Neo-Cytamen 1000micrograms/Ml Solution For Injection
Patient Information Leaflet:
Hydroxocobaiamin 1000 micrograms/ml solution for injection
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, Hydroxocobalamin 1000 micrograms/ml Solution for Injection will be called Hydroxocobalamin.
In this leaflet:
1. What Hydroxocobalamin is for
2. Before you are given Hydroxocobalamin
3. How you will be given Hydroxocobalamin
4. Possible side effects
5. How to store Hydroxocobalamin
6. Further information.
1. What Hydroxocobalamin is for
Hydroxocobalamin is a form of Vitamin B12, an essential vitamin which is needed for production of red blood cells. Hydroxocobalamin 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 Hydroxocobalamin
You should not be given Hydroxocobalamin if:
• You are allergic to the active ingredient, hydroxocobalamin
• You are allergic to any of the other ingredients of Hydroxocobalamin (see section 6.).
If the above applies to you talk to your doctor or nurse.
Check with your doctor before being given Hydroxocobalamin 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 Hydroxocobalamin
• The contraceptive 'pill'
• Any other medicine, including medicines obtained without a prescription Pregnancy and breast-feeding Hydroxocobalamin should not be used for the treatment of megaloblastic anaemia of pregnancy unless vitamin B12 deficiency has been demonstrated.
Hydroxocobalamin 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 Hydroxocobalamin.
Driving and using machines Hydroxocobalamin may cause dizziness. If this happens to you, do not drive or use machinery.
3. How you will be given Hydroxocobalamin
Hydroxocobalamin 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 Hydroxocobalamin 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 Hydroxocobalamin than you should
If you think you have been given too much Hydroxocobalamin, 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 Hydroxocobalamin 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.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
5. How to store Hydroxocobalamin
Keep out of the reach and sight of children.
Do not use Hydroxocobalamin after the expiry date on the label. The expiry date refers to the last day of that month.
Store below 25°C. Keep Hydroxocobalamin 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 Hydroxocobalamin 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 Hydroxocobalamin looks like
Hydroxocobalamin 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 Herderstrafte 2 and Tegernau 18 83512 Wasserburg Germany
This leaflet was last updated September 2012.
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