INFORMATION FOR CONSUMERS
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Please read this leaflet carefully before you are given NEO-CYTAMEN.
This leaflet answers some common questions about NEO-CYTAMEN. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the expected benefits of you receiving NEO-CYTAMEN against the risks this medicine could have for you.
If you have any concerns about being given NEO-CYTAMEN, ask your doctor or pharmacist.
Keep this leaflet. You may want to read it again.
NEO-CYTAMEN contains the active ingredient hydroxocobalamin (vitamin B12).
Vitamin B12 is important for the function of several key body enzymes. It is needed for physical growth and development and for formation of red blood cells in the bone marrow. This vitamin is also needed for the body to absorb folic acid and carbohydrates in the diet and for keeping the nervous system healthy.
Only small daily amounts of vitamin B12 are required. Deficiency of vitamin B12 may take months or years to develop, but eventually leads to anaemia, a condition in which the amount of oxygen-carrying pigment (haemoglobin) in the blood is reduced. Symptoms of vitamin B12 deficiency anaemia include sore mouth and tongue, numbness and tingling in the arms and legs, memory loss and depression. The most common type of vitamin B12 deficiency anaemia is Addisonian pernicious anaemia, in which absorption of vitamin B12 from the stomach does not take place properly.
NEO-CYTAMEN is used to replace the body's low vitamin B12 levels caused by:
NEO-CYTAMEN is also used to treat tobacco amblyopia (smoker's blindness) and another eye condition called Leber's optic atrophy.
Your doctor may have prescribed NEO-CYTAMEN for another purpose.
Ask your doctor if you have any questions about why NEO-CYTAMEN has been prescribed for you.
NEO-CYTAMEN is available only with a doctor's prescription, and is given as an injection by a doctor or nurse.
Do not take NEO-CYTAMEN if:
Tell your doctor if:
NEO-CYTAMEN can be used to treat vitamin B12 deficiency anaemia occurring during pregnancy (except for a condition called megaloblastic anaemia).
It is not known if hydroxocobalamin, the active ingredient in NEO-CYTAMEN, passes into breast milk, so it is recommended that you avoid breast feeding unless your doctor says you can.
If you have not told your doctor about any of the above, please do so before being given NEO-CYTAMEN.
Some medicines may affect the way others work.
Tell your doctor if you are taking any other medicines, including the oral contraceptive pill or medicines you buy without a prescription from a pharmacy, supermarket or health food shop.
If you are taking any of the following types of medicines, please let your doctor know before taking NEO-CYTAMEN:
Your doctor or pharmacist will be able to tell you more about what to do when you are given NEO-CYTAMEN while taking other medicines.
Your doctor will tell you how many NEO-CYTAMEN injections you need and how often.
For Addisonian pernicious anaemia and most other types of vitamin B12 deficiency anaemia, providing your nervous system is not affected, the usual dose is 250µg to 1000µg every second day for up to two weeks, then 250µg once a week until your vitamin B12 levels are normal. A 1000µg injection is often then given every two to three months to keep your vitamin B12 levels in the normal range. If your nervous system has been affected, the starting dose is 1000µg every second day, then 1000µg every two months, providing your condition is improving.
For vitamin B12 deficiency anaemia caused by stomach surgery, stomach disorders in which vitamin B12 is not absorbed normally and strict vegetarianism, the usual dose is 1000µg every two to three months.
If you have smoker's blindness or Leber's optic atrophy, the usual starting dose is at least 1000µg given every day for two weeks, then twice weekly, providing you are responding well. Your doctor may then give you a 1000µg injection once a month.
Depending on the disorder you are being given NEO-CYTAMEN for, you may need regular injections long term.
Your doctor may do regular blood tests to make sure NEO-CYTAMEN is working effectively for you.
NEO-CYTAMEN is given as an injection into a muscle by a doctor or nurse.
If you think that you or anyone else has been given too much NEO-CYTAMEN tell your doctor immediately. You can also telephone the National Poisons Information Centre [Ph (03) 474-7000] for advice or go to the Accident & Emergency service at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you are unsure what to do, ring your doctor or pharmacist.
Tell all doctors and pharmacists involved in your health care that you are being given NEO-CYTAMEN.
Tell your doctor if you become pregnant while receiving NEO-CYTAMEN.
Tell your doctor if you feel that NEO-CYTAMEN is not helping your condition.
Do not take any other medicines whether they require a prescription or not without first asking your doctor or a pharmacist.
Do not drive or operate machinery until you know how NEO-CYTAMEN is affecting you.
All medicines can have unwanted side effects. Sometimes they may be serious, but often they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Be sure that your doctor or pharmacist knows as soon as possible if you do not feel well after you have been given NEO-CYTAMEN.
If you think NEO-CYTAMEN is causing you to have an allergic (hypersensitivity) reaction, TELL YOUR DOCTOR IMMEDIATELY. Symptoms include:
Very occasionally, NEO-CYTAMEN can cause a sudden severe allergic reaction (anaphylaxis) soon after the injection. You should not leave your doctor's surgery after a NEO-CYTAMEN injection until your doctor says you can.
Tell your doctor if you notice any unusual acne-like eruptions on your skin.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not mentioned here.
Ask your doctor or pharmacist if you do not understand anything about the possible side effects of NEO-CYTAMEN.
NEO-CYTAMEN is stored at a doctor's surgery, hospital or pharmacy in cool dry place away from light.
NEO-CYTAMEN is a clear red solution supplied in a single-dose ampoule.
Hydroxocobalamin, Sodium chloride, Acetic acid, Water
Your doctor is the best person to give you advice on the treatment of your condition. You may also be able to find general information about its treatment from other sources, for example, books in public libraries and on the Internet.
NEO-CYTAMEN is supplied by:
GlaxoWellcome (New Zealand) Ltd
Quay Tower
Cnr Albert & Customs Sts
Private Bag 106600
Downtown, Auckland
NEW ZEALAND
Ph (09) 367-2900
Fax (09) 367-2910
This leaflet was prepared in October 2000, Issue 1. It is copyrighted to GlaxoWellcome (New Zealand) Ltd and may be reproduced but not altered in any way.
NEO-CYTAMEN is a trademark of the GlaxoWellcome Group of Companies.