Bocalex C1000

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Description

COMPOSITION:

Vitamin C ......................................... 1000 mg

Excipients q.s ................. 1 effervescent tablet

(Anhydrous citric acid, sodium saccharin, aspartame, sodium bicarbonate, effersoda, PEG 6000, sodium benzoate, orange-flavored powder, sunset yellow).

DOSAGE FORM: Effervescent tablets.

PRESENTATION: Box of 1 tube x 10 effervescent tablets

PHARMACODYNAMICS: Vitamin C is essential for the synthesis of collagen, tissue repairment in the body and participates in some redox reactions. Vitamin C takes part in the metabolism of phenylalamine, tyrosine, folic acid, norepinephrine, histamine, iron, and some medicine-metabolised systems, in the utilization of carbohydrate, in the synthesis of lipid and protein, in the immune function, in the resistance to infections, in the maintenance of blood vessel entireness and in the cellular respiration.

Vitamin C deficiency leads to the development of a well-defined syndrome known scurvy. This is characterized by no healing of wounds, trouble of tooth structure, capillary fragility, subcutaneous and mucosal bleeding (usually gums bleeding). Use of vitamin C completely loses symptoms of vitamin C deficiency.

PHARMACOKINETICS: Vitamin C is readily absorbed after oral administration; however, it may be limited by large doses. Gastrointestinal absorption of vitamin C may be reduced in patients with gastrointestinal diseases. Body store of vitamin C is about 1.5 g; about 30 - 45 mg is rotated daily. Clinical signs of scurvy become clear when suffering from vitamin C deficiency after 3 to 5 months. Vitamin C is widely distributed in the body tissues; about 25% is bound plasma protein. Vitamin C is eliminated in the kidney as inactive metabolism. Excessive vitamin C amount in the body is rapidly eliminated unchanged in the urine.

INDICATIONS:

Treatment of diseases caused by Vitamin C deficiency, including no healing of wound, trouble of tooth structure, capillary fragility, subcutaneous and mucosal bleeding (usually gums bleeding).

CONTRAINDICATIONS: Patients with renal calculus should not take over 1 g vitamin C daily. Do not administer high doses of vitamin C to patients with G6PD deficiency, hyperoxaluria, oxalosis, thalassemia (increased risk of iron absorption)

PRECAUTIONS: The use of high doses of vitamin C in the evening may cause sleeplessness in some patients.

Patients on low sodium or sodium-free diets are warned.

PREGNANCY AND LACTATION: Use of large doses of vitamin C during pregnant period has been reported to increase the demand of vitamin C, leading to scorbutus in the neonate.

Vitamin C is excreted into breast milk. No symptoms happen in the neonate if lactating women take vitamin C with the normal demand. Vitamin C should be used with caution in breast-feeding mothers.

VEHICLE DRIVERS AND MACHINERY OPERATORS: The drug does not affect the possibility of driving vehicles and operating machinery.

INTERACTIONS: Vitamin C acidifies urine; this alters the excretion of other drugs. Vitamin C is a potent reducer affecting the test results basing on redox reaction.

ADVERSE EFFECTS: Large doses are reported to cause diarrhoea, other gastrointestinal disturbances, and hemolytic symptoms in patients with G6PD deficiency. Continuous use of high doses of vitamin C (1g/day) may lead to oxalate renal calculus.

Inform the physician about any adverse effects occur during the treatment.

OVERDOSAGE: Symptoms of overdose include renal calculus, nausea, vomiting, gastritis, diarrhoea. Diuresis by fluid transfusion can be usefull after taking the large dose.

DOSAGE & ADMINISTRATION: Dissolve Bocalex C 1000 effervescent tablet in a glass of 150 to 200-ml water.

The drug is given 1 tablet daily for at least 1 week.

It should be taken in the daytime. Sleeping trouble has been reported by high doses of vitamin C given at night.

Or as directed by the physician.

        Keep out of the reach of children.               

Read the directions carefully before use.             Shelf-life: 24 months from the manufacturing date.

Consult the physician for more information.         Storage conditions: Store in dry places, not exceeding 30oC, protect from light.

This drug is for prescription only.              Specifications: Manufacturer's.

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