Energamma

Package Leaflet: Information for the Patient

Energamma, 1000 micrograms, Chewable Tablets

Cyanocobalamin (Vitamin B)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Energamma and what is it 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 is Energamma and what is it used for

Energamma contains cyanocobalamin, also known as vitamin B. This medicine is used to treat confirmed vitamin B deficiency of dietary origin, resulting from gastrointestinal disorders, including gastric resection, and pernicious anemia.
Most people get enough vitamin B from their diet, but in cases of stomach surgery, certain gastrointestinal diseases, or a strict diet, the body may not absorb enough vitamin B.
Vitamin B deficiency can cause:

• blood disorders such as anemia (low red blood cell count);
• neurological disorders, such as subacute combined degeneration of the spinal cord (degeneration of nerve tissue in the spine);
• changes in the lining of the gastrointestinal tract (mucous membranes), such as atrophic gastritis (persistent inflammation of the stomach lining), celiac disease (gluten intolerance);
• other disorders related to vitamin B deficiency. Energamma is intended for use in adults and adolescents from 12 years of age.

2. Important information before taking Energamma

When not to take Energamma:

• if you are allergic to cyanocobalamin or vitamin B or any of the other ingredients of this medicine (listed in section 6);
• if you have severe blood and nervous system symptoms; in such cases, vitamin B should be administered by injection or intravenously.
• if you have vision disorders caused by smoking (toxic amblyopia) or optic neuritis (extraocular optic neuritis) resulting from pernicious anemia, which is characterized by a lack of red blood cells, or any other disorder that requires the removal of cyanides from the body (detoxification). In these cases, other cobalamin-containing medicines should be used;
• if you have optic nerve atrophy (which can lead to vision disorders due to nerve damage that transmits signals from the retina to the brain).

Warnings and precautions

Before taking Energamma, talk to your doctor or pharmacist.
In cases of blood and neurological disorders (blood disorders can cause a decrease in blood cell production), remember that:
due to the serious nature of the disease, your doctor will want to check your response to treatment one week after starting treatment, and then every 4 weeks for the first three months of therapy.
This will require regular blood tests. If you follow your doctor's instructions, the frequency of tests may be changed – every six months or once a year. If your doctor suspects that you are not following the treatment plan, they may recommend more frequent tests.
If you have a folic acid deficiency, it may weaken your response to treatment. In this case, it is not recommended to take Energamma.
Do not take Energamma if you have intolerance to some sugars: 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 taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
The effect of Energamma may be affected by:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine.

Driving and using machines

Energamma should not affect your ability to drive or use machines.

Energamma contains lactose monohydrate, sucrose, and sodium.

Patients with intolerance to some sugars should inform their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Energamma

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Adults

The recommended daily dose is one Energamma tablet. This corresponds to 1000 micrograms of cyanocobalamin per day.
In severe cases, an initial dose of two Energamma tablets is recommended, which corresponds to 2000 micrograms of cyanocobalamin per day.
In cases of severe hematological and neurological symptoms, cyanocobalamin (vitamin B) should be administered parenterally.

Children and adolescents

Energamma is not recommended for children under 12 years of age due to a lack of appropriate data.
In adolescents from 12 years of age, oral cyanocobalamin is recommended at a dose of 1000 micrograms per day as an alternative to vitamin B deficiency treatment with injections or infusions.

Elderly

The same doses as for adults are used.

Patients with renal impairment

In patients with moderate renal impairment, Energamma can be used at the usual dose. In cases of severe renal impairment, a dose reduction is recommended. Additionally, vitamin B levels in the blood should be regularly monitored.

Patients with hepatic impairment

There are no data on the use of Energamma in patients with hepatic impairment. If you have liver disease, inform your doctor.
Method of administration
Energamma tablets should be swallowed whole with a sufficient amount of water, preferably in the morning, on an empty stomach. The duration of treatment depends on the response to treatment. Your doctor will determine the appropriate dose for you based on regular check-ups.

Overdose

If you take more Energamma than you should, talk to a doctor. No cases of overdose have been reported.
There is no known antidote. In case of overdose, symptomatic treatment should be used.

Missed dose

If you miss a dose of Energamma, take it as soon as possible, unless it is almost time for the next dose. In this case, take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment

Always talk to your doctor before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

• acne-like skin changes and blistering rashes
• severe allergic reactions, which can manifest as hives, skin rash, or itching over large areas of the body
• fever.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Energamma

Keep this medicine out of the sight and reach of children.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month.
Medicines should 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 pack 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: lactose monohydrate, povidone K30, stearic acid, sodium croscarmellose;
sugar coating: spray-dried acacia gum, calcium carbonate, macrogol hydroxy stearate, 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, triglycerides of saturated fatty acids of medium chain length, stearic acid, hydroxypropyl cellulose, montan glyceride wax.

What Energamma looks like and contents of the pack

White to light pink, round, biconvex, chewable tablets.
The cardboard box contains 50 or 100 chewable tablets in PVC/PVDC/Al blisters. Not all pack sizes may be marketed.

Marketing authorization 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

Date of last revision of the leaflet: