Pabrinex Intramuscular High Potency Injection

• 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.

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

• 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.

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.

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.

Tell your doctor if you are pregnant, planning to become pregnant or breast-feeding. Ask your doctor or pharmacist before taking any medicine.

Pabrinex Intramuscular is not expected to affect your ability to drive or operate machinery.

This medicine contains approximately 67 mg sodium (main component of cooking/table salt) in each 7 ml dose (1 pair of ampoules). This is equivalent to 3.4% of the WHO recommended maximum daily intake of 2 g sodium for an adult

This medicine contains approximately 139 mg benzyl alchohol in each 7 ml dose (1 pair of ampoules) which is equivalent to 19.9 mg/ml:

• Benzyl alcohol may cause allergic reactions.
• Benzyl alcohol has been linked with the risk of severe side effects including breathing problems (called “gasping syndrome”) in young children. Do not give to your newborn baby (up to 4 weeks old), unless recommended by your doctor.
• Do not use for more than a week in young children (less than 3 years old), unless advised by your doctor or pharmacist.
• Ask your doctor or pharmacist for advice if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
• Ask your doctor or pharmacist for advice if you have a liver or kidney disease. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

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 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, or 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.

The active substances are:

AMPOULE 1 (5 ml)

thiamine hydrochloride (vitamin B1) - 250mg

riboflavin (vitamin B2) - 4mg

pyridoxine hydrochloride (vitamin B6) - 50mg

AMPOULE 2 (2 ml)

ascorbic acid (vitamin C) - 500mg

nicotinamide - 160mg

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

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