sedating H1 antihistamines, sedating antidepressants, barbiturates, clonidine, and similar medicines that depress the central nervous system, as they may increase the sedative effect of these medicines and of METOCLOPRAMIDE S.A.L.F;
• neuroleptics, medicines used for mental disorders. Concurrent use with METOCLOPRAMIDE S.A.L.F. may worsen muscle disorders (extrapyramidal disorders);
• serotonergic medicines such as SSRIs, medicines used to treat mood disorders, as they may increase the risk of serotonin syndrome;
• digoxin, a medicine used to treat heart problems;
• cyclosporine, a medicine used to treat certain immune system disorders or in transplant patients;
• mivacurium and suxamethonium, medicines used to relax muscles; concurrent use may prolong the action of these medicines;
• fluoxetine and paroxetine, medicines used to treat depression;
• cisplatin: due to a possible increase in renal toxicity;
• insulin: your doctor may need to adjust the dose;
• rifampicin: a medicine used to treat tuberculosis and other infections; if taken concurrently, it may reduce metoclopramide blood levels;
• a medicine called apomorphine, as Plasil reduces its effects on the nervous system.

METOCLOPRAMIDE S.A.L.F. and alcohol
Avoid consuming alcohol during treatment with this medicine, as it may increase the sedative effect of the medicine.

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

Pregnancy
If you are pregnant, this medicine should be administered only if absolutely necessary and under direct medical supervision. Use of METOCLOPRAMIDE S.A.L.F. should be avoided towards the end of pregnancy, as it may cause movement disorders in the newborn (extrapyramidal syndrome). If you use METOCLOPRAMIDE S.A.L.F., your doctor will monitor your baby through neonatal monitoring.
Your doctor will decide whether or not you should take the medicine.

Breastfeeding
Use of METOCLOPRAMIDE S.A.L.F. is not recommended during breastfeeding, as this medicine passes into breast milk in small amounts and undesirable effects in the breastfed infant cannot be ruled out. Therefore, if you are breastfeeding, your doctor will consider discontinuing METOCLOPRAMIDE S.A.L.F.

Driving and using machines
This medicine may cause drowsiness, dizziness, vertigo, and uncontrolled muscle movements (dyskinesia, dystonia), which may affect vision. If you experience these effects, avoid driving vehicles or operating machinery.

METOCLOPRAMIDE S.A.L.F. contains sodium and sodium metabisulfite
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. it is practically 'sodium-free'.
This medicine contains sodium metabisulfite, which may rarely cause hypersensitivity reactions and bronchospasm.

3. How to use METOCLOPRAMIDE S.A.L.F.

This medicine will be administered to you by a doctor or nurse, and you must always follow the instructions given by the doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
This medicine will be administered via intramuscular injection or slow intravenous injection lasting at least 3 minutes, preferably before meals.
This medicine should be administered only for a short period of time, with an interval of at least 6 hours between doses, even in case of vomiting or regurgitation of the dose.
The vial can be opened without a file.

All indications (adult patients)
The doctor will determine the required dose according to your condition.
For the treatment of nausea and vomiting, including nausea and vomiting associated with acute migraine, and for the prevention of nausea and vomiting caused by radiotherapy: the recommended single dose is 10 mg, repeated up to 3 times daily.
The recommended single dose in adults for the prevention of postoperative nausea and vomiting is 10 mg. The recommended dose in adults for other therapeutic indications (listed in section 1) is 10 mg, repeatable up to a maximum of 3 times daily. The maximum daily dose is 30 mg or 0.5 mg/kg body weight.
The duration of injectable treatment should be as short as possible, switching as soon as possible to oral or rectal administration.

All indications (Use in children aged 1 to 18 years)
The recommended dose for intravenous administration ranges between 0.1 and 0.15 mg/kg body weight, repeatable up to three times daily, administered via slow intravenous injection. The maximum dose in a 24-hour period is 0.5 mg/kg body weight. The doctor will determine the required dose based on your child's weight and condition (see also information for doctors and healthcare professionals).
The maximum duration of treatment is 48 hours for the treatment of nausea and vomiting occurring after surgical procedures, and 5 days for the prevention of nausea and vomiting occurring after chemotherapy.
Administration of the drug at the indicated doses is recommended.

Use in children under 1 year of age
This medicine is contraindicated in children under 1 year of age.

Use in the elderly
The doctor will determine whether the dose should be reduced based on kidney and liver function.

Use in patients with kidney or liver problems
If you have kidney problems (renal insufficiency) or liver problems (hepatic insufficiency), the dose must be reduced (see also information for doctors and healthcare professionals).

If you use more METOCLOPRAMIDE S.A.L.F. than you should
Following administration of an excessive dose of this medicine, movement disorders (extrapyramidal symptoms), drowsiness, reduced level of consciousness, confusion, hallucinations, or heart and breathing blockage (cardiorespiratory arrest) may occur. The doctor will determine the appropriate treatment.
In case of accidental use or ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to use METOCLOPRAMIDE S.A.L.F.
A double dose must not be administered to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop treatment and speak immediately with your doctor, pharmacist or nurse if you experience any of the following symptoms during treatment with this medicine:

• Uncontrollable movements (often affecting the head or neck). These may occur in children or young adults, particularly when high doses are used. These symptoms usually appear at the beginning of treatment and may even occur after a single dose. These movements disappear if appropriately treated.
• High fever, high blood pressure, seizures, sweating, excessive salivation. These may be signs of a disorder called neuroleptic malignant syndrome.
• Itching or skin rashes, swelling of the face, lips or throat, difficulty breathing. These may be signs of an allergic reaction, which can be severe.

The side effects that may occur with METOCLOPRAMIDE S.A.L.F. are:
Very common (may affect more than 1 in 10 people)

• Drowsiness.

Common (may affect up to 1 in 10 people)

• Diarrhea
• Reduced muscle strength (asthenia)
• Disorders of muscle tone and involuntary movements such as tics, tremors, twisting movements (extrapyramidal disorders)
• Symptoms of Parkinson's disease (rigidity, tremors)
• Feeling of restlessness and agitation (akathisia)
• Mood disturbances (depression)
• Reduction in blood pressure (hypotension), especially when administered intravenously
• Feeling of weakness.

Uncommon (may affect up to 1 in 100 people)

• Slowing of the heartbeat (bradycardia), especially when administered intravenously
• Absence of menstrual periods (amenorrhea)
• Increased levels of prolactin in the blood (hyperprolactinemia), which may cause: milk production in men and women who are not breastfeeding
• Allergic reactions (hypersensitivity)
• Movement disorders (dystonia, dyskinesia)
• Reduced level of consciousness
• Hallucinations
• Visual disturbances and involuntary deviation of the eye.

Rare (may affect up to 1 in 1,000 people)

• Milk production in women who are not breastfeeding or in men (galactorrhea)
• Seizures, especially in epileptic patients
• Confusion.

Not known (frequency cannot be estimated from available data)

• Abnormal levels of blood pigment, which may change skin color (sulfhemoglobinemia)
• Abnormal levels of methemoglobin, a blood protein similar to hemoglobin (methemoglobinemia, which may be related to deficiency of NADH cytochrome b5 reductase, particularly in neonates, mainly with concomitant administration of high doses of medicines releasing sulfur)
• Heart block (cardiac arrest), particularly following injection
• Heart rhythm disorders (atrioventricular block, sinus arrest, especially when administered intravenously; prolongation of the QT interval on electrocardiogram, torsade de pointes)
• Abnormal development of breasts in men (gynecomastia)
• Severe allergic reactions (anaphylactic reaction, anaphylactic shock), especially when administered intravenously
• Involuntary muscle contractions (spasms) after prolonged use, particularly in elderly patients (dyskinesia)
• Muscle rigidity, high fever, changes in heart rate, seizures, sweating, salivation (neuroleptic malignant syndrome)
• Atrioventricular block and sinus arrest (particularly following injection)
• Severe drop in blood pressure (shock), particularly following injection
• Fainting (particularly when administered intravenously)
• Very high blood pressure
• Suicidal thoughts (suicidal ideation)

Additional side effects in children and adolescents

• Disorders of muscle tone and involuntary movements (extrapyramidal disorders).

The following reactions, sometimes occurring together, are more frequent when high doses are administered:

• Movement disorders (extrapyramidal disorders: acute dystonia and dyskinesia, parkinsonism, akathisia), even after a single dose of the medicine, particularly in children and young adults
• Drowsiness
• Reduced level of consciousness
• Confusion
• Hallucinations

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store METOCLOPRAMIDE S.A.L.F.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What METOCLOPRAMIDE S.A.L.F. contains

• The active substance is metoclopramide hydrochloride monohydrate: 1 vial contains 10.5 mg of metoclopramide hydrochloride monohydrate, equivalent to 10 mg of anhydrous metoclopramide hydrochloride.
• The other components are: sodium metabisulfite, sodium chloride, water for injections.

Description of the appearance of METOCLOPRAMIDE S.A.L.F. and contents of the pack
Box of 5 vials containing 10 mg/2 ml.
Marketing Authorization Holder and Manufacturer
S.A.L.F. SpA Laboratorio Farmacologico - Via Marconi, 2 - 24069 Cenate Sotto (BG)

Information for physicians and healthcare professionals
Posology and method of administration
Paediatric patients aged between 1 and 18 years: The recommended dose is 0.1 to 0.15 mg/kg body weight, repeatable up to three times daily by intravenous route. The maximum dose in 24 hours is 0.5 mg/kg body weight.
Dosage table

Renal impairment: In patients with end-stage renal disease (creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%.
In patients with moderate to severe renal impairment (creatinine clearance 15–60 ml/min), the daily dose should be reduced by 50%.
Hepatic impairment: In patients with severe hepatic impairment, the dose should be reduced by 50%.
For further information, consult the Summary of Product Characteristics.