VITAMIN

VITAMIN B12 1,000 μg Lichtenstein Ampoules

Important notes (mandatory information)

Vitamin B 12 Lichtenstein 1.000 µg/ml injection solution Active ingredient: Cyanocobalamin.

Indications

Vitamin B12 deficiency that cannot be corrected through diet.

For risks and side effects, read the package leaflet and consult your doctor, pharmacist or healthcare professional.


Patient information: Information for the user
Vitamin B 12 Lichtenstein 1.000 µg/ml injection solution
Active ingredient: Cyanocobalamin

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. This medicine is available without a prescription. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor, pharmacist or healthcare professional.
- Keep the package leaflet. You may need to read it again later.
- Ask your pharmacist if you need more information or advice.
- If you experience any side effects, talk to your doctor, pharmacist or healthcare professional. This also applies to any side effects not listed in this package leaflet. See section 4.
- If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains
1. WHAT IS VITAMIN B 12 LICHTENSTEIN AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VITAMIN B 12 LICHTENSTEIN?
3. HOW IS VITAMIN B 12 LICHTENSTEIN USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VITAMIN B 12 LICHTENSTEIN BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VITAMIN B 12 LICHTENSTEIN AND WHAT IS IT USED FOR?
Cyanocobalamin belongs to the group of substances that are collectively referred to as »Vitamin B12«.

Indications

Vitamin B12 deficiency that cannot be corrected through diet.

Vitamin B12 deficiency can manifest itself in the following clinical pictures

- hyperchromic macrocytic megaloblastic anemia (pernicious anemia, Biermer anemia, Addison anemia; these are maturation disorders of the red blood cells),
- funicular spinal disease (spinal cord damage).

A laboratory-confirmed vitamin B12 deficiency can occur in the following cases

- long-term malnutrition and malnutrition (e.g. due to a strictly vegetarian diet),
- malabsorption (insufficient absorption of vitamin B12 in the intestine) due to
- insufficient production of intrinsic factor (a protein that is produced in the gastric mucosa and is required for the absorption of vitamin B12),
- diseases in the terminal ileum (part of the small intestine), e.g. sprue,
- fish tapeworm infestation or
- blind loop syndrome (change in the course of the intestine after gastric surgery),
- congenital vitamin B12 transport disorders.

2. WHAT SHOULD YOU CONSIDER BEFORE USING VITAMIN B 12 LICHTENSTEIN?
Vitamin B 12 Lichtenstein must not be used if you are allergic to the active substance or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
Please talk to your doctor or pharmacist before using Vitamin B 12 Lichtenstein. No special precautions need to be taken.

Use of Vitamin B 12 Lichtenstein together with other medicines
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No interactions are known to date.

What chemical incompatibilities (incompatibilities) can occur?
Due to the instability of vitamin B 12, the addition of other drugs can lead to a loss of effect of the vitamin (infusion solutions see section 3. »How is Vitamin B 12 Lichtenstein used?«).

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The recommended daily vitamin B12 intake during pregnancy and breast-feeding is 4 micrograms. According to previous experience, higher doses have no adverse effects on the unborn child. Vitamin B12 is excreted in breast milk.

Driving and operating machinery
No special precautions are required.

Vitamin B 12 Lichtenstein contains sodium compounds.
Vitamin B 12 Lichtenstein contains sodium, but less than 1 mmol (23 mg) sodium per ml, i.e. it is virtually »sodium-free«.

3. HOW IS VITAMIN B 12 LICHTENSTEIN USED?
Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is: At the beginning of treatment, 1 ampoule with 1 ml Vitamin B 12 Lichtenstein (corresponding to 1000 micrograms cyanocobalamin) is administered twice a week for the first few weeks after diagnosis. In the case of a proven vitamin B12 absorption disorder in the intestine, 100 micrograms of cyanocobalamin are then administered once a month.

Type and duration of use
Vitamin B 12 Lichtenstein is usually administered intramuscularly (injected into a muscle). However, it can also be given slowly intravenously or subcutaneously (injected into a vein or under the skin). For infusion, Vitamin B 12 Lichtenstein can be added to a 0.9% saline solution (0.9% sodium chloride solution for the preparation of an infusion solution) or 5% glucose solution for the preparation of an infusion solution. Please note the limited shelf life (see section 5. »How should Vitamin B 12 Lichtenstein be stored?«). Vitamin B 12 Lichtenstein, injection solution, can be administered with Fol injekt Lichtenstein, injection solution, in a mixing ratio of 1 : 1. Please note the limited shelf life (see section 5. »How should Vitamin B 12 Lichtenstein be stored?«). Vitamin B 12 Lichtenstein is intended for long-term use. Please consult your doctor about this. Please talk to your doctor if you have the impression that the effect of Vitamin B 12 Lichtenstein is too strong or too weak.

If you have used more Vitamin B 12 Lichtenstein than you should
Poisoning or overdose symptoms are not known.

If you forget to use Vitamin B 12 Lichtenstein
Do not use twice the amount to make up for the missed dose. Please contact your doctor to discuss the further dosage.

If you stop using Vitamin B 12 Lichtenstein
If you interrupt treatment, you are jeopardizing the success of the treatment! If you experience any 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. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects
In very rare cases, skin reactions (acne as well as eczematous and urticarial drug reactions) and hypersensitivity reactions (anaphylactic or anaphylactoid reactions) have been observed.

Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package leaflet. You can also report side effects directly to the
Federal Institute for Drugs and Medical Devices
Dept. of Pharmacovigilance
Kurt-Georg-Kiesinger-Allee 3
D-53175 Bonn
Website: www.bfarm.de
By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD VITAMIN B 12 LICHTENSTEIN BE STORED?
Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the ampoule label after »Use by« or »Exp. date«. The expiry date refers to the last day of the month indicated.

Storage conditions: Store in the original package to protect the contents from light.
Note on shelf life after opening or preparation: Vitamin B 12 Lichtenstein must not be used after opening the ampoule, if there is visible damage to the ampoule glass or if the injection solution is cloudy.

The injection solution is for single use only. Any remaining solution in the ampoule must be discarded. After dilution in 0.9% sodium chloride solution or 5% glucose solution for the preparation of an infusion solution (storage at room temperature in a glass container and without direct sunlight), the solution must be used within 2 hours. A 1 : 1 mixture of Vitamin B 12 Lichtenstein with Fol injekt Lichtenstein, injection solution, must be used immediately after preparation.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Vitamin B 12 Lichtenstein contains
The active substance is cyanocobalamin. One ampoule with 1 ml injection solution contains 1,000 micrograms (1 mg) cyanocobalamin. The other ingredients are: sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections, sodium hydroxide for pH adjustment.

What Vitamin B 12 Lichtenstein looks like and contents of the pack
Vitamin B 12 Lichtenstein is a clear, red solution in brown glass ampoules (OPC ampoules).
Pack of 5 ampoules each with 1 ml injection solution. Pack of 10 ampoules each with 1 ml injection solution. Pack of 100 (4 x 25) ampoules each with 1 ml injection solution.

Pharmaceutical entrepreneur and manufacturer

Winthrop Arzneimittel GmbH
65927 Frankfurt am Main
Telephone: (01 80) 2 02 00 10*
Telefax: (01 80) 2 02 00 11*
*0.06 EUR/call (German landline); max. 0.42 EUR/min (mobile)

Co-distributor

Zentiva Pharma GmbH
65927 Frankfurt am Main

Sanofi-Aventis Deutschland GmbH
65926 Frankfurt am Main

Alternative manufacturers

Weimer Pharma GmbH, Im Steingerüst 30, 76437 Rastatt

as well as

Chinoin Pharmaceutical and Chemical Works Private Co.Ltd.,
Csanyikvölgy Site, Miskolc,
Csanyikvölgy, 3510 Hungary

This package leaflet was last revised in November 2014.

Source: Information from the package leaflet
Status: 02/2015
Active ingredient: Cyanocobalamin. Indications: Vitamin B12 deficiency that cannot be corrected through diet.