Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Accrete D3 film-coated 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.
What it is and what it is used for
for 2. What you need to know before you take Accrete D3 film-coated tablets 3. How to take Accrete D3 film-coated tablets 4. Possible side effects 5. How to store Accrete D3 film-coated tablets 6. Contents of the pack and other information
1. WHAT ACCRETE D3 FILM-COATED TABLET IS AND WHAT IT IS USED FOR The product is a combination of calcium (as calcium carbonate) and colecalciferol (Vitamin D3). It is recommended in the elderly for the prevention and treatment of deficiency of calcium and vitamin D3 that are essential for bone formation and normal bone metabolism. It is also recommended for use as a Vitamin D and calcium supplement alongside specific osteoporosis treatments in people who are at risk of vitamin D and calcium deficiency.
What you need to know before you take it
E ACCRETE D3 FILM-COATED TABLETS Do not take Accrete D3 film-coated tablets
- if you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6)
- Accrete D3 film-coated tablets contain hydrogenated soya oil. lf you are allergic to peanut or soya, do not use this medicinal product.
- if you have kidney stones
- if you have kidney failure or severe renal impairment
- if you have calcium deposits in your kidneys (nephrocalcinosis).
- if you have excessive amounts of vitamin D in the blood
- if you have chronically increased calcium level in your urine or elevated blood-calcium level
- if you have disturbed parathyroid hormone metabolism
- if you have sarcoidosis (an inflammatory disease of unidentified origin characterized by formation of cell agglomerates (lumps) in different locations
- if you are an immobilised patient with osteoporosis
- if you are taking thiazide diuretics (to treat high blood pressure)
- if you are taking cardiac glycosides (to treat heart conditions) such as digoxin
- if you are less than 18 years of age
Warnings and precautions
Talk to your doctor or pharmacist before taking Accrete D3 film-coated tablets
- if you have kidney disease or impaired kidney function
- if you have sarcoidosis (an inflammatory disease of unidentified origin characterized by formation of cell agglomerates (Iumps) in different locations)
- if you are prone to development of kidney stones
- if you are an immobilised patient with osteoporosis
Children and adolescents
Accrete D3 film-coated tablets are not intended for use in children and adolescents.
Other medicines and Accrete D3 film-coated tablets
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Consult your doctor or pharmacist if you use:
- other medicines or food supplements containing vitamin D or calcium, because concomitant (accompanying) use of such products with Accrete D3 film-coated tablets may lead to a significant elevation of bloodcalcium levels and cause adverse effects that
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may be harmful. During the treatment with Accrete D3 film-coated tablets, do not use any other products containing vitamin D or calcium without medical advice. thiazide diuretics systemic (per os [oral] or injection) corticosteroids (anti-inflammatory drugs) cardiac glycosides (used for the treatment of cardiac [heart] failure)
Take special care if you use:
- ion exchange resins such as cholestyramine or laxatives such as paraffin oil, as these medicines may reduce the gastrointestinal absorption of vitamin D.
- tetracycline containing preparations (antibiotics), as calcium carbonate may interfere with their absorption. Therefore, tetracycline preparations should be administered at least two hours before or four to six hours after using of Accrete D3 filmcoated tablets.
- bisphosphonate (used for the treatment of osteoporosis) or sodium fluoride is used concomitantly with Accrete D3 film-coated tablets, these preparations should be administered at least three hours before using Accrete D3 film-coated tablets.
- Rifampicin (a medicine for tuberculosis), phenytoin (a medicine for epilepsy) and barbiturates (medicines which are used for epilepsy or which help you sleep), as they may make the vitamin D3 less effective.
- Quinolone (antibiotics), as calcium may interfere with its absorption. Quinolone antibiotics should be taken two hours before or six hours after intake of calcium.
- Estramustin (a medicine used in chemotherapy), thyroid hormones or medicines containing iron, zinc or strontium, as the amount absorbed may be reduced. They should be taken at least 2 hours before or after Accrete D3 film-coated tablets.
Accrete D3 film-coated tablets with food and drink
Oxalic acid (found in e.g. spinach, sorrel and rhubarb), phosphate and phytic acid (found in whole cereals) may inhibit calcium absorption. The patient should not take Accrete D3 film-coated tablets within two hours after eating foods rich in oxalic acid, phosphate and phytic acid.
Pregnancy, breast-feeding and fertility
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. During pregnancy, the daily intake should not exceed 1500 mg calcium and 600 IU (International Unit) vitamin D. In pregnant women, overdoses of calcium and vitamin D should be avoided as permanent hypercalcaemia is related to adverse effects on the developing foetus. During pregnancy, Accrete D3 film-coated tablets should be used in the recommended doses only in cases of calcium and vitamin D3 deficiency. In other cases the daily dose of Accrete D3 film-coated tablets must not exceed one tablet per day. Accrete D3 film-coated tablets can be used during breast-feeding, but your doctor should be informed as calcium and vitamin D gets into the breast milk. This should be considered when giving additional vitamin D to the child. There are no data available on the effect of Accrete D3 film-coated tablets on fertility.
Driving and using machines
There are no data on the effect of this product on the ability to drive or use machines.
Accrete D3 film-coated tablets contain soya oil and sucrose
Accrete D3 film-coated tablets contain hydrogenated soya oil. If you are allergic to peanut or soya, do not use this medicinal product. Accrete D3 film-coated tablets contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. 93538942309 GB
How to take it
ACCRETE D3 FILMCOATED TABLETS Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for adults and the elderly is one film-coated tablet 2 times per day (e.g. one tablet in the morning and one tablet in the evening). It is recommended to take the film-coated tablet within one and a half hours of a meal with a glass of water or juice, without chewing it. The tablet can be broken in half, if needed.
Use in children and adolescents
Accrete D3 film-coated tablets are not intended for use in children and adolescents under 18 years.
If you take more Accrete D3 film-coated tablets than you should
Contact your doctor or pharmacist immediately if you have taken too much of this medicine. Remember to keep the pack and any remaining tablets with you.
Produkt/Product : ACCRETE 10UG_600MG FTA 60PC TR GB_PIL STADA Mat.-Nr./Mat.-No.: 9353894_2309 GB STADA Art.-Nr./Art.-No: 180782
Taking too much of this medicine may lead to symptoms such as lack of appetite, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, excess drinking and excess urination, bone pain, calcification of the kidneys and in severe cases cardiac arrhythmias (irregular heartbeat). In extreme cases calcium overdose can lead to coma and death. Long term increased calcium levels in the blood may also lead to irreversible kidney impairment and calcification of soft tissues.
If you forget to take Accrete D3 filmcoated tablets
Hersteller/Manufacturer: Beres Pharmaceuticals Hersteller Art.-Nr./Manufacturer Art.-No.: ADUK 10/23 Format/Size: 420 x 150 mm Schriftgröße/Font-size: 8.75pt NTIN/GTIN: N/A
Do not take a double dose to make up for a forgotten dose, as you would not substitute the missing amount but you risk an overdosing. Continue the treatment according to the instructions. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
PZN/EAN: N/A
Possible side effects
Pharma-Code: N/A Flattermarke/Collating mark: N/A Black 1. Farbe/Colour: 2. Farbe/Colour: 3. Farbe/Colour: 4. Farbe/Colour: 5. Farbe/Colour: 6. Farbe/Colour: 7. Farbe/Colour:
How to store it
ACCRETE D3 FILM-COATED TABLETS Do not store above 25°C. Store in the original package in order to protect from moisture. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton (EXP). The expiry date refers to the last day of that month. 93538942309 GB ADUK 10/23
Contents of the pack and other information
What Accrete D3 film-coated tablets contain –
The active substances: Colecalciferol 400IU (equivalent to 10 micrograms) and calcium 600 mg (as calcium carbonate 1500 mg) in each film-coated tablet.
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The other ingredients: Tablet core: magnesium stearate, crospovidone (Type A), copovidone (K-value: 25.2-30.8), microcrystalline cellulose, sucrose, gelatin, all-rac-a-tocopherol (E307), hydrogenated soya-bean oil, maize starch. Coating: yellow iron oxide (E172), hypromellose (15 mPa s), titanium dioxide (E171), macrogol 3350, talc.
What Accrete D3 film-coated tablets look like and contents of the pack Ochre, oval shaped, film-coated tablets scored on one side. When broken the exposed surface is white. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal halves. 10 film-coated tablets in transparent, colourless PVC/Alu blister and 3 or 6 blisters in cardboard box. Not all pack sizes may be marketed.
Marketing Authorisation Holder Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK.
Manufacturer:
Beres Pharmaceuticals Ltd., H-5000 Szolnok, Nagysándor József út 39., Hungary
This leaflet was last revised in October 2023
Like all medicines, this medicine can cause side effects, although not everybody gets them. Adverse reactions are listed below by classes of organ systems and frequency of occurrence. Frequency is defined as:
- Uncommon (affects 1 to 10 users in 1,000)
- Rare (affects 1 to 10 users in 10,000)
- Very rare (affects less than 1 in 10,000) Uncommon: significantly increased blood calcium level (hypercalcaemia)- the symptoms include nausea, vomiting, lack of appetite, constipation, stomach ache, bone pain, extreme thirst. needing to pass urine more often, muscle weakness, drowsiness and confusion; or markedly increased calcium content of the urine (hypercalciuria).
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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 to protect the environment.
Keyline (Non-Printing)
Version: 2
Datum/Date: 26.10.2023
Agentur/Agency: Cirrus Grafik erstellt von/Graphic made by: SFA Aktueller Umlauf/Current loop: KJA Genehmigt/Approved
Rare: constipation, flatulence (wind), nausea, abdominal pain, diarrhoea, itching, rash and urticaria (hives). Very rare: dyspepsia (indigestion), Milk alkali syndrome (usually only seen in overdose). Not known: Allergic reactions – symptoms include itching, wheezing, rash, swelling of the tongue or throat. If you have an allergic reaction stop taking the tablets and seek medical attention immediately. If you have impaired renal function, you may be at risk of increased amounts of phosphate in the blood, renal stone formation and increased amounts of calcium in the kidneys.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.
Frequently asked questions about Accrete D3 film-coated tablets
How do I take Accrete D3 film-coated tablets?
Accrete D3 film-coated tablets comes as tablet. 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 Accrete D3 film-coated tablets?
The active substance in Accrete D3 film-coated tablets is calcium carbonate, colecalciferol; cholecalciferol.
Are there equivalent medicines to Accrete D3 film-coated tablets?
Medicines with the same active substance, strength and form include: Adcal D3 Lemon Chewable Tablets, Adcal D3 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 Accrete D3 film-coated 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 Accrete D3 film-coated 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 →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Prevention and treatment of vitamin D and calcium deficiency in the elderly.
Vitamin D and calcium supplement as an adjunct to specific osteoporosis treatments of patients who are at risk of vitamin D and calcium deficiency.
4.2. Posology and method of administration
Posology
Adults and elderly
One tablet twice a day (e.g. one tablet in the morning and one tablet in the evening). Dose reduction should be considered as necessary following the monitoring of calcium levels as indicated in section 4.4 and 4.5.
Hepatic impairment
No dose adjustment is required.
Renal impairment
Accrete D3 film-coated tablets should not be used in patients with severe renal impairment.
Children and adolescents
Accrete D3 film coated tablets are not intended for use in children and adolescents.
Method of administration
It is recommended that the film-coated tablet is taken within one and a half hours of a meal with a glass of water or juice, without chewing it. The tablet can be broken in half, if needed.
4.3. Contraindications
• Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases or other malignant bone disease, sarcoidosis; primary hyperparathyroidism).
• Nephrolithiasis / nephrocalcinosis
• Severe renal impairment and renal failure
• Hypervitaminosis D
• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 (including soya or peanut).
• Relative contra-indications are osteoporosis due to prolonged immobilisation, renal stones, severe hypercalciuria.
4.4. Special warnings and precautions for use
Patients who are already taking thiazide diuretics and/or cardiac glycosides should be referred to their doctor prior to concomitant use (i.e. not suitable for pharmacy supply). Concomitant use should be prescribed with caution due to increased risk of hypercalcaemia (see section 4.5)
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 elderly patients on concomitant treatment with cardiac glycosides or diuretics (see section 4.5) and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued. It is advisable to reduce or interrupt treatment temporarily if urinary calcium exceeds 7.5 mmol/24 h (300 mg/24 h).
Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used (see section 4.3).
Accrete D3 film-coated tablets should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.
Accrete D3 film-coated tablets should be used with caution in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.
The content of vitamin D (400 IU) in Accrete D3 film-coated tablets should be considered when prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently. Milk-alkali syndrome (Burnett's syndrome), i.e. hypercalcaemia, alkalosis and renal impairment can develop when large amounts of calcium are ingested with absorbable alkali.
Accrete D3 film-coated tablets contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Allowances should be made for calcium and vitamin D supplements from other sources.
4.5. Interaction with other medicinal products and other forms of interaction
Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.
Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Accrete D3 film-coated tablets.
Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.
Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium.
Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.
If a bisphosphonate or sodium fluoride is used concomitantly with Accrete D3 film-coated tablets, these medicinal products should be administered at least three hours before the intake of Accrete D3 film-coated tablet since gastrointestinal absorption may be reduced.
Rifampicin, phenytoin or barbiturates may reduce the activity of vitamin D3, since they increase the rate of its metabolism.
The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or six hours after intake of calcium.
Calcium salts may decrease the absorption of iron, zinc or strontium. Consequently, the iron, zinc or strontium preparation should be taken at a distance of two hours from the calcium preparation.
Calcium salts may reduce the absorption of the estramustin or thyroid hormones. It is recommended that taking Accrete D3 film-coated tablets be spaced at least 2 hours from these medicines.
Oxalic acid (found in spinach, sorrel and rhubarb), phosphate and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.
4.6. Fertility, pregnancy and lactation
Pregnancy
Accrete D3 film-coated tablets may be given during pregnancy in cases of calcium and vitamin D3 deficiency.
During pregnancy the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D. Animal studies have shown toxic effects on reproduction at high doses of vitamin D. In pregnant women, all calcium or vitamin D overdoses must be avoided as prolonged hypercalcaemia in pregnancy may lead to retardation of physical and mental development, supravalvular aortic stenosis and retinopathy in the child. There are no indications that Vitamin D3 at therapeutic doses is teratogenic in human.
Breast-feeding
Accrete D3 film-coated tablets can be used during breast-feeding. Calcium and vitamin D pass into breast milk. This should be considered when giving additional vitamin D to the child.
Fertility
There is no known harmful effect of endogenous levels of calcium and vitamin D in the normal range on fertility. There are no data available on the effect of Accrete D3 film-coated tablets on fertility.
4.7. Effects on ability to drive and use machines
There are no data on the effect of this product on the ability to driver or use machines, however an effect is unlikely.
4.8. Undesirable effects
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); very rare (<1/10,000); not known (cannot be estimated from the available data).
Immune system disorders
Not known: Hypersensitivity reactions including pruritus, wheezing, urticaria and oropharyngeal swelling have been reported in the post-marketing environment.
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria.
Very rare: Seen usually only in overdose, see 4.9: Milk-alkali syndrome
Gastrointestinal disorders
Rare: Constipation, flatulence, nausea, abdominal pain, and diarrhoea.
Very rare: Dyspepsia
Skin and subcutaneous disorders
Rare: Pruritus, rash and urticaria.
Other special population
Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis. See section 4.4.
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
Website: www.mhra.gov.uk/yellowcard.
4.9. Overdose
Overdose can lead to hypervitaminosis and hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, renal calculi 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 occur in patients who ingest large amounts of calcium and absorbable alkali. Symptoms are frequent urge to urinate, continuing headache, continuing loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcaemia, alkalosis and renal impairment.
Treatment of hypercalcaemia: The treatment with calcium and vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Emptying of the stomach in patients with impaired consciousness. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.
💬 Ask about this leaflet
Ask anything about Accrete D3 film-coated 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.
Medicines containing Calcium carbonate, Colecalciferol; cholecalciferol
- Adcal D3 chewable tablets
- Adcal D3 Lemon Chewable Tablets
- Adcal-D3 Caplets, 750 mg/200 I.U
- Adcal-D3 Dissolve 1500mg/400IU Effervescent Tablets
- Cacit D3 500 mg/440 IU, effervescent granules for oral solution in sachets
- Calceos 500mg/400IU Chewable Tablets
- Calcichew-D3 1000 mg/800 IU Once Daily chewable tablets
- Calcichew-D3 500 mg/200 IU Chewable Tablets
- Calcichew-D3 Forte 500 mg/400 IU Chewable Tablets
- Natecal D3 600 mg + 400 I.U. chewable tablets
- theiCal-D3 1000mg/880 IU chewable tablets