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1. Pabrinex Intramuscular High Potency Solution For Injection
2. Pabrinex Intramuscular High Potency Solution For Injection

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.

-    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 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

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:

•    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 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.

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.

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.

Dosage for adults including the elderly:

7ml of the mixed vials (one pair) twice daily for up to 7 days.

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.

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 out of the sight and reach of children.

Pabrinex Intramuscular injection should be stored in a refrigerator at 2°C to 8°C 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

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 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-003

DESCRIPTION	Pabrinex Intramuscular (I.M.) PIL
PRODUCT No.	LFT-PAB-GB-003
ARCHIMEDES REF.	XXXXXX
VERSION No.	2
DATE YELLOWDOT REF	08/04/2015
REASON FOR CHANGE	Change address to Galabank Business Park..
SIZE	210mm x 158mm
COLOURS	Black
TEXT SIZE	9pt
LEADING	9.5pt (3.3mm)
FONTS	ITC New Baskerville Regular, Bold and Italic Times Regular