Neo-cytamen 1000 micrograms/ml Solution for Injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse . This includes any possible side effects not listed in this leaflet. See section 4

1. What Neo-Cytamen is and what it is used for
2. What you need to know before you are given Neo-Cytamen
3. How you will be given Neo-Cytamen
4. Possible side effects
5. How to store Neo-Cytamen
6. Contents of the pack and other information.

• You are allergic to the active ingredient, hydroxocobalamin
• You are allergic to any of the other ingredients of Neo-Cytamen (see section 6.).

If the above applies to you talk to your doctor or nurse.

• You are pregnant or are planning to become pregnant.
• You are breast-feeding.

Talk to you doctor or nurse if you have a known cobalt allergy.

• Antibiotics (for treating infections) or antimetabolites (medicines which stop cells dividing, such as mercaptopurine for leukaemia), as these treatments may interfere with tests to measure the levels of Vitamin B12 in your blood or urine
• An antibiotic called chloramphenicol, as you may not respond well to Neo-Cytamen
• The contraceptive 'pill'
• Any other medicine, including medicines obtained without a prescription.

Neo-Cytamen should not be used for the treatment of megaloblastic anaemia of pregnancy unless you have a vitamin B₁₂ deficiency.

Neo-Cytamen is found in breast-milk but it is unlikely that it will harm your baby.

If you are pregnant, trying to become pregnant or are breast-feeding, ask your doctor or nurse for advice before being given Neo-Cytamen.

Neo-Cytamen may cause dizziness. If this happens to you, do not drive or use ,machinery.

This medicine contains less than 1mmol sodium (23 mg) per 1ml, that is to say essentially “sodium-free”.

Your doctor will choose the dose that is right for you.

You will be given Neo-Cytamen by your doctor or nurse as an injection into a muscle. You may be given it just once or it may be repeated every other day, weekly or monthly, depending on how much your body needs.

• Treatment of anaemia:
  • Without neurological (nervous system) involvement:
    Initially 250 – 1000 micrograms, every other day for 1 to 2 weeks, then 250 micrograms weekly until the blood tests are normal.
    Maintenance dose: 1000 micrograms every 2 to 3 months.
  • With neurological involvement:
    1000 micrograms every other day for as long as improvement is noticed.
    Maintenance dose: 1000 micrograms every 2 months.
• Prevention of anaemia:
  1000 micrograms every 2 to 3 months.
• Tobacco amblyopia and Leber’s optic atrophy:
  Initially 1000 micrograms or more daily for 2 weeks, then twice weekly for as long as improvement is noticed.
  Maintenance dose: 1000 micrograms monthly.

While you are receiving this medicine, your doctor will want you to have regular blood tests to check your condition. This is to make sure that your medicine is working properly and that the dose you are receiving is right for you.

If you think you have been given too much Neo-Cytamen, you are unlikely to need any special treatment. However, if you suffer any discomfort or side effects you should tell your doctor.

• swelling of the lips, tongue or throat, difficulty in breathing, skin rash and redness (these may be symptoms of a serious allergic reaction)
• irregular heartbeat (caused by low levels of potassium in the blood) during early stages of treatment.

Other possible side effects (frequency not known)

• Acne-like rash
• Blisters
• Pain at the injection site
• Feeling of ‘pins and needles’
• Feeling unwell or sick
• Being sick
• Diarrhoea
• Dizziness
• Headache
• Fever
• Chills
• Hot flushes
• Pain.
• Unusually coloured urine
• Too may platelets in the blood

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 side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.. By reporting side effects you can help provide more information on the safety of this medicine.

Each 1ml ampoule of Neo-Cytamen solution for injection contains 1000 micrograms of the active ingredient hydroxocobalamin (as hydroxocobalamin chloride).

The other ingredients are sodium chloride, acetic acid and water for injection.

Neo-Cytamen® is a clear red-brown solution.

It comes in packs of 5 ampoules.