Becaren 1.000 micrograms tablets

Package leaflet: Information for the user

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 questions, ask 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Becaren is and what it is used for

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

Most people obtain sufficient vitamin B12 from food; however, if you have undergone stomach surgery, suffer from certain intestinal diseases, follow a restricted diet, or take certain medications, you may not absorb enough vitamin B12.

This medicine is used for the treatment of vitamin B12 deficiency and for maintenance treatment in adult patients:

• Who have been diagnosed with pernicious anemia.
• Who have poor vitamin B12 absorption (e.g., due to atrophic gastritis, inflammatory bowel disease, celiac disease, total or partial gastrectomy, ileal resection, gastric bypass, or other bariatric surgery).
• Who are on long-term treatment with histamine H2 receptor antagonists, proton pump inhibitors, aminosalicylates, or 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 taking Becaren

Do not take Becaren

• if you are allergic to cyanocobalamin or vitamin B12 or to any of the other ingredients of this medicine (listed in section 6 of this leaflet)
• if you have anaemia caused by impaired division of bone marrow cells (megaloblastic anaemia, a condition in which the body produces unusually large, immature red blood cells) due solely to folate deficiency (vitamin B9)
• if you have visual disturbances caused by tobacco or alcohol abuse, which are often associated with nutritional deficiencies (nutritional optic neuropathy), or inflammation of the optic nerve (retrobulbar neuritis) occurring as a result of a condition in which you do not have enough red blood cells (pernicious anaemia), or any other condition requiring detoxification of cyanide from your body. In such cases, different cobalamin-containing medicines should be used
• if you have optic nerve degeneration (which may cause vision problems due to damage to the nerve that transmits visual signals from the retina to the brain).

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

At the beginning of treatment, your doctor should diagnose your condition to determine the underlying cause of the deficiency, including an assessment of your gastrointestinal tract function. Your doctor will decide whether vitamin B12 absorption from food is insufficient and whether oral supplementation with this medicine is necessary.

Due to the serious nature of the condition, your doctor will likely monitor your response to this medicine during the first 3 months. This will probably involve blood tests. If you respond well to treatment, it may need to be continued for life, depending on your underlying condition.

If you require regular kidney dialysis, your doctor should perform regular blood tests and a dose reduction of this medicine may be necessary.

If you have folic acid deficiency, your response to treatment may be reduced. In such cases, the use of this medicine should be accompanied by folic acid supplements.

Becaren contains 1000 micrograms of cyanocobalamin per tablet. If you are undergoing laboratory tests, you must inform your doctor or laboratory staff that you are taking or have recently taken this medicine, as cyanocobalamin may affect test results (including blood and urine tests, skin tests using allergens, etc.) due to its red colour. This medicine may interfere with 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, as the safety and benefits of this medicine have not yet been established in this population.

Other medicines and Becaren

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

This medicine's effectiveness may be affected by:

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

Alcohol and Becaren

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

Pregnancy, breastfeeding and fertility

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. As a precautionary measure, it is preferable to avoid using this medicine during pregnancy unless the woman's condition requires treatment with cyanocobalamin. This medicine may be used during breastfeeding.

Driving and using machines

This medicine is not expected to affect the ability to drive or operate machinery.

3. How to take Becaren

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

Use in adults

Dose for the treatment of vitamin B12 deficiency:

The recommended daily dose is 1 tablet, corresponding 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 diagnosed with pernicious anemia or who have vitamin B12 malabsorption.
• Treatment in cases of prolonged use of histamine H2 receptor antagonists, proton pump inhibitors, aminosalicylates, and metformin.

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

If well tolerated, oral vitamin B12 may be used lifelong in cases of pernicious anemia or vitamin B12 malabsorption. Response to therapy should be monitored regularly. See also section 2. Warnings and precautions.

Maintenance dose:

1 tablet per week as maintenance dose.

Your doctor will determine the duration of treatment, which will depend on your blood levels of vitamin B12 being within the normal range.

If you have kidney problems

In patients with moderate kidney problems, this medicine may be used at the normal dose. In cases of severe kidney problems, dose reduction is recommended. In addition, serum vitamin B12 levels should be checked regularly.

If you have liver problems

It is unknown whether you can safely take this medicine if you have liver problems. Inform your doctor if you have any liver condition.

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 length of time you need to take the medicine depends on your body's response to it. To determine the optimal dose, your doctor must perform regular monitoring.

If you take more Becaren than you should

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

No cases of poisoning have been reported.

No antidote for overdose is known. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Becaren

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

If you stop taking Becaren

You should always consult your doctor before stopping treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Uncommon: may affect up to 1 in every 100 users

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

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

• acne-like rashes and blisters;
• fever.

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 can also report them directly through the Spanish System of Pharmacovigilance of Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 components (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

ITALFARMACO S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Spain

Manufacturer:

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

Via Grignano, 43 - 24041 BREMBAT (BG)

Italy

Date of the most recent revision of this leaflet: December 2024

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