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Cytacon 35 Micrograms/5ml Syrup

Document: leaflet MAH BRAND_PL 10972-0029 change

MercuryPharma

PATIENT INFORMATION LEAFLET

Cytacon® 35micrograms/5ml Syrup

Cyanocobalamin (Vitamin B12)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to take Cytacon Syrup carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Cytacon 35micrograms/5ml Syrup, it will be referred to as Cytacon Syrup throughout the PIL for ease hereafter.

What is in this leaflet:

1.    What Cytacon Syrup is and what it is used for

2.    What you need to know before you take Cytacon Syrup

3.    How to take Cytacon Syrup

4.    Possible side effects

5.    How to store Cytacon Syrup

6.    Contents of the pack and other information

1. WHAT CYTACON SYRUP IS AND WHAT IT IS USED FOR

Cytacon Syrup contains cyanocobalamin, which is known as vitamin B12.

Most people get enough vitamin B12 from their food, but if you have had stomach surgery, or certain diseases of the intestines, or a restricted diet, you may not absorb enough vitamin B12. Lack of vitamin B12 in the body causes a disease called pernicious anaemia (reduction in the number of red blood cells) which is often treated with vitamin B12 injections. Cytacon Syrup is used to treat vitamin B12 deficiency when injections cannot be used.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYTACON SYRUP

DO NOT take Cytacon Syrup if:

•    you know you are allergic to cyanocobalamin or any other ingredient present in this injection (see section 6 of this leaflet).

Patients who had allergic reaction to cyanocobalamin by injection may often tolerate cyancobalamin by the oral route without trouble.

Take special care with Cytacon Syrup if:

•    you have diabetes

If you have any other medical conditions, speak to your doctor before you take this medicine. Your doctor may want to monitor your response to this medicine carefully, particularly if you are young or elderly. This will probably involve regular examination of your blood.

Other medicines and Cytacon Syrup

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without prescription. The absorption of Cytacon Syrup may be affected by:

•    neomycin and chloramphenicol which are antibiotics

•    colchicines, a treatment for gout

•    biguanides, e.g. metformin, which is used to treat diabetes

•    cholestyramine which is used to reduce the amount of cholesterol (fats) in the blood

•    potassium chloride which is used to correct potassium deficiency

•    methyldopa which is used to treat high blood pressure

•    cimetidine which is used to treat excess acid in the stomach causing indigestion or ulcer

•    oral contraceptives

Antibiotics (used to treat infections) and antimetabolites (used to treat some cancers) can affect blood tests used to measure vitamin B12.

Cytacon Syrup with food and drink

Cytacon Syrup should be swallowed and taken between meals.

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should let your doctor know if you are or think you may be pregnant or are planning to become pregnant, or are breast feeding.

As with all drugs, Cytacon Syrup should only be given in pregnancy and when breast feeding if absolutely necessary.

Driving and using machines

Cytacon Syrup should not affect your ability to drive or use machinery.

Important information about some of the ingredients in Cytacon Syrup

This medicine also contains:

•    Sucrose. If you have been told by your doctor that you are intolerant of sugar, contact your doctor before taking this medicine

•    Amaranth E123 which may cause allergic reactions

•    Methylhydroxybenzoate (E218) may cause allergic reactions (possible delayed), and expectionally bronchospasm.

3. HOW CYTACON SYRUP IS GIVEN TO YOU

Always take Cytacon Syrup exactly as your doctor or pharmacist has told you. You should always check with your doctor or pharmacist if you are not sure.

Please read the label carefully, it will tell you how many spoonfuls of Cytacon Syrup to take each day.

USUAL DOSES

Adults and Elderly: one or two 5ml spoonfuls of Cytacon Syrup two or three times a day. Chidren: one 5ml spoonful of Cytacon Syrup two or three times a day.

Cytacon Syrup should be taken between meals. Do not stop taking this medicine, except on your doctor’s advice. Your doctor may change the dose, depending on how you react to it.

What to do if you have been given more Cytacon Syrup than you should

If you accidentally take too much of this medicine, bring any remaining syrup and this leaflet with you to your doctor or pharmacist so they know exactly what you have taken.

If you forget to take your Cytacon Syrup

If you miss a dose, take it as soon as you remember, if it is within a few hours of the normal time. Otherwise, leave out that dose completely and take your next dose at the normal time it is due. Do not take double the amount of Cytacon Syrup if you miss a dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines Cytacon Syrup can sometimes cause side-effects, although they are rare. Allergic reactions to this medicine is rare but may show as an itchy rash. Rarely, a serious allergic reaction may occur causing sudden onset of swelling of the face and neck, and shortness of breath

Acne like and blister eruptions have been reported rarely.

If you use Cytacon Syrup for a long time, the sugar content may increase the risk of tooth decay. This can be reduced by daily brushing of the teeth.

If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE CYTACON SYRUP

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date printed on the carton and label. The expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light.

If for any reason you have any medicine left after your treatment return it to you pharmacist who will dispose of it safely.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cytacon Syrup contains

The active substance is cyanocobalamin. Each 5ml syrup contains 35 micrograms cyanocobalamin.

The other ingredients are sucrose, sodium carboxymethylcellulose, saccharin sodium, methyl hydroxybenzoate sodium (E218), ariavit amaranth (E123), citric acid monohydrate and blackcurrent essence bush 36 as flavouring agent.

What Cytacon Syrup looks like and contents of pack

Cytacon Syrup is a red syrup and supplied in 200ml amber glass bottles with a child resistant cap.

Marketing authorisation holder

Mercury Pharma Group Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK Manufacturer

Universal Products Ltd., Fairfield, Bradshaw Lane, Greenhalgh, Kirkham, Preston, Lancashire, PR4 3JA, UK

This leaflet was last revised in December 2013    100007/LF/3

Cytacon is a registerd trademark of Mercury Pharma Group Ltd.