Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Thiamine hydrochloride 125 mg/ml solution for injection
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Thiamine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
FOR
Thiamine hydrochloride solution for injection contains the active substance thiamine (vitamin B1) as thiamine hydrochloride. This is a water-soluble vitamin that belongs to a group of medicines called "B vitamins". Sometimes your body requires a supplement of vitamin B1. This is because your diet doesn't contain enough thiamine or you may not absorb it effectively from your diet. You may also have a special need for extra thiamine if you are excreting it quickly from your body (e.g. in your urine). Thiamine hydrochloride solution for injection is used to treat or prevent vitamin B1 deficiencies (when your body does not have enough of this vitamin) like beriberi disease, chronic alcoholism, and Wernicke-Korsakoff syndrome. 2.
What you need to know before you take it
E THIAMINE HYDROCHLORIDE SOLUTION FOR INJECTION
Do not use Thiamine hydrochloride solution for injection If you are allergic to thiamine or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using Thiamine hydrochloride solution for injection. •
• •
The solution should be injected only when thiamine is immediately necessary (e.g. WernickeKorsakoff syndrome) or when the oral route is ineffective (e.g. in case of vomiting or malabsorption). 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 1
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risk increases in case of repeated doses. Your doctor must ensure 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 a possible 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". Having blood tests or other medical tests 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. Other medicines and 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 excessive fluid retention in the cavities and tissues of the body (oedema). Pregnancy, breast-feeding and fertility 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. Driving and using machines Thiamine hydrochloride solution for injection is not expected to affect your ability to drive or operate machinery. If you feel impaired, do not drive or use machines and speak to your doctor. Thiamine hydrochloride solution for injection contains sodium This medicine contains less than 1 mmol of sodium (23 mg) per 2 ml ampoule, that is to say essentially "sodium-free". 3.
How to take it
THIAMINE HYDROCHLORIDE SOLUTION FOR INJECTION
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The dosage, frequency of administration and duration of the treatment will be established by your doctor.
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Thiamine hydrochloride solution for injection will be given to you by a healthcare professional by injection into a muscle (intramuscular route) or slowly into a vein (slow intravenous route) as directed by your doctor. The dosage will be determined by your doctor. For further instructions for use, see information intended for healthcare professionals at the end of the leaflet. If you use more Thiamine hydrochloride solution for 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 forget to use Thiamine hydrochloride solution for injection If you miss a dose, tell your doctor, pharmacist or nurse. 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 have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.
POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you have any of the following side effects:
Possible side effects
with unknown frequency (frequency cannot be estimated from the available data):
- Allergic reactions such as breathing problems, itching (pruritus), shock and abdominal pain. Those reactions were frequently preceded by sneezing or itching. If you experience these symptoms after your injection tell your doctor immediately. This may be an indication that you are sensitive to Thiamine hydrochloride solution for injection and should not be given a repeated dose.
- Pain at the injection site. A slow administration in larger veins can avoid burning sensations in the arm.
- Skin inflammation at the injection site (contact dermatitis). This can appear after injection to sensitised patients. 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, 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. 5.
How to store it
THIAMINE HYDROCHLORIDE SOLUTION FOR INJECTION
Keep this medicine out of the sight and reach of children. Do not store above 25°C. Do not freeze. Keep the ampoules in the outer carton in order to protect from light. For single use only. Discard any unused solution after use. The solution must be used immediately after opening the ampoule. The product can be diluted in the following infusion fluids: 3
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Glucose 50 mg/ml (5%). Sodium chloride 9 mg/ml (0.9%).
Chemical and physical in-use stability has been demonstrated for up to 8 hours at a temperature between 15 and 25°C without protection from light when the product is diluted in 50 ml and 250 ml of sodium chloride 0.9% and glucose 5%. From a microbiological point of view, unless the method of opening/dilution precludes the risks of microbial contamination, the diluted product in an infusion fluid should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user. This medicinal product must not be mixed with other medicinal products except those mentioned above. Do not use this medicine after the expiry date which is stated on the carton after EXP. Do not use this medicine if you notice visible particles in the solution, if the solution is not clear or if it contains a precipitate. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Thiamine hydrochloride solution for injection contains
- The active substance is thiamine hydrochloride (vitamin B1). Each 2 ml ampoule contains 250 mg thiamine hydrochloride. Each 1 ml of solution contains 125 mg thiamine hydrochloride.
- The other ingredients are sodium hydroxide and water for injections. What Thiamine hydrochloride solution for injection looks like and contents of the pack 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. Marketing Authorisation Holder Brancaster Pharma Limited Church House 48 Church Street Reigate, Surrey RH2 0SN, United Kingdom Manufacturer LABORATOIRES STEROP NV Scheutlaan 46-50 1070 Brussels Belgium This leaflet was last revised in 02/2026. ————————————————————————————————The following information is intended for healthcare professionals only: Posology Adults 4
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Beriberi:
- Treatment: 10 mg – 20 mg by intramuscular injection or slow intravenous infusion (over 30 minutes) 3 times/day for up to 2 weeks. If severe life threatening form of beriberi (e.g. Shoshin beriberi): 100 mg to 300 mg/day by slow intravenous infusion.
- Maintenance treatment: the treatment should be continued with a suitable oral form of vitamin B1.
•
Wernicke-Korsakoff syndrome associated with alcohol use disorder:
- Prophylaxis in patients with high risk (e.g. hospitalised patients managed for alcohol withdrawal in presence of malnutrition): 250 mg by intramuscular or intravenous route once daily for 3 to 5 days.
- Treatment: 500 mg to 750 mg by intravenous route 3 times/day for at least 2 days (up to 1000 mg/dose during the first 12 hours may be used). In case of favorable response the treatment can be continued with 250 mg by intramuscular or intravenous route once daily for 5 days or until there is no further improvement.
- Maintenance treatment: the treatment should be continued with a suitable oral form of vitamin B1.
Patients with marginal thiamine status to whom glucose is being administered should receive parenteral thiamine in each of the first few litres of IV fluid to avoid precipitating heart failure (see section 4.4 of the SmPC). Paediatric population There is only limited experience with therapy in children and adolescents. Beriberi:
- Treatment: 10 mg to 25 mg/day by intramuscular injection or slow intravenous infusion for 2 weeks. IV doses of 100 mg/day or even higher may be needed in severe cases, for example 500 mg three times a day could be used.
- Maintenance treatment: the treatment should be continued with a suitable oral form of vitamin B1. Elderly There are no data available in the elderly. No dose adjustment is recommended for this population. Interactions with other medicines should be considered (see sections 4.5 and 5.2). Renal impairment The influence of renal impairment on the pharmacokinetics of thiamine has not been evaluated. No dose adjustment is recommended, but caution is advised when treating patients with renal impairment (see sections 4.4 and 5.2). Hepatic impairment The influence of hepatic impairment on the pharmacokinetics of thiamine has not been evaluated. No dose adjustment is recommended, but caution is advised when treating patients with hepatic impairment (see section 5.2). Method of administration Thiamine hydrochloride solution for injection should be administered by slow intravenous or intramuscular route. The injection is administered slowly over 30 minutes. For intramuscular administration, use the undiluted drug solution. Deep intramuscular injection must be given into a big muscular mass (upper outer quadrant of the buttock or the lateral part of the thigh).
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Before injection of the dose, aspirate to be sure that the needle is not into a vein. If blood appears, take the needle out and inject into another site. Change the injection site in case of repeated doses. The solution is to be visually inspected prior to use (also after dilution). Only clear solutions free from visible particles should be used. Dilution for infusion Thiamine hydrochloride solution for injection can be administered by slow intravenous injection after dilution in 50 ml to 250 ml of a 50 mg/ml glucose (5%) or a 9 mg/ml sodium chloride (0.9%) sterile solution for up to 8 hours without protection from light. The solution after dilution remains clear, colourless to slightly yellow and free of visible particles. From a microbiological point of view, unless the method of opening/dilution precludes the risks of microbial contamination, the diluted product in an infusion fluid should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
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Frequently asked questions about Thiamine hydrochloride 125 mg/ml solution for injection
How do I take Thiamine hydrochloride 125 mg/ml solution for injection?
Thiamine hydrochloride 125 mg/ml solution for injection comes as injection containing 125mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Thiamine hydrochloride 125 mg/ml solution for injection?
The active substance in Thiamine hydrochloride 125 mg/ml solution for injection is thiamine hydrochloride.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Thiamine hydrochloride 125 mg/ml solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Thiamine hydrochloride 125 mg/ml solution for injection without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: thiamine hydrochloride
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Thiamine hydrochloride 125 mg/ml solution for injection is indicated for the prevention and the treatment of vitamin B1 deficiencies like beriberi, deficiency related to chronic alcoholism and Wernicke-Korsakoff syndrome.
4.2. Posology and method of administration
Posology
Adults
• Beriberi:
o Treatment: 10 mg – 20 mg by intramuscular injection or slow intravenous infusion (over 30 minutes) 3 times/day for up to 2 weeks.
If severe life threatening form of beriberi (e.g. Shoshin beriberi): 100 mg to 300 mg/day by slow intravenous infusion.
o Maintenance treatment: the treatment should be continued with a suitable oral form of vitamin B1.
• Wernicke-Korsakoff syndrome associated with alcohol use disorder:
o Prophylaxis in patients with high risk (e.g. hospitalised patients managed for alcohol withdrawal in presence of malnutrition): 250 mg by intramuscular or intravenous route once daily for 3 to 5 days.
o Treatment: 500 mg to 750 mg by intravenous route 3 times/day for at least 2 days (up to 1000 mg/dose during the first 12 hours may be used). In case of favourable response the treatment can be continued with 250 mg by intramuscular or intravenous route once daily for 5 days or until there is no further improvement.
o Maintenance treatment: the treatment should be continued with a suitable oral form of vitamin B1.
Patients with marginal thiamine status to whom glucose is being administered should receive parenteral thiamine in each of the first few litres of IV fluid to avoid precipitating heart failure (see section 4.4).
Paediatric population
There is only limited experience with therapy in children and adolescents.
• Beriberi:
o Treatment: 10 mg to 25 mg/day by intramuscular injection or slow intravenous infusion for 2 weeks.
IV doses of 100 mg/day or even higher may be needed in severe cases, for example 500 mg three times a day could be used (see section 5.1).
o Maintenance treatment: the treatment should be continued with a suitable oral form of vitamin B1.
Elderly
There are no data available in the elderly. No dose adjustment is recommended for this population. Interactions with other medicines should be considered (see sections 4.5 and 5.2).
Renal impairment
The influence of renal impairment on the pharmacokinetics of thiamine has not been evaluated. No dose adjustment is recommended, but caution is advised when treating patients with renal impairment (see sections 4.4 and 5.2).
Hepatic impairment
The influence of hepatic impairment on the pharmacokinetics of thiamine has not been evaluated. No dose adjustment is recommended, but caution is advised when treating patients with hepatic impairment (see section 5.2).
Method of administration
Thiamine hydrochloride 125 mg/ml solution for injection should be administered by slow intravenous or intramuscular route.
For slow intravenous administration, the drug solution must be first diluted into 50 ml to 250 ml of 5% glucose or 0.9% sodium chloride sterile solutions. The injection is administered slowly over 30 minutes.
For instructions on dilution of the medicinal product before administration, see section 6.6.
For intramuscular administration, use the undiluted drug solution. Deep intramuscular injection must be given into a big muscular mass (upper outer quadrant of the buttock or the lateral part of the thigh). Before injection of the dose, aspirate to be sure that the needle is not into a vein. If blood appears, take the needle out and inject into another site. Change the injection site in case of repeated doses.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Warnings
• Parenteral route must be used only when rapid restoration of thiamine is necessary (e.g. Wernicke-Korsakoff syndrome) or when oral route is ineffective (e.g. in case of vomiting, malabsorption).
• Anaphylactic reactions leading to shock have been reported after thiamine hydrochloride parenteral administration (see section 4.8). This risk increases in case of repeated doses. An intradermal test dose is recommended prior to parenteral administration in patients suspected to be drug sensitive. Emergency medical equipment for treating anaphylactic shocks must be easily available.
• To reduce the risk of anaphylactic shock and reactions at the injection site, the intravenous injection must be administered slowly (over 30 minutes). Fast IV administration of thiamine has been associated with an immediate burning sensation in the arm after injection in the IV line, lasting seconds to minutes. This reaction can be avoided by slow administration into larger veins with higher IV fluid flow rates (see section 4.8).
• As thiamine plays the role of enzymatic cofactor in the normal metabolism of carbohydrates, a large intake of glucose quickly provokes a depletion of the reserves, and precipitates or aggravates Wernicke encephalopathy in patients suffering from underlying thiamine deficiency. It is consequently recommended to administer thiamine intravenously before or simultaneously with administration of glucose by bolus or by infusion (see sections 4.2 and 4.8).
• Patients with renal impairment may need an extra careful monitoring (see sections 4.2 and 5.2).
• This medicine contains less than 1 mmol sodium (23 mg) per 2 ml ampoule, that is to say essentially “sodium-free”.
Precautions for use
• Do not use this medicine if you notice visible particles in the solution, if the solution is not clear or if it contains a precipitate.
• This drug solution and any syringe containing this medicine are intended for single and individual use (see section 6.3).
Interference with laboratory tests
Thiamine can give false positive results for urobilinogen determination by the Ehrlich's reaction (urine test) and for uric acid determination by the phosphotungstic method. High doses of thiamine may interfere with Schack and Waxler spectrophotometric assays of theophylline plasma concentration.
4.5. Interaction with other medicinal products and other forms of interaction
Medicines that may decrease the effect of thiamine
• The thiamine antagonists: 5-fluorouracil, other fluoropyrimidines (e.g. capecitabine) and ifosfamide.
• Diuretics, e.g. furosemide that may increase urinary thiamine excretion.
Thiamine deficiency can occur with the chronic use of these medicines. Consider high-dose thiamine supplementation during the treatment with these medicines.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of thiamine in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). The use of the product is individualised based on condition and requirements in pregnant women and can be used in pregnant women if use is necessary to correct deficiencies and if benefits outweigh risks.
Caution should be exercised when prescribing to pregnant women. The risk of anaphylactic reactions during parenteral administration must be taken into account.
Breastfeeding
Thiamine is excreted in human milk. At recommended daily intake levels no effects on the breastfed newborns/infants are anticipated. However, there is insufficient information on the levels and possible effects of excretion of thiamine in human milk after administration of high levels of thiamine (> 50 mg/day). A risk to the breastfed child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from thiamine therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
No relevant data is available.
4.7. Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
However, given the nature of the product, no effects are anticipated.
4.8. Undesirable effects
Adverse effects with thiamine are rare, but hypersensitivity reactions have occurred, mainly after parenteral administration. These reactions have ranged in severity from very mild to very rarely, fatal anaphylactic shock. Pain and an immediate burning sensation in the arm have been reported after a fast intravenous administration.
The possible side effects are listed below. The frequency of the possible side effects is defined as following:
• Very common (>1/10).
• Common (>1/100, <1/10).
• Uncommon (>1/1,000, <1/100).
• Rare (>1/10,000, <1/1,000).
• Very rare (<1/10,000).
• Unknown (cannot be estimated from the available data).
The side effects are presented by System Organ Class and in order of decreasing seriousness within each frequency category.
Organ system
Undesirable effects
Frequency
Immune system disorders
Allergic or anaphylactic reactions (with respiratory depression, pruritus, shock and abdominal pain)1
Unknown
Skin and subcutaneous tissue disorders
Contact dermatitis (which can appear after administration to sensitised individuals)
Unknown
General disorders and administration site conditions
Injection site reactions (pain, burning in the arm)2
Unknown
1 Reaction observed after repeated injections of high doses from 25 mg to 100 mg thiamine hydrochloride, at intervals of more than 7 days. These reactions are frequently preceded by sneezing or transient pruritus. The risk of anaphylactic shock can be reduced by a slow administration over 30 minutes.
2 Fast intravenous administration of thiamine has been associated with an immediate burning sensation in the arm after injection in the IV line, lasting seconds to minutes. This reaction can be avoided by a slow administration into larger veins with higher IV fluid flow rates (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: 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.
4.9. Overdose
Symptoms and signs
Thiamine is widely used, serious toxicity is not expected.
Single parenteral doses of 100 mg to 500 mg have been given with no toxic effects reported.
Toxicity is uncommon following oral ingestion, excessive doses are usually excreted rapidly in the urine. Long-term ingestion of doses greater than 3000 mg daily has been known to produce toxicity.
Severe toxicity has not been reported.
Treatment
In the unlikely event of overdosage, treatment is symptomatic and supportive.
In case of mild or moderate anaphylaxis: antihistamines are given (with or without inhaled beta agonists), corticosteroids or epinephrine.
In case of severe anaphylaxis: oxygen, airway management, antihistamines, epinephrine, corticosteroids, ECG monitoring, and IV fluids.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- VITAMINA B1 KABI 50 mg/ml prescriptionTHIAMINUM · injection / infusion
- VITAMINA B1 ZENTIVA 100 mg/2 ml prescriptionTHIAMINUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- Vitaminum B1 Biowet PuławyThiamini hydrochloridum · injection / infusion
- VitaBim B1Thiamini hydrochloridum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Thiamine hydrochloride 125 mg/ml solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.