Maxolon Sr
Package leaflet: Information for the patient MAXOLON® SR (Metoclopramide hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you..
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor ,pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Maxolon SR is and what it is used for
2. What you need to know before you take Maxolon SR
3. How to take Maxolon SR
4. Possible side effects
5. How to store Maxolon SR
6. Contents of the pack and other information
1. WHAT MAXOLON SR IS AND WHAT IT IS USED FOR
The name of your medicine is Maxolon SR. Maxolon SR capsules contain the active ingredient Metoclopramide Hydrochloride BP 15 mg which belongs to a group of medicines called antiemetics. It works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting).
Adult population
Maxolon SR is used in adults:
- to prevent delayed nausea and vomiting that may occur after chemotherapy
- to prevent nausea and vomiting caused by radiotherapy
- to treat nausea and vomiting including nausea and vomiting which may occur with a migraine. Metoclopramide can be taken with oral painkillers in case of migraine to help painkillers work more effectively.
Paediatric population
Maxolon SR is indicated in children (aged 1-18 years) if other treatment does not work or cannot be used to prevent delayed nausea and vomiting that may occur after chemotherapy
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAXOLON SR Do not take Maxolon SR:
• 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 a tear in your stomach or gut.
• if you have or may have a rare tumour of the adrenal gland, which sits near the kidney (pheochromocytoma).
• if you have ever had involuntary muscle spasms (tardive dyskinesia), when you have been treated with a medicine.
• if you have epilepsy
• if you have Parkinson’s disease
• if you are taking levodopa (a medicine for Parkinson’s disease) or dopaminergic agonists (see below “Other medicines and Maxolon SR”)
• if you have ever had an abnormal blood pigment levels (methaemoglobinemia) or NADH cytochrome-b5 deficiency
• if you have had surgery on your digestive system in the last 3-4 days;
Do not give Maxolon SR to a child less than 1 year of age (see below “Children and adolescents”). Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Maxolon SR
- if you have a history of abnormal heart beats (QT interval prolongation) or any other heart problems
- if you have problems with the levels of salts in your blood, such as potassium, sodium and magnesium.
- if you are using other medicines known to affect the way your heart beats
- if you have any neurological (brain) problems
- if you have liver or kidney problems. The dose may be reduced (see section 3).
Your doctor may perform blood tests to check your blood pigment levels. In cases of abnormal levels (methaemoglobinemia), the treatment should be immediately and permanently stopped.
You must wait at least 12 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Do not exceed 3-month treatment because of the risk of involuntary muscle spasms.
Children and adolescents
Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults. This medicine must not be used in children below 1 year of age because of the increased risk of the uncontrollable movements (see above “Do not take Maxolon SR if’).
Other medicines and Maxolon SR
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because some medicines can affect the way Maxolon SR works or Maxolon SR can affect how other medicines work. These medicines include the following:
- levodopa or other medicines used to treat Parkinson’s disease (see above “Do not take Maxolon SR if”)
- anticholinergics (medicines used to relieve stomach cramps or spasms)
- morphine derivatives (medicines used to treat severe pain)
- sedative medicines
- any medicines used to treat mental health problems
- digoxin (medicine used to treat heart failure)
- cyclosporine (medicine used to treat certain problems with the immune system)
- mivacurium and suxamethonium (medicines used to relax muscles)
- fluoxetine and paroxetine (medicine used to treat depression)
- atovaquone, used to treat pneumonia.
Maxolon SR with food, drink and alcohol
Alcohol should not be consumed during treatment with metoclopramide because it increases the sedative effect of Maxolon SR.
Pregnancy, breast-feeding and fertility
Pregnancy:
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. If necessary, Maxolon SR may be taken during pregnancy. Your doctor will decide whether or not you should be given this medicine. Breast-feeding:
Maxolon SR is not recommended if you are breast-feeding because metoclopramide passes into breast milk and may affect your baby.
Driving and using machines
You may feel drowsy, dizzy or have uncontrollable twitching, jerking or writhing movements and unusual muscle tone causing distortion of the body after taking Maxolon SR. This may affect your vision and also interfere with your ability to drive and use machines.
| Maxolon SR contains Sucrose
Tell your doctor before taking this medicine if you have been told that you have an intolerance to some sugars. This is because Maxolon SR contains sucrose, a type of sugar.
3. HOW TO TAKE MAXOLON SR
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended single dose is 15 mg, repeated up to twice daily.
The maximum recommended dose per day is 30 mg or 0.5 mg/kg body weight.
The maximum recommended treatment duration is 5 days.
Use in Children and adolescents
To prevent delayed nausea and vomiting that may occur after chemotherapy (children aged 118 years)
The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to 3 times daily, taken by mouth (oral route).
The maximum dose in 24 hours is 0.5 mg/kg body weight.
Dosing table
|
Age |
Body Weight |
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 |
Instruction for use
You should not take this medicine for more than 5 days to prevent delayed nausea and vomiting that may occur after chemotherapy.
Maxolon SR is not suitable for use in children weighing less than 61 kg. Other pharmaceutical forms/strengths may be more appropriate for administration.
Method of administration
You must wait at least 12 hours between each metoclopramide dose, even in case of vomiting and rejection of the dose, in order to avoid overdose.
Elderly people
The dose may need to be reduced depending on kidney problems, liver problems and overall health. Adults with kidney problems
Talk to your doctor if you have kidney problems. The dose should be reduced if you have moderate or severe kidney problems.
Adults with liver problems
Talk to your doctor if you have liver problems. The dose should be reduced if you have severe liver problems.
Use in Children and adolescents
Metoclopramide must not be used in children aged less than 1 year (see section 2).
If you take more Maxolon SR than you should
Contact your doctor or pharmacist straight away. You may experience uncontrollable movements (extrapyramidal disorders), feel drowsy, have some troubles of consciousness, be confused, have hallucination and heart problems. Your doctor may prescribe you a treatment for these signs if necessary.
If you forget to take Maxolon SR
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop the treatment and talk straight away to your doctor, pharmacist or nurse if you experience one of the following signs while having this medicine:
Common (may affect up to 1 in 10 people)
- uncontrollable movements (often involving head or neck) tics, shaking, twisting movements or muscle contracture (stiffness, rigidity)
These may occur in children or young adults and particularly when high doses are used. These signs usually occur at the beginning of treatment and may even occur after one single administration. These movements will stop when treated appropriately.
- symptoms similar to Parkinson disease (rigidity, tremor)
Rare (may affect up to 1 in 1,000 people)
- convulsion (especially in patients with epilepsy).
Not known (frequency cannot be estimated from the available data)
- high fever, high blood pressure, convulsions, sweating, production of saliva. These may be signs of a condition called neuroleptic malignant syndrome.
- Itching or skin rashes, swelling of the face, lips or throat, difficulty in breathing. These may be signs of a serious allergic reaction, which may be severe.
- cardiac arrest (particularly with injection route)
Other side effects
Very common (may affect more than 1 in 10 people)
• feeling drowsy.
Common (may affect up to 1 in 10 people)
• depression
• feel restless
• blood pressure decrease (particularly with intravenous route)
• diarrhoea
• feeling weak.
Uncommon (may affect up to 1 in 100 people)
• raised levels of a hormone called prolactin in the blood which may cause: milk production in men, and women who are not breast-feeding
• irregular periods
• hallucination
• decreased level of consciousness
• slow heartbeat (particularly with intravenous route)
• allergy
Rare (may affect up to 1 in 1,000 people)
• confusional state
Not known (frequency cannot be estimated from the available data)
• abnormal blood pigment levels: which may change the colour of your skin
• abnormal development of breasts (gynaecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• changes in heart beat, which may be shown on an ECG test
• shock (severe decrease of heart pressure) (particularly with injection route)
• fainting (particularly with intravenous route)
• allergic reaction which may be severe (particularly with intravenous route)
• sudden increase in blood pressure in patients with tumour of the adrenal gland (pheochromocytoma)
• very high blood pressure.
Other side effects may include:
• disturbances in your vision
• increase or decrease in blood pressure
• tremors
• dizziness
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
You can also report any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Maxolon SR
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is printed on the carton. The expiry date refers to the last day of that month Protect from direct sunlight.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Maxolon SR contains
The active substance is metoclopramide hydrochloride. Each capsule contains 15 mg of metoclopramide hydrochloride.
The other ingredients are: sucrose, maize starch, gelatin, dibutyl phthalate, talc, polymethacrylates and black iron oxide.
What Maxolon SR looks like and content of the pack
Maxolon SR are colourless, transparent capsules with ‘Maxolon SR 15’ printed on the side, containing white microgranules.
Maxolon SR is available in polypropylene containers and blister packs of 8, 14 or 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amdipharm UK Limited,
Capital House,
85 King William Street,
London EC4N 7BL,
UK
Manufacturer
Eurand Laboratories 14 Rue du Clos Barrois,
ZI. de Nogent-Sur-Oise,
60183 Nogent Cedex, France.
This leaflet was last revised in August 2016
Maxolon is a registered trademark of Amdipharm Mercury International Limited
7