×
Components:
Calcium Carbonate
Method of action:
Antacid, Antiulcer, Compensating Calcium Deficiency, Mineral, Mineral Supplements
Available in countries
See all
close
Medically reviewed by Militian Inessa Mesropovna, PharmD. Last updated on 2019.10.20

Name of the medicinal product

Acical

Qualitative and quantitative composition

Calcium Carbonate

Therapeutic indications

The information provided in Therapeutic indications of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

Acical 500mg Chewable Tablets are to be chewed as a supplemental source of calcium in the correction of dietary deficiencies or when normal requirements are high.

Acical 500mg Chewable Tablets may be used as an adjunct to conventional therapy in the prevention and treatment of osteoporosis. They may be used as a phosphate binding agent in the management of renal failure in patients on renal dialysis.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

Posology

Adults:

Adjunctive therapy in osteoporosis

2 to 3 tablets daily.

Prevention and treatment of calcium deficiency

2 to 3 tablets daily.

Phosphate binder:

Dose as required by the individual patient depending on serum phosphate level.

Special patient populations

Elderly patients:

Dosage as for adults.

Paediatric patients:

Prevention and treatment of calcium deficiency

2 to 3 tablets daily.

Phosphate Binder:

Dose as required by the individual patient depending on serum phosphate level.

Impaired renal function:

In patients with severe renal failure having a creatinine clearance of less than 30 ml/minute, dosage adjustments may be necessary dependent on serum calcium levels.

Impaired hepatic function:

No dose adjustment is required.

Method of administration

Oral.

Tablets may be chewed or sucked.

For phosphate binding, the tablets should be taken just before, during or just after each meal in order to bind phosphate in the food.

Contraindications

The information provided in Contraindications of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

-

- Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria, for example in hyperparathyroidism, vitamin D overdosage, decalcifying tumours such as plasmacytoma and skeletal metastases, in severe renal failure untreated by renal dialysis and in osteoporosis due to immobilisation.

- Renal calculi (nephrolithiasis)

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

In renal insufficiency the tablets should be given only under controlled conditions for hyperphosphataemia. Caution should be exercised in patients with a history of renal calculi.

During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in patients on concomitant treatment with cardiac glycosides or diuretics (see 4.5), in patients with a high tendency to calculus formation, in cases of hypercalcaemia, or signs of impaired renal function.

Calcium carbonate should be used with caution in patients with hypercalcaemia or signs of impaired renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account.

During high dose therapy and especially during concomitant treatment with vitamin D and/or medications or nutrients (such as milk) containing calcium, there is a risk of hypercalcaemia and milk-alkali syndrome (hypercalcaemia, alkalosis and renal impairment) with subsequent kidney function impairment. In these patients, serum calcium levels should be followed and renal function should be monitored.

Acical 500 mg Chewable Tablets contain isomalt (E953). Patients with rare hereditary problems of fructose intolerance should not take this medicine.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

Calcium carbonate has no known influence on ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: uncommon (>1/1,000 to <1/100); rare (>1/10,000 to <1/1,000) or very rare (≤1/10,000)

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Very rare: Milk-alkali syndrome (frequent urge to urinate; continuing headache; continuing loss of appetite; nausea or vomiting; unusual tiredness or weakness; hypercalcaemia, alkalosis and renal impairment). Seen usually only in overdose (see 4.9).

Gastrointestinal disorders

Rare: Constipation, dyspepsia, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous disorders

Very rare: Pruritus, rash and urticaria.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

Overdose can lead to hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis and in severe cases, cardiac arrhythmias. Extreme hypercalcaemia may result in coma and death. Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification.

Milk-alkali syndrome may still occur in patients who ingest large amounts of calcium and absorbable alkali. It is not uncommon as a cause of hypercalcaemia requiring hospitalisation. The syndrome has also been reported in a patient taking recommended doses of antacids containing calcium carbonate for chronic epigastric discomfort, and in a pregnant woman taking high, but not grossly excessive, doses of calcium (about 3 g of elemental calcium daily). Metastatic calcification can develop.

Treatment of hypercalcaemia: The treatment with calcium must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Treatment: rehydration, and, according to severity of hypercalcaemia, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

Pharmacotherapeutic group: Calcium

ATC-code: A12A A04

An adequate intake of calcium is of importance during growth, pregnancy and breastfeeding.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

Absorption: The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.

Distribution and biotransformation: 99% of the calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood-calcium content is in the physiologically active ionised form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.

Excretion and elimination: Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close
Calcium

Preclinical safety data

The information provided in Preclinical safety data of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.

Incompatibilities

The information provided in Incompatibilities of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Acical is based on data of another medicine with exactly the same composition as the Acical of the medicine (Calcium Carbonate). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Acical directly from the package or from the pharmacist at the pharmacy.
more... close

No special requirements.

Site feedback

How easy to use our site?

Commentary is required, without it we won't know how to become better
The maximum length of review is 1000 symbols

Thanks!

You help us to become better