Vitaminum b12-sf

Patient Information Leaflet

Vitaminum B12-SF, 1000 micrograms, coated tablets
Cyanocobalaminum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of Contents

1. What is Vitaminum B12-SF and what is it used for
2. Important information before taking Vitaminum B12-SF
3. How to take Vitaminum B12-SF
4. Possible side effects
5. How to store Vitaminum B12-SF
6. Contents of the pack and other information

1. What is Vitaminum B12-SF and what is it used for

Vitaminum B12-SF contains vitamin B\textsubscript{12} in the form of cyanocobalamin (a synthetic form of the vitamin, which the body converts into active vitamin B\textsubscript{12}).
Most people obtain sufficient vitamin B\textsubscript{12} from their diet. However, if you have undergone stomach surgery, suffer from certain gastrointestinal disorders, follow a strict diet, or take certain medications, your body may not receive enough vitamin B\textsubscript{12}.
Vitaminum B12-SF is used in adults in the following cases:

• treatment of vitamin B\textsubscript{12} deficiency caused by poor nutrition;
• long-term treatment of vitamin B\textsubscript{12} deficiency, e.g., due to intestinal malabsorption;
• oral treatment of pernicious anemia (a specific type of anemia) and vitamin B\textsubscript{12} deficiency with neurological symptoms, after achieving normal blood vitamin B\textsubscript{12} levels with vitamin B\textsubscript{12} injections. Note: In patients requiring rapid normalization of blood vitamin B\textsubscript{12} levels, initial treatment should be administered via vitamin B\textsubscript{12} injections until remission is achieved.

2. Information before taking Vitaminum B12-SF

When not to take Vitaminum B12-SF

• if the patient is allergic to cyanocobalamin or any of the other ingredients of this medicine (listed in section 6);
• if the patient has a particular type of anaemia called megaloblastic anaemia caused solely by folic acid deficiency (vitamin B);
• if the patient is in a condition requiring cyanide removal from the body (detoxification) (e.g. pernicious anaemia with accompanying optic neuritis). In such a case, other vitamin B-containing products should be used;
• if the patient has vitamin B deficiency and suffers from a specific hereditary eye disease (optic atrophy in Leber's disease);
• if the patient has been diagnosed with visual impairment (low vision) caused by tobacco smoking or alcohol consumption.

Warnings and precautions
Before starting treatment with Vitaminum B12-SF, discuss it with your doctor or
pharmacist.
At the beginning of treatment, the patient's clinical condition must be diagnosed by a doctor to
determine the cause of the deficiency. This includes assessing gastrointestinal function.
The doctor will decide whether the patient receives sufficient vitamin B from food and whether
oral supplementation with Vitaminum B12-SF is necessary.
Depending on the severity of the disease, the doctor will monitor the patient's response to this
medicine during the first months of treatment. This will be done through blood tests. If the patient
carefully follows the treatment plan, treatment may continue for life, depending on the underlying
disease.
If the patient requires regular kidney dialysis, the doctor should perform regular blood tests and
a reduction in the dose of Vitaminum B12-SF may be necessary.
If the patient also has folic acid deficiency, this may impair the response to treatment. In such
cases, treatment with Vitaminum B12-SF should be accompanied by treatment for folic acid
deficiency.

Children and adolescents
Vitaminum B12-SF must not be used in children and adolescents under 18 years of age, as there
are insufficient clinical data and the dose is inappropriate for this age group.

Vitaminum B12-SF and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken,
or plan to take.
The absorption or effect of Vitaminum B12-SF may be reduced by the following
substances:

• proton pump inhibitors (e.g. omeprazole) and histamine H2-receptor antagonists (e.g. cimetidine), used in the treatment of excessive gastric acid production causing indigestion or peptic ulcer disease;
• colchicine, used in the treatment of gout;
• neomycin and chloramphenicol (antibiotics);
• cholestyramine;
• biguanides, including metformin, used in the treatment of diabetes;
• aminosalicylic acid, used in the treatment of inflammatory bowel diseases;
• long-term use of nitrous oxide (anaesthetic gas);
• second-generation antipsychotic drugs used in psychiatric disorders (e.g. olanzapine and risperidone).

The absorption or effect of Vitaminum B12-SF may be increased by the following
substances:

• glucocorticoids, including prednisone, used in the treatment of inflammatory conditions.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
baby, she should consult her doctor or pharmacist before using this medicine.
If necessary, the use of Vitaminum B12-SF may be considered during pregnancy.
Vitaminum B12-SF may be used during breastfeeding.

Driving and operating machinery
Vitaminum B12-SF has no influence on the ability to drive or operate machinery.

Vitaminum B12-SF contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning this medicine is considered "sodium-free".

3. How to take Vitaminum B12-SF

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use in adults
The usual dose is 1 coated tablet per day, preferably on an empty stomach.
In pernicious anaemia and neurological disorders, the medicine should initially be administered in the form of infusion/injection until blood test results return to normal.
The tablet should be taken with ½ glass of water.
Use in children and adolescents
Vitaminum B12-SF should not be used in children and adolescents under 18 years of age.
Use in elderly patients
Elderly patients should be given the same dose as adult patients.
Use in patients with renal impairment
Vitaminum B12-SF may be used at the standard dose in patients with moderate renal impairment. In cases of severe renal impairment, the doctor may reduce the dose. Additionally, vitamin B blood levels should be monitored regularly.
Use in patients with hepatic impairment
There is insufficient data on the safety of using this medicine in patients with liver disorders. If the patient has impaired liver function, inform the doctor.
Taking more than the recommended dose of Vitaminum B12-SF
Contact your doctor or pharmacist if you have taken too much of the medicine or if the medicine has been accidentally ingested by a child. For any other questions regarding the medicine, consult your doctor or pharmacist.
Missing a dose of Vitaminum B12-SF
Do not take a double dose to make up for a missed dose.
Stopping treatment with Vitaminum B12-SF
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

Not common (may affect up to 1 in 100 patients):

• severe allergic reactions, which may manifest as urticaria, rash, or itching affecting large areas of the body.

Frequency unknown (frequency cannot be estimated from the available data):

• acneiform skin eruptions and blisters,
• anaphylaxis and fever.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring 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
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions enables the collection of further information on the safety of the medicine.

5. How to store Vitaminum B12-SF

Keep the medicine out of sight and reach of children.
Store in the original packaging to protect from light.
Do not store above 30ºC.
Do not use this medicine after the expiry date stated on the blister and carton after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vitaminum B12-SF contains

• The active substance is: cyanocobalamin (vitamin B ). Each coated tablet contains 1000 micrograms of cyanocobalamin (vitamin B ).
• The other ingredients are:
  Tablet core
  Mannitol, microcrystalline cellulose, magnesium stearate, sodium carboxymethylstarch (type A)

Coating
Hypromellose, titanium dioxide (E 171), hydroxypropylcellulose, talc, medium-chain triglycerides

What Vitaminum B12-SF looks like and contents of the pack
Vitaminum B12-SF is a white to slightly pinkish, round, biconvex coated tablet.
Vitaminum B12-SF is available in PVC/PVDC/Aluminium blisters, packed in a cardboard box containing 10, 50 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany