BECAREN 1000 micrograms TABLETS

Introduction

Package Leaflet: Information for the User

Becaren 1000 micrograms tablets

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 pack

1. What is Becaren and what is it used for
2. What you need to know before you take Becaren
3. How to take Becaren
4. Possible side effects
5. Storage of Becaren
6. Contents of the pack and other information

1. What is Becaren and what is it used for

This medicine contains cyanocobalamin, which is known as vitamin B12.

Most people get enough vitamin B12 from their food, but if you have had stomach surgery or have certain intestinal diseases, if you follow a restricted diet or if you take certain medications, you may not absorb enough vitamin B12.

This medicine is used to treat vitamin B12 deficiency and maintenance treatment in adult patients:

• Who have been diagnosed with pernicious anemia.
• Who have poor absorption of vitamin B12 (e.g., due to atrophic gastritis, inflammatory bowel disease, celiac disease, total or partial gastrectomy, ileal resection, gastric bypass or other bariatric surgery).
• With prolonged use of histamine H2 receptor antagonists, proton pump inhibitors, aminosalicylates, and metformin.

This medicine is also used to treat vitamin B12 deficiency due to reduced dietary intake (e.g., vegetarian diet) in adults.

2. What you need to know before you take Becaren

Do not take Becaren

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

At the start of treatment, your doctor must diagnose your disease to clarify the underlying reason for the deficiency, which includes evaluating the functioning of your digestive tract. Your doctor will decide if the absorption of vitamin B12 from food is insufficient and if oral supplementation with this medicine is necessary.

Due to the serious nature of the disease, your doctor will probably want to monitor your response to this medicine during the first 3 months. This will likely involve a blood test. If you follow the treatment plan well, it may be for life, depending on your underlying disease.

If you need regular renal dialysis, your doctor should perform regular blood tests and it may be necessary to reduce the dose of this medicine.

If you have a folate deficiency, it may decrease your response to treatment. In this case, the use of this medicine should be accompanied by folate supplements.

Becaren contains 1000 micrograms of cyanocobalamin per tablet. If you are going to undergo analytical tests, you should inform your doctor or laboratory personnel that you are taking or have recently taken this medicine, as cyanocobalamin may affect the results of these tests (including blood tests, urine tests, skin tests using allergens, etc.) due to its red color. This medicine may affect the determination of antibodies against intrinsic factor (IF).

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age because the safety and benefits of this medicine are not yet known.

Other medicines and Becaren

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

This medicine may be affected by:

• Proton pump inhibitors (e.g., omeprazole) and H2 histamine receptor antagonists (e.g., cimetidine); both are used to treat excess stomach acid that causes indigestion or ulcers.
• Colchicine, for the treatment of gout.
• Aminoglycosides (e.g., neomycin) and chloramphenicol, which are antibiotics.
• Biguanides, e.g., metformin, which is used in the treatment of diabetes.
• Aminosalicylic acid, which is used to treat inflammatory bowel disease.
• Oral contraceptives.
• Antiepileptic medicines (e.g., carbamazepine).
• Potassium salts.
• Methyldopa, which is used to treat high blood pressure.
• Prolonged use of nitrous oxide (a gas used for anesthesia).
• Second-generation antipsychotics (e.g., olanzapine and risperidone).
• Colestyramine, which is used to reduce high cholesterol levels in the blood.
• Glucocorticoids (e.g., prednisolone), which are often used to treat inflammatory diseases.

Using Becaren with alcohol

Alcohol may affect the absorption of this medicine in your body.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. As a precautionary measure, it is preferable to avoid the use of this medicine during pregnancy, unless the woman's condition requires treatment with cyanocobalamin. This medicine can be used during breast-feeding.

Driving and using machines

This medicine should not affect your ability to drive or use machines.

3. How to take Becaren

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Use in adults

Dose for the treatment of vitamin B12 deficiency:

The recommended daily dose is 1 tablet, which corresponds to 1000 micrograms of cyanocobalamin, for 8 weeks, in the following indications:

• Treatment of vitamin B12 deficiency in patients with reduced dietary intake (e.g., vegetarian diet).
• Treatment of vitamin B12 deficiency and maintenance treatment in patients who have been diagnosed with pernicious anemia or who have poor absorption of vitamin B12.
• Treatment in case of prolonged use of histamine H2 receptor antagonists, proton pump inhibitors, aminosalicylates, and metformin.

Patient with severe hematological or neurological symptoms of vitamin B12 deficiency should be initially treated parenterally until normalization of blood levels.

If well tolerated, oral vitamin B12 can be replaced for life in case of pernicious anemia or poor absorption of vitamin B12. The response to therapy should be regularly monitored. See also section 2. Warnings and precautions.

Maintenance dose:

1 tablet per week as a maintenance dose.

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

If you have kidney problems

In patients with moderate kidney problems, this medicine can be used at the normal dose. In case of severe kidney problems, it is recommended to reduce the dose. Additionally, the amount of vitamin B12 in the blood serum should be regularly checked.

If you have liver problems

It is not known if you can take this medicine safely if you have liver problems. Inform your doctor if you have any liver problems.

How to take the tablets

This medicine is taken orally. The tablets should be swallowed whole with some water, preferably in the morning on an empty stomach. The way your body reacts to the medicine determines how long you have to take it. To find the optimal dose, your doctor must perform regular checks.

If you take more Becaren than you should

If you take more of this medicine than you should, talk to your doctor, who will decide on the necessary measures.

No cases of overdose have been reported.

No antidote is known for overdose. In case of overdose, the symptoms should be treated. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Becaren

If you forget to take a dose, you should take it as soon as you remember, unless it is time to take the next dose. If this happens, do not take the forgotten dose, but take your usual dose at the correct time. Do not take a double dose to make up for forgotten doses.

If you stop taking Becaren

You should always consult your doctor before stopping treatment.

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.

Uncommon: may affect up to 1 in 100 users

• Severe allergic reactions with symptoms such as hives, skin rash, or itching in large areas of the body.

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

• Acne-like rash and blisters;
• Fever.

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 Becaren

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

This medicine does not require any special storage conditions.

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

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 other information

Composition of Becaren

• The active substance is cyanocobalamin (vitamin B12). Each tablet contains 1,000 micrograms (1 mg) of cyanocobalamin.
• The other ingredients (excipients) are: microcrystalline cellulose, mannitol (E421), stearic acid, pregelatinized starch (from corn), potato starch, crospovidone, magnesium stearate, anhydrous colloidal silica.

Appearance of the product and contents of the pack

Becaren is presented in aluminum-PVC/PVDC blisters containing 30 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Vegal Farmacéutica, S.L.

Vía de las Dos Castillas, 9C portal 2, 2ºC

28224 Pozuelo de Alarcón, Madrid

Manufacturer:

FineFoods & Pharmaceuticals N.T.M S.p.A

Via Grignano, 43 - 24041 BREMBATE (BG)

Italy

Date of last revision of this leaflet: December 2024

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/