Description

Vitamin B12 Energamma contains vitamin B12 in the form of cyanocobalamin and is available in coated tablets. Vitamin B12 Energamma is used in adults to treat vitamin B12 deficiency, which may be due to dietary (e.g., vegetarian) malabsorption, previous surgery, or the use of certain medications.

Composition

The active substance of the drug is vitamin B12.

Each tablet contains 1000 micrograms of cyanocobalamin (vitamin B12).

Excipients: Tablet core: Lactose monohydrate; Povidone K30; Croscarmellose sodium; Stearic acid 50 (stearic acid and palmitic acid). Film coating: “AquaPolish P white” film coating (Hypromellose 15 mPa*s, Hydroxypropylcellulose, Stearic acid 50 (stearic acid and palmitic acid), Talc, Medium chain triglycerides, Titanium dioxide); Sucrose; Talc; Heavy kaolin; Calcium carbonate; Titanium dioxide (E 171); Gum arabic dried dispersion; Macrogol 6000; Macrogolglycerol hydroxystearate; Sodium laurilsulfate (E 487); Montan glycol wax.

Dosage

Always use this medicine exactly as described in this leaflet or as advised by your doctor or pharmacist.

The drug should be taken orally.

Recommended dose: 1 film-coated tablet daily, preferably on an empty stomach. In pernicious anemia and nervous system disorders, the drug should initially be administered by infusion/injection until blood counts return to normal.

Take the tablet with ½ glass of water.

Action

Replenishes Vitamin B12 deficiencies.

Indications

Vitaminum B12 Energamma is indicated for:
Treatment of vitamin B12 deficiency caused by malnutrition;
Long-term treatment of vitamin B12 deficiency, for example due to malabsorption;
Oral treatment of pernicious anemia and vitamin B12 deficiency with neurological symptoms, following rapid normalization of vitamin B12-related biomarkers with parenteral vitamin B12 administration.

Contraindications

Do not use this medicine in case of: Hypersensitivity to the active substance or any of the other ingredients; Megaloblastic anemia caused solely by folic acid deficiency; Patients requiring detoxification for cyanide poisoning (e.g., patients with retrobulbar optic neuritis in pernicious anemia). In such cases, another cobalamin derivative should be administered; Patients with vitamin B12 deficiency who are at risk of optic nerve atrophy in Leber's disease should not use cyanocobalamin to treat vitamin B12 deficiency; Patients with amblyopia related to smoking or alcoholism.

Side effects

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

Uncommon (may affect up to 1 in 100 people): severe hypersensitivity reactions that may include hives, rash or itching on large areas of the body.

Not known (frequency cannot be estimated from the available data): acne-like skin rashes and blisters; anaphylaxis and fever.

Warnings and precautions

Before taking Vitamin B12 Energamma, talk to your doctor or pharmacist. At the beginning of treatment, your doctor will need to assess your clinical condition to determine the cause of your deficiency.

Your doctor will monitor your response to this medication during the first few months of treatment with blood tests. If you follow your treatment plan carefully, treatment may continue for life, depending on your underlying condition.

If you require regular kidney dialysis, your doctor should perform regular blood tests and may need to reduce your dose of Vitamin B12 Energamma.

If you also have folic acid deficiency, this may hinder your response to treatment. In this case, Vitamin B12 Energamma should be used in conjunction with treatment for the folic acid deficiency.

Use of other medications

Please tell your doctor or pharmacist about all the medicines you are taking, have recently taken or might take, including medicines obtained without a prescription.

Vitamin B12 Energamma may interact, reduce the absorption or effect of the medicine with substances such as: proton pump inhibitors (e.g., omeprazole) and histamine H2 receptor antagonists (e.g., cimetidine), which are used to treat excess stomach acid production that causes indigestion or peptic ulcers; colchicine, used to treat gout; neomycin and chloramphenicol (antibiotics); cholestyramine; biguanides, including metformin, used to treat diabetes; aminosalicylic acid, used to treat inflammatory bowel diseases; long-term use of nitrous oxide (a gas used in anesthetic); second-generation antipsychotics used for mental disorders (e.g., olanzapine and risperidone).

Vitamin B12 Energamma may increase the absorption or action of the drug with substances such as: glucocorticoids, including prednisone, used to treat inflammation.

Pregnancy and breastfeeding

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.

The decision to use the drug during pregnancy is made by the doctor.

Vitaminum B12 Energamma can be used during breastfeeding.

Use of the drug in children and adolescents

The medicine should not be used in children and adolescents under 18 years of age.