PATIENT INFORMATION LEAFLET

ASCORBIC ACID 100mg, 200mg AND 500mg TABLETS

Read all of this leaflet carefully before you start to take these tablets as it contains important information for you. This medicine is available without prescription, however, you still need to take Ascorbic Acid Tablets carefully.

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

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

•    You must contact a doctor if your symptoms worsen or do not improve.

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

IN THIS LEAFLET

1.    What your medicine is and what it is used for

2.    Before you take your medicine

3.    How to take your medicine

4.    Possible side effects

5.    Storing your medicine

6.    More information

1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR

Ascorbic Acid Tablets belong to a group of medicines called vitamins.

Ascorbic acid is also known as Vitamin C.

Ascorbic Acid Tablets are used for the treatment and prevention of Vitamin C deficiency. They are also used to treat scurvy (a serious condition due to a long-term lack of dietary Vitamin C).

2. BEFORE YOU TAKE YOUR MEDICINE Do not take your medicine if you:

•    have had an allergic reaction to Ascorbic Acid Tablets or any of the other ingredients in this medicine (see list of ingredients in section 6, More information)

•    you suffer from hyperoxaluria (excretion of urine containing large amounts of calcium oxalate crystals) If the answer is yes to any of the above, please tell your doctor.

Take special care with your medicine

Before taking this medicine tell your doctor if you:

•    are to undergo any blood or urine tests as ascorbic acid can interfere with some blood and urine tests

•    are a regular smoker

•    have kidney failure as ascorbic acid enhances aluminium absorption (present in antacids) which may reach toxic levels.

Taking other medicines

Ascorbic Acid Tablets may interfere with other medicines that you may be taking. This includes medicines you can buy without a prescription, including herbal medicines.

In particular tell your doctor if you are taking any of the following:

•Amphetamines

•    Contraceptives •Aspirin

•    Iron-containing medicines

•    Antacids

•    Amygdalin (Vitamin B₁₇) - can cause cyanide toxicity

Ascorbic Acid Tablets should not be taken for the first month after starting desferrioxamine treatment. Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding please talk to your doctor before taking this medicine.

Driving and using machines

Ascorbic acid has no known effect on your ability to drive or operate machinery.

3. HOW TO TAKE YOUR MEDICINE

Unless advice is given to you by your doctor about how to take this medicine, always follow the instructions given in this leaflet. Check with your doctor or pharmacist if you are not sure how to take this medicine.

These tablets are to be taken by mouth.

Chew Ascorbic Acid 500mg Tablets before swallowing.

Adults (including the elderly)

For the treatment of Vitamin C deficiency:    250mg - 1000mg daily in divided doses

For the prevention of Vitamin C deficiency:    25mg - 75mg daily

The maximum daily dose is 1000mg.

Children (aged 4 to 12 years)

For the treatment of Vitamin C deficiency:    125mg - 500mg daily in divided doses

For the prevention of Vitamin C deficiency:    25mg - 75mg daily

Children under 4 years

Ascorbic Acid Tablets are not suitable for children under 4 years of age.

If you take more of your medicine than you should

If too many tablets are taken, consult your doctor or go to your nearest hospital casualty department IMMEDIATELY. Take the tablets or this leaflet with you so the doctor knows what has been taken.

If you forget to take your medicine

If you miss a dose, do not take an extra dose, just resume your schedule and go on as before. If you are not sure what to do, ask your pharmacist.

If you stop taking your medicine

Keep taking this medicine until your doctor tells you to stop. You may need to stop taking the tablets slowly as they may alter your kidney function.

4.    POSSIBLE SIDE EFFECTS

As with all medicines Ascorbic Acid Tablets can cause unwanted side effects in some patients.

Stop taking this medicine immediately and consult your doctor if you suffer an allergic reaction after taking this medicine. An allergic reaction may include itching, a rash, swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing.

If you experience any of the following you should see your doctor or pharmacist:

•    diarrhoea, stomach cramps, nausea (feeling sick), vomiting (being sick)

•    flushing or redness of the skin

•    haemolytic anaemia (where the body’s immune system attacks its own red blood cells), signs may include fatigue and paleness

•    diuretic effect (increased urine flow) due to increased intake of ascorbic acid over a prolonged period. This may lead to deficiency if the amount of ascorbic acid taken is reduced or stopped rapidly. High doses of over 600mg daily can have a diuretic effect in some patients.

Tell your doctor or pharmacist if you think you may have any of these symptoms or experience any other problems with your medicine not mentioned above. He or she will have more information about it and will tell you what to do.

Reporting of side effects

Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.aov.uk/vellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

5.    STORING YOUR MEDICINE

Do not use after the expiry date printed on the pack label.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Do not store above 25°C. Keep the container tightly closed. Store in the original container.

If your tablet becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will advise you what to do.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    MORE INFORMATION What your medicine looks like

Ascorbic Acid Tablets are white, round, biconvex tablets with the following markings:

100mg tablets: SMA100 200mg tablets: SMA200 500mg tablets: SMA500

Ascorbic Acid Tablets are available in pots of 28, 100, 500 and 1,000 tablets. Not all pack sizes may be marketed.

What your medicine contains

Ascorbic Acid Tablets are available in strengths of 100mg, 200mg and 500mg.

Ascorbic Acid 100mg Tablets contain 100mg of the active ingredient, ascorbic acid.

Ascorbic Acid 200mg Tablets contain 200mg of the active ingredient, ascorbic acid.

Ascorbic Acid 500mg Tablets contain 500mg of the active ingredient, ascorbic acid.

Ascorbic Acid 100mg and 200mg Tablets also contain microcrystalline cellulose, maize starch, stearic acid and talc.

Ascorbic Acid 500mg Tablets also contain microcrystalline cellulose, stearic acid and magnesium stearate. Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Manufacturers responsible for batch release

Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

Distributor

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.

PL 30464/0055-57

This leaflet was revised in May 2013.    cpasc.tjnt.v3P2