Vitamin B and C Intravenous High Potency, Concentrate for Solution for Infusion
(Vitamins B and C)
- 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 Vitamin B and C is and what it is used for
2. What you need to know before you use Vitamin B and C
3. How to use Vitamin B and C
4. Possible side effects
5. How to store Vitamin B and C
6. Contents of the pack and other 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.
This medicine 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 long-term intermittent haemodialysis.
- 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 or pharmacist before using Vitamin B and C.
Vitamin B and C 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 Vitamin B and C.
Tell your doctor if you are taking, have recently taken, or might take, any other medicines.
- Levodopa (used in the treatment of Parkinson’s disease) – Vitamin B and C interferes with the effects of this medicine.
- Vitamin B1 (thiamine) injections - if you are on repeated injections of such preparations, Vitamin B and C 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.
Vitamin B and C is not expected to affect your ability to drive or operate machinery.
This medicine contains 79mg sodium in each 1 pair of 5ml ampoules. This is equivalent to 4% of the recommended daily dietary intake of sodium for an adult.
Vitamin B and C will be given to you by a healthcare professional by drip infusion into a vein. The product comes in two ampoules, the contents of which are first diluted with either saline or 5% glucose solution and then given over a period of 30 minutes.
Vitamin B and C is for injection into a vein only and should not be given by any other route.
Dilute before use.
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 ampoules (1 pair) diluted with 50ml to 100ml of infusion solution and injected over 30 minutes. Injected twice daily for up to 7 days.
- For haemodialysis patients: 10ml of the mixed ampoules (1 pair) diluted with 50ml to 100ml of infusion solution and injected over 30 minutes. Injected at the end of dialysis, once every 2 weeks.
Vitamin B and C is not usually given to children; however, suitable doses according to the child’s age are:
Age Dose
under 6 years 1/4 of the adult dose
6-10 years 1/3 of the adult dose
10-14 years 1/2 to 2/3 of the adult dose
14 years and older one adult dose
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 Vitamin B and C, speak to your doctor.
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 Vitamin B and C, ask your doctor.
Like all medicines, Vitamin B and C 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 Vitamin B and C and should not be given a repeat dose.
- Severe allergic reaction (anaphylactic shock) - may result from repeated injections of Vitamin B and C. 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.
- Mild ache at the site of the injection - some swelling may develop at the site of injection.
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.
Keep this medicine out of the sight and reach of children.
Vitamin B and C should be stored below 25°C but not frozen, and protected from light.
Once diluted in an infusion fluid Vitamin B and C should normally be used immediately.
If necessary the diluted product can be kept at room temperature:
For 7 hours in the following infusion fluids:
- Glucose 5%
- Physiological saline (sodium chloride 0.9%)
- Compound sodium lactate;
For 4 hours in the following infusion fluids:
- Glucose 4.3% with sodium chloride 0.18%
- Glucose 5% with potassium chloride 0.3%
Each pair of ampoules are for single use only.
Do not freeze diluted solution.
Do not use this medicine after the expiry date which is stated on the outer carton and ampoule labels after “EXP”. The expiry date refers to the last day of that month.
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.
The active ingredients are:
AMPOULE 1 5ml
thiamine hydrochloride (vitamin B1) 250mg
riboflavin (vitamin B2) 4mg
pyridoxine hydrochloride (vitamin B6) 50mg
AMPOULE 2 5ml
ascorbic acid (vitamin C) 500mg
nicotinamide 160mg
glucose (as monohydrate) 1000mg
The other ingredients are: edetic acid, sodium hydroxide and water for injections.
The product is supplied in pairs of amber coloured glass ampoules containing 5ml of sterile solution.
Each pack contains 6 or 10 pairs of 5ml ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Aspire Pharma Limited
Unit 4
Rotherbrook Court
Bedford Road
Petersfield
Hampshire
GU32 3QG
United Kingdom
Manufacturer:
Alfasigma S.p.A.
Via Enrico Fermi 1
Alanno, PE
65020
Italy
This leaflet was last revised in 04/2024
1010615 - P1.6