United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information Lea
This medicine will be called Ascorbic Acid
Read all of this leaflet carefully before you start
taking this medicine.
Keep this leaflet. You may need to read it again.
This medicine is only for you. Do not give it to
anyone else to take. It may harm them, even if
their symptoms are the same as yours.
If you have any further questions, please ask your
doctor or pharmacist.
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
1. What Ascorbic Acid Tablets are and what they a
2. Before you take Ascorbic Acid
3. How to take Ascorbic Acid
4. Possible side e
5. How to store Ascorbic Acid
1. What Ascorbic Acid
what they are used
These tablets contain the active ingredient, a
acid. Ascorbic acid is the chemical name for
C. The tablets can be used to increase the amount
Vitamin C in the
Vitamin C Tablets are used to treat Vitamin C
deficiency including the prevention and treatment of
2. Before you take Ascorbic Acid
not take these tablets
You know you are allergic to ascorbic acid or to any
of the other ingredients
e are listed in Section 6
You suffer from hyperoxaluria
You are pregnant or
You have an intolerance to some sugars.
tablets contain lactose and
If any of the conditions above apply to you,
discuss your treatment with your doctor before
Ascorbic Acid Tablets can affect some
medicines you may be taking. Make sure your
knows if you are taking an iron
Always tell your doctor or pharmacist about all
medicines you are taking. This means medicines
have bought yourself as well as those you have
Ascorbic Acid Tablets should not affect your ability
drive or operate
Taking Ascorbic Acid Tablets can affect the results
a number of laboratory tests. If you are going to
blood, urine or other tests make sure the doctor
aware that you are taking Ascorbic Acid
3. How to take Ascorbic Acid
The tablets can be sucked, chewed or
with a drink of
If this medicine has been given to you by your
will decide what dose you need to
take the tablets exactly as the doctor has
you. The dose will be on the pharmacist’s label. If
are not sure, ask your doctor or pharmacist. Carry
taking them for as long as you have been told
you have any problems. In that case, check with
Adults, the elderly and children over 12: The usual
dose is 1 to 5 tablets a day in divided doses.
Children aged 4 to 12:
The usual dose is ½ to 2½ tablets a
ay in divided
If you have bought the tablets yourself, take the
take more tablets than
If you have taken a lot more tablets than you
speak to your doctor or pharmacist
Take your tablets or the pack with
forget to take
If you miss a dose don’t worry. Miss this dose
carry on with the normal
4. Possible side
Like all medicines ascorbic acid can ca
effects, although not everybody gets them. The
following have been
d if you have taken too
high a dose
deficiency taking this medicine may develop a type
shortness of breath,
Continued, please turn
If you get any side effects, talk to your
pharmacist or nurse.
includes any possible side
effects not listed in
leaflet. You can also report
side effects directly
Yellow Card Scheme
effects you can help provide
e information on the
safety of this
5. How to store Ascorbic Acid
Keep out of the sight and reach of
Do not store above 25
C. Store in the
container to protect the tablets from light. Keep
container tightly closed to protect the tablets
Do not use the tablets after the expiry date shown
stop taking the tablets, please take
to your pharmacist to be d
Each tablet contains 500 mg of the active
ascorbic acid. The other ingredients are
microcrystalline cellulose, stearic acid, lactose,
and pregelatinized maize
the medicine looks like
The tablets are round and white and marked
one side. They are supplied to your pharmacist
packs of 28, 50, 100 or 500 tablets. Not all
may be a
Product licence holder
The product licence holder
Crescent Pharma Ltd, Units 3 & 4, Quidhampton
Business Units, Polhampton Lane, Overton,
Hampshire, RG25 3ED.
Manufactured by Surepharm Services Ltd.,
Burton upon Trent, Staffs, DE15 0YZ, UK.
Product Licence Number: PL 20416/0289
Date of revision: S e p t e m b e r 2014.
If you would like the leaflet in a different
please contact the licence holder at the a
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE MEDICINAL PRODUCT
Ascorbic Acid 500mg Tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 500mg ascorbic acid
Excipients with known effect: contains 3.00 mg/tablet lactose monohydrate
For the full list of excipients, see section 6.1.
White to off-white uncoated tablets.
Ascorbic Acid 500mg Tablets are 12.5 mm, white to off-white, plain round, biconvex tablets.
Vitamin C deficiency
Treatment of scurvy
Posology and method of administration
Therapeutic use – at least 250mg daily in divided doses.
Maximum of 1000mg daily.
Elderly: As for other adults. As the dietary intake of vitamin C may be less in the elderly, they have greater risk
of presenting with vitamin C deficiency.
Method of administration
For oral administration.
Ascorbic acid should not be given to patients with hyperoxaluria.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Increased intake of ascorbic acid over a prolonged period may result in increased renal clearance of ascorbic
acid, and deficiency may result if the intake is reduced or withdrawn rapidly. (See section 4.8)
Interference with serological testing
Ascorbic acid may interfere with tests and assays for urinary glucose, giving false-negative results with methods
utilising glucose oxidase with indicator (e.g. Labstix, Testape) and false- positive results with neocuproin
Estimation of uric acid by phosphotungstate or uricase with copper reduction and measurement of creatinine in
non-deproteinised serum may also be affected.
High doses of ascorbic acid may give false-negative readings in faecal occult blood tests.
This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.
Interactions with other medicinal products and other forms of interaction
Ascorbic acid increases the renal excretion of amphetamine. The plasma concentration of
ascorbate is decreased by smoking and oral contraceptives.
Ascorbic acid increases the absorption of iron.
Concomitant administration of aspirin and ascorbic acid may interfere with absorption of
ascorbic acid. Renal excretion of salicylate is not affected and does not lead to reduced anti-
inflammatory effects of aspirin.
Concomitant administration of aluminium-containing antacids may increase urinary
aluminium elimination. Concurrent administration of antacids and ascorbic acid is not
recommended, especially in patients with renal insufficiency.
Co-administration with amygdalin (a complementary medicine) can cause cyanide toxicity.
Concurrent administration of ascorbic acid with desferrioxamine enhances urinary iron
excretion. Cases of cardiomyopathy and congestive heart failure have been reported in
patients with idiopathic haemochromatosis and thalassaemias receiving desferrioxamine who
were subsequently given ascorbic acid. Ascorbic acid should be used with caution in these
patients and cardiac function monitored.
Ascorbic acid may interfere with biochemical determinations of creatinine, uric acid and
glucose in samples of blood and urine.
Fertility, pregnancy and lactation
For ascorbic acid no clinical data on exposed pregnancies are available. Animal studies do not
indicate direct or harmful effects with respect to pregnancy, embryonal/foetal development,
parturition or postnatal development. Pregnant women should exercise caution.
Ascorbic acid is excreted in breast milk. Though again caution should be exercised, no
evidence exists suggesting such excretion is hazardous to the infant.
Effects on ability to drive and use machines
On the basis of the product’s pharmacodynamic profile and reported adverse events, ascorbic
acid has no known effect on an individual’s ability to drive or operate machinery.
Nervous system disorders: headache.
Vascular disorders: flushing
Gastrointestinal disturbances: nausea, vomiting and stomach cramps.
Large doses of ascorbic acid may cause diarrhoea.
Skin and subcutaneous tissue disorders: redness of skin.
Renal and urinary disorders: Patients known to be at risk of hyperoxaluria should not ingest
ascorbic acid doses exceeding 1gm daily as there may be increased urinary oxalate excretion.
However, such risk has not been demonstrated in normal, non-hyper oxaluric individuals.
Ascorbic acid has been implicated in precipitating haemolytic anaemia in certain individuals
deficient of glucose-6-phosphate dehydrogenase
Increased intake of ascorbic acid over a prolonged period may result in increased renal
clearance of ascorbic acid, and deficiency may result if the intake is reduced or withdrawn
rapidly. Doses of more than 600mg daily have a diuretic effect.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
At doses of over 3gm per day unabsorbed ascorbic acid is mainly excreted unmetabolised in
the faeces. Absorbed ascorbic acid additional to the body’s needs is rapidly eliminated. Large
doses of ascorbic acid may cause diarrhoea and the formation of renal oxalate calculi.
Symptomatic treatment may be required.
Ascorbic acid may cause acidosis or haemolytic anaemia in certain individuals with a
deficiency of glucose 6-phosphate dyhydrogenase. Renal failure can occur with massive
ascorbic acid overdosage.
Gastric lavage may be given if ingestion is recent otherwise general supportive measures
should be employed as required
5.1 Pharmacodynamic properties
ATC Code of Ascorbic Acid : A11G A01
Ascorbic acid, coupled with dehydroascorbic acid to which it is reversibly oxidised, has a
variety of functions in cellular oxidation processes. Ascorbic acid is required in several
important hydroxylations, including the conversion of proline to hydroxyproline (and thus in
collagen formation e.g. for intercellular substances and during wound healing); the formation
of the neurotransmitters 5-hydroxytryptamine from tryptophan and noradrenaline from
dopamine, and the biosynthesis of carnatine from lysine and methionine. Ascorbic acid
appears to have an important role in metal ion metabolism, including the gastrointestinal
absorption of iron and its transport between plasma and storage organs. There is evidence that
ascorbic acid is required for normal leucocyte functions and that it participates in the
detoxification of numerous foreign substances by the hepatic microsomal system. Deficiency
of ascorbic acid leads to scurvy, which may be manifested by weakness, fatigue, dyspnoea,
aching bones, perifollicular hyperkeratoses, petechia and ecchymosis, swelling and bleeding
of the gums, hypochromic anaemia and other haematopoietic disorders, together with reduced
residence to infections and impaired would healing.
Ascorbic acid is well absorbed from the gastro-intestinal tract, and is widely distributed to all
tissues. Body stores of ascorbic acid normally are about 1.5g. The concentration is higher in
leucocytes and platelets than in erythrocytes and plasma. Ascorbic acid additional to the
body’s needs, generally amounts above 200mg daily, is rapidly eliminated; unmetabolised
ascorbic acid and its inactive metabolic products are chiefly excreted in the urine. The amount
of ascorbic acid excreted unchanged in the urine is dose-dependent and may be accompanied
by mild diuresis.
Preclinical safety data
There is no pre-clinical data of relevance to a prescriber which is additional to that already
included in other sections of the SmPC.
List of excipients
Sodium starch glycolate
Colloidal anhydrous silica
Special precautions for storage
Do not store above 25°C. Store in the original package to protect from light and moisture
Nature and contents of container
Blister strips of 14 tablets each consisting of 250 µm white PVC, a 90 g/m
and 20 µm hard temper aluminium foil, contained in a carton. Total pack size of 28
tablets per carton.
Special precautions for disposal
Always close the cap securely after use.
MARKETING AUTHORISATION HOLDER
Athlone Pharmaceuticals Limited
MARKETING AUTHORISATION NUMBER(S)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT