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Calceos 500mg/400IU Chewable Tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Calcium carbonate, Colecalciferol; cholecalciferol may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Calcium carbonate, Colecalciferol; cholecalciferol

Equivalent medicines (same active substance, strength and form)

Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Calceos 500mg/400IU Chewable Tablets belong to a group of medicines which act on the calcium and vitamin D balance in your body. Calceos 500mg/400IU Chewable Tablets contain the active substances calcium carbonate and colecalciferol (vitamin D3). Calceos is recommended for the treatment of calcium and vitamin D deficiency in elderly patients, that has been diagnosed by a doctor. It can be used in combination with other medicines for the treatment of osteoporosis (a condition where bone mass decreases and bone brittleness increases) in adults and elderly patients. Calceos can also be taken by adults and elderly patients who have been identified by their doctor as having a high risk of developing a deficiency of both calcium and vitamin D. You must talk to a doctor if you do not feel better or if you feel worse after taking this medicine. 2.

What you need to know before you take it

e Calceos 500mg/400IU Chewable Tablets Do not take Calceos 500mg/400IU Chewable Tablets

  • if you are allergic to calcium or vitamin D or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic (hypersensitive) to peanut or soya (this product contains soybean oil)
  • if you have high blood calcium levels (hypercalcaemia)
  • if you have high urine calcium levels (hypercalciuria)
  • if you suffer from severe kidney problems

1.3.1 Package Leaflet

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if you have kidney stones or calcium deposits in your kidneys if you have too much vitamin D in your body if you have a condition that leads to hypercalcaemia and/or hypercalciuria (e.g., overactive parathyroid glands, a disease of the bone marrow (myeloma), a malignant bone tumour (bone metastases)) Talk to your doctor before taking this medicine if any of the above apply to you. Warnings and precautions

Talk to your doctor or pharmacist before taking Calceos 500mg/400IU Chewable Tablets:

  • if you are suffering from sarcoidosis, a disease with most commonly symptoms such as tiredness, increase of nodules size and inflammation of lungs and other organs.
  • if you are suffering from kidney disease (kidney insufficiency).
  • if you are already taking additional doses of calcium (e.g. nutritional supplements or foods enriched with calcium) and are using medicinal products containing carbonate (e.g. so-called antacids) at the same time, the calcium content of the serum and the urine should be monitored.
  • if you have a long period of immobility and if you have a high concentration of calcium in blood and/or urine. Your doctor will allow you to take this medicine when you walk again,
  • if you have long term treatment, regular blood and urine tests are necessary to monitor calcium levels. This monitoring is particularly important in the elderly and where treatment is being taken at the same time as cardiac glycosides (e.g. digoxin) or diuretics. Depending upon the result, your doctor may decide to reduce or even stop your treatment,
  • if you take other medicines or other products containing calcium and/or vitamin D. High levels of calcium and vitamin D may be harmful to health. If in doubt, ask your doctor or pharmacist for advice. Children and adolescents The safety and efficacy of CALCEOS in children have not been established. No data are available. Other medicines and Calceos 500mg/400IU Chewable Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes those medicines obtained without a prescription. This is especially important if you are taking: − Other medications containing vitamin D or calcium. − Cardiac glycosides, for example digitoxin and digoxin (medicine used to treat heart problems), as they may cause more side effects. − Bisphosphonates, or strontium containing medicines (used in osteoporosis). − Antibiotics (medicines used to treat infections due to bacteria): oral use tetracycline, rifampicin and fluoroquinolones (for example ciprofloxacin and norfloxacin). − Dolutegravir (a medicine used to treat HIV infection). − Medicines or supplements containing iron or zinc. − Estramustine (a medicine used to treat some prostate cancers). − Thyroid hormones, used in cases of thyroid disease. 1.3.1 Package Leaflet

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− Carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone: medicines used to treat epileptic seizures. − Orlistat (a medicine used to treat obesity) as it may reduce the amount of vitamin D3 you absorb. − Thiazide diuretics (medicines used to treat high blood pressure or oedema), as they may increase the amount of calcium in your blood. − Roxadustat (a medicine used to treat anemia). You should wait: − More than 1 hour between taking CALCEOS and roxadustat − More than 2 hours between taking Calceos 500mg/400IU Chewable Tablets and the following medicines: bisphosphonates, medicines containing strontium, iron or zinc, estramustine, thyroid hormones, some fluoroquinolones (ciprofloxacin, norfloxacin), tetracycline antibiotics. − It is advisable to take Calceos 500mg/400IU Chewable Tablets at least 2 hours after or 6 hours before dolutegravir intake. Calceos 500mg/400IU Chewable Tablets with food and drink Possible interactions with food. You must take CALCEOS either before or after meals containing: − oxalic acid (spinach, rhubarb, sorrel, cocoa, tea…), − phosphate (pork meat, ham, sausages, processed cheese, dessert cream, drinks with cola…), − phytic acid (complete cereals, dry vegetables, oleaginous seeds, chocolate…). Pregnancy, breast-feeding and fertility During pregnancy and breast-feeding, the daily dose should not exceed 1500mg of calcium and 600IU of vitamin D3 i.e. one tablet a day. Calceos 500mg/400IU Chewable Tablets can be used during breast-feeding. Calcium and vitamin D3 pass into breast milk. This should be considered when giving additional vitamin D to the child. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Calceos 500mg/400IU Chewable Tablets are not expected to affect your ability to drive or use machines. Calceos 500mg/400IU Chewable Tablets contains sorbitol, sucrose and hydrogenated soya bean oil Calceos 500mg/400IU Chewable Tablets contains 475mg sorbitol (E420) in each chewable tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take this medicine. Calceos 500mg/400IU Chewable Tablets contains sucrose (sucrose is present in small quantities in cholecalciferol concentrate). If you have been told by your doctor that you have an

1.3.1 Package Leaflet

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intolerance to some sugars, contact your doctor before taking this medicinal product. May be harmful to the teeth. Calceos 500mg/400IU Chewable Tablets contains hydrogenated soya bean oil. If you are allergic to peanut or soya, do not take this medicinal product (see Do not take CALCEOS 500mg/400IU Chewable Tablets). 3.

How to take it

Calceos 500mg/400IU Chewable Tablets

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. The recommended dose for adults and the elderly is one tablet, to be taken twice a day. Chew the tablets completely before swallowing. Then drink a glass of water. If you take more Calceos 500mg/400IU Chewable Tablets than you should Following symptoms may occur: loss of appetite, excessive thirst, feeling sick (nausea), vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental health problems, increased urine output, bone pain, kidney stones and high blood pressure. These symptoms may be part of milk-alkali which can occur when, for example, large amounts of calcium and carbonate containing drugs (so-called antacids) are taken at the same time (see "warnings and precautions"). In these cases, stop taking CALCEOS and immediately contact your doctor for action (who will undertake the necessary procedures). If you take too many CALCEOS during a long time, calcium deposits may appear in blood vessels or body tissues. If you forget to take Calceos 500mg/400IU Chewable Tablets If you forget to take your tablet, take it as soon as you remember and then continue with the next dose as instructed. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Uncommon (may affect up to 1 in 100 people):

  • excess calcium levels in the blood or urine. Rare (may affect up to 1 in 1,000 people):
  • constipation, flatulence, feeling sick (nausea), abdominal pain, diarrhoea.
  • itching, skin rashes and hives (urticaria). Not known (frequency cannot be estimated from the available data):

1.3.1 Package Leaflet

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Milk-alkali syndrome associated with a high concentration of calcium in the blood (hypercalcemia), elevated blood pH (alkalosis) and renal failure which may occur with large doses (see "Warnings and precautions" and "If you take more CALCEOS than you should"). Serious allergic (hypersensitivity) reactions such as swelling of the face, lips, tongue or throat that may lead to difficulty beathing (angioedema or laryngeal oedema).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

Possible side effects

not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.

How to store it

Calceos 500mg/400IU Chewable Tablets

Keep this medicine out of the sight and reach of children. The stopper contains small granules of silica gel to keep the tablets dry. Keep the stopper out of the sight and reach of children. Do not swallow the silica gel granules. Do not use this medicine after the expiry date which is stated on the carton and container. The expiry date refers to the last day of that month. Store in the original packaging in order to protect the tablets from moisture. Do not use this medicine if you notice that the pack or any of the tablets are damaged. Do not store above 25°C. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.

Contents of the pack and other information

What Calceos 500mg/400IU Chewable Tablets contain The active substances are calcium carbonate and colecalciferol (vitamin D3). Each chewable tablet contains 1250mg of calcium carbonate (equivalent to 500mg elemental calcium) and 10 micrograms colecalciferol (equivalent to 400IU vitamin D3). The other ingredients of the tablet are: xylitol, sorbitol, povidone, magnesium stearate, lemon flavouring (flavouring preparations, natural flavouring substances, maltodextrin, acacia, sodium citrate, citric acid, butylated hydroxyanisole), alpha tocopherol, hydrogenated soybean oil, gelatin, sucrose, silicon dioxide, corn starch. What Calceos 500mg/400IU Chewable Tablets look like and contents of the pack Calceos 500mg/400IU Chewable Tablets are greyish white, square chewable tablets. 1.3.1 Package Leaflet

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Calceos 500mg/400IU Chewable Tablets are available in packs of 60 tablets. Each pack of 60 tablets contains 4 tubes each containing 15 tablets. Marketing Authorisation Holder and Manufacturer: Marketing Authorisation Holder: Laboratoire Innotech International, 22 avenue Aristide Briand, 94110 Arcueil, France. Distributed by: Galen Limited, Seagoe Industrial Estate, Craigavon, BT63 5UA, UK. Manufacturer: Innothéra Chouzy, Rue René Chantereau, Chouzy-sur-Cisse, 41150 Valloire-sur-Cisse, France. This leaflet was last revised in 04/2026 Calceos is a Trade Mark

1.3.1 Package Leaflet

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Frequently asked questions about Calceos 500mg/400IU Chewable Tablets

How do I take Calceos 500mg/400IU Chewable Tablets?

Calceos 500mg/400IU Chewable Tablets comes as tablet containing 500mg / 400iu. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Calceos 500mg/400IU Chewable Tablets?

The active substance in Calceos 500mg/400IU Chewable Tablets is calcium carbonate, colecalciferol; cholecalciferol.

Are there equivalent medicines to Calceos 500mg/400IU Chewable Tablets?

Medicines with the same active substance, strength and form include: Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Calceos 500mg/400IU Chewable Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Calceos 500mg/400IU Chewable Tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

  • Source: electronic medicines compendium (emc), Datapharm
  • Active substance: calcium carbonate, colecalciferol; cholecalciferol
  • Official document: view the original leaflet on emc →
Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Calcium carbonate (45 medicines), Calcium carbonate, colecalciferol; cholecalciferol (12 medicines), Colecalciferol; cholecalciferol (34 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

CALCEOS is indicated only in adults for:

- Vitamin D and calcium deficiency correction in the elderly.

- Vitamin D and calcium supplement as an adjunct to specific therapy for osteoporosis and in patients at high risk of vitamin D and calcium combined deficiencies.

4.2. Posology and method of administration

Posology

Adults

One tablet, twice per day.

Paediatric population

The safety and efficacy of CALCEOS in children has not been established. No data are available.

Method of administration

Oral use.

Chew the tablets and drink a glass of water.

4.3. Contraindications

- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.

- This product contains partially hydrogenated soybean oil. Patients should not take this medicinal product if they are allergic to peanut or soya.

- Hypercalcaemia, hypercalciuria and diseases and/or conditions, which lead to hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases, primary hyperparathyroidism).

- Calcium lithiasis, nephrocalcinosis.

- Vitamin D overdose.

- Severe renal impairment (glomerular filtration rate < 30 ml/min). In patients with severe renal impairment, Vitamin D3 in the form of colecalciferol is not metabolised in the normal way and other forms of Vitamin D3 must be used.

4.4. Special warnings and precautions for use

- The product should be prescribed with caution in patients with sarcoidosis because of possible increase of metabolism of vitamin D to its active form. These patients should be monitored for serum and urinary calcium.

- The product should be used with caution in renal impairment patients (glomerular filtration rate ≥ 30 ml/min) and with monitoring of calcium and phosphate homeostasis. The risk of soft tissue calcification must be taken into account.

- Calcium and alkali intake from other sources (foods, dietary supplements or other drugs) should be considered when prescribing CALCEOS. If very high doses of calcium are taken in combination with absorbable alkaline agents (such as carbonates), there is a risk of Burnett syndrome (or milk-alkali syndrome) consisting of hypercalcemia, metabolic alkalosis, renal failure, and soft tissue calcification. In this case, frequent monitoring of serum calcium and calciuria may be necessary.

- In case of prolonged immobilisation in patients with hypercalciuria and/or hypercalcaemia, vitamin D and calcium treatment should only be resumed when the patient becomes mobile.

- In case of long term treatment, it is advisable to monitor serum and urinary calcium levels and kidney function (serum creatinine levels). It is advisable to reduce or interrupt treatment temporarily if urinary calcium exceeds 7.5mmol/24h (300mg/24h). This monitoring is particularly important in the elderly, in cases of combined treatment with cardiac glycosides or diuretics (see section 4.5) and in patients who are frequently subject to the formation of kidney stones. In the presence of hypercalcaemia or signs of problems with renal function, the dose must be reduced or treatment interrupted.

- Additional administration of vitamin D or calcium should be carried out under strict medical supervision. In such situation, weekly monitoring of serum and urinary calcium is absolutely necessary.

Excipients:

CALCEOS contains sorbitol (E420).

Patients with hereditary fructose intolerance (HFI) should not take this medicine.

CALCEOS contains sucrose (sucrose is present in small quantities in colecalciferol concentrate).

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. The sucrose may be harmful to teeth if this product is taken chronically, e.g. for two weeks or more.

4.5. Interaction with other medicinal products and other forms of interaction

Combinations requiring precautions for use:

Cardiac glycosides

Risk of serious dysrhythmia. Medical supervision and if necessary, monitoring electrocardiographic and calcaemia.

Bisphosphonates

Risk of decrease in the gastrointestinal absorption of bisphosphonates. It is advisable to take calcium salts apart from bisphosphonates (a minimum period of at least 2 hours)

Strontium

Reduction in strontium gastrointestinal absorption on concomitant administration of calcium-containing products. It is advisable to take calcium more than two hours apart from strontium-containing medications.

Tetracyclines orally

Possible reduction in the absorption of tetracycline. It is advisable to take calcium salts at least two hours apart from tetracyclines.

Rifampicin

Possible decrease in vitamin D concentrations. Vitamin D concentrations should be measured and supplementation provided if necessary.

Fluoroquinolones

Risk of reduction in the intestinal absorption of fluoroquinolones. It is advisable to take calcium more than two hours apart from fluoroquinolones.

Dolutegravir

Risk of reduction in the intestinal absorption of dolutegravir. It is advisable to take calcium at least 2 hours after or 6 hours before dolutegravir intake.

Ferrous salt

Risk of reduced gastrointestinal absorption of ferrous salt. It is advisable to allow a period of more than two hours between calcium and ferrous salt.

Zinc

Risk of reduced gastrointestinal absorption of zinc. It is advisable to allow a period of more than two hours between calcium and zinc.

Estramustine

Risk of reduction in the gastrointestinal absorption of estramustine. It is advisable to allow a period of more than two hours between calcium and estramustine.

Thyroid hormones

Risk of reduction in the gastrointestinal absorption of thyroid hormones. It is advisable to allow a period of more than two hours between calcium and thyroid hormones.

Enzyme-inducing antiepileptic drugs (AEDs) (carbamazepine, fosphenytoin, phenobarbital, phenytoin and primidone)

Possible decrease in vitamin D concentrations. Vitamin D concentrations should be measured and supplementation provided if necessary.

Roxadustat

The intake of divalent cation may decrease intestinal absorption and the efficacy of roxadustat when taken simultaneously.

Administration of calcium with roxadustat should be separated by more than 1 hour (if possible).

Combinations to be taken into account:

Orlistat

Treatment with orlistat may potentially reduce the absorption of Vitamin D3.

Thiazide diuretics

Risk of hypercalcemia due to a decrease in the urinary excretion of calcium. It is recommended that the calcium levels in plasma are monitored regularly.

Food

Possible interaction with food, for example foods containing oxalic acid (spinach, rhubarb, sorrel, cocoa, tea), phosphate (pork, ham, sausages, processed cheese, dessert cream, beverages containing cola, etc.) or phytic acid (wholemeal cereals, dry vegetables, oleaginous seeds, chocolate, etc.). These types of foods may reduce the absorption of calcium. It is therefore recommended that meals containing these foods be taken some time before or after ingestion of the product.

4.6. Fertility, pregnancy and lactation

This product may be used during pregnancy and lactation. However, the daily intake should not exceed 1500mg calcium and 600IU vitamin D3.

Pregnancy

In pregnancy, an overdose of colecalciferol must be avoided:

- overdoses of vitamin D during pregnancy have shown teratogenic effects in animals (see section 5.3).

- in pregnant woman: overdoses of vitamin D must be avoided as permanent hypercalcaemia can lead to physical and mental retardation, supravalvular aortic stenosis and retinopathy in the child.

There are however several case reports of administration of very high doses in hypoparathyroidism in the mother, with no adverse effect on the infant.

Lactation

Vitamin D and its metabolites pass into the breast milk. This should be considered when giving additional vitamin D to the child.

Fertility

No data is available on the effects of CALCEOS on fertility. However, normal endogenous calcium and vitamin D levels are not expected to have undesired effects on fertility.

4.7. Effects on ability to drive and use machines

CALCEOS has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders:

Not known: Hypersensitivity reactions such as angioedema or laryngeal oedema.

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Not known: Milk-alkali syndrome (hypercalcaemia, alkalosis and renal impairment). Seen usually only in overdose (see sections 4.4 and 4.9).

Gastrointestinal disorders

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

Skin and subcutaneous tissue disorders

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

4.9. Overdose

An overdose can lead to hypervitaminosis and hypercalcaemia.

Symptoms

The symptoms of hypercalcaemia can include: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, hypertension, mental disturbances, polydipsia, polyuria, skeletal pain, renal calcinosis, kidney stones, and in severe cases, cardiac arrhythmia. Extreme hypercalcaemia may lead to coma and death. Continuous high calcium levels may lead to irreversible damage to the kidneys and soft tissue calcification.

The risk of overdose may be increased if other calcium containing products or alkaline agents are taken (Milk-alkali syndrome). See Section 4.4 and 4.8.

Management

Treatment of hypercalcaemia: all calcium and Vitamin D3 treatments must be stopped. The need to continue all other concomitant medicines should be reconsidered by the physician. Rehydrate and, depending on severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Peritoneal dialysis should be considered in patients with renal failure or in patients refractory to other therapies.

Serum electrolytes, kidney function and diuresis must be monitored. In severe cases, ECG and calcaemia should be monitored.

💬 Ask about this leaflet

Ask anything about Calceos 500mg/400IU Chewable Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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