5 mg / ml solution for injection
metoclopramide
What Primperan is and what it is used for
Primperan is an antiemetic (medicine for nausea and vomiting). It contains a substance called metoclopramide. It acts on an area of the brain that prevents you from getting nauseous and vomiting.
Adults
Primperan is used in adults to:
- prevent nausea and vomiting that may occur after surgery
- treat nausea and vomiting, including nausea and vomiting that may occur with migraines
- prevent nausea and vomiting caused by radiation therapy.
Children and young people
Primperan is used in children (aged 1-18 years) if other treatment does not work or can not be used to:
- prevent delayed nausea and vomiting that may occur after chemotherapy
- treat nausea and vomiting that have occurred after surgery.
What you need to know before using Primperan
Do not use Primperan
- if you are allergic to metoclopramide or any of the other ingredients of this medicine (listed in section 6.1)
- if you have bleeding, obstruction, or ulcers in the gastrointestinal tract
- if you have or may have a rare adrenal tumor ( pheochromocytoma )
- if you have ever had involuntary muscle twitching ( tardive dyskinesia ), after being treated with medication
- if you have epilepsy
- if you have Parkinson’s disease
- if you are taking levodopa (a medicine used to treat Parkinson’s disease ) or dopamine agonists (see below “Other medicines and Primperan”)
- if you have ever had abnormal pigment levels in your blood (methemoglobinemia) or
- or NADH cytochrome ‑ b5 deficiency
Primperan should not be given to children under 1 year of age (see below “Children and adolescents”).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Primperan if:
- you have had an abnormal heart rhythm ( QT prolongation) or other heart problems
- you have high blood pressure
- you have problems with salt levels in the blood, such as potassium, sodium, and magnesium
- you are using other medicines that affect your heart rhythm
- you have a neurological condition (nerve or muscle disease)
- you have kidney or liver problems. Dose one may need to be reduced (see section 3).
Your doctor may need to take blood samples to check your pigment levels in the blood. In case of abnormal levels (methemoglobinemia), treatment should be stopped immediately and permanently.
Do not exceed three months of treatment due to the risk of involuntary muscle twitching.
Children and young people
Involuntary movements (extrapyramidal disorders) may occur in children and adolescents. Primperan must not be used in children under 1 year of age due to the increased risk of involuntary movements (see above “Do not use Primperan”).
Other medicines and Primperan
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. The reason is that certain drugs can affect how Primperan works or that Primperan can affect how other drugs work. These medicines include the following:
- levodopa or other medicines used to treat Parkinson’s disease (see above “Do not use Primperan”)
- anticholinergics (medicines for stomach cramps or spasms )
- morphine derivatives (medicines used to treat severe pain)
- sedative (sedative) drugs, also include some antihistamines with a sedative effect
- drugs for the treatment of psychosis and depression, such as fluoxetine and paroxetine
- digoxin (a drug for the treatment of heart failure )
- ciclosporin (medicines used to treat certain disorders of the immune system)
- mivacurium and suxamethone (muscle relaxants)
- atovaquone, a remedy for a certain type of pneumonia and malaria
Primperan with alcohol
Alcohol should not be consumed during treatment with metoclopramide as it increases the sedative (calming/calming) effect of Primperan.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Primperan can be taken during pregnancy if necessary. Your doctor will decide if you should receive this medicine.
Primperan is not recommended if you are breastfeeding because metoclopramide passes into breast milk and may affect your baby.
Driving and using machines
You may feel drowsy and dizzy. Extrapyramidal side effects such as involuntary movements and abnormal muscle tension may occur after taking Primperan. This may affect your ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Primperan
The medicine will normally be given to you by a doctor or nurse. It will be given as a slow injection into a vein (for at least 3 minutes) or by injection into a muscle.
There must be at least 6 hours between each dose of Primperan to avoid overdose.
Adults:
For the treatment of nausea and vomiting including nausea and vomiting that may occur in migraine and for the prevention of nausea and vomiting during radiation therapy: The recommended single dose is 10 mg, which can be repeated up to 3 times daily.
The maximum recommended dose per day is 30 mg or 0.5 mg/kg body weight.
To prevent nausea and vomiting that may occur after surgery, a single dose of 10 mg is recommended.
Children and adolescents (1-18 years):
The recommended dose is 0.1 to 0.15 mg/kg body weight, which can be repeated up to three times a day, given as a slow injection into a vein.
The maximum dose for 24 hours is 0.5 mg/kg body weight.
| Age | Bodyweight | Dose | Frequency |
| 1-3 years | 10-14 kg | 1 mg | Up to 3 times daily |
| 3-5 years | 15-19 kg | 2 mg | Up to 3 times daily |
| 5-9 years | 20-29 kg | 2.5 mg | Up to 3 times daily |
| 9-18 years | 30-60 kg | 5 mg | Up to 3 times daily |
| 15-18 years | Over 60kg | 10 mg | Up to 3 times daily |
Treatment should not exceed 48 hours for the treatment of nausea and vomiting that have occurred after surgery.
Treatment should not exceed 5 days for the prevention of delayed nausea and vomiting that may occur after chemotherapy.
Elderly
Dose one may need to be lowered depending on kidney problems, liver problems, and general condition.
Adults with kidney problems
Talk to your doctor if you have kidney problems. Dose one should be lowered if you have moderate or severe kidney problems.
Adults with liver problems
Talk to your doctor if you have liver problems. Dose one should be lowered if you have severe liver problems.
Children and young people
Metoclopramide should not be used in children under 1 year of age (see section 2).
If you take more Primperan than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your treatment. Always ask if you are unsure why you are receiving a dose of medicine.
The following symptoms may occur if you get too much Primperan: involuntary movements (extrapyramidal disorders), drowsiness, decreased level of consciousness, confusion, hallucinations, and heart problems. Tell your healthcare provider if you experience any of these symptoms. In that case, your doctor will prescribe treatment for these symptoms as needed.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Talk to your doctor, pharmacist, or nurse immediately if you get any of the following symptoms while taking this medicine, then treatment must be stopped:
- involuntary movements or muscle contractions (often involving the head or neck). It can occur in children or adolescents and especially when high doses are used. These symptoms usually appear at the beginning of treatment and may even occur after a single dose. These movements will cease after they have been treated appropriately.
- high fever, high blood pressure, cramps, sweating, salivation. It may be a symptom of a condition called a malignant neuroleptic syndrome.
- itching or rash, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cold sweaty skin, palpitations, dizziness, weakness, or fainting. It can be a symptom of an allergic reaction, which can be serious.
The following side effects may occur:
Very common (may affect more than 1 user in 10)
- fatigue and increased need for sleep.
Common (may affect up to 1 in 10 people)
- Depression
- involuntary movements such as tics, tremors, twisting movements, or muscle contractions (stiffness, stiffness)
- symptoms similar to Parkinson’s disease (stiffness, tremors)
- restlessness
- lowering of blood pressure (especially with intravenous administration )
- diarrhea
- feeling weak.
Uncommon (may affect up to 1 in 100 people)
- elevated levels in the blood of a hormone called prolactin, which can cause: milk production in men and in women who are not breastfeeding
- irregular menstruation
- hallucinations
- impaired consciousness
- slow heart rhythm (especially with intravenous administration )
- allergy
- dry mouth
- rash
- visual disturbances and involuntary eye movements
Rare (may affect up to 1 in 1,000 people)
- state of confusion
- seizures (especially in patients with epilepsy )
- high blood pressure
- hives
No known frequency (can not be calculated from the available data)
- allergic reactions (such as anaphylaxis, angioedema, and hives ). Symptoms may include rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cold sweaty skin, palpitations, dizziness, weakness, or fainting. Contact a doctor or other healthcare professional immediately or see the nearest emergency department.
- Abnormal levels of blood pigments that can change the color of your skin
- abnormal development of the breast ( gynecomastia )
- involuntary muscle spasms after prolonged use, especially in elderly patients
- high fever, high blood pressure, cramps, sweating, salivation. It can be a symptom of a condition called neuroleptic malignant syndrome
- changes in heart rate that can be seen on an ECG test
- cardiac arrest (especially with injection )
- shock (severe decrease in heart pressure) (especially with injection )
- fainting (especially with intravenous administration )
- increase in blood pressure et
- very high blood pressure
- suicidal thoughts
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address
5. How to store Primperan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. or EXP. The expiration date is the last day of the specified month.
6. Contents of the pack and other information
Content declaration
- The active substance is metoclopramide
- The other ingredients are sodium chloride 7.5 mg, water for injections
What the medicine looks like and the contents of the pack
Each pack contains 12 glass ampoules of 2 ml
Marketing Authorisation Holder
Sanofi AB, Box 30052, 104 25 Stockholm