Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Neo-cytamen 1000 micrograms/ml Solution for Injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hydroxocobalamin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
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 NeoCytamen.
What you need to know before you take it
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 "sodiumfree".
How to take it
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.
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.
How to store it
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.
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.
Frequently asked questions about Neo-cytamen 1000 micrograms/ml Solution for Injection
How do I take Neo-cytamen 1000 micrograms/ml Solution for Injection?
Neo-cytamen 1000 micrograms/ml Solution for Injection comes as injection containing 1000micrograms/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Neo-cytamen 1000 micrograms/ml Solution for Injection?
The active substance in Neo-cytamen 1000 micrograms/ml Solution for Injection is hydroxocobalamin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Neo-cytamen 1000 micrograms/ml Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Neo-cytamen 1000 micrograms/ml Solution for Injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: hydroxocobalamin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Addisonian pernicious anaemia.
Prophylaxis and treatment of other macrocytic anaemias associated with vitamin B12 deficiency.
Tobacco amblyopia and Leber's optic atrophy.
4.2. Posology and method of administration
Posology
Adults and Children
Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement:
Initially:
250 to 1000mcg on alternate days for one to two weeks, then 250mcg weekly until the blood count is normal.
Maintenance:
1000mcg every two to three months.
Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement:
Initially:
1000mcg on alternate days as long as improvement is occurring
Maintenance:
1000mcg every two months.
Prophylaxis of macrocytic anaemia associated with vitamin B12 deficiency resulting from gastrectomy, some malabsorption syndromes and strict vegetarianism:
1000mcg every two to three months.
Tobacco amblyopia and Leber's optic atrophy:
Initially
1000mcg or more daily for two weeks. Then twice weekly as long as improvement is occurring.
Maintenance:
1000mcg monthly.
Method of administration
Intramuscular injection
4.3. Contraindications
Hypersensitivity to any ingredient of the preparation.
Neo-Cytamen should not be used for treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated.
4.4. Special warnings and precautions for use
The dosage schemes given above are usually satisfactory, but regular examination of the blood is advisable.
If megaloblastic anaemia fails to respond to hydroxocobalamin, folate metabolism should be investigated.
Doses in excess of 10mcg daily may produce a haematological response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis. The haematological and neurological state should be monitored regularly to ensure adequacy of therapy.
Cardiac arrhythmias
Cardiac arrhythmias secondary to hypokalaemia during initial therapy have been reported. Plasma potassium should therefore be monitored during this period.
Reactive thrombocytosis
Platelet count should be monitored during the first weeks of use in megaloblastic anaemia due to the possible occurrence of reactive thrombocytosis.
Sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'
4.5. Interaction with other medicinal products and other forms of interaction
Chloramphenicol
Chloramphenicol-treated patients may respond poorly to Neo-Cytamen.
Oral contraceptives
Serum concentrations of hydroxocobalamin may be lowered by oral contraceptives but this interaction is unlikely to have clinical significance.
Antimetabolites and most antibiotics invalidate vitamin B12 assays by microbiological techniques.
4.6. Fertility, pregnancy and lactation
Pregnancy
Neo-Cytamen should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated.
Breast-feeding
Neo-Cytamen is secreted into breast milk but this is unlikely to harm the infant, and may be beneficial if the mother and infant are vitamin B12 deficient.
Fertility
No data available
4.7. Effects on ability to drive and use machines
None stated.
4.8. Undesirable effects
The following effects have been reported and are listed below by body system:
Blood and lymphatic system disorders
Reactive thrombocytosis can occur during the first weeks of use in megaloblastic anaemia.
Cardiovascular disorders:
Arrhythmias secondary to hypokalaemia.
Disorders of the immune system:
Hypersensitivity reactions including skin reactions (e.g. rash, itching) and exceptionally anaphylaxis.
Gastro intestinal disorders:
Nausea, vomiting, diarrhoea.
General disorders:
Fever, chills, hot flushing, dizziness, malaise, pain. Injection site reactions including injection site pain, injection site erythema, injection site pruritus, injection site induration, and injection site swelling.
Neurological disorders:
Headache, sensory abnormalities such as paraesthesiae.
Tremor.
Renal and unrinary disorders:
Chromaturia
Skin and subcutaneous tissue disorders:
Acneiform and bullous eruptions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Treatment is unlikely to be needed in cases of overdosage.
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- CyanokitHydroxocobalaminum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Neo-cytamen 1000 micrograms/ml Solution for Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.