Berocca^® Calcium and Magnesium (Tablets) Instructions for Use

Marketing Authorization Holder

Bayer Consumer Care, AG (Switzerland)

Manufactured By

Bayer Sante Familiale LLC (France)

ATC Code

A11AA03 (Multivitamins and other minerals, including their combinations)

Dosage Form

Berocca® Calcium and Magnesium

Effervescent tablets: 10 or 15 pcs.

Dosage Form, Packaging, and Composition

Auxiliary substances : anhydrous citric acid, sodium bicarbonate, sodium chloride, aspartame, beet red, betacarotene 1% CWS, orange flavor, sodium lauryl sulfate, mannitol.

10 pcs. – aluminum cylinders (1) – cardboard boxes.
15 pcs. – aluminum cylinders (1) – cardboard boxes.

Clinical-Pharmacological Group

Multivitamins with macroelements

Pharmacotherapeutic Group

Multivitamin agent + multimineral

Indications

• For the treatment and prevention of vitamin and mineral deficiencies in conditions accompanied by an increased need for these micronutrients, such as during periods of convalescence after serious illnesses, surgeries, or infectious diseases.
• As an adjunctive therapy in patients with inadequate or unbalanced nutrition, including during periods of intense physical or mental stress, to support metabolic functions.
• To support the body’s needs during periods of increased physiological demand, though the specific clinical context should be evaluated by a healthcare professional.

Contraindications

• Hypersensitivity to any of the active substances or to any of the excipients listed in the composition. A history of severe allergic reactions to any vitamin or mineral supplement warrants avoidance.
• Severe renal impairment or end-stage renal disease, due to the risk of hypercalcemia, hypermagnesemia, and impaired excretion of the components, which could lead to toxic accumulations.
• Hypercalcemia (elevated blood calcium levels), hypercalciuria (excessive calcium in urine), or conditions predisposing to these states, such as certain malignancies or hyperparathyroidism.
• Patients with phenylketonuria, as the product contains aspartame, a source of phenylalanine.

Dosage Regimen

The dosage must be determined by a physician based on the individual’s clinical needs and nutritional status. The following represents common adult dosing guidance.

One effervescent tablet daily is the typical recommended dose. The tablet must be completely dissolved in a glass (approximately 200 ml) of water before consumption. The prepared solution should be taken immediately after dissolution.

The duration of treatment is determined by the prescribing physician. It is not intended for indefinite use without periodic medical evaluation. Do not exceed the recommended daily dose, as excessive intake of certain vitamins and minerals can be harmful.

Adverse Reactions

Adverse reactions are generally rare and mild, particularly when taken at the recommended dosage. However, like all medicines, this product can cause side effects, although not everybody gets them.

Gastrointestinal disturbances such as nausea, abdominal discomfort, or diarrhea may occur, especially at the beginning of therapy. These symptoms are often transient.

Allergic reactions, including skin rash, itching, urticaria, and in very rare cases, anaphylaxis, have been reported with components of multivitamin preparations. Discontinue use immediately if any signs of hypersensitivity appear.

Very high doses of ascorbic acid (Vitamin C) may lead to acidification of urine and, in predisposed individuals, contribute to the formation of oxalate urinary calculi (kidney stones).

Drug Interactions

Concurrent use with other medicinal products should be discussed with a doctor or pharmacist to avoid potential interactions.

The calcium component can decrease the absorption of tetracycline and fluoroquinolone antibiotics (e.g., ciprofloxacin, levofloxacin), as well as bisphosphonates (e.g., alendronate) and levothyroxine. A minimum time interval of 2-3 hours between ingestion of Berocca and these medications is recommended.

High doses of ascorbic acid may interfere with urine glucose tests and, in very high doses, can potentially reduce the anticoagulant effect of warfarin. It may also increase the absorption of iron supplements.

Pyridoxine (Vitamin B6) at high doses may reduce the efficacy of levodopa in the treatment of Parkinson’s disease, though this is less of a concern when levodopa is administered with a decarboxylase inhibitor.

Overdose

Acute overdose with a single tablet is unlikely to cause serious harm due to the water-soluble nature of most vitamins. However, chronic excessive intake can lead to toxic levels of certain components.

Symptoms of acute overdose may include pronounced gastrointestinal upset (nausea, vomiting, diarrhea). Symptoms of chronic overdose from high doses of specific components can include hypercalcemia (from calcium), neurological symptoms such as sensory neuropathy (from pyridoxine), or oxalate nephrolithiasis (from ascorbic acid).

In case of suspected overdose, discontinue the product and seek immediate medical attention. Treatment is symptomatic and supportive. There is no specific antidote. Inform the treating physician of the product ingested.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.