Package leaflet: Information for the user

Vitaminum B12-SF, 1000 micrograms/ml, solution for injection
Cyanocobalaminum
Please read this leaflet carefully before using the medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Vitaminum B12-SF is and what it is used for
Important information before using Vitaminum B12-SF
How to use Vitaminum B12-SF
Possible side effects
How to store Vitaminum B12-SF
Contents of the pack and other information

1. What Vitaminum B12-SF is and what it is used for
Vitaminum B12-SF contains a vitamin from the B group, used in the treatment of anaemia.
Vitaminum B12-SF is used in cases of vitamin B12 deficiency that cannot be corrected by an appropriate diet.
Specifically:

In pernicious anaemia (Addison-Biermer disease) (a specific type of anaemia caused by vitamin B12 deficiency);
In other megaloblastic anaemias due to vitamin B12 deficiency;
In vitamin B12 deficiency due to the following causes:
- Complete exclusion of animal-derived products from the diet (strict vegetarianism);
- Impaired (congenital or acquired) secretion of intrinsic factor required for vitamin B12 absorption (Castle's factor);
- Absence of Castle's factor following gastrectomy (surgical removal of the stomach);
- Chronic atrophic gastritis;
- Malabsorption syndromes following resection of the ileum, in celiac disease (a disease caused by gluten intolerance), tropical sprue (also known as psylosis – a gastrointestinal disorder leading to impaired nutrient absorption), or Crohn's disease (an inflammatory bowel disease);
- Utilization of vitamin B12 by intestinal bacteria (blind loop syndrome) or parasites (infection with Diphyllobothrium latum);
In the Schilling test (a test assessing vitamin B12 absorption).

2. Important information before using Vitaminum B12-SF
When not to use Vitaminum B12-SF

If the patient is allergic to cyanocobalamin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Vitaminum B12-SF, discuss it with your doctor or pharmacist.

In patients with Leber's disease (visual disturbances due to optic nerve atrophy), the medicine should be used with caution, as cyanocobalamin may accelerate optic nerve atrophy.
In patients with pernicious anaemia, treatment with high doses of vitamin B12 may lead to decreased potassium levels in the blood.
In Addison-Biermer disease, vitamin B12 must be administered regularly for life. A temporary interruption of treatment, even if seemingly justified by good blood test results (haematology), may lead to irreversible neurological damage.
Vitamin B12 treatment may unmask symptoms of polycythaemia vera (intense redness of the face, hands, feet, and oral mucosa).
Before starting treatment and between the 5th and 7th day of treatment, the following laboratory tests are recommended: serum folate levels, haematocrit, reticulocytes (a marked increase in reticulocyte count – young red blood cells – is an early sign of effective treatment), and vitamin B12 levels. In long-term treatment, monitoring of haematological parameters and vitamin B12 levels every 3 to 6 months is recommended.

Special patient groups
Based on available data, dose adjustment is not required in patients with impaired renal or hepatic function or in elderly patients.
Children and adolescents
Due to limited clinical data, an optimal dosing regimen for this medicine in children cannot be established.
Vitaminum B12-SF and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.

Some antibiotics, methotrexate (used in cancer treatment), or pyrimethamine (used in malaria treatment) may interfere with vitamin B12 serum assays, leading to false-negative results.
Concurrent use of bone marrow suppressants (e.g. chloramphenicol) may reduce the response to vitamin B12 therapy.
Long-term use of high-dose folic acid may reduce vitamin B12 levels in the blood.

Due to the instability of vitamin B12, mixing with other medicines may result in loss of activity.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
The recommended daily dose of vitamin B12 during pregnancy and breastfeeding is 4 micrograms. Current experience indicates that higher doses do not adversely affect the foetus.
Vitamin B12 passes into human milk.
Driving and operating machinery
No special precautions are required.
Vitaminum B12-SF contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, i.e. it is considered "sodium-free".
3. How to use Vitaminum B12-SF
This medicine should always be used as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
At the beginning of treatment, during the first weeks after diagnosis, 1 ml of Vitaminum B12-SF (corresponding to 1000 micrograms of cyanocobalamin) is administered twice weekly.
In confirmed cases of impaired intestinal absorption of vitamin B12, 1000 micrograms of cyanocobalamin should be administered once monthly.
Schilling test:
After oral administration of radiolabelled vitamin B12, 1000 micrograms of vitamin B12 is administered intramuscularly as a single dose.
Parenteral medicines should be inspected visually before use. Only clear solutions without visible particles should be used.
Vitaminum B12-SF is usually administered intramuscularly, but may also be given subcutaneously.
Vitaminum B12-SF is intended for long-term use. Discuss this with your doctor.
Overdose of Vitaminum B12-SF
Symptoms of poisoning or overdose are not known.
Discontinuation of Vitaminum B12-SF
Discontinuing treatment may compromise treatment efficacy. If adverse reactions occur, contact your doctor to discuss further management.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this product may cause side effects, although not everybody experiences them.
The medicinal product is generally well tolerated, but the following adverse reactions may occur in some patients:
Immune system disorders
Very rare (<1/10,000): anaphylactic or anaphylactoid reactions.
Skin and subcutaneous tissue disorders
Very rare (<1/10,000): acne, rash, and urticarial reactions.
Gastrointestinal disorders
Frequency not known: dyspepsia, nausea, vomiting, mild transient diarrhoea.
General disorders and administration site conditions
Frequency not known: local irritation and intolerance symptoms (burning, itching, redness, hyperthermia, tingling).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Vitaminum B12-SF
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the stated month.
Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Vitaminum B12-SF contains

The active substance is cyanocobalamin. 1 ml of solution contains 1000 micrograms of cyanocobalamin.
The other ingredients are: sodium chloride, hydrochloric acid (for pH adjustment), water for injections.

What Vitaminum B12-SF looks like and contents of the pack
A 1 ml ampoule made of amber glass type I with a break-point (OPC), containing a clear red solution for injection, packed in a cardboard box.
Vitaminum B12-SF is available in the following pack sizes:

5 ampoules with 1 ml of solution for injection,
10 ampoules with 1 ml of solution for injection.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki