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Cytamen Injection 1000mcg

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Document: leaflet MAH BRAND_PL 36301-0010 change

Cytamen® 1000 micrograms/ml Solution for injection

PATIENT INFORMATION LEAFLET

This leaflet is to help you get the most from your medicine.

Please read this leaflet carefully BEFORE you are given your medicine. If you have any questions or you want to know more about this medicine, please ask your doctor or pharmacist.

What is your medicine?

It


This medicine is called Cytamen® Injection 1000mcg. It is a sterile solution for injection and contains 1 milligram (1000 micrograms) of cyanocobalamin BP as the active ingredient. also contains sodium chloride, acetic acid and water for injection. It is supplied in packs of 5 glass ampoules each containing 1ml of solution.

Cyanocobalamin is a form of Vitamin B12, an essential vitamin which is needed for production of red blood cells.

Who makes it?

The Marketing Authorisation Holder is: RPH Pharmaceuticals AB, Lagervagen 7, 136 50 Haninge, Sweden.

It is made by: Recipharm Ltd, Vale of Bardsley, Ashton-under-Lyne, OL7 9RR, UK.

What is this medicine used for?

Cytamen® Injection 1000mcg is used for a test called the Schilling Test which measures your ability to absorb Vitamin B12 from the bowel. It is also used to prevent and treat certain types of anaemia. These include Addisonian pernicious anaemia and other kinds of anaemia which result from a deficiency of Vitamin B12.

Before you take this medicine:

Do not take this medicine if:

• You are allergic to any of the ingredients

• You have a condition called toxic amblyopia (poor vision which may be due to Vitamin B12 deficiency)

If the answer to any of the following questions is YES, tell your doctor before taking this medicine. They may want to change your treatment or give you special advice.

• Are you pregnant, likely to become pregnant or breastfeeding?

• Are you taking an antibiotic drug called chloramphenicol?

• Are you taking any other antibiotics (for an infection) or antimetabolites (which stop cells dividing) such as mercaptopurine for leukaemia? These treatments may interfere with tests to measure the levels of Vitamin B12 in your blood or urine.

• Are you using the contraceptive "pill"?

How do I take Cytamen® Injection 1000mcg?

Cytamen® Injection 1000mcg is given into a muscle. The dose used will depend on your medical condition, and your doctor will want to perform regular blood tests to monitor your condition. The following are intended as a guide:

Schilling Test:

1000mcg injected into a muscle.

Treatment of Anaemia:

Without neurological (nervous system) involvement: Initially 250 - 1000mcg injected into a muscle every other day for 1 to 2 weeks, then 250mcg weekly, until the blood tests are normal. The maintenance dose is then 1000mcg every month.

With neurological involvement: 1000mcg into a muscle every other day for as long as improvement is noticed, then 1000mcg every month.

Prevention of Anaemia:

250mcg - 1000mcg every month.


What if I take too much?

If you receive too much of this medicine, you are unlikely to need any special treatment. However, if you suffer any discomfort or side effects you should tell your doctor.

After using Cytamen® Injection 1000mcg

As with all medicines, side effects can occur and these may include any of the following: Fever, chills, hot flushes, dizziness, tremor, feeling unwell or sick,an acne-like rash and blisters have been reported.

Hypersensitivity reactions including skin reactions (e.g. rash, itching), and occasionally anaphylaxis (which may include collapse and difficulty breathing).

Irregular heartbeat has been reported during early stages of treatment.

If you suffer from any of the above, or if you think this medicine has upset you in any way please tell your doctor.

How to store this medicine

Cytamen® Injection should be protected from light. Do not store above 25°C.

Do not use this medicine after the expiry date shown on the pack.

KEEP THIS AND ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.

Further information

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who will have access to further information.

YOU MAY WANT TO READ THIS LEAFLET AGAIN. PLEASE DO NOT THROW IT AWAY UNTIL YOU HAVE FINISHED YOUR MEDICINE.

This leaflet only applies to the product (Cytamen®) for which it has been prepared. Cytamen® is a Registered Trade Mark.

Date of preparation of leaflet: May 2010.

P1202C