STEROBION

(Sterop, Belgium)

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

1. WHAT STEROBION IS AND WHAT IT IS USED FOR
The name of your medicine is STEROBION 2ml. It is referred to as “STEROBION” in the rest of this leaflet.
STEROBION is a solution for injection containing a complex of vitamin B1 (thiamine.HCl), vitamin B6
(pyridoxine.HCl) and vitamin B12 (cyanocobalamin).
STEROBION is used for the treatment of lack of vitamin B1, B6 and B12, when it cannot be corrected through the diet
and when the oral route is not feasible.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE STEROBION
Do not use STEROBION
• Do not use STEROBION if you are allergic to vitamin B1, vitamin B6, vitamin B12, cobalt or any of the other
ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include a rash, itching or
breathing problems, and swelling of your lips, throat or tongue.
• You must not use sterobion if you are using levodopa (see Other medicines and STEROBION).
If you are not sure if any of these apply to you, talk to your doctor or nurse before being given STEROBION.
Warnings and precautions
Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Talk to your doctor, pharmacist or nurse before using STEROBION:
• If you suffer from a folate deficiency. The therapeutic effect of vitamin B12 may be decreased.
• If you suffer from Leber’s disease (an hereditary optic nerve atrophy). Vitamin B12 may increase the risk of optic
atrophy may be increased causing you to loss vision (see section 4).
• If you suffer from kidney impairment. Prolonged use of vitamin B12 may increase the risk of aluminium toxicity,
particularly in premature infants.
• If you suffer from anaemia. Vitamin B12 may hide pernicious anaemia, thus in case of anaemia is recommended to
make a precise diagnosis before to start the treatment.
• If you have ever had an hypersensitivity reaction to any other vitamin or vitamin complex.
Other medicines and STEROBION
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes
medicines obtained without a prescription and herbal products.
Taking STEROBION with other medicines can affect the way these medicines work or the way STEROBION
works. These medicines includes:
• Levodopa (to treat Parkinson’s disease), concurrent use with vitamin B6 may decrease levodopa effects.
• Altretamine (to treat cancer), concurrent use with vitamin B6 may decrease altretamine effects.
• Fluorouacil (to treat cancer), vitamin B1 may decrease the level of this medicine (consider vitamin B1
supplementation at 100mg/day).
• Colchicine (to treat gout), may decrease the absorption of vitamin B12.
• Vitamin C may decrease the level of vitamin B12.
• Chloramphenicol (to treat infections), may decrease the effects of vitamin B12 in the blood.
• Omeprazole (to treat dyspepsia and peptic ulcer), may decrease the absorption of vitamin B12.

STEROBION with food and drink
Not relevant.

Pregnancy and breast-feeding
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 taking this medicine. The doctor will decide if STEROBION is suitable for you.
You can use this medicine if you are pregnant. There is no evidence that this medicine might be harmful for you or
for the foetus.
You can use this medicine during breast-feeding, although it may cause the decrease of breast milk.

Driving and using machines
This product should not affect your ability to drive or to use machinery.

Important information about some of the ingredients of STEROBION
STEROBION contains sulphites and can cause severe allergic reactions and difficulty breathing.

3. HOW TO USE STEROBION
Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not
sure.
STEROBION is given to you by a healthcare professional into a muscle (intramuscular injection) preferably deep in
the gluteus maximus.
The posology, frequency of administration and duration of the treatment will be established by your doctor.
Usual dose
Adults
Depending on the intensity of the lack symptoms, from 2-3 ampoules per week to 1 ampoule daily until body
reserves are recovered.
Children
This medicine must not be administered to children.

If you use more STEROBION than you should
Sensibility problems may occur during a long-term administration of doses higher than 1g (10 ampoules) of vitamin
B6 daily.
As STEROBION is administered by a healthcare professional it is unlikely that you will be given too much.
If you think someone has administrated too much STEROBION to you, contact immediately your doctor, nurse,
pharmacist or hospital emergency department or call the Poison Centre for advice.
Always take the labelled medicine package and the leaflet with you. This will allow an easier identification of the
medicine.

If you forget to use STEROBION
This is unlikely as the injection is given to you by a healthcare professional, but if you are concerned about missing a
dose, speak to your doctor or nurse.
Do not use a double dose to make up for a forgotten dose.

If you stop using STEROBION
In case of a sudden stop of the treatment (if the dose is higher than 2 ampoules per day) withdrawal symptoms may
occur due to vitamin B6.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During the treatment with STEROBION, it is possible to observe the following side effects:
• Very common (affects more than one patient out of 10):
- Joint pain (arthralgia).
- Physical weakness or lack of energy (asthenia)
- Dizziness
- Headache.
• Not known (the frequency cannot be estimated from the available data):
- Local hypersensitivity reactions and pain at the site of injection.
- Hypersensitivity reactions: frequently preceded by sneezing, with breath difficulty, intense itching (pruritus), skin
rash, urticaria, abdominal pain, anaphylactic shock , swelling of the skin and mucosa (angioedema).
- Skin affections: sensitivity to sunlight (photosensitivity), perspiration.
- Appearance of red or purple discolourations on the skin (purpura).
- Nausea, abdominal pain, vomiting, diarrhea and loss of appetite.
- Neuropathies periferique that is a condition affecting nerves, which may cause numbness, tremor, pins and
needles, itching, pain or cramps among others.
- Memory problems.
- Insomnia.
- Fast heart beating (tachycardia).
- Heart failure.
- Blood clotting in peripheral blood vessels (thrombosis).
- Fluid accumulation in the lungs (pulmonary oedema).
- Respiratory problems in infants has been associated with vitamin B6.
- Feeling of swelling of the entire body.
- Increased the risk of optic atrophy (loss of vision) in patients suffering from Leber’s disease due to Vitamin B12.
If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed
in this leaflet.

5. HOW TO STORE STEROBION
Keep this medicine out of the sight and reach of children.
Store this medicine between 2 and 8°C (in a fridge) in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the packaging after EXP (month/year). 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.
Do not use this medicine if you notice any particles in the ampoule, or if it is discoloured in any way.
This medicinal solution must be used immediately after the ampoule opening. It is intended for single use only.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What STEROBION contains
The active substances are vitamin B1 (thiamine.HCl), vitamin B6 (pyridoxine.HCl) and vitamin B12
(cyanocobalamin).
Each 2ml ampoule contains vitamin B1 100mg, vitamin B6 100mg and vitamin B12 1mg.
The other ingredients are sodium metabisulfite (E223) and water for injections.
What STEROBION looks like and contents of the pack
STEROBION is a red, aqueous, sterile solution for injection.
This medicine is available in 2ml glass ampoules, packed in boxes containing 5, 10, 50 or 100 ampoules.
Export Declaration holder
STEROP OVERSEAS, Avenue de Scheut 194, 1070 Brussels, BELGIUM
Manufacturer
Laboratoires STEROP, Avenue de Scheut 46-50, 1070 Brussels, BELGIUM
Belgian Export declaration number: 1114ED187F12
This leaflet was last updated in 05/2014