10 mg film-coated tablets
metoclopramide hydrochloride
What Metoclopramide Alternova is and what it is used for
Metoclopramide Alternova 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 Alternova 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 can be taken with painkillers (taken by mouth) for migraines to get a better effect of the painkiller.
Children and young people
Metoclopramide Alternova 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 Alternova 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 use Metoclopramide Alternova
Do not use Metoclopramide Alternova
- 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 dopaminergic agonists (see below ‘Other medicines and Metoclopramide Alternova’)
- if you have ever had abnormal pigment levels in your blood (methemoglobinemia) or NADH cytochrome-b5 deficiency
Do not give Metoclopramide Alternova to children under 1 year of age (see below “Children and adolescents”).
Do not take Metoclopramide Alternova if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist, or nurse before taking Metoclopramide Alternova.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Metoclopramide Alternova 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 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 Alternova 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 Alternova”).
Other medicines and Metoclopramide Alternova
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The reason is that certain medicines may affect the way Metoclopramide Alternova works or that Metoclopramide Alternova 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 use Metoclopramide Alternova’)
- anticholinergics (medicines for stomach cramps or spasms )
- morphine derivatives (medicines used to treat severe pain)
- sedatives _ _
- 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)
- atovaquone, a remedy for a certain type of pneumonia and malaria
Metoclopramide Alternova with alcohol
Alcohol should not be consumed during treatment with metoclopramide as it increases the sedative ( sedative ) effect of Metoclopramide Alternova.
Pregnancy and breastfeeding
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 Alternova can be taken during pregnancy if necessary. Your doctor will decide if you should receive this medicine.
Metoclopramide Alternova 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 Alternova. 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 Alternova
Always use 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 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 Alternova is not suitable for use in children weighing less than 30 kg. Other dosage forms/strengths may be more suitable for administration.
Metoclopramide Alternova can cause dry mouth, which increases the risk of tooth decay (cavities ). Therefore, teeth should be thoroughly cleaned with fluoride toothpaste twice a day during treatment with Metoclopramide Alternova.
Method of administration
The tablet should be swallowed with a glass of water and usually taken before a meal.
The tablet can be divided into two equal doses.
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.
Elderly
Dose one may need to be lowered depending on kidney problems, liver problems, and general condition.
Other dosage forms/strengths may be more suitable for administration.
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.
Other dosage forms/strengths may be more suitable for administration.
Adults with liver problems
Talk to your doctor if you have liver problems. Dose one should be lowered if you have severe liver problems.
Other dosage forms/strengths may be more suitable for administration.
Children and young people
Metoclopramide should not be used in children under 1 year of age (see section 2).
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 such as tics , tremors, twisting movements or muscle contractions (stiffness, stiffness) (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 (may occur in up to 1 in 10 users).
- high fever, high blood pressure , cramps, sweating, salivation. It may be a symptom of a condition called malignant neuroleptic syndrome (occurring in an unknown number of users).
- itching or rash, swelling of the face, lips or throat, difficulty breathing. It may be a symptom of an allergic reaction , which may be severe (occurs in an unknown number of users).
Other side effects that may occur:
Very common (may affect more than 1 user in 10):
- Drowsiness
Common (may affect up to 1 in 10 people):
- Depression
- 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
- Decreased level of consciousness
- Slow heartbeat (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
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
- 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 (in patients with adrenal tumor ( pheochromocytoma ))
- Suicidal thoughts
How to store Metoclopramide Alternova
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 and blister after “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
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 active substance is metoclopramide hydrochloride
- The other ingredients are:
Tablet core: Corn starch; starch , pregelatinized corn; microcrystalline cellulose; silica, colloidal , anhydrous; stearic acid.
Film coating: Hypromellos (E 464); macrogols; titanium dioxide (E 171); talc.
What the medicine looks like and contents of the pack
Appearance
Metoclopramide Alternova 10 mg film-coated tablets are white to off-white round, biconvex film-coated tablets, 7 mm in diameter with a scoreline on both sides.
Pack sizes
Blister pack: 40 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Alternova A / S, Lodhusvej 11, 4230 Skælskør, Denmark
Manufacturer
Orifarm Generics A / S, Energivej 15, 5260 Odense S, Denmark