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COBALIN-H INJECTION 1000MCG/ML

Active substance(s): HYDROXOCOBALAMIN

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LF-104155-01

PACKAGE LEAFLET: INFORMATION FOR THE USER

COBALIN-H® 1000 microgram/ml INJECTION
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor
or pharmacist.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
The name of your medicine is Cobalin-H
1000 microgram/ml Injection, it will be referred
to as Cobalin-H Injection throughout the PIL for
ease hereafter.
What is in this leaflet:
1. What Cobalin-H Injection is and what it is
used for
2. What you need to know before Cobalin-H
Injection is given
3. How Cobalin-H Injection is given
4. Possible side effects
5. How to store Cobalin-H Injection
6. Contents of the pack and other information
1. WHAT COBALIN-H INJECTION IS
AND WHAT IT IS USED FOR

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This medicine contains hydroxocobalamin which
is a form of Vitamin B12. It is given for:
• Addisonian pernicious anaemia (caused when
absorption of Vitamin B12 from the stomach
is reduced).
• Tobacco amblyopia (poor sight caused by
toxins such as tobacco).
• Leber’s atrophy (degeneration of the optic
nerve resulting in loss of central vision).
• Treatment/prevention of other macrocytic
anaemias due to deficiency in vitamin B12.
Vitamin B12 is needed for physical growth and
development and for the formation of red blood
cells in the bone marrow. It is also required for
absorption of folic acid and carbohydrates from
food and for keeping the nerve (neurological)
system healthy.
The body only requires a small amount of the
vitamin daily so a deficiency may take months or
even years to develop. Eventually, the formation
of abnormally large red blood cells
(macrocytes)with reduced ability to carry oxygen
from enlarged cells (megaloblasts) in the bone
marrow, gives rise to anaemia. Symptoms of
Vitamin B12 deficiency anaemia include sore
mouth and tongue, numbness and tingling in the
arms and legs, memory loss and depression.
This injection is usually given to you by your
doctor or someone else trained to give it to you.
2. WHAT YOU NEED TO KNOW
BEFORE COBALIN-H INJECTION IS
GIVEN
Do not use Cobalin-H Injection:
• If you are allergic to active substance or any of
the other ingredients of this medicine (listed
in section 6).

Warnings and Precautions:
Talk to your doctor or nurse before using
Cobalin-H Injection
• If you are aware of abnormal heart beats, tell
your doctor or nurse.
• If, after several weeks’ treatment, you do not
feel any improvement, discuss this with your
doctor or nurse.
Other medicines and Cobalin-H Injection
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Cobalin-H Injection can interfere with the action
of some other drugs and some drugs can have an
effect on Cobalin-H Injection. The following
drugs can cause some problems when taken
together with Cobalin-H Injection:
• chloramphenicol (an antibiotic) can reduce
the effects of Cobalin-H Injection.
• oral contraceptives may reduce the blood
levels of Cobalin-H Injection.
The following medicines do not alter the
effectiveness of Cobalin-H Injection but make it
more difficult to measure the amount of
Vitamin B12 in the body:
• antibiotics.
• antimetabolites (used to treat tumours and
blood disorders).
Pregnancy, breast feeding and fertility
Pregnancy
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.Cobalin-H Injection should
not be used for the treatment of megaloblastic
anaemia of pregnancy.
Breast feeding
If you are breast feeding you should tell your
doctor before you are given this medicine.
Cobalin-H Injection passes into the breast milk
but is unlikely affect your baby.
Fertility
No data available
Driving and using machines
Your medicine is unlikely to affect your ability to
drive or to operate machinery. However, some
people may feel dizzy or drowsy when given
Cobalin-H Injection. If this happens to you, do
not drive or operate machinery.
Cobalin-H Injection contains sodium
Cobalin-H Injection contains less than 1mmol
sodium (23 mg) per 1ml (essentially
“sodium-free”).
3. HOW COBALIN-H INJECTION IS
GIVEN
Cobalin-H Injection will be given to you by
injection into a muscle. The dose depends on
your individual needs and responses to treatment.
Your blood levels of Vitamin B12 and folic acid
are likely to be monitored both before and during
treatment. If you have doubts about the
treatment or want more information about your

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(hydroxocobalamin)

4. POSSIBLE SIDE EFFECTS

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Like all medicines this medicine 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. Although they are
very rare, these symptoms can be serious.
• swelling of the lips and face, 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.
Rare: may affect up to 1 in 1,000 people
• Acniform and bullous eruptions (acne-like
and blistery skin eruptions).
Not known: frequency cannot be estimated from
the available data
• Headache, dizziness
• Nausea (feeling sick), vomiting, diarrhoea
• Malaise (feeling unwell)
• Rash, itching
• Injection site reactions including injection site
pain, injection site erythema, injection site
pruritus, injection site induration, and
injection site swelling (Reactions at the site of
the injection)
• Exanthema (a widespread skin rash)
• Chromaturia (unusual coloured urine)
• Fever
• Hot flushes (a feeling of intense heat with
sweating and rapid heartbeat)
• Chills (feeling of coldness accompanied by
shivering)

• Paraesthesia (feeling of pins and needles)
• Tremor (tremble or shakes)
• Hypokalaemia (decreased potassium levels in
the blood)
• Reactive thrombocytosis (body produces too
many platelets).
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 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.
5. HOW TO STORE COBALIN-H
INJECTION
Keep this medicine out of the sight and reach of
children. Store below 25ºC and protect from
light.
The product should not be used if it is not a clear
red liquid or if it contains visible particles.
Do not use Cobalin-H Injection after the expiry
date which is stated on the ampoule and carton
after Exp:. The expiry date refers to the last day of
that month.
Do not throw away any medicines via wastewater
or household waste.
Ask your pharmacist how to throw away
medicines you no longer use. These measures will
help protect the environment.
6. CONTENTS OF THE PACK AND
OTHER INFORMATION
What Cobalin-H Injection contains
The active substance is: hydroxocobalamin
1000 microgram/ml.
The other ingredients are: sodium dihydrogen
orthophosphate, sodium chloride and Water for
Injections with sodium hydroxide and/or
hydrochloric acid as pH adjusters.
The product is suitable for vegetarians and
vegans.
What Cobalin-H Injection looks like and
contents of the pack
The product is a clear red liquid, supplied in
5 clear glass vials. Each vial contains
1000 micrograms hydroxocobalamin.
Marketing Authorisation Holder
Amdipharm UK Limited, Capital House,
85 King William Street, London EC4N 7BL, UK
(send all enquiries to this address).
Manufacturer
Amdipharm UK Limited, Capital House,
85 King William Street, London EC4N 7BL, UK
®Cobalin-H injection is a registered trade mark
PL 20072/0217
This leaflet was last revised in January 2018.

22535009

147

medicine or the monitoring procedure, do ask the
doctor or nurse.
Always use this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Adults and Children
Initial dose: This varies between 250 microgram
and 1000 microgram given daily or on alternative
days. The actual dosage depends on your specific
illness and your response to treatment.
Maintenance dose: Your doctor will check your
condition regularly. When he/she feels that your
health has improved sufficiently, your dose of
Cobalin-H Injection will be reduced to 1mg
every 2-3 months or as required.
If you use more Cobalin-H Injection than you
should :
Being given more than the intended dose of
hydroxocobalamin is unlikely to cause a problem
requiring treatment.
Tell the doctor if you are experiencing any side
effects or think you may be reacting badly so that
he/she can give appropriate treatment.
If you have already left the medical premises,
contact your nearest hospital, doctor or nurse.
If you forget to take Cobalin-H injection:
It is unlikely that you will miss a dose as your
doctor or nurse will be giving it to you. However,
it is important not to have a double dose if you
have missed one. Ask your doctor or nurse when
you should have the next dose.
If you have any further questions on the use of
this medicine, ask your doctor or nurse.

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