10 mg film-coated tablets
metoclopramide hydrochloride
What Metoclopramide Orion is and what it is used for
Metoclopramide Orion 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
Metoclopramide Orion is used in adults:
- to prevent delayed
- to prevent nausea and vomiting caused by radiation therapy
- to treat nausea and vomiting including nausea and vomiting that may occur with migraine .
Metoclopramide can be taken with painkillers (taken orally) for migraines to get the better effect of the painkiller.
Children and young people
Metoclopramide Orion 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.
Metoclopramide contained in Metoclopramide Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Metoclopramide Orion
Do not take Metoclopramide Orion:
- if you are allergic to metoclopramide or anything
- if you have bleeding, obstruction or ulcers in the gastrointestinal tract
- if you have or may have a rare tumor in the adrenal gland, which is located near the kidney ( pheochromocytoma ).
- if you ever
- if you take
- if you have ever had abnormal pigment levels in your blood (methemoglobinemia) or NADH cytochrome-b5 deficiency
Do not give Metoclopramide Orion to children under 1 year of age (see below “Children and adolescents”).
Do not take Metoclopramide Orion if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Metoclopramide Orion.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Metoclopramide Orion if:
- you have had an abnormal heart rhythm ( QT prolongation) or other heart problems
- 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 neurological (brain) problems
- you have liver or kidney 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.
You must wait at least 6 hours between each dose of metoclopramide, even if you are not allowed to keep one dose (eg for vomiting or diarrhea), to avoid overdose.
Do not exceed three months of treatment due to the risk of involuntary muscle twitching.
Children and young people
Involuntary movements (extrapyramidal disorders) can occur in children and adolescents. Metoclopramide Orion must not be used in children under 1 year of age due to the increased risk of involuntary movements (see above “Do not use Metoclopramide Orion”).
Other medicines and Metoclopramide Orion
Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines. The reason is that some medicines may affect the way Metoclopramide Orion works or that Metoclopramide Orion may affect the way other medicines work. These medicines include the following:
- levodopa
- anticholinergics (medicines for stomach cramps or spasms )
- morphine derivatives (medicines used to treat severe pain)
- soothing ( sedative ) drugs
- medicines used in mental illness
- digoxin (drug for the treatment of heart failure )
- ciclosporin (medicines used to treat certain disorders of the immune system)
- mivacurium and suxamethone (medicines used to relax muscles)
- fluoxetine and paroxetine (medicines used to treat depression)
Metoclopramide Orion with alcohol
Alcohol should not be consumed during treatment with metoclopramide as it increases the sedative ( sedative ) effect of Metoclopramide Orion.
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. Metoclopramide Orion can be taken during pregnancy if necessary. Your doctor will decide if you should receive this medicine.
Metoclopramide Orion 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, dizzy, or have involuntary movements (cramps, twitching) and abnormal muscle tension that causes the body to distort after taking Metoclopramide Orion. This can affect your vision and also 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 attention. 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 Metoclopramide Orion
Always use Metoclopramide Orion exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults
The recommended single dose is 10 mg, which can be repeated up to 3 times daily.
The highest recommended dose per day is 30 mg or 0.5 mg/kg body weight.
The maximum recommended treatment time is 5 days.
To prevent delayed nausea and vomiting that may occur after chemotherapy (children aged 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, by mouth ( oral administration ).
The maximum dose for 24 hours is 0.5 mg/kg body weight.
Dosage table
| 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 60 kg | 10 mg | Up to 3 times daily |
You should not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.
Metoclopramide Orion is not suitable for use in children weighing less than 30 kg. Other dosage forms/strengths may be more suitable for administration.
The tablet can be divided into equal doses.
Method of administration
You must wait at least 6 hours between each dose of metoclopramide, even if you are not allowed to keep it (eg in case of vomiting or diarrhea), to avoid overdose.
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 use more Metoclopramide Orion than you should
You may experience involuntary movements (extrapyramidal disorders), drowsiness, decreased consciousness, confusion, hallucinations, and heart problems. Your doctor may prescribe treatment for these symptoms as needed.
If you forget to use Metoclopramide Orion
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment and talk to your doctor, pharmacist, or nurse immediately if you get any of the following symptoms while taking this medicine:
- involuntary movements (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 can be a symptom of a condition called neuroleptic malignant syndrome.
- itching or rash, swelling of the face, lips or throat, difficulty breathing. 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)
- drowsiness.
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
- visual disturbances and involuntary eye movements
- impaired consciousness
- slow heart rhythm (especially with intravenous administration )
- allergy
- rash.
Rare (may affect up to 1 in 1,000 people)
- state of confusion
- seizures (especially in patients with epilepsy )
- high blood pressure
- hives.
Has been reported (occurs in an unknown number of users)
- Abnormal levels of blood pigments: which 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 )
- allergic reaction which may be severe (especially with intravenous administration )
- suicidal thoughts.
How to store Metoclopramide Orion
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 carton.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is metoclopramide hydrochloride.
- The other ingredients are corn starch, pregelatinized starch , microcrystalline cellulose, anhydrous colloidal silica, stearic acid, hypromellose, macrogol, titanium dioxide (E171), talc.
What the medicine looks like and contents of the pack
White or almost white, round, biconvex film-coated tablet with a diameter of 7 mm and a score line on both sides.
Pack sizes: 20, 30, 40, 50 and 100 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com