Package leaflet: Information for the user

Vitaminum B Energamma, 1000 micrograms, coated tablets
Cyanocobalaminum
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Vitaminum B Energamma is and what it is used for
Important information before taking Vitaminum B Energamma
How to take Vitaminum B Energamma
Possible side effects
How to store Vitaminum B Energamma
Contents of the pack and other information

1. What Vitaminum B Energamma is and what it is used for

Vitaminum B Energamma contains cyanocobalamin, also known as vitamin B .
Most people obtain sufficient vitamin B through their diet. However, if you have undergone stomach surgery, suffer from certain gastrointestinal disorders, follow a strict diet, or take certain medications, your body may not receive enough vitamin B .
This medicine is used for the treatment of vitamin B deficiency and for maintenance therapy in adult patients:

diagnosed with pernicious anaemia,
who have impaired vitamin B absorption (e.g. due to atrophic gastritis, inflammatory bowel disease, coeliac disease, total or partial gastrectomy, ileal resection, gastric bypass surgery, or other bariatric surgery),
undergoing long-term treatment with histamine H2-receptor antagonists, proton pump inhibitors, aminosalicylates, or metformin.

This medicine is also used for treating vitamin B deficiency caused by reduced dietary intake (e.g. vegetarian diet) in adults.

2. Important information before taking Vitaminum B Energamma
When not to take Vitaminum B Energamma:

if you are allergic to cyanocobalamin or vitamin B , or to any of the other ingredients of this medicine (listed in section 6);
if you have anaemia due to impaired bone marrow cell division (megaloblastic anaemia, a condition in which the body produces abnormally large, immature red blood cells) caused exclusively by folic acid deficiency (vitamin B );
if you have visual disturbances caused by excessive tobacco or alcohol use, often associated with nutritional deficiencies (nutritional optic neuropathy), or optic nerve inflammation (retrobulbar optic neuritis) resulting from a disease causing insufficient red blood cells (pernicious anaemia), or any other condition requiring cyanide detoxification. In such cases, cobalamin-containing medicines other than cyanocobalamin should be used;
if you have optic nerve degeneration (which may lead to visual disturbances due to damage to the nerve transmitting signals from the retina of the eye to the brain).

Warnings and precautions
Before starting treatment with Vitaminum B Energamma, please discuss it with your doctor or pharmacist.
Before initiating treatment, your doctor should diagnose your condition to determine the cause of the deficiency, including evaluation of gastrointestinal function. Your doctor will decide whether vitamin B 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 of treatment, which may include blood tests. If you adhere well to the treatment plan, therapy may continue for life, depending on the underlying disease.
If periodic kidney dialysis is required, your doctor should regularly perform blood tests and may need to reduce the dose of this medicine.
If you have folic acid deficiency, this may reduce the response to treatment. In such cases, folic acid supplementation should be administered concurrently with this medicine.
Vitaminum B Energamma contains 1000 micrograms of cyanocobalamin per tablet. If you are undergoing laboratory tests, inform your doctor or laboratory staff about current or past use of this medicine, as cyanocobalamin may affect test results (including blood and urine tests, skin allergy tests, etc.) due to its red colour. This medicine may interfere with assays for antibodies against intrinsic factor (IF).

Children and adolescents
This medicine should not be given to children and adolescents under 18 years of age, as the safety and efficacy of this medicine in children and adolescents have not yet been established.

Vitaminum B Energamma and other medicines
Please inform your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines.
The effect of Vitaminum B Energamma may be reduced by:

proton pump inhibitors (e.g. omeprazole) and histamine H2-receptor antagonists (e.g. cimetidine), used to treat excessive stomach acid production causing indigestion or peptic ulcer disease;
colchicine, used in the treatment of gout;
aminoglycosides (e.g. neomycin) and chloramphenicol (antibiotics);
biguanides, e.g. metformin, used in diabetes;
aminosalicylic acid, used in inflammatory bowel disease;
oral contraceptives;
antiepileptic drugs (e.g. carbamazepine);
potassium salts;
methyldopa, used in the treatment of high blood pressure;
prolonged use of nitrous oxide (anaesthetic gas);
second-generation antipsychotics (olanzapine and risperidone);
cholestyramine, used to lower high blood cholesterol levels;
glucocorticosteroids, e.g. prednisone, used in the treatment of inflammatory conditions.

Taking Vitaminum B Energamma with alcohol
Alcohol may affect the absorption of this medicine into the body.

Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine. As a precautionary measure, it is recommended 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
Vitaminum B Energamma is unlikely to affect your ability to drive or operate machinery.

Vitaminum B Energamma contains monohydrate lactose, sucrose, macrogolglycerol hydroxystearate, and sodium.
Monohydrate lactose and sucrose
If you have been previously diagnosed with intolerance to certain sugars, please consult your doctor before taking this medicine.
Macrogolglycerol hydroxystearate
May cause gastrointestinal disturbances and diarrhoea.
Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Vitaminum B12 Energamma

This medicine should always be taken according to the instructions of your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Use in adults
The recommended daily dose is 1 tablet of Vitaminum B12 Energamma. This corresponds to 1000
micrograms of cyanocobalamin in the following indications:

treatment of vitamin B12 deficiency due to reduced dietary intake of vitamin B12 (e.g. vegetarian diet),
treatment of vitamin B12 deficiency and maintenance therapy in patients diagnosed with pernicious anemia or impaired absorption of vitamin B12,
treatment related to long-term use of histamine H2-receptor blockers, proton pump inhibitors, aminosalicylates, and metformin.

Patients with severe hematological or neurological symptoms of vitamin B12 deficiency must
initially be treated with vitamin B12 administered parenterally until blood vitamin B12 levels normalize.
If oral vitamin B12 is well tolerated, there are no limitations regarding the duration of treatment in cases of pernicious anemia or impaired vitamin B12 absorption.
The response to treatment should be monitored regularly (see also section 2: Warnings and precautions).
Use in patients with renal impairment
In patients with moderate renal impairment, Vitaminum B12 Energamma may be used at the
usual recommended dose for adults. In cases of severe renal impairment, dose reduction is recommended. Additionally, serum vitamin B12 levels should be monitored regularly.
Use in patients with hepatic impairment
There is no data available on the use of this medicine in patients with hepatic impairment. If a patient has liver problems, this should be reported to the doctor.
Method of administration
Tablets of Vitaminum B12 Energamma should be swallowed whole with sufficient water, preferably in the morning on an empty stomach. The duration of treatment depends on the response to therapy.
The appropriate dose for the patient will be determined by the doctor based on regular monitoring.
If you take more Vitaminum B12 Energamma than you should
If you take more Vitaminum B12 Energamma than recommended, contact your doctor, who will decide on appropriate management. No cases of overdose have been reported.
There is no known antidote. In case of overdose, symptomatic treatment should be applied.
If you forget to take Vitaminum B12 Energamma
If you miss a dose of Vitaminum B12 Energamma, take it as soon as possible, unless it is almost time for the next dose. In that case, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping Vitaminum B12 Energamma
Always consult your doctor before stopping treatment with this medicine.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Not common (may affect no more than 1 in 100 people):

severe allergic reactions, which may manifest as urticaria, skin rash, or widespread itching

Frequency unknown (cannot be estimated from available data):

acne-like skin changes and blisters
fever

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Vitaminum B Energamma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25ºC.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Vitaminum B12 Energamma contains
The active substance is: 1000 micrograms of cyanocobalamin (synthetic form of
vitamin B12).
The other components are: monohydrate lactose, povidone K30, sodium croscarmellose, stearic acid 50 (stearic acid and palmitic acid), AquaPolish P
white*, sucrose, talc, heavy kaolin, calcium carbonate, titanium dioxide
(E 171), dried gum arabic dispersion, macrogol 6000,
glycol monooleate of polyoxyl 40 stearate, sodium lauryl sulfate (E487),
Montana glycol wax.
(*Composition of the coating "AquaPolish P white": hypromellose,
hydroxypropylcellulose, stearic acid 50 (stearic acid and palmitic acid), talc, medium-chain triglycerides, titanium dioxide (E 171)).

What Vitaminum B12 Energamma looks like and contents of the pack
Round, biconvex, white coated tablets with a diameter of approx. 9.8 mm.
The cardboard box contains 10, 25, 30, 50, 60, 90 or 100 coated tablets in PVC/PVDC/Aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wörwag Pharma GmbH & Co. KG
Flugfeld-Allee 24
71034 Böblingen
Germany

Manufacturer
Artesan Pharma GmbH & Co. KG
Wendlandstraße 1
29439 Lüchow
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: Ankermann 1 000 microgrammi compresse rivestite
Latvia: Ankermann 1000 mikrogrami apvalkotās tabletes
Lithuania: Ankermann 1000 mikrogramų dengtos tabletės
Estonia: Ankermann 1000 mikrogrammi kaetud tabletid

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Woerwag Pharma Polska Sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
tel. (+48) 22 863 72 81