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HYDROXOCOBALAMIN 1MG/ML SOLUTION FOR INJECTION

Active substance(s): HYDROXOCOBALAMIN ACETATE

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Version No:
Product Name:

PATIENT INFORMATION LEAFLET

5021309

Hydroxocobalamin 1mg/ml Solution for Injection
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
If any of the side effects become serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Hydroxocobalamin 1mg/ml Solution for Injection. It
will be referred to as Hydroxocobalamin Injection for ease of use hereafter.
In this leaflet:
1. What Hydroxocobalamin Injection is and what it is used for
2. Before you are given Hydroxocobalamin injection
3. How Hydroxocobalamin injection is given to you
4. Possible side effects
5. How to store Hydroxocobalamin injection
6. Further information
1. WHAT HYDROXOCOBALAMIN INJECTION IS AND WHAT IT IS USED FOR
Hydroxocobalamin injection is an injection which contains hydroxocobalamin acetate.
It is used to treat deficiency of vitamin B12 which causes various types of anaemia
(reduction in the number of red blood cells). Most people get enough vitamin B12 from
their food, but if you have had stomach surgery, or certain diseases of the intestines, or
a restricted diet, you may not absorb enough vitamin B12.
2. BEFORE YOU ARE GIVEN HYDROXOCOBALAMIN INJECTION
You should not be given Hydroxocobalamin injection if:
• You know you are allergic to hydroxocobalamin injection or any other ingredient
present in this injection (see section 6 of this leaflet).
Make sure your doctor knows if you suffer from the above.
Before you are given Hydroxocobalamin injection, you should tell your doctor if:
• You have suffered from any heart problems.
Your doctor may want to monitor your response to this medicine carefully, particularly if
you are young or elderly. This will probably involve regular examination of your blood.
Taking other medicines
Please talk to your doctor if you are taking or have recently taken any other medicines,
including medicines obtained without prescription.
Some medicines can interact with Hydroxocobalamin injection which can significantly
alter their effects. These drugs include:
• Chloramphenicol (an antibiotic used to treat infections)
• Oral contraceptives
Antibiotics (used to treat infections) and antimetabolites (used to treat some cancers)
can affect blood tests used to measure vitamin B12.
Pregnancy and breast feeding
Tell your doctor before you are given this medicine if you are pregnant, think you may
be pregnant or are planning to become pregnant or are breast-feeding.
Hydroxocobalamin Injection should not be used to treat certain types of anaemia
caused by pregnancy.
Driving and using machines
Hydroxocobalamin injection should not affect your ability to drive or use machinery.
Important information about some of the ingredients in Hydroxocobalamin injection
This injection contains less than 1mmol (23mg) of sodium per 2ml (essentially ‘sodiumfree’).

100027/LF/036/05

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Hydroxocobalamin
1mg/ml Soln. for Inj.
5 Ampoules
Leaflet
100027
UK
Delpharm Tours
2
16/02/2015
PAT

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

210 x 127 mm
N/A
163
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Black

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No
8 pt

CRF:
DOA:
DOI:

AMCo.CRF.061.2014
N/A
N/A

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APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

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3. HOW HYDROXOCOBALAMIN INJECTION IS GIVEN TO YOU
Hydroxocobalamin injection is administered by injection into a muscle.
Your doctor will decide the correct dose for you depending on your circumstances.
You will be given a starting treatment and then maintenance.
The injection may need to be repeated depending on your response.
Hydoxocobalamin injection is also suitable for use in children and the elderly.
What to do if you have been given more Hydroxocobalamin injection than you should
This is unlikely because the dose will be administered by a health professional. If you
suspect you have been given too much, you should tell your doctor immediately.
If you have any further questions on the use of this product ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines Hydroxocobalamin injection can sometimes cause side-effects,
although they are rare.
All medicines can cause allergic reactions, although serious allergic reactions are rare.
Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash
or itching (especially affecting your whole body) should be reported to a doctor
immediately. These reactions might also occur on handling the injection directly.
• Allergic reactions to the active ingredient, hydroxocobalamin is rare but may cause
unpleasant sensation that causes the desire or reflex to scratch (itching), widespread
rash (exanthema) and exceptionally as an anaphylactic reaction (swelling and
shortness of breath)
• Acne like and blister eruptions have been reported rarely.
• You may get a headache or feel feverish, cold, dizzy or sick
• You may develop a wide spread rash
• You may feel some pain at the site of the injection
• During initial treatment your potassium levels may drop, this may cause you to get
muscle weakness.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: 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 INJECTION
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton
after “EXP”. The expiry date refers to the last day of that month.
Do not store above 25˚C. Keep the ampoule in the outer carton in order to protect
from light.
If only part used, discard the remaining solution.
6. FURTHER INFORMATION
The active substance is Hydroxocobalamin.
The other ingredients are sodium chloride, glacial acetic acid in water for injections.
What Hydroxocobalamin injection looks like and contents of pack
Hydroxocobalamin injection is a sterile solution for injection.
Each glass ampoule contains 1ml of solution, which contains the active ingredient
hydroxocobalamin acetate (equivalent to hydroxocobalamin 1mg in 1ml sterile
solution). Each carton contains five 1ml ampoules.
Marketing authorisation holder
Mercury Pharmaceuticals Ltd.,
Capital House, 85 King William Street, London EC4N 7BL, UK
Manufacturer
Delpharm Tours, Rue Paul Langevin, 37170 Chambray Les Tours, France.
This leaflet was last revised in February 2015.
100027/LF/036/05

Version No:
Product Name:

100027/LF/036/05

Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:

Hydroxocobalamin
1mg/ml Soln. for Inj.
5 Ampoules
Leaflet
100027
UK
Delpharm Tours
2
16/02/2015
PAT

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

210 x 127 mm
N/A
163
N/A
N/A
Black

Non-Print Colours: Cutter
Tech App. Date:
Min. Font Size:

No
8 pt

CRF:
DOA:
DOI:

AMCo.CRF.061.2014
N/A
N/A

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature .......................................................................
Name .............................................................................
Date ...............................................................................

PAGE 2 OF 2

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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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