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PACKAGE LEAFLET: INFORMATION FOR THE USER

Pabrinex® Intravenous High Potency, Solution for injection

(Vitamins B & C Injection BP)

Read all of this leaflet carefully before you start taking this medicine.

-    Please keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor.

-    If you suffer from any side effects that get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Pabrinex Intravenous injection is and what it is used for

2.    Before Pabrinex Intravenous injection is given

3.    How Pabrinex Intravenous injection is given

4.    Possible side effects

5.    How to store Pabrinex Intravenous injection

6.    Further information

1. WHAT PABRINEX INTRAVENOUS

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 Intravenous 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.

The product is also used to maintain levels of vitamins B and C in patients who are on longterm intermittent haemodialysis.

2. BEFORE PABRINEX INTRAVENOUS INJECTION IS GIVEN

You MUST NOT be given Pabrinex Intravenous injection if you have:

•    an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 What Pabrinex contains ’)

•    a history of sensitivity to vitamins B and/or C.

Take special care with Pabrinex Intravenous injection

Pabrinex Intravenous injection 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 Intravenous injection.

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 interferes with the effects of this medicine.

•    Vitamin B1 (thiamine) injections - if you are on repeated injections of such preparations, Pabrinex Intravenous injection may cause sneezing or mild asthma (chest tightness and wheezing) 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 is not expected to affect your ability to drive or operate machinery.

3. HOW PABRINEX INTRAVENOUS INJECTION IS GIVEN

Pabrinex Intravenous injection will be given to you by a healthcare professional by drip infusion into a vein. The product comes in two vials, the contents of which are first diluted with either saline or 5% glucose solution and then given over a period of 30 minutes. Alternatively, Pabrinex Intravenous injection can be given undiluted by mixing the contents of each vial in a syringe just before use and injecting slowly into a vein over a period of 10 minutes.

Dosage for adults including the elderly:

•    For rapid therapy of severe depletion or malabsorption of water soluble vitamins B and C, particularly in alcoholism: 2 to 3 pairs of 5ml ampoules (1 pair = ampoule 1 + ampoule 2) diluted with 50ml to 100ml of infusion solution and injected over 30 minutes at intervals decided by your doctor (typically every 8 hours).

•    For psychosis following unconsciousness from a narcotic drug (narcosis) or electroconvulsive therapy,

or poisoning from infection: 10ml of the mixed vials (1 pair) injected twice daily for up to 7 days.

•    For haemodialysis patients: 10ml of the mixed vials (1 pair) injected at the end of dialysis, once every 2 weeks.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Pabrinex Intravenous 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 Intravenous and should not be given a repeat dose.

•    Severe allergic reaction (anaphylactic 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 Intravenous.

•    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.

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

The other ingredients are: edetic acid, sodium hydroxide and water for injections.

What Pabrinex Intravenous injection looks like and contents of the pack

The product is supplied in pairs of yellow coloured glass vials containing 5ml or 10ml of sterile solution. Pack sizes contain 10 pairs of 5ml or 5 pairs of 10ml vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Archimedes Pharma UK Limited Galabank Business Park,

Galashiels,

TD1 1QH,

United Kingdom

Manufacturer

Haupt Pharma Wulfing GmbH Bethelner LandstraBe 18 D-31028 Gronau/Leine Germany.

® Pabrinex is a registered trade mark This leaflet was last revised: 04/2015

LFT-PAB-GB-001

DESCRIPTION	Pabrinex UK Intravenous (I.V.) PIL
PRODUCT No.	LFT-PAB-GB-001
VERSION No.	2
DATE YELLOWDOT REF	14/04/2015
REASON FOR CHANGE	Change address to Galabank Business Park...
SIZE	210mm x 249mm
COLOURS	Black
TEXT SIZE	9pt
LEADING	10pt (3.5mm)
FONTS	ITC New Baskerville Regular, Bold and Italic Times Regular, Symbol Regular