MULTIVITAMINS + MINERALS (BEROCCA ENERGY) ORANGE, MANGO, MIXED BERRIES

Care that should be taken when taking this Medicine?

Do not exceed labelled dose. Acute and chronic overdose increases risk of adverse effects. Allowance should be made for intake of the vitamins and minerals from all other sources including fortified foods, dietary supplements, and concomitant medications.

Individuals receiving other single vitamins or multivitamin preparations, any other medication, placed on a restricted diet, or those on medical care should first consult a health care professional before use of the product.

Intake of the product should be separated from other medications by 4 hours unless otherwise specified.

The product may interfere with laboratory tests resulting in false reading. Inform your physician or health care professional when taking this product and laboratory tests are planned.

Vitamin C may interfere with testing kits and meters that measure glucose levels resulting in false readings.

Refer to the package insert of the testing kit or the meter for guidance.

Vitamin C increases iron absorption. Individuals with hemochromatosis should use precaution with use of the product and avoid intake of Vitamin C >500mg/day.

Overdose of Vitamin C in individuals with glucose-6-phosphate dehydrogenase deficiency (>3g in children and > 15g in adults) has been associated with hemolytic anemia.

The product is not formulated for treatment of Vitamin B12 deficiency due to atrophic gastritis, disorder of the ileum or pancreas and gastrointestinal malabsorption of Vitamin B12 or intrinsic factor deficiency.

For effervescent formulations: For effervescent tablet dosage form contains sodium. This should be taken into consideration by individuals on a controlled sodium diet.

PREGNANCY & LACTATION

The product is generally considered safe during pregnancy or lactation within labelled dose but should only be used when recommended by the physician.

The labelled dose should not be exceeded as it may be harmful to the fetus or neonate. The vitamins and minerals in the product are excreted into breast milk.

What other medicine or food should be avoided while taking this Medicine?

Drug-Interactions per Active Ingredient in the Product:

Food Interactions

Vitamin C

Iron: Vitamin C may enhance iron absorption, especially in individuals with iron deficiency. Small incremental increases of iron could be important in subjects with conditions such as hereditary hemochromatosis or in subjects heterozygous to this condition, as it may exacerbate iron overload.

Calcium, Magnesium, and Zinc

Since oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit Calcium, Magnesium, and Zinc absorption, it is not recommended to take this product within two hours of eating foods containing high oxalic acid and phytic acid concentrations.

Lab Interactions

Vitamin C

Because Vitamin C is a strong reducing agent (i.e. electron donor), it can cause chemical interference in laboratory tests that involve oxidation-reduction reactions, such as the analyses of glucose, creatinine, carbamazepine, uric acid, and inorganic phosphates in urine, serum and of occult blood in feces. Using specific tests that are not dependent on reducing properties or discontinuing extra dietary Vitamin C will avoid any undesirable interference. Refer to the manufacturer’s information to determine if Vitamin C interferes with the test.

Vitamin C may interfere with tests that measure urinary and blood glucose resulting in false readings, although it has no effect on blood glucose levels. Refer to the package insert of the meter or testing kit to determine if vitamin C (ascorbic acid) interferes and guidance for accuracy in readings.

Vitamin B1 and Vitamin B6

Urobilinogen: Thiamine and/or pyridoxine can cause a false positive result in the spot test with Ehrlich’s reagent.

What should you do if you miss 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 minerals from all other sources. General manifestation of overdose may include confusion and gastrointestinal disturbances such as constipation, diarrhea, nausea, and vomiting.

If such symptoms occur, the product should be stopped and a health care professional consulted. 

Acute or chronic overdose of the product (i.e. with intake up to 10 times the labelled dose) may cause specific toxicity associated with Vitamin C, Vitamin B6, or Zinc. 

Specific clinical signs and symptoms, laboratory findings, and consequences of overdose are highly diverse, dependent on an individual’s susceptibility, and surrounding circumstances. 

Specific clinical manifestations (i.e. with intake of the product up to 10 times the daily dose) may include the following: 

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 result in hyperoxaluria, calcium oxalate crystalluria, calcium oxalate deposition, kidney stone formation, tubulointerstitial nephropathy, and acute renal failure.

Chronic consumption of high doses of ascorbic acid (> 500 mg /day in adults) may exacerbate iron overload and result in tissue damage in patients with hemochromatosis.

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.

Vitamin B6:

Intake above UL (> 60 mg in adolescents 12 of age and 100 mg/day in adults) increases risk of sensory axonal neuropathy.

Central effects have also been described. Neuropathy has been most commonly reported after chronic ingestion of 200 to 6000 mg/day for months or years. The neuropathy gradually improved in all cases, following removal of pyridoxine. Irreversible destruction of sensory ganglion cells (neuronopathy) may also occur after a single extremely large parenteral dose, but the exact toxic amount is not well documented in humans.

Zinc: 

Zinc overdose (> 40 mg / day in adults) can cause diarrhea, irritation, and corrosion of the gastrointestinal (GI) tract, acute renal tubular necrosis, interstitial nephritis, copper deficiency, sideroblastic anemia and myeloneuropathies. 

Calcium, Magnesium, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B5, Vitamin B7, Vitamin B9, Vitamin B12: 

No discernible effects other than increase in general gastro-intestinal distress are expected with intake of product of up to 10 times the daily dose due to Calcium, Magnesium, and Vitamins B1, B2, B3, B5, B7, B9, and B12.

If overdose is suspected, the product should be stopped and a health care professional consulted for treatment of clinical manifestations.

What to do when you have taken more than the recommended dosage?

There is no specific antidote however patients should still consult their physician.

How should you keep this Medicine?

STORAGE CONDITION:

Store at temperatures not exceeding 30ºC.

Tube: Keep the container tightly closed.

Sachet: Keep in the original package.

Keep out of reach of children.

When should you consult your doctor?

If symptoms of overdosage occur, the product should be stopped and a health care professional consulted.

Name and Address of Marketing Authorization Holder

Bayer Philippines, Inc.

8th Floor Science Hub Tower 1, Campus Avenue Corner Turin St., McKinley Hill Cyberpark, Pinagsama, Taguig City.

Name and Address of Manufacturer

PT. Bayer Indonesia

Jalan Raya Jakarta Bogor KM 32, Cisalak, Kec. Sukmajaya, Kota Depok, Jawa Barat, Indonesia

ADR Reporting Statement

If you want to report a product complaint or side effect, please contact your health care professional or the Philippine FDA at adr@fda.gov.ph

Inquiries can also be directed to:

Bayer Philippines, Inc. Taguig City, Philippines

E-mail: MedInfoCH-PH@bayer.com

drugsafety.philippines@bayer.com

Date of Revision of Patient Information Leaflet

Date of Revision: March 2023 (Based on CCDS version 4 dated 10-July-2015)