Vitamin B1 Salf
ItalyTable of Contents
Package leaflet: Information for the user
Vitamin B1 S.A.L.F. 100 mg injectable solution
Thiamine hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- What VITAMIN B1 S.A.L.F. is and what it is used for
- What you need to know before using VITAMIN B1 S.A.L.F.
- How to use VITAMIN B1 S.A.L.F.
- Possible side effects
- How to store VITAMIN B1 S.A.L.F.
- Contents of the pack and other information
1. What VITAMINA B1 S.A.L.F. is and what it is used for
This medicinal product contains the active substance vitamin B1, also known as thiamine, which is important for the proper functioning of the nervous system, particularly the nerves.
VITAMINA B1 S.A.L.F. is indicated:
- for the prevention and treatment of low levels of vitamin B1 (beriberi);
- for the treatment of nerve damage (deficiency-related polyneuritis) in individuals who abuse alcohol and in pregnant women (alcoholic or gestational polyneuritis);
- for the treatment of heart diseases in individuals who abuse alcohol (alcoholic cardiomyopathies);
- for the treatment of nerve inflammation and damage (neuritis and polyneuritis) not due to reduced levels of vitamin B1 (non-deficiency-related), as an addition to other medicinal products.
2. What you need to know before using VITAMINA B1 S.A.L.F.
Do not use VITAMINA B1 S.A.L.F.
- if you are allergic to vitamin B1 or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using VITAMINA B1 S.A.L.F.
Use special caution if you have previously experienced allergic-type reactions (sensitization phenomena) or
allergy-related diseases (manifestations of allergic disorders).
The risk of allergic-type reactions (hypersensitivity reactions) increases with repeated use of VITAMINA B1
S.A.L.F. and when administered intramuscularly (into the muscle).
Other medicines and VITAMINA B1 S.A.L.F.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicine.
Use this medicine with caution and inform your doctor if you are taking:
- thiocarbazone, used to treat viral diseases;
- 5-fluorouracil, used in the treatment of certain types of cancer.
Vitamin B1 may interfere with the results of certain urine tests (urinary urobilinogen determination using
Ehrlich's reagent) and blood serum tests (spectrophotometric determination of serum theophylline), especially
when used at high doses.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or
pharmacist before using this medicine.
VITAMINA B1 S.A.L.F. is not recommended during pregnancy or breastfeeding.
Driving and using machines
VITAMINA B1 S.A.L.F. does not affect the ability to drive or operate machinery.
However, it is recommended to pay particular attention to the onset of any symptoms caused by the medicine before driving or operating machinery.
VITAMINA B1 S.A.L.F. contains sodium chloride
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. practically "sodium-free".
3. How to use VITAMINA B1 S.A.L.F.
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 vial daily or on alternate days, administered by injection into a muscle (intramuscular route), as prescribed by your doctor.
Use this medicine immediately after opening the container, after ensuring that the solution is clear, colourless and free from visible particles, in a single administration, discarding any unused portion.
If you use more VITAMINA B1 S.A.L.F. than you should
Isolated cases of toxicity have been reported.
If you take/ingest an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, contact your doctor or pharmacist immediately.
If you forget to use VITAMINA B1 S.A.L.F.
Do not use a double dose to make up for the forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will get them.
Not known (frequency cannot be estimated from the available data)
- pain at the site of administration;
- allergic reactions, even severe (anaphylactic) reactions, presenting with the following symptoms:
- sneezing;
- itching;
- skin irritation (urticaria);
- swelling of the face, lips, throat and/or tongue (angioedema);
- abdominal pain;
- difficulty breathing;
- increased heart rate (tachycardia) and awareness of heartbeats (palpitations).
Administration of medicines containing vitamin B1 or its derivatives may also cause more severe allergic reactions (anaphylactic shock).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store VITAMINA B1 S.A.L.F.
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton after “Expiry”.
The expiry date refers to the last day of that month.
Store in the original container tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What VITAMINA B1 S.A.L.F. 100 mg/2 ml injectable solution for intramuscular use contains
- The active substance is thiamine hydrochloride. Each vial contains 100 mg of thiamine hydrochloride.
- The other components are: sodium chloride, hydrochloric acid, water for injectable preparations and sodium hydroxide (for pH adjustment).
Description of the appearance of VITAMINA B1 S.A.L.F. and package contents
Vitamina B1 S.A.L.F. 100 mg - injectable solution for intramuscular use - Box containing 5 vials of 2 ml
Marketing Authorization Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico - via Marconi, 2 - 24069 Cenate Sotto (BG) - Italy