Ankermann

Leaflet attached to the packaging: patient information

Ankermann, 1000 micrograms, chewable tablets

Cyanocobalamin(Vitamin B12)

Read the 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ankermann and what is it used for

Ankermann contains cyanocobalamin, also known as Vitamin B12.
Most people get enough Vitamin B12 through their diet, but if you have had stomach surgery, have certain stomach or intestinal disorders, follow a strict diet, or take certain medications, your body may not get enough Vitamin B12.
This medicine is used to treat Vitamin B12 deficiency and to maintain treatment in adult patients:

• who have been diagnosed with megaloblastic anemia,
• who have a malabsorption disorder (e.g., due to atrophic gastritis, inflammatory bowel disease, celiac disease, total or partial gastrectomy, resection of the ileum, gastric bypass surgery, or other bariatric surgery)
• who are taking long-term histamine H2 receptor blockers, proton pump inhibitors, aminosalicylates, and metformin.

This medicine is also used to treat Vitamin B12 deficiency caused by reduced intake (e.g., in a vegetarian diet) in adults.

2. Important information before taking Ankermann:

When not to take Ankermann:

Warnings and precautions

Before starting to take Ankermann, discuss it with your doctor or pharmacist.
Before starting treatment, your doctor should diagnose your condition to determine the cause of the deficiency. This includes checking the function of the digestive tract. The doctor will decide whether Vitamin B12 absorption from food is insufficient and whether oral supplementation with this medicine is necessary.
Due to the serious nature of the disease, your doctor will likely want to monitor your response to this medicine during the first 3 months of treatment. This will likely include blood tests. If you follow the treatment plan, treatment may last a lifetime, depending on the underlying disease.
If you need regular dialysis, your doctor should regularly perform blood tests and may need to reduce the dose of this medicine.
If you have a folic acid deficiency, it may weaken your response to treatment.
In this case, you should take folic acid supplements in parallel with this medicine.
Ankermann contains 1000 micrograms of cyanocobalamin per tablet. If you are going to have laboratory tests, tell your doctor or laboratory staff that you are taking this medicine, as cyanocobalamin may affect the results of such tests (including blood, urine, skin tests with allergens, etc.) due to its red color. This medicine may affect the determination of intrinsic factor antibodies.

Children and adolescents

Do not give this medicine 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.

Ankermann and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including those available without a prescription.
The effect of Ankermann may be altered 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
• aminoglycosides (e.g., neomycin) and chloramphenicol (antibiotics)
• biguanides, e.g., metformin, used in diabetes
• aminosalicylic acid, used to treat inflammatory bowel disease
• oral contraceptives
• antiepileptic drugs (e.g., carbamazepine)
• potassium salts
• methyldopa, used to treat high blood pressure
• long-term use of nitrous oxide (anesthesia gas)
• second-generation antipsychotic drugs (olanzapine and risperidone)
• cholestyramine, used to lower high cholesterol levels in the blood
• glucocorticosteroids, e.g., prednisone, used to treat inflammatory conditions

Taking Ankermann with alcohol

Alcohol may affect the absorption of this medicine into the body.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. As a precautionary measure, it is recommended to avoid taking this medicine during pregnancy, unless the woman's condition requires treatment with cyanocobalamin.
This medicine can be used during breastfeeding.

Driving and using machines

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

Ankermann contains lactose monohydrate, sucrose, macrogolglycerol hydroxystearate, and sodium.

Lactose monohydrate and sucrose
If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
Macrogolglycerol hydroxystearate
May cause stomach upset and diarrhea.
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 Ankermann

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 1 tablet of Ankermann. This corresponds to 1000 micrograms of cyanocobalamin in the following indications:

• treatment of Vitamin B12 deficiency caused by reduced intake of Vitamin B12 in the diet (e.g., vegetarian diet),
• treatment of Vitamin B12 deficiency and maintenance treatment in patients with diagnosed megaloblastic anemia or malabsorption disorder,
• treatment in connection with long-term use of histamine H2 receptor blockers, proton pump inhibitors, aminosalicylates, and metformin.

Patient with severe hematological or neurological symptoms of Vitamin B12 deficiency must initially be treated with parenteral Vitamin B12 until the Vitamin B12 level in the blood is normalized.
If oral Vitamin B12 is well tolerated, there are no restrictions on the duration of treatment in the case of megaloblastic anemia or malabsorption disorder.
Regular monitoring of the response to treatment is necessary (see also section 2 Warnings and precautions).

Patients with renal impairment

In patients with moderate renal impairment, Ankermann can be taken using the usual recommended dose for adults. In the case of severe renal impairment, a dose reduction is recommended. Additionally, regular monitoring of Vitamin B12 levels in the blood is necessary.

Patients with hepatic impairment

There are no data on the use of Ankermann in patients with hepatic impairment. If you have liver disease, inform your doctor.
Method of administration
Ankermann 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 of Ankermann

In the event of an overdose of Ankermann, consult your doctor, who will decide on the appropriate course of action. No cases of overdose have been reported.
There is no known antidote. In the event of an overdose, symptomatic treatment should be used.

Missed dose of Ankermann

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

Stopping Ankermann

Always consult your doctor before stopping treatment with Ankermann.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Uncommon (may affect up to 1 in 100 people):

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

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

• acne-like changes and blisters
• fever

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 Ankermann

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

6. Contents of the pack and other information

What Ankermann contains

The active substance is:
1000 micrograms of cyanocobalamin (synthetic form of Vitamin B12).
The other ingredients are:
lactose monohydrate, povidone K30, croscarmellose sodium, stearic acid 50 (stearic acid and palmitic acid), AquaPolish P white*, sucrose, talc, kaolin, calcium carbonate, titanium dioxide (E 171), arabic gum dispersion dried, macrogol 6000, macrogolglycerol hydroxystearate 40, sodium lauryl sulfate (E487), montan glycol wax.
(*The composition of the "AquaPolish P white" coating is: hypromellose, hydroxypropylcellulose, stearic acid 50 (stearic acid and palmitic acid), talc, medium-chain triglycerides, titanium dioxide (E 171)).

What Ankermann looks like and contents of the pack

Round, biconvex, white chewable tablets with a diameter of approximately 9.8 mm.
The carton contains 10, 25, 30, 50, 60, 90, or 100 chewable tablets in PVC/PVDC/Aluminum blisters.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Woerwag Pharma Polska Sp. z o.o.
ul. Józefa Piusa Dziekońskiego 1
00-728 Warsaw
tel. (+48) 22 863 72 81
fax (+48) 22 877 13 70

Date of last revision of the leaflet: