Ascorbic acid, zinc, cholecalciferol (vitamin D3).
Each effervescent tablet contains: Ascorbic Acid 1 g, Zinc 10 mg, Cholecalciferol (Vitamin D3) 400 IU.
The product is a round flat tablet with bevelled edges, speckled orange colour and odour of orange.
The treatment of Vitamin C, Vitamin D and Zinc deficiency.
This product is indicated for the prevention and treatment of Vitamin C, Vitamin D and Zinc deficiencies during situations and conditions with increased requirements or increased risk of deficiencies.
Further, Vitamin C, Vitamin D and Zinc are independently essential for the defense potential and disease resistance mechanisms of the body.
For adults and children above 12 years of age, dissolve 1 tablet per day in a glass of water.
Do not exceed the recommended daily intake.
What to do if patient misses a dose: No available information.
Signs and Symptoms of Overdose: There is no evidence that this product can lead to an overdose when used as labeled.
Allowance should be made for intake of the Vitamins and Zinc from other sources.
General manifestations of overdose may include increase of gastrointestinal disturbances including diarrhea, nausea, and vomiting.
If such symptoms occur, the product should be stopped and a healthcare professional must be consulted.
Acute or chronic overdose of the product may cause specific toxicity associated with either Vitamin C, Vitamin D, and/or Zinc.
Clinical signs and symptoms, laboratory findings, and consequences of overdose are highly diverse, dependent on an individual's susceptibility, and surrounding circumstances. Specific clinical manifestation (i.e. with intake up to 10 times the labelled dose) may include the following: Ascorbic Acid (Vitamin C): Acute or chronic overdose of Vitamin C (>2 g/day in adults) may significantly elevate serum and urinary oxalate levels. In some instances, this results in hyperoxaluria, calcium oxalate crystalluria, calcium oxalate deposition, kidney stone formation, tubulointerstitial nephropathy, and acute renal failure. Overdose of Vitamin C in individuals with glucose-6-phosphate dehydrogenase deficiency (>3 g/day in children and >15 g/day in adults) may result in oxidative hemolysis or disseminated intravascular coagulation.
Cholecalciferol (Vitamin D3): Chronic ingestion of Vitamin D in excess of 400 IU/day (100 mcg/day) increases risk of hypervitaminosis D. Many of the effects of chronic Vitamin D toxicity are due to induced hypercalcemia and hypercalciuria. Symptoms may include anorexia, nausea, vomiting, weight loss, polyuria, heart arrhythmia, fatigue and soft tissue calcification.
Material hypercalcemia, possibly caused excessive Vitamin D intake during pregnancy, has been associated with hypercalcemia in neonates, which may lead to supravalvular aortic stenosis syndrome, the failures of which may include retinopathy, mental or growth retardation, strabismus and other effects.
Zinc: Zinc overdose (>40 mg/day in adults) can cause diarrhea, irritation, and corrosion of the gastrointestinal (GI) tract, acute tubular necrosis, interstitial nephritis, copper deficiency, sideroblastic anemia and myeloneuropathies.
If overdose with the product is suspected, intake should be stopped and a healthcare professional consulted for treatment of clinical manifestations.
What to do when the patient has taken more than the recommended dosage: There is no specific antidote however patients should still consult their physician.
The product is not suitable for individuals with following conditions: Hemochromatosis (iron overload in body); Hypercalcemia (elevated calcium level in the blood); Kidney disease/disorders (Severe renal insufficiency (GFR <30 mL/min), including individuals on dialysis, Nephrolithiasis or history of nephrolithiasis, Hyperoxaluria); Hypervitaminosis D (abnormally high level of Vitamin D); Hypersensitivity to any of the active substances or to any of the excipients.
Do not exceed the labelled dose. Acute and chronic overdose increases risk of adverse effects.
Use caution with concomitant intake of food supplements or medication containing Vitamin C, Vitamin D, Vitamin D analogues, and/or Zinc. Separate intake of the product from other medication by 4 hours unless otherwise specified. Vitamin C may interfere with laboratory tests resulting in false reading. Inform the physician or health care professional when taking the product and laboratory tests are planned. Vitamin C may interfere with testing kits and meters that measure glucose levels resulting in false readings. This should be taken into consideration by individuals on a controlled sodium diet.
When to consult a doctor: If symptoms of overdosage occur, the product should be stopped and a health care professional consulted.
Pregnancy: The product is generally considered safe during pregnancy. However, given the amount of Vitamin C, a healthcare professional should be consulted before the use of the product. The labeled dose should not be exceeded since chronic overdose might be harmful to the fetus. Allowance should be made for intake of the Vitamins and Zinc from other sources.
Lactation: The product is generally considered safe during lactation. However, given the amount of Vitamin C, a healthcare professional should be consulted before use of the product. The Vitamins and Zinc in the product are excreted into breast milk. This should be taken into consideration.
Fertility: There is no evidence suggestive that normal endogenous levels of the Vitamins and Zinc cause any adverse reproductive effects in humans.
The frequency of listed events is not known based on available data.
Gastrointestinal Disorders: Diarrhea, nausea, vomiting, gastrointestinal and abdominal pains.
Immune System Disorders: Allergic reaction and anaphylactic reaction.
Hypersensitivity reactions with respective laboratory and clinical manifestations include allergic asthma syndrome, mild to moderate reactions potentially affecting skin, respiratory tract, gastrointestinal tract, and cardiovascular system including symptoms such as rash, urticaria, allergic edema and angioedema, pruritus, and cardio-respiratory distress.
If an allergic reaction is suspected, use of the product must be stopped and a healthcare professional must be consulted.
See table.
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Store at temperatures not exceeding 30°C.
A11GB - Ascorbic acid (vitamin C), combinations ; Used as dietary supplements.
Berocca Immuno effervescent tab
15's;30's