Panpharma Vitamin B12 Depot 1000 µg/ml Injection Solution, 10 ampoules

Vitamin B12 Depot Panpharma 1000 µg/ml solution for injection. Active ingredient: Hydroxocobalamin acetate. Indications: For vitamin B12 deficiency that cannot be corrected by diet.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vitamin B12 Depot Panpharma 1000 µg/ml solution for injection
Active ingredient: Hydroxocobalamin acetate

Read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment success, Vitamin B12 Depot Panpharma must be used correctly.

• Keep the package leaflet. You may want to read it again later.
• If you have any further questions, please consult your doctor or pharmacist.
• If your symptoms worsen or do not improve, you should definitely see a doctor.
• If any of the listed side effects become serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

This package leaflet contains:

1. WHAT IS VITAMIN B12 DEPOTPANPHARMA AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE USING VITAMIN B12 DEPOT PANPHARMA?
3. HOW IS VITAMIN B12 DEPOT PANPHARMA TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ISTVITAMIN B12 DEPOT PANPHARMA?
6. MORE INFORMATION

1. WHAT IS VITAMIN B12 DEPOTPANPHARMA AND WHAT IS IT USED FOR?

Vitamin B12 Depot Panpharma is a vitamin B12 supplement. Hydroxocobalamin acetate belongs to the group of substances collectively known as vitamin B12. Vitamin B12 Depot Panpharma is used for vitamin B12 deficiency that cannot be corrected through diet.

Vitamin B12 deficiency can manifest in the following conditions:

• Hyperchromic macrocytic megaloblastic anemia (pernicious anemia, Biermer anemia, Addison's anemia – these are maturation disorders of red blood cells).
• Funicular spinal disease (spinal cord damage).

A laboratory-confirmed vitamin B12 deficiency can occur in:

• Years of malnutrition and undernourishment (e.g., due to a strict vegetarian diet).
• Malabsorption (insufficient absorption of vitamin B12 in the intestine) due to
  • insufficient production of intrinsic factor (a protein produced in the stomach lining and required for the absorption of vitamin B12),
  • Diseases affecting the terminal ileum (part of the small intestine), e.g., celiac disease,
  • Fish tapeworm infestation or
  • Blind loop syndrome (change in the course of the intestine after stomach surgery).
• Congenital vitamin B12 transport disorders.

2. WHAT YOU NEED TO KNOW BEFORE USING VITAMIN B12 DEPOT PANPHARMA:

Do not use Vitamin B12 Depot Panpharma if you are hypersensitive (allergic) to hydroxocobalamin acetate or any of the other ingredients of this medicine.

When using Vitamin B12 Depot Panpharma with other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. No interactions are currently known. Due to the instability of vitamin B12, the vitamin may be less effective if mixed with other drugs.

Pregnancy and breastfeeding:
Ask your doctor or pharmacist for advice before taking any medicine. The recommended daily intake of vitamin B12 during pregnancy and breastfeeding is 4 µg. Based on current experience, higher doses have not had any adverse effects on the unborn child. Vitamin B12 is excreted in breast milk.

3. HOW TO USE VITAMIN B12 DEPOT PANPHARMA?

Use this medicine according to the following dosage recommendations.

The following dosage recommendations apply unless otherwise prescribed:
At the start of treatment, 1 ampoule of Vitamin B12 Depot Panpharma (corresponding to 1000 µg hydroxocobalamin acetate) is administered twice a week for the first few weeks after diagnosis. If a vitamin B12 absorption disorder in the intestine is confirmed, 100 µg hydroxocobalamin acetate is then administered once a month.

Method of administration:
Vitamin B12 Depot Panpharma is usually administered intramuscularly (injected into a muscle). However, it can also be administered slowly intravenously or subcutaneously (injected into a vein or under the skin).

Duration of use:
Vitamin B12 Depot Panpharma is intended for long-term use. Please consult your doctor about this. Please talk to your doctor or pharmacist if you feel that the effect of Vitamin B12 Depot Panpharma is too strong or too weak.

If you have used a larger amount of Vitamin B12 Depot Panpharma:
Poisoning or overdose symptoms are not known.

If you stop using Vitamin B12 Depot Panpharma:
Interrupting treatment jeopardizes the success of the treatment! If you experience unpleasant side effects, please talk to your doctor about further treatment.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Vitamin B12 Depot Panpharma can have side effects, but these do not necessarily occur in everyone.

Possible side effects:
Very rarely, skin reactions (acne, as well as eczematous and urticarial drug reactions) and hypersensitivity reactions (anaphylactic or anaphylactoid reactions) have been observed.

Please inform your doctor or pharmacist if any of the listed side effects become serious or if you notice any side effects not listed in this leaflet.

5. HOW TO STORE Vitamin B12 DEPOT PANPHARMA?

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and carton after "EXP". The expiry date refers to the last day of that month.

Storage conditions:
Keep the ampoules in the outer carton to protect the contents from light.

Note on shelf life after opening or preparation:
Vitamin B12 Depot Panpharma is intended for immediate use after opening the ampoules! Any remaining solution in the ampoule must be discarded!

Due to the instability of vitamin B12, the addition of other medications can lead to a loss of the vitamin's effectiveness. This medicine must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.

6. FURTHER INFORMATION

What Vitamin B12 Depot Panpharma contains:
The active ingredient is hydroxocobalamin acetate. One ampoule containing 1 ml of solution for injection contains 1000 µg of hydroxocobalamin acetate. The other ingredients are: sodium chloride, sodium acetate, acetic acid, and water for injections.

What Vitamin B12 Depot Panpharma looks like and contents of the pack:
Original pack containing 10 ampoules of 1 ml solution for injection and hospital pack containing 100 (10 x 10) ampoules of 1 ml solution for injection.

Pharmaceutical company and manufacturer:
Panpharma GmbH,
Bunsenstraße 4,
22946 Trittau.

This patient information leaflet was last revised in March 2020.

(Apo) Usually ship out within 3-5 business days