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Neo-cytamen 1000 micrograms/ml Solution for Injection

Active Ingredient:
hydroxocobalamin
Company:  
RPH Pharmaceuticals AB See contact details
ATC code: 
B03BA03
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 26 Jul 2024
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

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

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PIL - Neo-Cytamen 1000 mcg/ml solution for injection (35743)

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.
  • 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

In this leaflet:

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.

1. What Neo-Cytamen is and what it is used for

Neo-Cytamen 1000 micrograms/ml solution for injection contains hydroxocobalamin, a form of Vitamin B12, which is an essential vitamin which is needed for production of red blood cells.

Vitamin B12 contains cobalt.

It 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.

In this leaflet, Neo-Cytamen® 1000 micrograms/ml solution for injection will be called Neo-Cytamen.

2. What you need to know 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.

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

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 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.

Driving and using machines

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

Neo-Cytamen contains sodium

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

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.

Tell your doctor immediately if you experience any of the following symptoms after you have been given the injection, these symptoms can be serious.
  • 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

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 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.

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 25ºC. 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. Contents of the pack and other information
What Neo-Cytamen contains

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.

What Neo-Cytamen looks like

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

It comes in packs of 5 ampoules.

Marketing Authorisation Holder
RPH Pharmaceuticals AB
Box 603
101 32 Stockholm
Sweden

Manufacturer
Biologici Italia Laboratories S.r.I
Via Filippo Serpero 2
20060 Masate (MI)
Italy

This leaflet was last revised in 06/2024

® 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
Box 603
101 32 Stockholm
Sweden

RPH Pharmaceuticals AB
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Address
Box 603, 101 32 Stockholm, Sweden
WWW
www.recipharm.com
Telephone
+44 (0)845 023 0467
Medical Information Direct Line
+44 207 862 1716
Medical Information e-mail
[email protected]
Customer Care direct line
+44(0)845 023 0467
Stock Availability
+44(0)845 023 0467
E-mail
[email protected]