Read all of this leaflet carefully before youare given this medicine.

• Keep this leaflet. You may need to read itagain.

• If you have any further questions, askyour doctor or nurse.

• In this leaflet, Neo-Cytamen® 1000micrograms/ml Solution for Injection willbe called Neo-Cytamen.

In this leaflet:1. What Neo-Cytamen is for2. Before you are given Neo-Cytamen3. How you will be given Neo-Cytamen4. Possible side effects5. How to store Neo-Cytamen6. Further information.

1. What Neo-Cytamen is forNeo-Cytamen is a form of Vitamin B12, anessential vitamin which is needed forproduction of red blood cells.Neo-Cytamen is used to prevent and treatcertain types of anaemia, includingAddisonian pernicious anaemia, and otherkinds of anaemia which result from adeficiency of Vitamin B12.It is also used to treat conditions calledtobacco amblyopia and Leber’s opticatrophy, which result in a dimming of vision.

2. Before you are given Neo-CytamenYou should not be given Neo-Cytamen if:

• You are allergic to the active ingredient,hydroxocobalamin

• You are allergic to any of the otheringredients of Neo-Cytamen (see section6.).

If the above applies to you talk to yourdoctor or nurse.

Check with your doctor before being givenNeo-Cytamen if:

• You are pregnant or are planning tobecome pregnant.

• You are breast-feeding.Tell your doctor if you are taking any of

the following medicines:• Antibiotics (for treating infections) or

antimetabolites (medicines which stopcells dividing, such as mercaptopurinefor leukaemia), as these treatments mayinterfere with tests to measure the levelsof Vitamin B12 in your blood or urine

• An antibiotic called chloramphenicol, asyou may not respond well to Neo-Cytamen

• The contraceptive 'pill'• Any other medicine, including medicines

obtained without a prescription

Pregnancy and breast-feedingNeo-Cytamen should not be used for thetreatment of megaloblastic anaemia ofpregnancy unless vitamin B12 deficiencyhas been demonstrated.Neo-Cytamen is found in breast-milk but itis unlikely that it will harm your baby.If you are pregnant, trying to becomepregnant or are breast-feeding, ask yourdoctor or nurse for advice before beinggiven Neo-Cytamen.

Driving and using machinesNeo-Cytamen may cause dizziness. If thishappens to you, do not drive or usemachinery.

3. How you will be given Neo-CytamenNeo-Cytamen will be given to you by yourdoctor or nurse.

Important:Your doctor will choose the dose that isright for you.You will be given Neo-Cytamen by yourdoctor or nurse as an injection into amuscle. You may be given it just once or itmay be repeated every other day, weekly ormonthly, depending on how much yourbody needs.

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Adults and Children• Treatment of anaemia:- Without neurological (nervous system) involvement:

Initially 250 – 1000 micrograms, every other day for 1 to 2 weeks, then 250 micrograms weekly until the blood tests are normal.Maintenance dose: 1000 micrograms every 2 to 3 months.

- With neurological involvement:1000 micrograms every other day for as long as improvement is noticed.Maintenance dose: 1000 micrograms every 2 months.

• Prevention of anaemia:1000 micrograms every 2 to 3 months.

4. Possible side effectsLike all medicines Neo-Cytamen can causeside effects, although not everybody gets them.These are:

Effects on the heart and blood• Low blood potassium levels and irregular

heart beat during the early stages of treatment

Effects on the eyes and skin

• Hypersensitivity reactions including skinreactions (such as rash, itching)

• Exceptionally, anaphhylaxis (which mayinclude collapse and difficulty in breathing)

• Acne-like rash• Blisters• Pain at the injection site• Feeling of ‘pins and needles’

Effects on the stomach and bowel

• Feeling unwell or sick• Being sick• DiarrhoeaEffects on the nervous system• Dizziness• Headache

Other effects

• Fever• Chills

• Hot flushes• Pain.Reporting of side effectsIf you get any side effects, talk to your doctoror nurse. This includes any possible sideeffects not listed in this leaflet. You can alsoreport side effects directly via Yellow CardScheme Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in theGoogle Play or Apple App Store. By reportingside effects you can help provide moreinformation on the safety of this medicine.

5. How to store Neo-Cytamen

6. Further informationWhat Neo-Cytamen containsThe active substance is Hydroxocobalamin ata strength of 1000 micrograms (1 mg) perml of solution.The other ingredients are sodium chloride,acetic acid and water for injection.

• Tobacco amblyopia and Leber’s optic atrophy: Initially 1000 micrograms or more daily for 2 weeks, then twice weekly for as long as improvement is noticed. Maintenance dose: 1000 micrograms monthly.

Medical check-ups

While you are receiving this medicine, your doctor will want you to have regular blood tests to check your condition. This is to make sure that your medicine is working properly and that the dose you are receiving is right for you.

If you are given more Neo-Cytamen than you should

If you think you have been given too much Neo-Cytamen, you are unlikely to need any special treatment. However, if you suffer any discomfort or side effects you should tell your doctor.

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

What Neo-Cytamen looks likeNeo-Cytamen® 1000 micrograms/ml Solution for Injection is a sterile solution.It comes in packs of 5 ampoules, each containing 1 ml of solution.

Marketing Authorisation HolderRPH Pharmaceuticals AB, Box 603,101 32 Stockholm, SwedenManufacturerWasserburger Arzneimittelwerk GmbH Herderstraße 2D-83512 WasserburgGermanyThis leaflet was last revised in 11/2020® Neo-Cytamen is a RegisteredTrade Mark

If this leaflet is difficult to see or read or you would like it in a different format, please contact: RPH Pharmaceuticals AB,Box 603, 101 32 Stockholm, Sweden.

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Keep this medicine out of the sight and reach of children.Do not use Neo-Cytamen after the expiry date on the label. The expiry date refers to the last day of that month.Store below 25ºC. Keep Neo-Cytamen in the original packaging in order to protect it from light.Your doctor or nurse will make sure your medicine is correctly stored and disposed of.