Vitaminum B12-sf

Package Leaflet: Information for the User

Vitaminum B 12-SF, 1000 micrograms/ml, Solution for Injection

Cyanocobalamin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 1. What Vitaminum B 12-SF is and what it is used for
• 2. Important information before using Vitaminum B 12-SF
• 3. How to use Vitaminum B 12-SF
• 4. Possible side effects
• 5. How to store Vitaminum B 12-SF
• 6. Contents of the pack and other information

1. What Vitaminum B 12-SF is and what it is used for

Vitaminum B 12-SF contains a vitamin from the B group, used to treat anemia.
Vitaminum B 12-SF is used in cases of vitamin B deficiency that cannot be treated with an appropriate diet.
In particular:

• in malignant Addison-Biermer anemia (a specific type of anemia resulting from a lack of vitamin B);
• in other megaloblastic anemias with a vitamin B deficiency;
• in vitamin B deficiencies due to the following reasons:
• complete exclusion of animal products from the diet (strict vegetarianism);
• inhibition (congenital or acquired) of the secretion of intrinsic factor enabling vitamin B absorption (Castle's factor);
• lack of Castle's factor due to gastric resection;
• chronic atrophic gastritis;
• malabsorption syndromes after resection of the ileum, in the course of celiac disease (a disease caused by gluten intolerance), tropical sprue (a gastrointestinal disease leading to disturbances in the absorption of nutrients), Crohn's disease (an inflammatory disease of the gastrointestinal tract);
• utilization of vitamin B by intestinal bacteria (blind loop syndrome) or parasites (infection with Diphyllobothrium latum);
• in the Schilling test (a test for vitamin B absorption).

2. Important information before using Vitaminum B 12-SF

When not to use Vitaminum B 12-SF

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

Warnings and precautions

Before starting treatment with Vitaminum B 12-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 malignant anemia, during treatment with high doses of vitamin B, the potassium level in the blood may decrease.
• In Addison-Biermer disease, vitamin B should be used regularly throughout life. A few months' break in administration, seemingly justified by good blood test results (morphology), may lead to irreversible damage to the nervous system.
• Treatment with vitamin B may reveal symptoms of erythema (severe redness of the face, hands, feet, and mucous membranes).
• Before starting treatment and between the 5th and 7th day of treatment, it is recommended to perform the following laboratory tests: folic acid level, hematocrit, reticulocytes (a significant increase in the number of reticulocytes - young red blood cells is an early sign of treatment efficacy) and vitamin B level. In the case of long-term treatment, it is recommended to monitor hematological parameters (blood condition) and vitamin B level every 3 to 6 months.

Special patient groups

Based on available data, in patients with renal, hepatic, or elderly patients, there is no need to adjust the dose.

Children and adolescents

Due to limited clinical data, it is not possible to determine the optimal dosing regimen for this medicine in children.

Vitaminum B 12-SF and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• Certain antibiotics, methotrexate (used to treat cancer) or pyrimethamine (used to treat malaria) may affect vitamin B levels in the serum, giving false-negative results.
• Concomitant use of medicines that suppress bone marrow function (e.g., chloramphenicol) may weaken the response to vitamin B treatment.
• Folic acid used in high doses for a long time may decrease vitamin B levels in the blood.

Due to the instability of vitamin B, mixing with other medicines may lead to loss of activity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
The recommended daily dose of vitamin B during pregnancy and breastfeeding is 4 micrograms. So far, experience has shown that the use of higher doses does not have a negative effect on the fetus.
Vitamin B passes into breast milk.

Driving and using machines

No special precautions are necessary.

Vitaminum B 12-SF contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per ampoule, which is considered to be "sodium-free".

3. How to use Vitaminum B 12-SF

Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
At the beginning of treatment, during the first weeks after diagnosis, 1 ml of Vitaminum B 12-SF (corresponding to 1000 micrograms of cyanocobalamin) is administered twice a week.
In cases of confirmed vitamin B malabsorption in the intestine, 1000 micrograms of cyanocobalamin are administered once a month.
Schilling test:
After oral administration of labeled vitamin B, 1000 micrograms of vitamin B are administered intramuscularly once.
Medicines for parenteral administration should be inspected before use. Only clear solutions without visible particles should be used.
Vitaminum B 12-SF is usually administered intramuscularly, but it can also be administered subcutaneously.
Vitaminum B 12-SF is intended for long-term use. Discuss this with your doctor.

Using more than the recommended dose of Vitaminum B 12-SF

Signs of overdose or poisoning are not known.

Stopping the use of Vitaminum B 12-SF

Stopping the use of the medicine threatens the effectiveness of the treatment. If side effects occur, contact your doctor to discuss further treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Vitaminum B 12-SF can cause side effects, although not everybody gets them.
The medicinal product is generally well tolerated, but the following side effects may occur in some patients:
Immune system disorders
Very rare (<1>Skin and subcutaneous tissue disorders
Very rare (<1>Gastrointestinal disorders
Frequency not known: nausea, vomiting, mild transient diarrhea.
General disorders and administration site conditions
Frequency not known: local irritation and intolerance symptoms (burning, itching, redness, hyperthermia, tingling).

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vitaminum B 12-SF

Keep this 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 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 required. This will help protect the environment.

6. Contents of the pack and other information

What Vitaminum B 12-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 B 12-SF looks like and contents of the pack

A 1 ml glass ampoule of type I orange glass with a break-off point (OPC) containing a clear, red solution for injection, in a cardboard box.
Vitaminum B 12-SF is available in packs of:

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

Date of last revision of the package leaflet: