PATIENT INFORMATION LEAFLET - UK GB 726-8758-APIL 8093545-04

Maxolon* Injection 5 mg / ml
(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 the 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 Injection is and what it is used for 2. Before you are given Maxolon Injection 3. How you will be given Maxolon Injection 4. Possible side effects 5. How to store Maxolon Injection 6. Further Information 1. WHAT MAXOLON INJECTION IS AND WHAT IT IS USED FOR The name of your medicine is Maxolon Injection. Maxolon Injection contains the active ingredient Metoclopramide Hydrochloride BP which belongs to a group of medicines called antiemetics. Maxolon Injection is used to treat problems in adults such as: Feeling sick (nausea) and being sick (vomiting) caused by, amongst other things, diseases of the digestive system, heart problems and by treatments such as radiotherapy and antitumour drugs. Pain and discomfort of problems such as indigestion, heartburn, wind, sickness and bringing up bile. These problems can be caused by acid rising from the stomach, hiatus hernia, inflammation or ulcer of the upper part of your digestive system, gallstones or after an operation to remove gallstones. Migraines to stop nausea and vomiting and to help painkillers work more effectively. Maxolon Injection is used to treat severe vomiting or is given before surgery in children and adolescents (aged 1-20 years). 2. BEFORE YOU TAKE MAXOLON INJECTION Do not take Maxolon Injection if you: are allergic to metoclopramide hydrochloride or any of the other ingredients of Maxolon Injection; have a tumour in your adrenal gland (phaeochromocytoma); have had surgery on your digestive system in the last 3-4 days; have been told by your doctor that you have a blockage, bleeding or a tear in your digestive system; are in early stages of pregnancy or are breast-feeding; have epilepsy; Maxolon Injection should not be given to children under the age of 1 year.

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 how 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 INJECTION Maxolon Injection will be given to you as injection into a muscle, or as a slow injection into a vein (taking 1-2 minutes). Your doctor will work out the correct dose for you based on your weight. The usual doses taken to treat a condition are: Adults 21 years and over: 10 mg given three times a day. 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. For diagnostic purposes a single dose of Maxolon may be given 5-10 minutes before investigations of the upper digestive system: Adults 21 years and over: 10-20 mg. 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 are given more Maxolon Injection 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 (only in the elderly who are on long term treatment), 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; increase or decrease in blood pressure; tremors; dizziness. Rare: drowsiness; confusion; anxiety; diarrhoea; heart problems such as a very low heart rate; agitation. 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 Injection 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 INJECTION KEEP OUT OF THE REACH AND SIGHT OF CHILDREN Do not use Maxolon Injection after the expiry date which is printed on the pack. Protect from light. o Do not store above 25 C 6. FURTHER INFORMATION What Maxolon Injection contains Maxolon Injection contains 10 mg of the active ingredient metoclopramide hydrochloride BP. Other inactive ingredients are: sodium chloride, sodium metabisulphite and water for injection. What Maxolon Injection looks like and content of the pack Maxolon Injection is a clear, colourless solution available in clear glass 2 ml ampoules, in packs of 1 or 12 ampoules or 1 ampoule and 12 tablets in an aluminium canister as a home visit pack. Marketing Authorisation Holder Amdipharm plc, Regency House, Miles Gray Road, Basildon, Essex, SS14 3AF.

Take special care with Maxolon Injection 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. Maxolon when given intravenously in patients with any heart problems can cause irregular heart beats, palpitations, fainting or dizziness. Please 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.

Manufacturer responsible for release: Kern Pharma SL, Poligono Ind. Colon II, C/Venus 72, 08228 Terrassa, Barcelona, Spain.
Date of last revision: June 2011 * Trade mark