Vitaminum B12-sf

Package Leaflet: Information for the Patient

Vitaminum B12-SF, 1000 micrograms, coated tablets

Cyanocobalamin

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

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package Leaflet

• 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 in the form of cyanocobalamin (a synthetic form of the vitamin that the body converts into active vitamin B).
Most people get enough vitamin B from their diet, but if a patient has had stomach surgery, suffers from certain gastrointestinal disorders, follows a strict diet, or takes certain medications, their body may not get enough vitamin B.
Vitaminum B12-SF is used in adults in the following cases:

• treatment of vitamin B deficiency caused by poor nutrition;
• long-term treatment of vitamin B deficiency, e.g., due to malabsorption;
• oral treatment of megaloblastic anemia (a specific type of anemia) and vitamin B deficiency with neurological symptoms, after achieving normal vitamin B levels in the blood with vitamin B injections. Note: In patients who require rapid achievement of normal vitamin B levels in the blood, initial treatment should be performed with vitamin B injections until remission is achieved.

2. Important 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 specific type of anemia called megaloblastic anemia, which is caused solely by a lack of folic acid (vitamin B9);
• if the patient has a condition that requires the removal of cyanide from the body (detoxification) (e.g., in megaloblastic anemia with optic neuritis). In such cases, other products containing vitamin B should be used;
• if the patient has a vitamin B deficiency and suffers from a specific inherited eye disease (Leber's optic neuropathy);
• if the patient has been diagnosed with a visual impairment (amblyopia) caused by smoking or drinking alcohol.

Warnings and precautions

Before starting to take Vitaminum B12-SF, the doctor or pharmacist should be consulted.
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 checking the gastrointestinal function.
The doctor will decide whether the patient is getting enough 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 in the first months of treatment. This will be done through blood tests. If the patient carefully follows the treatment plan, treatment may last a lifetime, depending on the underlying disease.
If the patient requires regular dialysis, the doctor should perform regular blood tests and may need to reduce the dose of Vitaminum B12-SF.
If the patient also has a folic acid deficiency, this may hinder the response to treatment. In such cases, the use of Vitaminum B12-SF should be accompanied by treatment of folic acid deficiency.

Children and adolescents

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

Vitaminum B12-SF and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The absorption or action 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), which are used to treat excessive stomach acid production, causing indigestion or stomach ulcers;
• colchicine, used to treat gout;
• neomycin and chloramphenicol (antibiotics);
• cholestyramine;
• biguanides, including metformin, used to treat diabetes;
• aminosalicylic acid, used to treat inflammatory bowel disease;
• long-term use of nitrous oxide (a gas used for anesthesia);
• second-generation antipsychotic drugs used to treat mental disorders (e.g., olanzapine and risperidone).

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

• glucocorticoids, including prednisone, used to treat inflammatory conditions.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Vitaminum B12-SF may be used during pregnancy if necessary.
Vitaminum B12-SF can be used during breastfeeding.

Driving and using machines

Vitaminum B12-SF does not affect the ability to drive and use machines.

Vitaminum B12-SF contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Vitaminum B12-SF

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

Use in adults

The usual dose is 1 coated tablet per day, preferably on an empty stomach.
In megaloblastic anemia and neurological disorders, the medicine should be initially administered in the form of infusions/injections 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 the elderly

The same dose as for adults should be given to elderly patients.

Use in patients with renal impairment

Vitaminum B12-SF can be used in the usual dose in patients with moderate renal impairment. In cases of severe renal impairment, the doctor may reduce the dose. Additionally, regular monitoring of vitamin B levels in the blood is recommended.

Use in patients with hepatic impairment

There are no data on the safety of using the medicine in patients with liver disorders. If the patient has liver disorders, they should inform their doctor.

Overdose of Vitaminum B12-SF

In case of overdose or accidental ingestion by a child, a doctor or pharmacist should be consulted. For other questions about the medicine, a doctor or pharmacist should be consulted.

Missed dose of Vitaminum B12-SF

A double dose should not be taken to make up for a missed dose.

Stopping treatment with Vitaminum B12-SF

In case of further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Vitaminum B12-SF can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

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

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

• acne-like skin rashes and blisters,
• anaphylaxis and fever.

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, the doctor or pharmacist should be informed. 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
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vitaminum B12-SF

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light.
Do not store above 30°C.
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 month.
Medicines should not be disposed of via wastewater. A pharmacist should be asked how to dispose of unused medicines. 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 B12). Each coated tablet contains 1000 micrograms of cyanocobalamin (vitamin B12).
• The other ingredients are: CoreMannitol, microcrystalline cellulose, magnesium stearate, sodium carboxymethyl cellulose (type A)

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

What Vitaminum B12-SF looks like and contents of the pack

Vitaminum B12-SF is a white to light pink, round, biconvex coated tablet.
Vitaminum B12-SF is available in PVC/PVDC/Aluminum blisters in a carton containing 10 or 50 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
phone: +48 22 350 66 69

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
Date of last revision of the package leaflet:12.2023