Vitamina B12 Farmasierra 1000 microgramos hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vitamina B12 Farmasierra 1000 microgram capsules

Cyanocobalamin (vitamin B12)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Vitamina B12 Farmasierra

3. How to take Vitamina B12 Farmasierra

4. Possible side effects

5. How to store Vitamina B12 Farmasierra

6. Contents of the pack and other information

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

Vitamin B12 Farmasierra is a medicine that contains the active substance Cyanocobalamin (Vitamin B12). This vitamin is essential for the normal functioning of the nervous system, the formation of red blood cells, and the metabolism of homocysteine.

It is used for the treatment of vitamin B12 deficiency, which may occur due to insufficient dietary intake, malabsorption syndromes (such as pernicious anemia), or increased requirements (e.g., during pregnancy or in certain diseases). Symptoms of deficiency include anemia, fatigue, neurological disorders (such as numbness and tingling in the extremities), and cognitive disturbances.

Vitamin B12 Farmasierra is indicated for:

• Treatment of vitamin B12 deficiency states of various origins.
• Supportive treatment in neurological and hematological disorders associated with vitamin B12 deficiency.

The active substance, Cyanocobalamin, is a synthetic form of vitamin B12 that the body can use effectively after conversion into active coenzyme forms (methylcobalamin and 5'-deoxyadenosylcobalamin).

Contains cyanocobalamin (vitamin B12) as the active substance. Vitamin B12, which is water-soluble, plays a role 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 significantly increased requirements for this vitamin. Vitamin B12 deficiency may result from diet (strict vegetarians), drug-induced causes, or malabsorption syndromes (difficulty in 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 vitamin B12 deficiency).
• Dementia associated with vitamin B12 deficiency.
• In cases of gastrectomy (removal of all or part of the stomach).

2. What you need to know before starting to take Vitamina B12 Farmasierra

Do not take vitamin B12 Farmasierra

If you are allergic to cyanocobalamin or other cobalamins (vitamina 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 Vitamina B12 Farmasierra.

• Before starting treatment, your vitamin B12 deficiency must be confirmed. If left untreated, it may lead to spinal cord damage starting from the third month.
• If you take folic acid instead of cyanocobalamin, folic acid will resolve the anemia but not the neurological disorders (of the nervous system).
• Prior to initiating treatment, blood tests should be performed to determine several parameters such as hematocrit (volume of red blood cells relative to total blood volume), reticulocytes (immature red blood cells), which should be monitored daily during the first days of treatment; as well as levels of vitamin B12, folic acid, and iron.
• Possible interactions with other medications you are taking should be considered.
• If you have a hereditary disease causing optic nerve atrophy (Leber's disease), administration of cyanocobalamin may worsen the condition (an alternative treatment must be followed).
• If you have a genetic disorder (polycythemia vera) that causes an increase in red blood cells, additional monitoring during treatment is required, as symptoms may be masked.
• If you have been treated for megaloblastic anemia (decreased number of red blood cells with increased size, most commonly due to pernicious anemia) and this is resolving, a decrease in blood potassium levels may occur. Potassium levels may also drop during initial treatment of pernicious anemia. Your blood potassium should be monitored at the beginning of treatment; if necessary, your doctor may recommend taking a potassium supplement.
• If you are predisposed to gout (joint pain due to elevated uric acid), cyanocobalamin may trigger a gout attack.
• If you follow a vegetarian diet without animal products, it is recommended that you periodically take vitamin B12 (as cyanocobalamin).
• During pregnancy and lactation, the need for vitamin B12 increases. Vitamin B12 deficiency has been detected in breastfed infants of vegetarian mothers who were exclusively breastfed.
• If you have pernicious anemia, you will require monthly vitamin B12 treatment. Without it, anemia may recur and irreversible nerve damage in the spinal cord may occur. Patients with pernicious anemia have a higher risk of developing stomach cancer compared to the general population.

Interference with diagnostic tests: If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results. This medicine may interfere with the determination of antibodies against intrinsic factor (IF).

Most antibiotics, methotrexate, and pyrimethamine may invalidate vitamin B12 blood test values.

Children

Vitamina B12 Farmasierra should only be administered to children under 14 years of age under medical prescription and supervision.

Other medicines and Vitamina B12 Farmasierra

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Vitamina B12 Farmasierra may interact with the following medicines:

• Chloramphenicol (antibiotic)
• Several medicines 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), antibiotics such as oral neomycin, colchicine (for gout treatment), H2 antagonists (medicines for acidity or stomach ulcer), omeprazole (for stomach ulcer), aminosalicylic acid in long-term treatments (for intestinal diseases), antiepileptic drugs, metformin (for diabetes).
• Oral contraceptives: may reduce blood concentrations of vitamin B12.

Taking Vitamina B12 Farmasierra with alcohol

Excessive alcohol intake reduces 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Vitamin B12 may be administered to pregnant women if necessary and only at doses prescribed by the doctor.

Vitamin B12 is excreted in breast milk, but its use is compatible with breastfeeding. Vitamin B12 deficiency has been observed in infants breastfed by vegetarian mothers. The recommended dosage should be determined by your doctor.

Driving and operating machinery

The effect of Vitamina B12 Farmasierra on the ability to drive and operate machinery is none or negligible.

3. How to take Vitamin B12 Farmasierra

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended doses are:

Adults and adolescents over 14 years of age: for prevention and treatment of vitamin B12 deficiency, the usual recommendation is: 1 capsule daily for 8 weeks; then 1 capsule per week as maintenance dose.

Your doctor will determine the duration of treatment, which will depend on your blood levels of vitamin B12 reaching normal values.

In cases of pernicious anemia, if there are serious complications such as neurological manifestations, immediate injectable treatment will be required.

Oral administration: Take the capsule with a small amount of water or milk. The capsule may also be opened and its contents emptied into a small amount of water or milk.

Use in children

Vitamin B12 Farmasierra must not be administered to children under 14 years of age. It may only be given to children under medical prescription and under physician supervision.

If you take more Vitamin B12 Farmasierra than you should

If you take a larger amount than recommended in this leaflet or prescribed by your doctor (overdose), you may experience gastrointestinal discomfort such as diarrhea, nausea or vomiting, and headache. Rarely, an exaggerated allergic reaction (anaphylactic shock) may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 5620420, indicating the medicine and the amount ingested. However, if the amount ingested is significant, go to the doctor or the nearest hospital emergency department as soon as possible. Bring this leaflet with you.

If you forget to take Vitamin B12 Farmasierra

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

If you forget to take a dose, take it as soon as possible. Then continue taking the medicine as directed.

If you stop taking Vitamin B12 Farmasierra

Your doctor will advise you on the duration of your treatment with Vitamin B12 Farmasierra. Do not discontinue treatment prematurely.

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

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

The assessment of adverse 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 reddish itchy skin rashes (urticaria), or an exaggerated allergic reaction (anaphylactic reaction).
• In some patients with Leber's disease (hereditary optic nerve atrophy), rapid worsening has occurred during administration of cyanocobalamin.
• One case of a chronic inflammatory skin disease affecting blood vessels, sebaceous glands, and hair follicles of the cheeks, nose, forehead, and chin (fulminant rosacea) has been reported with ingestion of vitamin B complex supplements.

Reporting of 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 leaflet.

You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vitamin B12 Farmasierra 1000 micrograms hard capsules

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

Appearance of the product and contents of the pack

Vitamin B12 Farmasierra is presented as white hard capsules in blisters.

Each pack contains 28 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent revision of this leaflet: April 2021.

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