VITAMIN B12 FARMASIERRA 1000 MICROGRAMS HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Vitamin B12Farmasierra 1000 micrograms hard capsules

Cyanocobalamin (Vitamin B12)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Vitamin B12 Farmasierra and what is it used for
2. What you need to know before you take Vitamin B12 Farmasierra
3. How to take Vitamin B12 Farmasierra
4. Possible side effects
5. Storage of Vitamin B12 Farmasierra

1. Contents of the pack and further information

1. What is Vitamin B12 Farmasierra and what is it used for

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

Vitamin 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), drug-induced, or malabsorption syndromes (difficulty digesting nutrients from food), such as in 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 lack of Vitamin B12).
• Dementia associated with Vitamin B12 deficiency.
• In case of gastrectomy (removal of all or part of the stomach).

2. What you need to know before you take Vitamin B12 Farmasierra

Do not take Vitamin B12 Farmasierra

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

Warnings and precautions

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

• Before starting treatment, your doctor must confirm the Vitamin B12 deficiency. If this is not corrected, it can lead to spinal cord lesions from the third month onwards.
• If you take folic acid instead of cyanocobalamin, folic acid will resolve the anemia but not the neurological disorders.
• Before starting treatment, your doctor must perform blood tests 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.
• The possible interference with other medications being taken should be taken into account.
• If you have hereditary optic nerve atrophy (Leber's disease), it may worsen with the administration of cyanocobalamin (you should follow an alternative treatment).
• If you have a genetic disease (polycythemia vera) that produces an increase in red blood cells, especially, you will require additional monitoring during treatment because symptoms may be masked.
• If you have been treated for megaloblastic anemia (decrease in the number of red blood cells with an increase in their size, being the most frequent cause of pernicious anemia) and it is reversing, a decrease in blood potassium levels may occur. Potassium levels may also decrease during initial treatment of pernicious anemia. Your doctor will check your potassium levels in the blood at the start of treatment; if necessary, your doctor may indicate taking a supplement.
• If you are prone to gout (joint pain due to elevated uric acid), cyanocobalamin may precipitate a gout attack.
• If you follow a vegetarian diet without animal products, it is recommended that you take Vitamin B12 (such as cyanocobalamin) periodically.
• During pregnancy and lactation, the need for Vitamin B12 increases. In breastfed infants of vegetarian mothers, Vitamin B12 deficiency has been detected.
• If you have pernicious anemia, you will need monthly treatment with Vitamin B12. If you do not receive it, the anemia may recur and cause irreversible damage to the nerves of the spinal cord. Patients with pernicious anemia are more likely to develop stomach cancer than the general population.

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

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 of age under medical prescription and supervision.

Other medicines and Vitamin B12Farmasierra

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Vitamin B12Farmasierra may interact with the following medicines:

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

Taking Vitamin B12Farmasierra with alcohol

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

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 taking this medicine.

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

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

Driving and using machines

The influence of Vitamin B12 Farmasierra on the ability to drive and use machines is zero or insignificant.

3. How to take Vitamin B12 Farmasierra

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

The recommended doses are:

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

Your doctor will indicate the duration of your treatment with Vitamin B12 Farmasierra, which will depend on your blood Vitamin B12 levels being normal.

In case of pernicious anemia, if there are serious complications such as neurological ones, injectable treatment will be necessary immediately.

Oral route: the capsule should be taken with a little water or milk. The capsule can also be opened and its contents poured into a little water or milk.

Use in children

Vitamin B12 Farmasierra should not be administered to children under 14 years of age. It can only be administered to children with a medical prescription and under the supervision of a doctor.

If you take more Vitamin B12 Farmasierra than you should

If you take more than the recommended amount in the leaflet or as indicated by your doctor (overdose), you may experience digestive discomfort such as diarrhea, nausea, or vomiting, and headache. In rare cases, an exaggerated 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 medicine 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 leaflet with you.

If you forget to take Vitamin B12Farmasierra

Do not take a double dose to make up for forgotten doses.

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

If you stop taking Vitamin B12Farmasierra

Your doctor will indicate the duration of your treatment with Vitamin B12 Farmasierra. Do not stop treatment before.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Rarely, hypersensitivity reactions to some of the components, such as red rashes on the skin with itching (urticaria) or an exaggerated allergic reaction (anaphylactic reaction).
• In some patients with Leber's disease (hereditary optic nerve atrophy), rapid worsening has occurred during the administration of cyanocobalamin.
• A case of chronic inflammatory disease of the skin that affects blood vessels and sebaceous glands and hair follicles, of the cheeks, nose, forehead, and chin (rosacea fulminans) has been described with the ingestion of Vitamin B supplements.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vitamin B12 Farmasierra

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Vitamin B12 Farmasierra 1000 micrograms hard capsules

• The active ingredient is cyanocobalamin (Vitamin B12). Each hard capsule contains 1,000 micrograms (1 mg) of cyanocobalamin.
• The other ingredients (excipients) are: microcrystalline cellulose and magnesium stearate. The capsule is made of gelatin, water, and titanium dioxide.

Appearance of the product and pack contents

Vitamin B12 Farmasierra is presented in hard capsules, white in color, in blisters.

Each pack contains 28 capsules.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Farmasierra Laboratorios S.L.

Carretera de Irún, km. 26,200

28709, San Sebastián de los Reyes (Madrid)

Manufacturer

Farmasierra Manufacturing S.L.

Carretera de Irún, Km. 26,200

28709, San Sebastián de los Reyes (Madrid)

Date of last revision of this leaflet:April 2021.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es