10 mg tablets
metoclopramide hydrochloride
What Metoclopramide Accord is and what it is used for
Metoclopramide Accord is an antiemetic (anti-nausea medicine). It contains a substance called metoclopramide. It acts on an area of the brain that prevents you from getting nauseous and vomiting.
Adults:
Metoclopramide Accord is used in adults
- to prevent delayed nausea and vomiting that may occur after chemotherapy
- to prevent nausea and vomiting caused by radiation therapy
- to treat nausea and vomiting including nausea and vomiting that may occur with migraine .
Metoclopramide Accord can be taken with painkillers (taken by mouth) for migraines to get the better effect of the painkiller.
Children and young people
Metoclopramide Accord is used in children (aged 1-18 years) if other treatments do not work or can not be used to prevent delayed nausea and vomiting that may occur after chemotherapy.
Metoclopramide hydrochloride contained in Metoclopramide Accord 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 using Metoclopramide Accord
Do not use Metoclopramide Accord
- 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 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 have ever had involuntary muscle twitching ( tardive dyskinesia ) after being treated with a medicine.
- if you have epilepsy .
- if you have Parkinson’s disease .
- if you are taking levodopa (a medicine used to treat Parkinson’s disease ) or a dopaminergic agonist (see below ‘Other medicines and Metoclopramide Accord’).
- if you have ever had abnormal pigment levels in your blood (methemoglobinemia) or NADH cytochrome b5 deficiency.
Do not give Metoclopramide Accord to children under 1 year of age (see below “Children and adolescents”).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Metoclopramide Accord:
- if you have had an abnormal heart rhythm ( QT prolongation) or other heart problems.
- if you have problems with salt levels in your blood, such as potassium , sodium and magnesium .
- if you are taking other medicines that are known to affect your heart rhythm.
- if you have neurological problems (brain and spinal cord).
- if 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 Accord, even if you are not allowed to keep a dose such as in case of vomiting, to avoid overdose.
Children and young people
Involuntary movements (extrapyramidal disorders) can occur in children and adolescents.
This medicine must not be used in children under 1 year of age due to the increased risk of involuntary movements (see above “Do not take Metoclopramide Accord”).
Other medicines and Metoclopramide Accord
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 Accord works or that Metoclopramide Accord 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 Metoclopramide Accord’)
- 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 Accord with food, drink and alcohol
Alcohol should not be consumed during treatment with metoclopramide as it increases the sedative ( sedative ) effect of Metoclopramide Accord.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Metoclopramide Accord can be taken during pregnancy if necessary. Your doctor will decide if you should receive this medicine.
Metoclopramide Accord 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, twitches, and abnormal muscle tension that cause the body to distort after taking Metoclopramide Accord. 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. A description 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.
Metoclopramide Accord contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Metoclopramide Accord
Always take this medicine exactly as your doctor or pharmacist 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 three 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.
The maximum dose for 24 hours is 0.5 mg/kg body weight.
The 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 |
Instructions for use:
You should not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.
Metoclopramide Accord is not suitable for use in children weighing less than 30 kg.
Other dosage forms/strengths may be more suitable for administration to this patient group.
Method of administration
Swallow the tablet with a glass of water.
You must wait at least 6 hours between each dose of metoclopramide, even if you are not allowed to keep a dose such as in case of vomiting, to avoid overdose.
Older
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.
Use for children and adolescents
Metoclopramide Accord should not be used in children under 1 year of age (see section 2).
If you use more Metoclopramide Accord than you should
Contact a doctor or pharmacist immediately. 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 Accord
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). This 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, saliva production. This may be a sign of a condition called malignant neuroleptic syndrome.
- itching or rash, swelling of the face, lips or throat, difficulty breathing. This may be a sign of an allergic reaction , which may be severe.
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
- impaired consciousness
- slow heart rhythm (especially with intravenous administration )
- allergy
- 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 )
No known frequency (can not be calculated from the available data)
- 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, saliva production This may be a sign of a condition called malignant neuroleptic syndrome
- changes in heart rate that can be seen on an ECG test
- cardiac arrest (especially with intravenous administration )
- shock (severe decrease in heart pressure) (especially with intravenous administration )
- fainting (especially with intravenous administration )
- allergic reaction which may be severe (especially with intravenous administration )
- very high blood pressure
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are 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
How to store Metoclopramide Accord
- Keep this medicine out of the sight and reach of children
- Do not store above 30 ° C.
- Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
- The medicine 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 pack and other information
Content declaration
The name of this medicine is Metoclopramide Accord. The active substance is metoclopramide hydrochloride.
Metoclopramide Accord contains 10 mg metoclopramide hydrochloride.
The other ingredients are lactose monohydrate, pregelatinized starch, corn starch, colloidal anhydrous silica, and magnesium stearate.
What the medicine looks like and contents of the pack
White to off-white, round biconvex tablet, marked with “BD” on one side and notched on the other side.
The tablet can be divided into two equal parts.
The tablets are packaged in PVC / PVDC / aluminum blisters.
The carton contains 20, 24, 28, 30, 40, 50, 60, 84, 100 or 500 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 kV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow
Middlesex HA1 4HF
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland