PABRINEX INTRAMUSCULAR HIGH POTENCY SOLUTION FOR INJECTION

Active substance: 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.
– 
Please keep this leaflet. You may need to read
it again.
– you have any further questions, ask your
If
doctor.
– you suffer from any side effects that get
If
serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor.

Take special care with 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.

In this leaflet:
1. 
What Pabrinex Intramuscular injection is and
what it is used for
2. Before Pabrinex Intramuscular injection is
given
3. How Pabrinex Intramuscular injection is given
4. Possible side effects
5. How to store Pabrinex Intramuscular
injection
6. Further information

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including those obtained without a
prescription. These include:
• 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
a severe reaction if you have become
hypersensitive.

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. BEFORE PABRINEX INTRAMUSCULAR
INJECTION IS GIVEN
You MUST NOT be given Pabrinex Intramuscular
injection if you have:
•  n allergy (hypersensitivity) to any of the
a
ingredients in the product (see Section 6 ‘What
Pabrinex contains’)
• a history of sensitivity to vitamins B and/or C.

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.
3. HOW PABRINEX INTRAMUSCULAR
INJECTION IS GIVEN
Pabrinex Intramuscular, the contents of which
are mixed from two vials, 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 vials (one pair) twice daily for
up to 7 days.

Children: 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 product, ask your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Pabrinex Intramuscular
injection 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
product. 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.
If any of these side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

5. HOW TO STORE PABRINEX
INTRAMUSCULAR INJECTION
Keep out of the reach and sight of children.
Pabrinex Intramuscular injection should be stored
in a refrigerator at 2ºC to 8ºC but not frozen, and
protected from light. The product must not be
used after the expiry date printed on the outer
carton and vial labels.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. FURTHER INFORMATION
What Pabrinex Intramuscular injection contains
The active ingredients are:
VIAL 1

5ml

thiamine hydrochloride (vitamin B1)

250mg

riboflavin (vitamin B2)

4mg

pyridoxine hydrochloride (vitamin B6)

50mg

VIAL 2

2ml

ascorbic acid (vitamin C)

500mg

nicotinamide

160mg

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 yellow
coloured glass vials containing 5ml or 2ml of
sterile solution. Pack sizes contain 10 pairs of 5ml
and 2ml ampoules
Marketing Authorisation Holder
Archimedes Pharma UK Limited
250 South Oak Way, Green Park
Reading, RG2 6UG, UK.
Manufacturer
Haupt Pharma Wülfing GmbH
Bethelner Landstraße 18
D-31028 Gronau/Leine
Germany.
® Pabrinex is a registered trade mark
This leaflet was last approved: 03/2013

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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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