Ascorbic acid 100mg 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:
100mg
Pharmaceutical form:
Tablet
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 09060300

Read the complete document

piega 35 mm

piega 35 mm

280 mm

150 mm

Package leaflet: Information for the patient

ASCORBIC ACID 100mg, 200mg AND 500mg TABLETS

Ascorbic acid

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you. Always take this medicine exactly as described in this leaflet or as your

doctor or pharmacist has told you.

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

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

You must talk to a doctor if you do not feel better or if you feel worse.

WHAT IS IN THIS LEAFLET

1. What Ascorbic Acid is and what it is used for

2. What you need to know before you take Ascorbic Acid

3. How to take Ascorbic Acid

4. Possible side effects

5. How to store Ascorbic Acid

6. Contents of the pack and other information

If you stop taking Ascorbic Acid

Keep taking this medicine until your doctor or

pharmacist tells you to stop. You may need to

stop taking the tablets slowly as they may alter

your kidney function.

If you have any further questions on the use of

this medicine, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause

side effects, although not everybody gets

them.

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.

headache

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

If you get any side effects, talk to your doctor

or pharmacist. This includes any possible side

effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card

Scheme at www.mhra.gov.uk/yellowcard or

search for MHRA Yellow Card in the Google

Play or Apple App Store. By reporting side

effects you can help provide more information

about the safety of this medicine.

HOW TO STORE ASCORBIC ACID

KEEP THIS MEDICINE OUT OF THE SIGHT

AND REACH OF CHILDREN.

Do not use this medicine after the expiry date

which is stated on the carton. The expiry date

refers to the last day of that month.

Do not store above 25

C. Store in the original

package to protect from light and moisture.

Do not use this medicine if you notice

discoloured tablets or any other signs of

deterioration.

Do not throw away any medicines via

wastewater or household waste. Ask your

pharmacist how to throw away medicines you

no longer use. These measures will help to

protect the environment.

CONTENTS OF THE PACK AND

OTHER INFORMATION

What Ascorbic Acid 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, 200mg and 500mg

Tablets also contains cellulose

microcrystalline, macrogol 6000, sodium

starch glycolate, magnesium stearate, lactose

monohydrate, colloidal anhydrous silica.

What Ascorbic Acid looks like and contents

of the pack

Ascorbic Acid Tablets are white to off-white,

plain, round, biconvex tablets.

Ascorbic Acid Tablets are available in blisters

of 28 tablets.

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray,

Co. Roscommon, Ireland.

Manufacturers responsible for batch

release

Fine Foods & Pharmaceuticals, Via R.

Follereau, 25, 24027, Nembro (BG) Italy.

Fine Foods & Pharmaceuticals N.T.M. S.p.A,

Via Grignano, 43 – 24041 Brembate (BG) Italy

PL 30464/0055-57

This leaflet was revised in April 2019.

WHAT ASCORBIC ACID 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 of Vitamin C deficiency. They are

also used to treat scurvy (a serious condition

due to a long-term lack of dietary Vitamin C).

WHAT YOU NEED TO KNOW

BEFORE YOU TAKE ASCORBIC ACID

Do not take Ascorbic Acid:

if you are allergic to Ascorbic Acid or any

of the other ingredients of this medicine

(listed in section 6)

if you suffer from hyperoxaluria (excretion

of urine containing large amounts of

calcium oxalate crystals)

Warnings and precautions

Talk to your doctor or pharmacist before taking

Ascorbic Acid 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.

Other medicines and Ascorbic Acid

Tell your doctor or pharmacist if you are

taking, have recently taken or might take any

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 or breast-feeding, think

you may be pregnant or are planning to have

a baby ask your doctor or pharmacist for

advice before taking this medicine.

Driving and using machines

Ascorbic acid has no known effect on your

ability to drive or operate machinery.

Important information about some of the

ingredients in your medicine

This product contains lactose monohydrate. If

you have been told by your doctor that you

have an intolerance to some sugars, contact

your doctor before taking this medicinal

product.

HOW TO TAKE ASCORBIC ACID

Always take this medicine exactly as

described in this leaflet or as your doctor or

pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

These tablets are to be taken by mouth. The

recommended dose is:

Adults (including the elderly)

For the treatment of Vitamin C deficiency:

250mg - 1000mg daily in divided doses.

The maximum daily dose is 1000mg.

If you take more Ascorbic Acid 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 Ascorbic Acid

If you miss a dose, do not take a double dose

to make up for a forgotten dose, just resume

your schedule and go on as before. If you are

not sure what to do, ask your pharmacist.

3.

2.

1.

piega 35 mm

piega 35 mm

150 mm

280 mm

CP.ASC.JNT.T.FF.V5P1

Colours

Customer: FF

Originated by: SCY

Product: Ascorbic Acid Leaflet

Item Code:

CP.ASC.JNT.T.FF.V5P1

Proof No and Date: 1 27Apr19

Revision:

ARTWORK FOR SUBMISSION

Supersedes:

Pantone

280 C

Dimensions: 150mm x 280mm

If you stop taking Ascorbic Acid

Keep taking this medicine until your doctor or

pharmacist tells you to stop. You may need to

stop taking the tablets slowly as they may alter

your kidney function.

If you have any further questions on the use of

this medicine, ask your doctor or pharmacist.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause

side effects, although not everybody gets

them.

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.

headache

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

If you get any side effects, talk to your doctor

or pharmacist. This includes any possible side

effects not listed in this leaflet. You can also

report side effects directly via the Yellow Card

Scheme at www.mhra.gov.uk/yellowcard or

search for MHRA Yellow Card in the Google

Play or Apple App Store. By reporting side

effects you can help provide more information

about the safety of this medicine.

HOW TO STORE ASCORBIC ACID

KEEP THIS MEDICINE OUT OF THE SIGHT

AND REACH OF CHILDREN.

Do not use this medicine after the expiry date

which is stated on the carton. The expiry date

refers to the last day of that month.

Do not store above 25

C. Store in the original

package to protect from light and moisture.

Do not use this medicine if you notice

discoloured tablets or any other signs of

deterioration.

Do not throw away any medicines via

wastewater or household waste. Ask your

pharmacist how to throw away medicines you

no longer use. These measures will help to

protect the environment.

CONTENTS OF THE PACK AND

OTHER INFORMATION

What Ascorbic Acid 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, 200mg and 500mg

Tablets also contains cellulose

microcrystalline, macrogol 6000, sodium

starch glycolate, magnesium stearate, lactose

monohydrate, colloidal anhydrous silica.

What Ascorbic Acid looks like and contents

of the pack

Ascorbic Acid Tablets are white to off-white,

plain, round, biconvex tablets.

Ascorbic Acid Tablets are available in blisters

of 28 tablets.

Marketing Authorisation Holder

Athlone Pharmaceuticals Limited, Ballymurray,

Co. Roscommon, Ireland.

Manufacturers responsible for batch

release

Fine Foods & Pharmaceuticals, Via R.

Follereau, 25, 24027, Nembro (BG) Italy.

Fine Foods & Pharmaceuticals N.T.M. S.p.A,

Via Grignano, 43 – 24041 Brembate (BG) Italy

PL 30464/0055-57

This leaflet was revised in April 2019.

WHAT ASCORBIC ACID 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 of Vitamin C deficiency. They are

also used to treat scurvy (a serious condition

due to a long-term lack of dietary Vitamin C).

WHAT YOU NEED TO KNOW

BEFORE YOU TAKE ASCORBIC ACID

Do not take Ascorbic Acid:

if you are allergic to Ascorbic Acid or any

of the other ingredients of this medicine

(listed in section 6)

if you suffer from hyperoxaluria (excretion

of urine containing large amounts of

calcium oxalate crystals)

Warnings and precautions

Talk to your doctor or pharmacist before taking

Ascorbic Acid 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.

Other medicines and Ascorbic Acid

Tell your doctor or pharmacist if you are

taking, have recently taken or might take any

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 or breast-feeding, think

you may be pregnant or are planning to have

a baby ask your doctor or pharmacist for

advice before taking this medicine.

Driving and using machines

Ascorbic acid has no known effect on your

ability to drive or operate machinery.

Important information about some of the

ingredients in your medicine

This product contains lactose monohydrate. If

you have been told by your doctor that you

have an intolerance to some sugars, contact

your doctor before taking this medicinal

product.

HOW TO TAKE ASCORBIC ACID

Always take this medicine exactly as

described in this leaflet or as your doctor or

pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

These tablets are to be taken by mouth. The

recommended dose is:

Adults (including the elderly)

For the treatment of Vitamin C deficiency:

250mg - 1000mg daily in divided doses.

The maximum daily dose is 1000mg.

If you take more Ascorbic Acid 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 Ascorbic Acid

If you miss a dose, do not take a double dose

to make up for a forgotten dose, just resume

your schedule and go on as before. If you are

not sure what to do, ask your pharmacist.

6.

5.

4.

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Ascorbic Acid 100mg Tablets BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains Ascorbic Acid 100mg

For excipients, see 6.1

3

PHARMACEUTICAL FORM

Tablet

White uncoated bi-convex tablets with tablet markings “100”

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

For the treatment of scurvy.

Prophylactically in cases where deficiency might be expected to occur.

4.2.

Posology and Method of Administration

For oral administration.

Adults, the elderly and children:

For the treatment of scurvy: One tablet three times a day.

For prophylactic use: One tablet a day.

4.3

Contraindications

Hypersensitivity to ascorbic acid or any of the other ingredients.

Ascorbic acid supplements should not be given to patients with hyperoxaluria.

4.4

Special warnings and precautions for use

Vitamin C 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 by uricase with copper

reduction and measurement of creatinine in non-deproteinised serum may also

be affected. High doses of vitamin C may give false negative readings in

faecal occult blood tests.

Patients with rare hereditary problems of fructose or galactose intolerance, the LAPP

lactase

deficiency,

glucose-galactose

malabsorption

sucrase-isomaltase

insufficiency should not take this medicine as it contains lactose and sucrose.

4.5.

Interactions with other Medicaments and other forms of Interaction

Large doses of ascorbic acid may cause acidification of the urine which could

alter the rate of renal excretion of some drugs. Ascorbic acid may increase the

oral absorption of iron. It may also increase iron excretion when used in

conjunction with desferrioxamine in the treatment of iron overload.

4.6

Fertility, pregnancy and lactation

There is inadequate evidence of the safety of ascorbic acid in human pregnancy but it

has been in wide use for many years without apparent ill consequences, animal

studies having shown no hazard. Ascorbic acid crosses the placenta. The established

medical principal of only administering drugs in early pregnancy when considered

absolutely necessary should be observed. Ascorbic acid is excreted in breast milk but

there is no evidence of any hazard.

4.7.

Effects on Ability to Drive and Use Machines

None.

4.8

Undesirable effects

Large doses of ascorbic acid may cause diarrhoea. Patients known to be at risk

of hyperoxaluria should not ingest ascorbic acid in doses exceeding 1 gram

daily, as there may be increased urinary oxalate excretion. However such a

risk has not been demonstrated in normal, non-hyperoxaluric individuals.

Ascorbic acid has been implicated in precipitating haemolytic anaemia in

certain individuals with a deficiency of glucose-6-phosphate dehydrogenase.

Increased intake of ascorbic acid over a prolonged period may result in an

increase in renal clearance of ascorbic acid, and deficiency may result if the

intake is reduced or withdrawn rapidly. Doses of more than 600mg 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

At doses of over 3 grams per day unabsorbed ascorbic acid is chiefly 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 oxylate calculi. Symptomatic treatment may be required.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

A11G A01 – Ascorbic Acid (Vit C), Plain

Ascorbic acid is essential for the synthesis of collagen and intercellular

material involved in conversion of folic acid to folinic acid.

Ascorbic acid coupled with dehydroascorbic acid to which it is reversibly

oxidised, has a variety of functions in cellular oxidation processes. Vitamin C

is required in several important hydroxylations, including the conversion of

proline to hydroxyproline (and thus in collagen formation e.g. for intercellular

substances during wound healing); the formation of the neurotransmitters 5-

hydroxytryptamine from tryptophan and noradrenaline from dopamine; and

the biosynthesis of carnitine from lysine and methionine. Vitamin C 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 also evidence that vitamin C is required for normal leukocyte function and

that it participates in the detoxification of numerous foreign substances by the

hepatic microsomal system.

Deficiency in vitamin C leads to scurvy, which may be manifested by

weakness, fatigue, dyspnoea, aching bones, perifollicular hyperkeratoses,

petechiae and ecchymoses, swelling and bleeding of gums, hypochromic

anaemia and other haemopoietic disorders, together with reduced resistance to

infection (and impaired wound 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 1.5

grams. The concentration is higher in leukocytes and platelets than in

erythrocytes and plasma. Ascorbic acid additional to the body’s needs

(generally amounts above 200mg daily) is rapidly eliminated; unmetabolised

vitamin C 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

No data of relevance which is additional to that already included in other

sections of the SPC.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Lactose

Potato Starch

Syrup

Talc

Microcrystalline Cellulose

Stearic Acid

Magnesium Stearate

6.2.

Incompatibilities

Not applicable.

6.3.

Shelf Life

3 years.

6.4.

Special Precautions for Storage

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

original container.

6.5.

Nature and Contents of Container

High density polypropylene containers with low density polyethylene caps of

28 100, 500 & 1000 tablets.

Not all pack sizes may be marketed.

6.6.

Instruction for Use/Handling

Not applicable.

7.

MARKETING AUTHORISATION HOLDER

Dalkeith Laboratories Ltd

2 Park Street

Woburn

Bedfordshire

MK17 9PG

8.

MARKETING AUTHORISATION NUMBER(S)

PL 17496/0013

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

23 October 2000

10

DATE OF REVISION OF THE TEXT

07/07/2015

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