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PABRINEX INTRAMUSCULAR HIGH POTENCY SOLUTION FOR INJECTION

Active substance(s): ASCORBIC ACID / NICOTINAMIDE / PYRIDOXINE HYDROCHLORIDE / RIBOFLAVIN SODIUM PHOSPHATE / THIAMINE HYDROCHLORIDE / ASCORBIC ACID / NICOTINAMIDE / PYRIDOXINE HYDROCHLORIDE / RIBOFLAVIN SODIUM PHOSPHATE / THIAMINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pabrinex® Intramuscular High Potency, Solution for injection
(Vitamins B & C Injection)

Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
– Please keep this leaflet. You may need to
read it again.
– If you have any further questions, ask your
doctor.
– If you get any side effects, talk to your
doctor. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Pabrinex Intramuscular injection is and
what it is used for
2. What you need to know before you are given
Pabrinex Intramuscular injection
3. How Pabrinex Intramuscular injection is given
4. Possible side effects
5. How to store Pabrinex Intramuscular injection
6. Contents of the pack and other information
1. What Pabrinex Intramuscular Injection Is And
What It Is Used For
Vitamins B and C are important for a number of
bodily functions including releasing energy from
food and in the formation of healthy skin, bones
and teeth.
Pabrinex Intramuscular High Potency, Solution
for injection (‘Pabrinex’) provides additional
vitamins B and C to correct deficiencies that may
have occurred, for example:
• in alcoholism
• after infections
• after operations
• in certain psychiatric states.
2. What You Need To Know Before You Are
Given Pabrinex Intramuscular Injection
You MUST NOT be given Pabrinex Intramuscular
injection:
• if you are allergic to any of the ingredients of
this medicine (listed in Section 6)
• if you have a history of sensitivity to vitamins
B and/or C.
Warnings and precautions
Talk to your doctor before taking Pabrinex
Intramuscular injection.
Pabrinex should be given with extreme caution if
you have:
• ever had a mild allergic reaction (sneezing
or mild asthma) to any previous injections of
vitamin B1 (thiamine). This could mean that
you may have become hypersensitive, and

could have a more severe allergic reaction
if given Pabrinex Intramuscular injection.
Other medicines and Pabrinex Intramuscular
injection
Tell your doctor or pharmacist if you are taking,
or have recently taken, or might take, any other
medicines:
• Levodopa (used in the treatment of
Parkinson’s disease) - Pabrinex Intramuscular
injection interferes with the effects of this
medicine.
• Vitamin B1 (thiamine) injections - if you are
on repeated injections of such preparations,
Pabrinex Intramuscular injection may cause
sneezing or mild asthma (chest tightness and
wheezing) or even anaphylactic shock if you
have become hypersensitive.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, planning
to become pregnant or breast-feeding. Ask your
doctor or pharmacist before taking any medicine.
Driving and using machines
Pabrinex Intramuscular is not expected to affect
your ability to drive or operate machinery.
Pabrinex Intramuscular contains sodium and
benzyl alcohol:
This medicinal product contains approximately
3 mmol (or 67 mg) sodium per dose (1 pair of
ampoules). To be taken into consideration by
patients on a controlled sodium diet.
This medicinal product contains approximately
139 mg benzyl alchohol per 7 ml dose (1 pair
of ampoules). Must not be given to premature
babies or neonates. May cause toxic reactions
and allergic reactions in infants and children up
to 3 years old.
3. How Pabrinex Intramuscular Injection Is
Given
Pabrinex Intramuscular, the contents of which
are mixed from two ampoules, is usually given by
slow injection into your gluteal (bottom) muscle
by a healthcare professional.

This medicine is for injection into a muscle
only and should not be given by any other
route.
Dosage for adults including the elderly:
7ml of the mixed ampoules (one pair) twice daily
for up to 7 days.

Use in children and adolescents: Pabrinex
Intramuscular injection is not usually given to
children; however, suitable doses according to
the child’s age are:
Age

Dose

under 6 years

1/4 of the adult dose

6-10 years

1/3 of the adult dose

10-14 years

1/2 to 2/3 of the adult dose

14 years and
older

one adult dose

The exact dose you will be given will be decided
by your doctor who will monitor your condition
and determine what treatment you need. If you
feel that you have been given an inappropriate
dose or if you would like more information
about Pabrinex Intramuscular injection, speak to
your doctor.
If you are given more Pabrinex Intramuscular
injection than you should
This product will be given to you under medical
supervision. It is therefore unlikely that you will
be given too much. However, if you feel unwell,
you should tell your doctor immediately.
If you have any further questions on the use of
this medicine, ask your doctor.
4. Possible Side Effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
• Allergic reaction - if following your injection
you experience symptoms such as sneezing or
mild asthma (chest tightness and wheezing)
tell your doctor immediately. This may be an
indication that you are sensitive to Pabrinex
Intramuscular injection and should not be
given a repeat dose.
• Severe allergic reaction (Anaphylatic shock)
- may result from repeated injections of this
medicine. Symptoms may include: swelling
of the face and or throat, rash, severe
itching, difficulty in breathing and loss of
consciousness due to very low blood pressure.
• Low blood pressure and feeling of ‘pins and
needles’ (mild paraesthesia) - can occur in
some patients given Pabrinex Intramuscular
injection
• Mild ache - some swelling may develop at the
site where Pabrinex is injected.
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. 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 Pabrinex Intramuscular
Injection
Keep this medicine out of the sight and reach of
children.
Pabrinex Intramuscular injection should be
stored in a refrigerator at 2ºC to 8ºC but not
frozen, and protected from light. Do not use this
medicine after the expiry date which is stated
on the outer carton and ampoule labels 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 to protect the environment.
6. Contents Of The Pack And Other Information
What Pabrinex Intramuscular injection contains
The active substances are:
AMPOULE 1

5 ml

thiamine hydrochloride (vitamin B1)

250 mg

riboflavin (vitamin B2)

4 mg

pyridoxine hydrochloride (vitamin B6)

50 mg

AMPOULE 2

2 ml

ascorbic acid (vitamin c)

500 mg

nicotinamide

160 mg

The other ingredients are: edetic acid, sodium
hydroxide, benzyl alcohol and water for
injections.
What Pabrinex Intramuscular injection looks like
and contents of the pack
The product is supplied in pairs of amber
coloured glass ampoules containing 5 ml or 2 ml
of sterile solution. Pack sizes contain 10 pairs of
5 ml and 2 ml ampoules
Marketing Authorisation Holder
Archimedes Pharma UK Limited
Galabank Business Park
Galashiels
TD1 1QH
United Kingdom
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner Landstraße 18
D-31028 Gronau/Leine
Germany.
® Pabrinex is a registered trade mark
This leaflet was last revised: 03/2017
LFT-PAB-GB-007

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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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