Label: information for the user

Vitamin B12Farmasierra 1000 microgramos hard capsules

Cyanocobalamin (vitamin B12)

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this label. See section 4.

6. Contents of the pack and additional information

It contains cianocobalamina (vitamin B12) as the active ingredient. Vitamin B12, which is water-soluble, is involved in the body in many metabolic processes, including some related to the nervous system and the formation of blood cells.

Vitamina B12 Farmasierra is indicated for the prevention and treatment of vitamin B12 deficiency states in adults:

• Prevention of deficiency in adult patients with a significant increase in the requirements for this vitamin. Vitamin B12 deficiency may be due to diet (strict vegetarians), induced by medications, or due to malabsorption syndromes (difficulty in digesting nutrients from food), such as sprue (inflammation of the small intestine causing diarrhea) and Crohn's disease (a form of intestinal inflammation).
• Pernicious anemia (decrease in the number of red blood cells due to a lack of vitamin B12).
• Dementia associated with vitamin B12 deficiency.
• In cases of gastrectomy (removal of all or part of the stomach).

Do not take Farmasierra Vitamin B12

If you are allergic to cyanocobalamin or other cobalamins (Vitamin B12), cobalt, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Vitamin B12Farmasierra.

• Before starting treatment, your deficiency of Vitamin B12 must be confirmed. If this is not corrected, it may lead to spinal cord damage from the third month.
• If you take folic acid instead of cyanocobalamin, folic acid will resolve the anemia but not the neurological disorders.
• Before starting treatment, blood tests must be performed to determine various parameters such as hematocrit (volume of red blood cells in relation to total blood), reticulocytes (immature red blood cells), which will be done daily during the first days of treatment; Vitamin B12, folic acid, and iron levels.
• Interference with other medications you are taking must be taken into account.
• If you have a hereditary optic nerve atrophy disease (Leber's disease), it may worsen with the administration of cyanocobalamin (you must follow an alternative treatment).
• If you have a genetic disease (polycythemia vera) that produces an increase in red blood cells, especially, requires additional monitoring during treatment because symptoms may be masked.
• If you have been treated for megaloblastic anemia (decrease in red blood cells with increased size of these, being the most frequent cause of pernicious anemia) and it is reversing, a decrease in blood potassium levels may occur. Potassium levels may also decreaseduring the initial treatment of pernicious anemia. Your potassium levels in the blood must be monitored at the beginning of treatment; if necessary, your doctor may prescribe a supplement.
• If you are prone to gout (joint pain due to elevated uric acid), cyanocobalamin may precipitate a gout crisis.
• If you follow a vegetarian diet without animal products, it is recommended that you take Vitamin B12 (as cyanocobalamin) periodically.
• During pregnancy and lactation, Vitamin B12 needs increase. Vitamin B12 deficiency has been detected in breastfed babies of vegetarian mothers.
• If you have pernicious anemia, you will require monthly treatment with Vitamin B12. If you do not have it, anemia may recur and irreversible damage to the nerves of the spinal cord may occur. Patients with pernicious anemia have a higher probability of developing stomach cancer than the general population.

Interference with diagnostic tests: If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results. This medication may affect the determination of antibodies against intrinsic factor (FI).

Most antibiotics, methotrexate, and pyrimethamine may invalidate Vitamin B12 values in blood tests.

Children

Vitamin B12Farmasierra will only be administered to children under 14 years old under prescription and medical supervision.

Other medications and Vitamin B12Farmasierra

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Vitamin B12Farmasierra may interact with the following medications:

• Chloramphenicol (antibiotic)
• Various medications may decrease the absorption of cyanocobalamin or reduce its effect, such as: high doses of ascorbic acid (vitamin C) (ascorbic acid should be taken 2 or more hours after the Vitamin B12 supplement), oral neomycin antibiotics, colchicine (for gout treatment), H2 antagonists (medications for acid reflux or stomach ulcers), omeprazole (for stomach ulcers), long-term use of aminosalicylic acid (for intestinal diseases), epilepsy medications,metformin (for diabetes).
• Oral contraceptives: may decrease blood Vitamin B12concentrations.

Taking Vitamin B12Farmasierra with alcohol

Excessive alcohol consumption decreases the absorption of vitamins such as Vitamin B12.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Vitamin B12 will be administered to pregnant women if necessary, and only in the doses indicated by your doctor.

Vitamin B12 is excreted in breast milk, but its use is compatible with breastfeeding. Vitamin B12 deficiency has been detected in breastfed babies of vegetarian mothers. The recommended dose should be indicated by your doctor.

Driving and operating machinery

The influence of Vitamin B12Farmasierra on the ability to drive and operate machinery is negligible or insignificant.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended doses are:

Adults and adolescents over 14 years old: in prevention and treatment of vitamin B12 deficiency, it is generally recommended: 1 capsule per day for 8 weeks; 1 capsule per week as maintenance dose.

Your doctor will indicate the duration of treatment, which will depend on your blood levels of vitamin B12, which should be normal.

In case of pernicious anemia, if there are severe complications such as neurological type, immediate injectable treatment will be required.

Oral route: the capsule will be taken with a little water or milk. It can also be opened and its contents poured over a little water or milk.

Use in children

This medication should not be administered to children under 14 years old. It can only be administered to children with a doctor's prescription and under the doctor's supervision.

If you take more vitamin B12 Farmasierra than you should

If you take more than the recommended amount in the prospectus or what your doctor has indicated (overdose), you may experience digestive discomfort such as diarrhea, nausea, or vomiting, and headache. In rare cases, an excessive allergic reaction (anaphylactic shock) may occur.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. However, if the amount ingested is significant, go to the doctor as soon as possible or to the emergency service of the nearest hospital. Bring this prospectus with you.

If you forgot to take VitaminaB12Farmasierra

Do not take a double dose to compensate for the missed doses.

If you forget to take a dose, take another dose as soon as possible. Then, continue taking the medication as indicated.

If you interrupt the treatment VitaminaB12Farmasierra

Your doctor will indicate the duration of your treatment with VitaminaB12Farmasierra. Do not suspend the treatment before.

If you take the medication and do not feel better, inform your doctor as soon as possible.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The assessment of adverse effects is based on the following frequencies: rare (may affect up to 1 in 1,000 people).

• On rare occasions, hypersensitivity reactions to some of the components, such as red itchy patches on the skin (urticaria) or an exaggerated allergic reaction (anaphylactic reaction).
• In some patients with Leber's disease (hereditary optic nerve atrophy), a rapid deterioration has occurred during administration of cyanocobalamin.
• A case of chronic inflammatory skin disease affecting blood vessels and sebaceous glands and hair follicles on the cheeks, nose, forehead, and chin (fulminant rosacea) has been described with the ingestion of vitamin B supplements.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Vitamina B12 Farmasierra 1000 microgramos hard capsules

- The active ingredient is cianocobalamina (vitamin B12). Each hard capsule contains 1,000 micrograms (1 mg) of cianocobalamina.

- The other components (excipients) are: microcrystalline cellulose and magnesium stearate. The capsule is made of gelatin, water, and titanium dioxide.

Appearance of the product and content of the packaging

Vitamina B12Farmasierra is presented in hard capsules, white in color, in blisters.

Each package contains 28 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorizationof commercialization

Farmasierra Laboratorios S,L.

Carretera de Irún, km. 26,200

28709, San Sebastián de los Reyes (Madrid)

Responsible for manufacturing

Farmasierra Manufacturing S.L.

Carretera de Irún, Km. 26,200

28709, San Sebastián de los Reyes (Madrid)

Last review date of this leaflet:April2021.

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es