ENERGAMMA

Package leaflet: Information for the patient

Energamma, 1000 micrograms, coated tablets
Cyanocobalamin (vitamin B )
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Energamma is and what it is used for

Energamma contains cyanocobalamin, also known as vitamin B . This medicine is used for the
treatment of confirmed vitamin B deficiency of dietary origin, resulting from gastrointestinal disorders, including after gastric resection, and in pernicious anemia.
Most people obtain sufficient vitamin B from their diet; however, following stomach surgery, certain gastrointestinal diseases, or a strict diet, the body may not absorb enough vitamin B .
Vitamin B deficiency may cause:

• hematological disorders such as anemia (low number of red blood cells);
• neurological disorders, such as subacute combined degeneration of the spinal cord (degeneration of nerve tissue in the spinal cord);
• changes in the internal lining of the gastrointestinal tract (mucosa), such as atrophic gastritis (chronic inflammation of the stomach mucosa), celiac disease (gluten intolerance);
• other disorders associated with vitamin B deficiency.
  Energamma is intended for use in adults and adolescents aged 12 years and older.

2. Important information before taking Energamma

When not to take Energamma:

• if the patient is hypersensitive to cyanocobalamin or vitamin B or any of the ingredients of this medicine (listed in section 6);
• if the patient has severe blood or neurological disorders; in such cases vitamin B should be administered by injection or intravenously;
• if the patient has visual disturbances caused by tobacco use (toxic amblyopia) or optic neuritis (retrobulbar neuritis) due to pernicious anaemia, which is characterized by insufficient red blood cells, or in any condition requiring removal of cyanides from the body (detoxification). In the above cases, other cobalamin-containing medicines should be used;
• if the patient has 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 taking Energamma, talk to your doctor or pharmacist. In case of haematological disorders and/or neurological disorders (haematological disorders may cause inhibition of blood cell production), remember that: due to the serious nature of the disease, the doctor will want to monitor the treatment response one week after starting therapy, and then every 4 weeks during the first three months of treatment. This will require regular blood tests. If the patient strictly follows the doctor's recommendations, the frequency of testing may be reduced to every six months or once a year. If the doctor suspects that the patient is not adhering to the treatment plan, more frequent testing may be recommended. If the patient has folic acid deficiency, this may reduce the response to treatment. In such a case, Energamma should not be used. Do not take Energamma if the patient has disorders of sugar tolerance: hereditary galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome, hereditary fructose intolerance, or sucrase-isomaltase deficiency.

Energamma and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including over-the-counter medicines. The effect of Energamma may be disturbed by:

• proton pump inhibitors (e.g. omeprazole) and histamine H2 receptor antagonists (e.g. cimetidine), used to treat excessive gastric acid production causing indigestion or peptic ulcer disease;
• colchicine, used to treat gout;
• neomycin and chloramphenicol (antibiotics);
• biguanides, e.g. metformin, used in diabetes;
• aminosalicylic acid, used in inflammatory bowel disease;
• oral contraceptives;
• glucocorticosteroids, e.g. prednisone, used to treat inflammatory conditions;
• second-generation antipsychotics (olanzapine and risperidone).

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before taking this medicine.

Driving and operating machinery
Energamma is unlikely to affect the ability to drive or operate machinery.

Energamma contains monohydrate lactose, sucrose and sodium.
Patients with sugar intolerance should inform their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is essentially "sodium-free".

3. How to take Energamma

This medicine should always be taken according to the recommendations of your doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Use in adults
The recommended daily dose is 1 tablet of Energamma. This corresponds to 1000 micrograms
of cyanocobalamin per day.
In severe cases, an initial dose of 2 tablets of Energamma is recommended, corresponding to
2000 micrograms of cyanocobalamin per day.
In the presence of severe haematological and neurological symptoms, cyanocobalamin (vitamin B ) should be administered in the form of an injectable preparation.
Use in children and adolescents
The use of Energamma is not recommended in children under 12 years of age due to lack of
adequate data.
In adolescents from 12 years of age, oral cyanocobalamin at a dose of 1000 micrograms
per day is recommended as an alternative to vitamin B deficiency treatment with injections or infusions.
Use in elderly patients
The same doses as in adult patients should be used.
Use in patients with renal impairment
In patients with moderate renal impairment, Energamma may be used at the usual dose. In cases of severe renal impairment, dose reduction is recommended. Additionally, vitamin B blood levels should be monitored regularly.
Use in patients with hepatic impairment
There is lack of data regarding the use of this medicine in patients with hepatic impairment. If the patient has liver problems, this should be reported to the doctor.
Method of administration
Energamma tablets 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.
Taking more Energamma than recommended
If more Energamma has been taken than recommended, contact your doctor, who will decide on appropriate management. No cases of overdose have been reported.
There is no known antidote. In the event of overdose, symptomatic treatment should be applied.
Missing a dose of Energamma
If a dose of Energamma is missed, it should be taken as soon as possible, unless the next dose is approaching. In that case, the next dose should be taken at the scheduled time. A double dose should not be taken to make up for the missed dose.
Stopping Energamma treatment
Always consult your doctor before stopping treatment with this medicine.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Frequency unknown (cannot be estimated from available data)

• Acne-like skin changes and blistering skin eruptions
• Severe hypersensitivity reactions, which may manifest as urticaria, skin rash, or itching over large areas of the body
• Fever

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

5. How to store Energamma

Keep this medicine out of sight and reach of children.
Store below 25°C.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Energamma contains
The active substance is:
1000 micrograms of cyanocobalamin (synthetic form of vitamin B )

The other ingredients are:
Tablet core: monohydrate lactose, povidone K30, stearic acid, sodium croscarmellose;
Sugar coating: spray-dried gum arabic, calcium carbonate, macrogol glyceryl hydroxystearate, macrogol 6000, sucrose, talc, titanium dioxide (E 171), heavy kaolin, sodium lauryl sulfate.
"Aquapolish P white" coating: hypromellose 15 mPa.s, titanium dioxide (E 171), talc, medium-chain saturated triglycerides, stearic acid, hydroxypropylcellulose, montanoglycol wax.

What Energamma looks like and contents of the pack
White to slightly pinkish, round, biconvex coated tablets.
The cardboard box contains 50 or 100 coated tablets in PVC/PVDC/Al blisters.
Not all pack sizes may be marketed.

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

Saneca Pharmaceuticals a.s.
Nitrianska 100
92027 Hlohovec
Slovakia