Package leaflet: Information for the patient

Cobalaxin, 1 mg, tablets
Cyanocobalaminum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, consult your doctor.

Table of contents

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

1. What Cobalaxin is and what it is used for

Cobalaxin contains vitamin B({12}) in the form of cyanocobalamin.
Most people obtain sufficient vitamin B({12}) through their diet; however, in cases of previous stomach surgery, including gastrectomy, certain gastrointestinal disorders, or a strict diet, the body may not receive enough vitamin B(_{12}).
Cobalaxin may be used in adults in the following cases:

treatment of vitamin B(_{12}) deficiency caused by inadequate nutrition,
long-term treatment of vitamin B(_{12}) deficiency, for example due to intestinal malabsorption,
oral treatment of pernicious anemia and vitamin B({12}) deficiency with neurological symptoms, after achieving normal blood vitamin B({12}) levels using parenteral vitamin B({12}). In patients requiring rapid normalization of vitamin B({12}) levels in the blood, initial treatment should be carried out using parenteral vitamin B(_{12}) until stabilization is achieved.

2. Important information before taking Cobalaxin

When not to take Cobalaxin

if the patient is allergic to cyanocobalamin (vitamin B₁₂) or any of the other ingredients of this medicine (listed in section 6);
if the patient has a specific type of anaemia called folate-deficiency megaloblastic anaemia caused solely by a lack of folic acid (vitamin B₉);
if the patient requires cyanide removal from the body (detoxification) (e.g. in patients with toxic amblyopia or retrobulbar optic neuritis in pernicious anaemia). In such cases, other vitamin B₁₂ preparations should be used;
if the patient has optic nerve atrophy in Leber's disease (a specific hereditary eye disorder);
if the patient has visual disturbances caused by tobacco smoking or alcohol consumption.

Warnings and precautions
Before starting treatment with Cobalaxin, consult your doctor or pharmacist.
Prior to initiating therapy, a physician must diagnose the patient to determine the cause of vitamin B₁₂ deficiency. This includes assessment of gastrointestinal function. The physician will decide whether the patient is receiving adequate vitamin B₁₂ from diet and whether oral vitamin B₁₂ treatment should be initiated.
Depending on the severity of the condition, treatment with Cobalaxin during the first months should be monitored by a physician through regular blood tests ordered for the patient.
Medical advice should be sought after one month of self-administration due to the need for monitoring vitamin B₁₂-related biomarkers and possible dose adjustments, interruption, or change in therapy.
If the patient strictly follows medical recommendations, Cobalaxin may be safely used lifelong, depending on the underlying disease.
In patients undergoing regular kidney dialysis, the physician should perform regular blood tests and, if necessary, reduce the dose of the medicine.
If the patient also has folic acid deficiency, this may impair the response to treatment. In such cases, treatment with Cobalaxin should be combined with therapy addressing folic acid deficiency.
If the patient is scheduled for laboratory tests, inform the 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 color. This medicine may interfere with assays for antibodies against intrinsic factor (IF).

Children and adolescents
Cobalaxin should not be used in children and adolescents under 18 years of age due to insufficient clinical data and inappropriate dosing for this age group.

Cobalaxin and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Absorption or response to treatment may be reduced by:

proton pump inhibitors (e.g. omeprazole) and histamine H₂ receptor antagonists (e.g. cimetidine), used in the treatment of excessive gastric acid production leading to peptic ulcer disease or indigestion;
colchicine, used in the treatment of gout;
neomycin and chloramphenicol (antibiotics);
cholestyramine;
biguanides, e.g. metformin, used in diabetes;
aminosalicylic acid, used among others in inflammatory bowel disease;
long-term use of nitrous oxide (anaesthetic gas);
oral contraceptives;
second-generation antipsychotics used in psychiatric disorders (e.g. olanzapine and risperidone).

In patients with pernicious anaemia, absorption may be increased by:

glucocorticosteroids, e.g. prednisone, used in inflammatory conditions.

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 or pharmacist before using this medicine.
If necessary, and with physician approval, use of Cobalaxin during pregnancy may be considered.
The recommended daily intake of vitamin B₁₂ during pregnancy is 4.5 micrograms per day.
Cobalaxin may be used during breastfeeding, with physician approval. The recommended daily intake of vitamin B₁₂ during breastfeeding is 5 micrograms per day.

Driving and operating machinery
Cobalaxin has no effect on the ability to drive or operate machinery.

3. How to take Cobalaxin

This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use in adults
The recommended daily dose is 1 Cobalaxin tablet per day, corresponding to 1 milligram of
cyanocobalamin per day. It is best to take the tablet on an empty stomach with water.
In cases of severe haematological symptoms or neurological disorders, cyanocobalamin (vitamin B )
should first be administered parenterally until vitamin B blood levels normalize.
Use in children and adolescents
Cobalaxin must not be used in children and adolescents under 18 years of age.
Use in elderly patients
Elderly patients may take the same dose as adult patients.
Use in patients with renal impairment
In patients with moderate renal impairment, Cobalaxin may be used at the standard dose. In cases of severe renal impairment, the doctor may decide to reduce the dose. Additionally, regular monitoring of vitamin B blood levels is required.
Use in patients with hepatic impairment
There are no data available on the safety of Cobalaxin in patients with hepatic impairment. If a patient has impaired liver function, this should be reported to the doctor.
Taking more Cobalaxin than recommended
If you have taken more Cobalaxin than recommended, contact your doctor or pharmacist.
Missing a dose of Cobalaxin
Do not take a double dose to make up for a missed dose.
Stopping Cobalaxin
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

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

severe hypersensitivity reactions, which may manifest as urticaria, skin rash, or itching over large areas of the body;

Frequency unknown (cannot be estimated based on available data):

acneiform skin lesions and blisters;
fever;
anaphylactic reaction.

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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181C
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 to provide more information on the safety of the medicine.

5. How to store Cobalaxin

Keep this medicine out of sight and reach of children.
Store below 30 °C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the blister and carton after:
"EXP". The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Cobalaxin contains

The active substance is: cyanocobalamin (vitamin B ). Each tablet contains 1 milligram of cyanocobalamin (vitamin B ).
The other ingredients are: microcrystalline cellulose, mannitol (E 421), corn starch, pregelatinized, magnesium stearate.

What Cobalaxin looks like and contents of the pack
Pink, round, biconvex, uncoated tablets, 6 mm in diameter, mottled
(not uniformly pink) with dark and light specks.
Cobalaxin is available in PVC/PVDC/Aluminum blisters, packed in a cardboard box
containing 30 or 50 tablets.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy „GALENA”
Dożynkowa 10
52-311 Wrocław
Poland
Tel. +48 71 71 06 201