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HYDROXOCOBALAMIN 1000MICROGRAMS/ML SOLUTION FOR INJECTION

Active substance(s): HYDROXOCOBALAMIN CHLORIDE

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Patient Information Leaflet:
Neo-Cytamen® 1000 micrograms/ml Solution for Injection Hydroxocobalamin

282844_B01-MU-Neo_UK_Layout 1 17/12/2014 10:05 Page 1

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.

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.

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.

MU-Neo-UK

282844_B01-MU-Neo_UK_Layout 1 17/12/2014 10:05 Page 2

• 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 out of the reach and sight 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. 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 December 2014
® 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
MU-Neo-UK

Hydroxocobalamin 1000 micrograms/ml solution for injection

Patient Information Leaflet:

282843_B01-MU-Hyd-UK_Layout 1 17/12/2014 09:59 Page 1

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.

MU-Hyd-UK

282843_B01-MU-Hyd-UK_Layout 1 17/12/2014 09:59 Page 2

• 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.
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 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 25ºC. 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
Herderstraße 2
D-83512 Wasserburg
Germany
This leaflet was last updated December 2014

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

MU-Hyd-UK

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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