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CYTAMEN INJECTION 1000MCG

Active substance(s): CYANOCOBALAMIN

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Patient Information Leaflet: Cytamen® 1000 micrograms/ml Solution for
Injection
Cyanocobalamin

282847_B01-MU-Cyt-RWA_UK_Layout 1 17/12/2014 10:16 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, Cytamen® 1000
micrograms/ml Solution for Injection will
be called Cytamen.
In this leaflet:
1. What Cytamen is for
2. Before you are given Cytamen
3. How you will be given Cytamen
4. Possible side effects
5. How to store Cytamen
6. Further information.

1. What Cytamen is for
Cytamen is a form of Vitamin B12, an
essential vitamin which is needed for the
production of red blood cells.
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 for a test called the Schilling
Test, which measures your ability to absorb
Vitamin B12 from the bowel.

2. Before you are given Cytamen
You should not be given Cytamen if:
• You are allergic to the active ingredient,
cyanocobalamin
• You are allergic to any of the other
ingredients of Cytamen (see section 6.)
• You have a condition called toxic
amblyopia (poor vision which may be
due to Vitamin B12 deficiency).
If any of the above applies to you talk to
your doctor or nurse.
Check with your doctor before being given
Cytamen if:
• You are pregnant, planning to become
pregnant or breast-feeding
• You have megaloblastic anaemia. This is
a blood disorder where you have larger
than normal blood cells
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 Cytamen
• Oral contraceptives 'The Pill'

• Any other medicine, including medicines
obtained without a prescription.
If any of the above applies to you talk to
your doctor or nurse.
Pregnancy and breast-feeding
Cytamen should not be used in pregnancy
for treating a kind of anaemia called
megaloblastic anaemia, unless you also have
a Vitamin B12 deficiency.
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 Cytamen.
Driving and using machines
Cytamen may cause dizziness. If this
happens to you, do not drive or use
machinery.

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 month.
- With neurological involvement: 1000
micrograms every other day for as long
as improvement is noticed.
Maintenance dose: 1000 micrograms
every month.
• Prevention of anaemia:
- 250 -1000 micrograms every month.
• Schilling Test:
- 1000 micrograms.

3. How you will be given Cytamen
Important:
Your doctor will choose the dose that is
right for you.
You will be given 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-Cyt-RWA-UK

282847_B01-MU-Cyt-RWA_UK_Layout 1 17/12/2014 10:16 Page 2

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 Cytamen than you
should
If you think you have been given too much
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 Cytamen can cause side
effects, although not everybody gets them.
Stop using Cytamen and seek immediate
medical help if you have an allergic reaction.
This includes any of the following
symptoms:
• Difficulties in breathing
• Swelling of your eyelids, face or lips
• Rash or itching especially those covering
your whole body
• Collapse.

Effects on the heart and blood
• Low blood potassium levels and irregular
heart beat during the early stages of
treatment
• Thrombocytosis (where you have a high
number of platelets in your blood)
Effects on the eyes and skin
• Acne-like rash
• Blisters
• Pain at the site of injection
• The skin may become hard at the site of
injection
• The skin around the injection site may die.
Effects on the stomach and bowel
• Feeling unwell or sick
Effects on the nervous system
• Dizziness
• Tremor
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 Cytamen
Keep out of the reach and sight of children.
Do not use Cytamen after the expiry date on
the label. The expiry date refers to the last
day of that month.
Store below 25ºC. Keep 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 Cytamen contains
The active substance is cyanocobalamin BP
at a strength of 1000 micrograms (1 mg)
per ml of solution.
The other ingredients are sodium chloride,
acetic acid and water for injection.

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.
® 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

What Cytamen looks like
Cytamen® 1000 micrograms/ml Solution
for Injection is a sterile solution.
It comes in packs of 5 ampoules, each
containing 1 ml of solution.

MU-Cyt-RWA-UK

Patient Information Leaflet: Cytamen® 1000 micrograms/ml Solution for
Injection
Cyanocobalamin

282848_B01-MU-Cyt_RAL-UK_Layout 1 17/12/2014 11:29 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, Cytamen® 1000
micrograms/ml Solution for Injection will
be called Cytamen.
In this leaflet:
1. What Cytamen is for
2. Before you are given Cytamen
3. How you will be given Cytamen
4. Possible side effects
5. How to store Cytamen
6. Further information.

1. What Cytamen is for
Cytamen is a form of Vitamin B12, an
essential vitamin which is needed for the
production of red blood cells.
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 for a test called the Schilling
Test, which measures your ability to absorb
Vitamin B12 from the bowel.

2. Before you are given Cytamen
You should not be given Cytamen if:
• You are allergic to the active ingredient,
cyanocobalamin
• You are allergic to any of the other
ingredients of Cytamen (see section 6.)
• You have a condition called toxic
amblyopia (poor vision which may be
due to Vitamin B12 deficiency).
If any of the above applies to you talk to
your doctor or nurse.
Check with your doctor before being given
Cytamen if:
• You are pregnant, planning to become
pregnant or breast-feeding
• You have megaloblastic anaemia. This is
a blood disorder where you have larger
than normal blood cells
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 Cytamen
• Oral contraceptives 'The Pill'

• Any other medicine, including medicines
obtained without a prescription.
If any of the above applies to you talk to
your doctor or nurse.
Pregnancy and breast-feeding
Cytamen should not be used in pregnancy
for treating a kind of anaemia called
megaloblastic anaemia, unless you also have
a Vitamin B12 deficiency.
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 Cytamen.
Driving and using machines
Cytamen may cause dizziness. If this
happens to you, do not drive or use
machinery.

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 month.
- With neurological involvement: 1000
micrograms every other day for as long
as improvement is noticed.
Maintenance dose: 1000 micrograms
every month.
• Prevention of anaemia:
- 250 -1000 micrograms every month.
• Schilling Test:
- 1000 micrograms.

3. How you will be given Cytamen
Important:
Your doctor will choose the dose that is
right for you.
You will be given 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-Cyt-RAL-UK

282848_B01-MU-Cyt_RAL-UK_Layout 1 17/12/2014 11:29 Page 2

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 Cytamen than you
should
If you think you have been given too much
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 Cytamen can cause side
effects, although not everybody gets them.
Stop using Cytamen and seek immediate
medical help if you have an allergic reaction.
This includes any of the following
symptoms:
• Difficulties in breathing
• Swelling of your eyelids, face or lips
• Rash or itching especially those covering
your whole body
• Collapse.

Effects on the heart and blood
• Low blood potassium levels and irregular
heart beat during the early stages of
treatment
• Thrombocytosis (where you have a high
number of platelets in your blood)
Effects on the eyes and skin
• Acne-like rash
• Blisters
• Pain at the site of injection
• The skin may become hard at the site of
injection
• The skin around the injection site may die.
Effects on the stomach and bowel
• Feeling unwell or sick
Effects on the nervous system
• Dizziness
• Tremor
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.

Marketing Authorisation Holder

5. How to store Cytamen

Manufacturer

Keep out of the reach and sight of children.
Do not use Cytamen after the expiry date on
the label. The expiry date refers to the last
day of that month.
Store below 25ºC. Keep 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.

Recipharm Limited, Vale of Bardsley,
Ashton-under-Lyne, OL7 9RR, UK

6. Further information
What Cytamen contains
The active substance is cyanocobalamin BP
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 Cytamen looks like
Cytamen® 1000 micrograms/ml Solution
for Injection is a sterile solution.
It comes in packs of 5 ampoules, each
containing 1 ml of solution.

RPH Pharmaceuticals AB, Lagervagen 7,
136 50 Haninge, Sweden

This leaflet was last updated December
2014.
® 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-Cyt-RAL-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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