What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 36301/0011 .


Neo-cytamen 1000 micrograms/ml Solution for Injection

Patient Information Leaflet:

Neo-Cytamen® 1000 micrograms/ml Solution for Injection Hydroxocobalamin

Read all of this leaflet carefully before you are given this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • In this leaflet, Neo-Cytamen® 1000 micrograms/ml Solution for Injection will be called Neo-Cytamen.

In this leaflet:

1. What Neo-Cytamen is for
2. 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. Further information.

1. What Neo-Cytamen is for

Neo-Cytamen is a form of Vitamin B12, an essential vitamin which is needed for production of red blood cells.

Neo-Cytamen is used to prevent and treat certain types of anaemia, including Addisonian pernicious anaemia, and other kinds of anaemia which result from a deficiency of Vitamin B12.

It is also used to treat conditions called tobacco amblyopia and Leber’s optic atrophy, which result in a dimming of vision.

2. Before you are given Neo-Cytamen

You should not be given Neo-Cytamen if:

  • 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.

Check with your doctor before being given Neo-Cytamen if:

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

Tell your doctor if you are taking any of the following medicines:

  • 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

Pregnancy and breast-feeding

Neo-Cytamen should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated.

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.

Driving and using machines

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

3. How you will be given Neo-Cytamen

Neo-Cytamen will be given to you by your doctor or nurse.

Important:

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.

Adults and Children

  • 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.

Medical check-ups

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 are given more Neo-Cytamen than you should

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.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines Neo-Cytamen can cause side effects, although not everybody gets them. These are:

Effects on the heart and blood

  • Low blood potassium levels and irregular heart beat during the early stages of treatment

Effects on the eyes and skin

  • Hypersensitivity reactions including skin reactions (such as rash, itching)
  • Exceptionally, anaphhylaxis (which may include collapse and difficulty in breathing)
  • Acne-like rash
  • Blisters
  • Pain at the injection site
  • Feeling of ‘pins and needles’

Effects on the stomach and bowel

  • Feeling unwell or sick
  • Being sick
  • Diarrhoea

Effects on the nervous system

  • Dizziness
  • Headache

Other effects

  • Fever
  • Chills
  • Hot flushes
  • Pain.

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 side effects directly via Yellow Card Scheme on the MHRA website (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 Neo-Cytamen

Keep this medicine out of the sight and reach of children.

Do not use Neo-Cytamen after the expiry date on the label. The expiry date refers to the last day of that month.

Store below 25°C. Keep Neo-Cytamen in the original packaging in order to protect it from light.

Your doctor or nurse will make sure your medicine is correctly stored and disposed of.

6. Further information

What Neo-Cytamen contains

The active substance is Hydroxocobalamin at a strength of 1000 micrograms (1 mg) per ml of solution.

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

What Neo-Cytamen looks like

Neo-Cytamen® 1000 micrograms/ml Solution for Injection is a sterile solution.

It comes in packs of 5 ampoules, each containing 1 ml of solution.

Marketing Authorisation Holder

RPH Pharmaceuticals AB
Lagervagen 7
136 50 Haninge
Sweden

Manufacturer

Wasserburger Arzneimittelwerk GmbH
Herderstraße 2
D-83512 Wasserburg
Germany

This leaflet was last updated January 2018

® Neo-Cytamen is a Registered Trade Mark

If this leaflet is difficult to see or read or you would like it in a different format, please contact:

RPH Pharmaceuticals AB
Lagervagen 7
136 50 Haninge
Sweden

700355

Code 355