Ascorbic Acid Tablets USP 100mg Taj Pharma

1.NAME OF THE MEDICINAL PRODUCT
Ascorbic Acid Tablets USP 100mg Taj Pharma.
Ascorbic Acid Tablets USP 500mg Taj Pharma.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
a) Each tablet contains:
Ascorbic acid USP 100mg
Excipients q.s.

b) Each tablet contains:
Ascorbic acid USP 500mg
Excipients q.s.
For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM
Tablet
White to off-white convex tablets.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Prevention and treatment of scurvy.

4.2 Posology and method of administration
Posology
Adults and children over 6 years:
Prophylactic: 25 – 75 mg daily.
Note: This unit dosage form is unsuitable for prophylactic use.

Therapeutic: Not less than 250mg daily in divided doses. Maximum of 1000mg daily.

Children under 6 years:

This unit dosage form is unsuitable for children under 6 years.

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
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Ascorbic acid should not be given to patients with hyperoxaluria.

4.4 Special Warnings and precautions for use
Increased intake of ascorbic acid over a prolonged period may result in an increased renal clearance of ascorbic acid, and deficiency may result if the intake is reduced or withdrawn rapidly (see section 4.8).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, Tes-Tape) and false-positive results with neocuproine 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.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction 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 disorders: 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 1g 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.

4.9 Overdose
Symptoms
At doses of over 3g 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 dehydrogenase. Renal failure can occur with massive ascorbic acid overdosage.

Management
Gastric lavage may be given if ingestion is recent otherwise general supportive measure should be employed as required.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Vitamins – Ascorbic acid (vitamin C), plain

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 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 carnitine 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 hyperkeratosis, petechia and ecchymosis, swelling and bleeding of the gums, hypochromic anaemia and other haematopoietic disorders, together with reduced resistance to infections and impaired wound healing.

5.2 Pharmacokinetic properties
Absorption
Ascorbic acid is well absorbed from the gastrointestinal tract.

Distribution
Ascorbic acid 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.

Elimination
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 are no other preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Microcrystalline cellulose
Magnesium stearate
Lactose monohydrate
Polyethylenglycol
Sodium starch glycollate
Silica colloidal anhydrous

6.2 Incompatibilities
None.

6.3 Shelf life
Plastic containers: 3 years
Blister packs: 2 years.

6.4 Special precautions for storage
Plastic containers: Keep the container tightly closed to protect from light and moisture.
Blister packs: Keep the blister in the outer carton to protect from light and moisture.

6.5 Nature and contents of container
Opaque plastic containers (securitainers) fitted with plastic caps with a packaging inclusion of a silica gel desiccant pack.
Pack sizes are 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 tablets.
Opaque plastic containers composed of either high density polypropylene or high density polyethylene with a tamper-evident or child-resistant tamper-evident closure composed of high density polyethylene with a packing inclusion of standard polyether foam or polyethylene or polypropylene-made filler and a silica desiccant pack.
Pack sizes are 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 tablets.
Blister packs of aluminium/opaque PVC/PVDC packed in printed boxboard
Pack sizes are 28, 30, 56, 60, 84, 90 and 112 tablets.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
No special requirements.

Manufactured In India By:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

Ascorbic Acid Tablets USP 100mg Taj Pharma.

Package leaflet: Information for the patient

A) Ascorbic Acid Tablets USP 100mg Taj Pharma.
B) Ascorbic Acid Tablets USP 500mg Taj Pharma.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet

1.What Ascorbic Acid Tablets is and what it is used for
2. Before you are given Ascorbic Acid Tablets
3. How you will be given Ascorbic Acid Tablets
4. Possible side effects
5. How Ascorbic Acid Tablets is stored
6. Further Information

1. What Ascorbic Acid Tablets is and what it is used for
Ascorbic Acid Tablets contain ascorbic acid. Ascorbic acid is a form of vitamin C. It is used as a supplement for the prevention and treatment of scurvy.

2. Before you are given Ascorbic Acid Tablets
Do not take Ascorbic Acid Tablets if:
• You are allergic to Ascorbic Acid or any of the other ingredients of this medicine (listed in section 6).
• You suffer from hype roxaluria (excretion of urine containing large amounts of calcium oxalate crystals).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ascorbic Acid Tablets:
• If you are to undergo any blood or urine tests as ascorbic acid can interfere with some blood and urine tests.
• If you are a regular smoker.
• If you have kidney failure as ascorbic acid enhances aluminium absorption (present in antacids) which may reach toxic levels.

Other medicines and Ascorbic Acid Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This is particularly important 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 fo r the first month after starting desferrioxamine treatment.

If you need to have a blood or urine test you should tell the doctor or nurse you are taking these tablets as they may interfere with the results.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking this medicine.

If you want to breast-feed your baby you should talk to your doctor first before taking these tablets.

Driving and using machines
This medicine should not affect your ability to drive or operate machinery. However, if you think you are affected you should not drive or operate machinery until you feel better.

Ascorbic Acid Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How you will be given Ascorbic Acid Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Chew the tablets carefully before swallowing.

Adults, the elderly and children over 6 years of age
For the prevention of scurvy: 25-75 mg daily.

For the treatment of scurvy: Not less than 250 mg daily in divided doses. Maximum of 1000 mg daily.

Children under 6 years of age
Ascorbic Acid Tablets are not suitable for use in children under 6 years of age.

If you take more Ascorbic Acid Tablets than you should
If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Take this leaflet and any remaining tablets with you so the doctor knows what has been taken.

If you forget to take Ascorbic Acid Tablets
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.

If you stop taking Ascorbic Acid Tablets
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.

4. 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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How Ascorbic Acid Tablets is stored
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 or label. The expiry date refers to the last day of that month.
Blister packs: Store in the original carton in order to protect from light and moisture. Securitainers: Keep the bottle tightly closed in order to protect from light and moisture.
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 protect the environment.

6. Further information

What Ascorbic Acid Tablets contains
The active substance is ascorbic acid.

a) Each tablet contains:
Ascorbic acid USP 100mg
Excipients q.s.

b) Each tablet contains:
Ascorbic acid USP 500mg
Excipients q.s.

The other ingredients are microcrystalline cellulose, magnesum stearate, lactose monohydrate (see section 2), polyethylene glycol, sodium starch glycolate and silica colloidal anhydrous.

What Ascorbic Acid Tablets looks like and contents of the pack
Ascorbic Acid tablets are white to off-white convex tablets.
Ascorbic Acid Tablets are available in securitainer packs containing 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 or 1000 tablets or cartons containing 28, 30, 56, 60, 84, 90 or 112 tablets.
Not all packs are marketed.