Maxolon High Dose
Out of date information, search anotherProspecto 160 j
PATIENT INFORMATION LEAFLET - UK
102882/LF/1
8093548-04
Maxolon* High Dose
(Metoclopramide Hydrochloride BP)
Read all of this leaflet carefully before you start taking this medicine.
- Please keep this leaflet. You may need to read It again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others; It may harm them, even if their symptoms are the same as yours.
- If any of trie side effects becomes severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Maxolon High Dose is and what it is used for
2. Before you take Maxolon High Dose
3. How to take Maxolon High Dose
4. Possible side effects
5. How to store Maxolon High Dose
6. Further Information
1. WHAT MAXOLON HIGH DOSE IS AND WHAT IT IS USED FOR
The name of your medicine is Maxolon High Dose. Maxolon High Dose contains the active ingredient Metoclopramide Hydrochloride BP which belongs to a group of medicines called antiemetics.
Maxolon High Dose is used to help adults to stop feeling sick (nausea) and adults or children being sick (vomiting) caused by treatments such as radiotherapy and antitumour drugs.
2. BEFORE YOU TAKE MAXOLON HIGH DOSE Do not take Maxolon High Dose if you:
• are allergic to metoclonramide nydrochloride
or any ofthe other ingredients of Maxolon High Dose;
• have a tumour in your adrenal gland (phaeochromocytoma);
• nave had surgery on your digestive system in the last 3-4 days;
• havejieenjold by your doctor that you have a
• haveep1lepsy;9eS° P 69 3 Cy° 3 6 63S 66 9’
• Maxolon Injection should not be given to children under the age of 1 year.
Take special care with Maxolon High Dose if you have:
• severe liver or kidney problems:
• a history of allergic asthma or other allergic type reactions;
• an uncommon inherited blood disorder called porphyria. If any of these apply to you, please see your doctor before being treated with Maxolon,
o
AMDIPHARM
Maxolon when given intravenously in patients with any heart problems can cause irregular heart beats,
Kations, fainting or dizziness.
; inform your doctor if you have any heart problems.
If vomiting persists, even when you are taking this medicine, you should talk to your doctor.
Taking other medicines
Tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including those obtained without a prescription.
This is especially important if you are taking:
• painkillers, such as aspirin and paracetamol;
• any medicine belonging to a group called anticholinergic medicines, such as atropine, scopolamine or suxamethonium;
• levodopa, bromocriptine and pergolide used to treat Parkinson's Disease;
• ciclosporin, an immunosuppressant medicine;
• any medicines for mental health problems;
• a medicine used to control movement disorders in conditions such as Huntington's Chorea called tetrabenazine;
• any medicine used to treat depression: Selective Serotonin Reuptake Inhibitors (SSRIs) such as fluoxetine or citalopram; Monoamine Oxidase Inhibitors (MAOIs) such as procarbazine;
• any other medicine taken by mouth, as the dose may be affected by Maxolon;
• atovaquone, used to treat pneumonia.
Taking Maxolon with food and drink
Alcohol should be avoided when you are taking Maxolon.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or are trying to become pregnant, please tell your doctor before taking Maxolon. Maxolon is not recommended for use in the early stages of pregnancy.
Maxolon passes into the breast milk therefore breast-feeding is not recommended while taking Maxolon.
Driving and using machines You can drive while being treated with Maxolon, but do not drive until you know now it affects you. It may make you feel drowsy or dizzy and could cause movement disorders, if it affects you in this way, do not drive or operate machinery.
3. HOW TO TAKE MAXOLON HIGH DOSE
Maxolon High Dose will be given to you as a drip, usually over a few hours. Your doctor will work out the correct dose for you based on your weight.
Dose:
The usual dose given to adults is 2-4 mg/kg of body weight for the first 15-20 minutes before you receive your radiotherapy or other antitumour medicine. The dose will then change to 3-5 mg/Kg of body weight either over the course of a few hours or repeated every 2 hours for 15 minutes.
Paediatric population including adolescents (aged 1-20 years):
0.15 mg/kg as a slow infusion (at least 3 minutes) per dose. The maximum daily dose is 0.5 mg/kg over 24 hours. Each dose of 0.15 mg/kg should be separated by at least 6 hours, even if vomiting continues, to avoid an overdose.
If you feel unwell at the end of your treatment, or continue to be sick please tell your doctor.
If you are given more Maxolon High Dose than you should
It is unlikely that you will be given more Maxolon than you should, however a doctor would treat any symptoms that follow.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Maxolon can cause side effects although not everybody gets them.
If you notice:
• itching or skin rashes;
• swelling of the face, lips or throat;
• difficulty in breathing or wheeziness,
Seek medical advice immediately. These may be signs of an allergic reaction.
If you notice:
• a very high fever;
• loss of consciousness;
• stiff muscles;
• slurred speech;
• odd tongue or eye movements;
• body spasms;
• unnatural position of the head and shoulders;
• slow repeated movements, such as head nodding
a in the elderly who are on long term treatment), ing the medicine and seek medical advice immediately.
Other side effects may include:
• raised prolactin levels in the blood. Symptoms include; milk production in men, and women who are not breast-feeding; irregular periods; breast tissue growth in men;
• repetitive muscle contractions, leading to jerky and twisted movements;
• disturbances in your vision;
• drowsiness;
• confusion;
• anxiety;
• increase or decrease in blood pressure;
• agitation;
• tremors;
• dizziness;
• diarrhoea.
Very rare:
• neart problems such as a very low heart rate.
Extremely rare:
• depression;
• Maxolon may affect the blood and cause breathing problems, headache and tiredness. The lips, nail beds and ears may look blue. If this happens stop taking Maxolon High Dose and get in touch with your doctor.
If any of the side effects becomes severe, or if you notice a side effect not listed in the leaflet, please tell your doctor or pharmacist immediately.
5. HOW TO STORE MAXOLON HIGH DOSE
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN
Do not use Maxolon High Dose after the expiry date which is printed on the pack.
Protect from light.
6. FURTHER INFORMATION What Maxolon High Dose contain
Maxolon High Dose contains 100 mg of the active ingredient metoclopramide hydrochloride BP.
Other inactive ingredients are: sodium chloride and water for injections.
What Maxolon High Dose looks like and content of the pack
Maxolon High Dose is a clear, colourless solution available in clear glass 20 ml ampoules, packed in boxes
Marketing Authorisation Holder and Manufacturer
Amdipharm UK Limited,
Capital House,
85 King William Street,
London EC4N 7BL,
UK
|
0 | |
|
AMDIPHARM | |
|
PRODUCT NAME: |
Maxolon 100mg/20ml High |
|
Dose | |
|
PIP CODE: |
102882/LF/l |
|
COMPONENT: |
Leaflet |
|
SIZE: |
160 x 204 mm |
|
MARKET: |
Great Britain |
|
COMMODITY NO.: | |
|
PRODUCT SITE: |
TBC |
|
SCALE: |
100% |
|
COLOURS: |
Black |
|
DATE: |
02/12/2013 |
|
FONT SIZE: |
7 pt |
|
VERSION NO: |
1 |
|
AMENDED BY: |
AMCo |
|
PROJECT: |
CAC |
REGULATORY AUTHORITY APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA IMB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market.
Accept Artwork ................................................................
Reject Artwork.................................................................
Signature..........................................................................
Name................................................................................
Date...................................................................................
Manufacturer responsible for release:
Kern Pharma SL,
Poligono Ind. Colon II,
C/Venus 72, 08228 Terrassa,
Barcelona, Spain.
This leaflet was last revised in December 2013.
* Trade mark