Mayanmar Product

Ascozin Tablets

Ascozin Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Deficiency and increased requirement of vitamin C.
Deficiency and increased requirement of Zinc.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:
The most commonly found adverse reactions are mild transient multivitamin/mineral gastrointestinal disturbances, occurring in up to 5% of patients. Allergic reactions are very rare (<1/10,000). Urticaria, throat swelling and rash have been reported in isolated cases. Ascorbic acid may cause haemolytic anaemia in certain individuals with a deficiency in glucose-6-phosphatedehydrogenase.

What to do if you miss a dose?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

CONTRAINDICATIONS:
Known allergy or hypersensitivity to the active substances or to any of the excipients in Ascozin chewable tablets.
Hypercalcemia Hypermagnesemia Nephrolithiasis/urolithiasis Hemochromatosis.
Ascorbic acid should not be given to patients with hyperoxaluria, reduced renal function or deficiency of glucose-6-phosphate dehydrogenase.

What to do if you accidentally take too much (overdose) of the medicine?

OVERDOSE AND TREATMENT:
Cases of overdoses have not been reported. Symptoms of overdose may include gastrointestinal disturbance, such as diarrhoea and abdominal discomfort.

Is it safe in pregnancy and breast-feeding?

Tell your doctor immediately if you become pregnant while taking this medication. For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store below 30ºC. Store in cool and dry place.

Drug Description

Composition:
Each chewable tablet contains:
Ascorbic acid USP 100 mg
Sodium ascorbate USP 450 mg equivalent to Ascorbic acid 400 mg
Zinc oxide BP equivalent to Zinc 15 mg

Indications and dosage.

INDICATIONS:
Deficiency and increased requirement of vitamin C.
Deficiency and increased requirement of Zinc.
RECOMMENDED DOSE:
Adults and adolescents:
1 chewable tablet daily.
The recommended daily dose of one tablet per day must not be exceeded.
MODE OF ADMINISTRATION:
Oral
Ascozin tablets can be taken with or without food.

Side effects and drug interactions.

UNDESIRABLE EFFECTS:
The most commonly found adverse reactions are mild transient multivitamin/mineral gastrointestinal disturbances, occurring in up to 5% of patients. Allergic reactions are very rare (<1/10,000). Urticaria, throat swelling and rash have been reported in isolated cases. Ascorbic acid may cause haemolytic anaemia in certain individuals with a deficiency in glucose-6-phosphatedehydrogenase.
INTERACTIONS WITH OTHER MEDICAMENTS:
Vitamin C (ascorbic acid) may interfere with some tests for glucose in the urine. Therefore, the administration of ascorbic acid (vitamin C) should be interrupted several days before such tests are performed.

Warnings and precautions

WARNINGS AND PRECAUTIONS:
The recommended daily dose of one tablet per day must not be exceeded.
It should only be used for the treatment of vitamin C deficiency if the cause is dietary.
Patients receiving any other medication or those under medical care should consult a physician before taking this medicinal product. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Ascozin Chewable Tablets.
PREGNANCY AND LACTATION:
No indications exist that the nutrients contained in Ascozin chewable tablets have any adverse effects on pregnancy or on the health of the foetus/newborn child at the recommended dose of one tablet per day. However, Ascozin chewable tablets should be administered in pregnancy only when clinically indicated. The vitamins and minerals in Ascozin chewable tablets are excreted into breast milk, but harmful effects on the child are unlikely at therapeutic doses.

Overdosage and Contraindications

OVERDOSE AND TREATMENT:
Cases of overdoses have not been reported. Symptoms of overdose may include gastrointestinal disturbance, such as diarrhoea and abdominal discomfort.
CONTRAINDICATIONS:
Known allergy or hypersensitivity to the active substances or to any of the excipients in Ascozin chewable tablets.
Hypercalcemia Hypermagnesemia Nephrolithiasis/urolithiasis Hemochromatosis.
Ascorbic acid should not be given to patients with hyperoxaluria, reduced renal function or deficiency of glucose-6-phosphate dehydrogenase.

Clinical pharmacology.

PHARMACODYNAMIC PROPERTIES:
Pharmacotherapeutic group: Vitamin C and zinc
ATC code: A 11 E C
The vitamin content of the Ascozin chewable tablets is intended for use in deficiencies and increased requirement states. As a result, the content of the ascorbic acid and zinc in Ascozin chewable tablets was formulated above the recommended nutritional Recommended Dietary Allowances (RDAs) which are not: intended for therapeutic use.
Each tablet contains:
ascorbic acid 500 mg (RDA = 60 mg). Since the water-soluble vitamins are not stored by the body to any appreciable extent, the supply of water-soluble vitamins might be insufficient in the elderly, during pregnancy and lactation, in persons on diet, during certain chronic diseases, during extensive physical exercise and during long-lasting stress and chronic alcohol abuse. The demand of vitamin C (ascorbic acid) is higher than normal in smokers and in women using oral contraceptive.
Vitamin C (ascorbic acid) is a biological antioxidant and plays an important role in the inactivation of free radicals. It is also required for the activity of a number of enzymes involved in hydroxylation reactions and in the metabolism of e.g. cholesterol, bile acids and drugs. Vitamin C (ascorbic acid) enhances the absorption of iron in the intestine, influences folic acid metabolism and leukocyte function. It promotes the formation of connective tissue and is essential for the formulation and function of teeth, bones and capillaries.
Zinc is an important trace element in the body and is involved as a catalyst in more than 200 enzymes. It is a natural constituent of many proteins, hormones, neuropeptides and hormone receptors. Amongst others, zinc is directly involved in the synthesis of co-enzymes derived from vitamin B6 (pyridoxine).
PHARMACOKINETIC PROPERTIES:
Human health and well-being is naturally dependent on the continuous uptake and management of vitamins and trace elements, and their absorption, distribution, metabolism and elimination are maintained by specific physiological mechanisms. As the Bayer Multivitamin & Mineral Film Coated Tablets are completely dissolved in the gastrointestinal tract a good availability of these compounds is assured.
STORAGE CONDITIONS:
Store below 30ºC. Store in cool and dry place.
DOSAGE FORMS AND PACKAGING AVAILABLE:
Tablets
Aluminium strip of 10 tablets. 1, 3 or 10 strips are packed in a carton.
NAME AND ADDRESS OF MANUFACTURER:
Kusum Healthcare Pvt. Ltd.
SP 289(A), RIICO Indl. Area,
Chopanki, Bhiwadi (Rajasthan), India
DATE OF REVISION OF PACKAGE INSERT:
Not Applicable
MM Reg. No.: 1709AA 4707

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
D-158A, OKHLA,INDUSTRIAL AREA,
PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
Fax: +91-11-40527575