Ascorbic acid 500mg tablets

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:
Ascorbic acid
Available from:
Alissa Healthcare Research Ltd
ATC code:
A11GA01
INN (International Name):
Ascorbic acid
Dosage:
500mg
Pharmaceutical form:
Tablet
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 09060300

Read the complete document

Patient Information Lea

A

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b

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A

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50

0

m

g

T

ab

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e

t

s

This medicine will be called Ascorbic Acid

in this

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.

In

this

l

e

a

fl

e

t

:

1. What Ascorbic Acid Tablets are and what they a

used

2. Before you take Ascorbic Acid

3. How to take Ascorbic Acid

4. Possible side e

5. How to store Ascorbic Acid

6. Further

1. What Ascorbic Acid

Tablets

are

a

nd

what they are used

f

o

r

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

scurvy.

2. Before you take Ascorbic Acid

Ta

b

le

t

s

Some

people

must not

take these

t

a

b

l

e

t

s.

Do

not take these tablets

if

:

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

oxalic acid

You

must

be

especially careful

if

:

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

this

Taking other

m

e

dicines

Ascorbic Acid Tablets can affect some

medicines you may be taking. Make sure your

or pharmacist

knows if you are taking an iron

preparation,

Always tell your doctor or pharmacist about all

medicines you are taking. This means medicines

have bought yourself as well as those you have

prescription

from your

Driving

and

using m

achinery

Ascorbic Acid Tablets should not affect your ability

drive or operate

Other special

w

arnings

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

Ta

b

le

t

s

The tablets can be sucked, chewed or

llow

with a drink of

If this medicine has been given to you by your

he/she

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

usual

doses

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

doses.

If you have bought the tablets yourself, take the

described a

If

you

take more tablets than

you

sh

o

u

l

d

If you have taken a lot more tablets than you

speak to your doctor or pharmacist

Take your tablets or the pack with

If

you

forget to take

a dose

of Ascorbic

A

c

i

d

Ta

b

l

e

t

s

If you miss a dose don’t worry. Miss this dose

carry on with the normal

4. Possible side

e

ff

e

c

t

s

Like all medicines ascorbic acid can ca

e side

effects, although not everybody gets them. The

following have been

d if you have taken too

high a dose

Passing water

Patients with

glucose-6-phosphate

deficiency taking this medicine may develop a type

anaemia

include headache,

shortness of breath,

Continued, please turn

Reporting

of side

e

ff

e

c

t

s

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

a the

Yellow Card Scheme

llow

reporting side

effects you can help provide

e information on the

safety of this

5. How to store Ascorbic Acid

Ta

b

le

t

s

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

y left

over

back

to your pharmacist to be d

6.

Further

I

n

f

o

r

ma

t

i

o

n

In

gredien

t

s

Each tablet contains 500 mg of the active

ascorbic acid. The other ingredients are

microcrystalline cellulose, stearic acid, lactose,

talc,

syru

and pregelatinized maize

W

h

a

t

the medicine looks like

The tablets are round and white and marked

“500”

one side. They are supplied to your pharmacist

packs of 28, 50, 100 or 500 tablets. Not all

sizes

may be a

Product licence holder

and

m

a

nu

f

acturer

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

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Ascorbic Acid 500mg Tablets

2

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.

3

PHARMACEUTICAL FORM

White to off-white uncoated tablets.

Ascorbic Acid 500mg Tablets are 12.5 mm, white to off-white, plain round, biconvex tablets.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Vitamin C deficiency

Treatment of scurvy

4.2

Posology and method of administration

Posology

Adults:

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.

4.3

Contraindications

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.

4.4

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

methods.

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.

4.5

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.

4.6

Fertility, pregnancy and lactation

Pregnancy

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.

Breast-feeding

Ascorbic acid is excreted in breast milk. Though again caution should be exercised, no

evidence exists suggesting such excretion is hazardous to the infant.

4.7

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.

4.8

Undesirable effects

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.

4.9

Overdose

Symptoms

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.

Management

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.

5.2

Pharmacokinetic properties

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.

5.3

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.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Microcrystalline cellulose

Macrogol 6000

Sodium starch glycolate

Magnesium sterate

Lactose monohydrate

Colloidal anhydrous silica

6.2

Incompatibilities

None known

6.3

Shelf life

36 months

6.4

Special precautions for storage

Do not store above 25°C. Store in the original package to protect from light and moisture

6.5

Nature and contents of container

Blister strips of 14 tablets each consisting of 250 µm white PVC, a 90 g/m

PVDC layer

and 20 µm hard temper aluminium foil, contained in a carton. Total pack size of 28

tablets per carton.

6.6

Special precautions for disposal

Always close the cap securely after use.

7

MARKETING AUTHORISATION HOLDER

Athlone Pharmaceuticals Limited

Ballymurray

Co. Roscommon

Ireland

8

MARKETING AUTHORISATION NUMBER(S)

PL 30464/0057

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

21/07/2000

16/11/2005

10

DATE OF REVISION OF THE TEXT

16/08/2018

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