Thiamine hydrochloride 125 mg/ml solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Thiamine hydrochloride solution for injection is and what it is used for
2. What you need to know before you use Thiamine hydrochloride solution for injection
3. How to use Thiamine hydrochloride solution for injection
4. Possible side effects
5. How to store Thiamine hydrochloride solution for injection
6. Contents of the pack and other information

If you are allergic to thiamine or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor, pharmacist or nurse before using Thiamine hydrochloride solution for injection.

• The solution should be injected only when thiamine is rapidly necessary (e.g. Wernicke-Korsakoff syndrome) or when the oral route is ineffective (e.g. in case of vomiting or malabsorption).
• The 50 mg/ml solution will be less painful when administered by IM route as it is much less hypertonic than the 125 mg/ml solution. Prefer the IV administration (after dilution) for the 125 mg/ml solution, especially for long-term treatment.
• Be careful if you have ever had a mild allergic reaction (sneezing or mild asthma) to any previous administrations of thiamine. This could mean that you may have become hypersensitive, and could have a more severe allergic reaction if given Thiamine hydrochloride solution for injection. This risk increases in case of repeated doses. Your doctor must be ensured before administration of the solution that you are not allergic to thiamine. A skin test should be performed in case of doubt. Emergency medical equipment should be present for treating an eventual anaphylactic shock when injecting the solution.
• The solution should be injected SLOWLY by the intravenous route (over 30 minutes). This can reduce the risk of anaphylactic shock and reactions at the injection site.
• The solution should be injected into a vein before or simultaneously to an administration of glucose.
• If you have problems with your kidneys, your doctor will carefully monitor you.

If you use other drugs, read also the following section “Other medicines and Thiamine hydrochloride solution for injection”.

High concentrations of thiamine in the blood can affect certain medical tests. If you are having a blood test, scan or any other medical test (e.g. urinary test) tell your doctor that you are using Thiamine hydrochloride solution for injection.

Tell your doctor if you are using, have recently used or might use any other medicines. This includes medicines obtained without a prescription and herbal products.

Tell your doctor if you are using the following medicines because he/she may need to adjust your treatment:

• Fluorouracil, other fluoropyrimidines (e.g. capecitabine) and ifosfamide, medicines used to treat certain cancers.
• Diuretics (e.g. furosemide), medicines used for the treatment of high blood pressure (hypertension) and the excess of watery fluid collecting in the cavities and tissues of the body (oedema).

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

This medicine can be used during pregnancy and breast-feeding if necessary when benefit outweighs risk.

Your doctor will decide whether you should discontinue breastfeeding or discontinue/abstain from thiamine therapy, taking into account the benefit of breastfeeding for your child or the benefit of the treatment for you.

Thiamine hydrochloride solution for injection is not expected to affect your ability to drive or operate machinery.

If you feel you may be affected, do not drive or use machines and speak to your doctor.

This medicine contains less than 1 mmol of sodium (23 mg) per 2 ml ampoule, that is to say essentially “sodium-free”.

This product will be given to you under medical supervision. It is therefore unlikely that you will be given too much.

Nevertheless, if you used more Thiamine hydrochloride solution for injection than you should, contact your doctor, your pharmacist, the Poison Centre or the nearest hospital emergency department immediately.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, then skip the missed dose and resume your usual dosing schedule. Missing a dose shouldn’t constitute a risk for your health. Do not use a double dose to make up for a forgotten dose.

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 substance is thiamine hydrochloride (vitamin B1). Each 2 ml ampoule contains 100 mg or 250 mg thiamine hydrochloride. Each ml solution contains 50 mg or 125 mg thiamine hydrochloride.
• The other ingredients are sodium hydroxide and water for injections.

Thiamine hydrochloride solution for injection is a solution for injection.

This an aqueous, clear, colourless to slightly yellow sterile solution, free of visible particles.

Thiamine hydrochloride solution for injection is available in 2ml uncoloured glass ampoules, packaged into boxes containing 5, 10 or 100 ampoules. Not all pack sizes may be marketed.