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Internis Pharmaceuticals Ltd

Carradine House, 237 Regent's Park Road, London, N3 3LF, UK
Telephone: +44 (0)208 346 5588
Fax: +44 (0)1271 326 371
Medical Information Direct Line: +44 (0)01271 334 609
Medical Information e-mail: regulatory@jensongroup.com
Customer Care direct line: +44 (0)1271 314 320
Medical Information Fax: +44 (0)1271 326 371
Stock Availability: +44 (0)7763329345

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Summary of Product Characteristics last updated on the eMC: 07/12/2011
SPC Accrete D3


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1. Name of the medicinal product

Accrete D3 film-coated tablets


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2. Qualitative and quantitative composition

Each film-coated tablet contains 600 mg calcium (as calcium carbonate 1500 mg) and 10 micrograms of colecalciferol (equivalent to 400 IU vitamin D3)

Excipients: hydrogenated soya-bean oil 0.3 mg and sucrose 1.52 mg. For a full list of excipients, see 6.1


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3. Pharmaceutical form

Film-coated tablet.

Ochre-coloured oval film-coated tablet scored on one side. The breakage surface is white.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.


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4. Clinical particulars

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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.


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4.2 Posology and method of administration

Adults and the 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.

Accrete D3 film-coated tablets should not be used for longer than one month without medical advice.

Dosage in hepatic impairment

No dose adjustment is required.

Dosage in 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.

It is recommended to take the film-coated tablet within one hour and an hour and a half after meals with a glass of water or juice, without chewing it. The tablet can be broken in half, if needed.


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4.3 Contraindications

• Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases, primary hyperparathyroidism).

• Nephrolithiasis / nephrocalcinosis

• Renal failure

• Hypervitaminosis D

• Hypersensitivity to the active substances or to any of the excipients (including soya or peanut).


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4.4 Special warnings and precautions for use

During long-term treatment, serum and urinary 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.

Patients with mild to moderate impairment of renal function should be supervised carefully 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).

In patients with a history of renal stones urinary calcium exretion should be measured to exclude hypercalciuria.

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.

Accrete D3 film-coated tablets should be used with caution in other patients with increased risk of hypercalcaemia e.g. those suffering from malignancies.

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.

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.


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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. Hypercalcaemia must be avoided in digitalised patients.

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.

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) 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.


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4.6 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.


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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.


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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) or rare (>1/10,000 to <1/1,000).

Metabolism and nutrition disorders

Uncommon: Hypercalcaemia and hypercalciuria.

Gastrointestinal disorders

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

Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.


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4.9 Overdose

Overdose can lead to hypervitaminosis D 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.

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. Gastric lavage 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.


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5. Pharmacological properties

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5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Calcium, combination with other drugs ATC code: A12AX Vitamin D increases the intestinal absorption of calcium.

Administration of calcium and vitamin D3 (colecalciferol) counteracts the increase of parathyreoid hormone (PTH), which is caused by calcium deficiency and which causes increased bone resorption.

A clinical study of institutionalised patients suffering from vitamin D deficiency indicated that a daily intake of two tablets of calcium 500 mg/Vitamin D 400 IU for six months normalised the value of the 25-hydroxylated metabolite of Vitamin D3 and reduced secondary hyperparathyroidism and alkaline phosphatases.

An 18-month double blind, placebo controlled study including 3270 institutionalised women aged 84±6 years that received supplementation of vitamin D (800 IU/day) and calcium phosphate (corresponding to 1200 mg/day of elemental calcium), showed a significant decrease of PTH secretion. After 18 month, an “intent-to treat” analysis showed 80 hip fractures in the calcium-vitamin D group and 110 hip fractures in the placebo group (p=0.004). A follow-up study after 36 months showed 137 women with at least one hip fracture in the calcium-vitamin D group (n=1176) and 178 in the placebo group (n=1127, p<0.02).


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5.2 Pharmacokinetic properties

Calcium

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

Distribution and metabolism: 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.

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

Vitamin D

Absorption: Vitamin D3 is absorbed in the small intestine.

Distribution and metabolism: Colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is converted in the liver by hydroxylation to the active form 25-hydroxycolecalciferol. It is then further converted in the kidneys to 1,25 hydroxycolecalciferol. 1,25 hydroxycolecalciferol is the metabolite responsible for increasing calcium absorption. Vitamin D which is not metabolised is stored in adipose and muscle tissues.

Elimination: Vitamin D is excreted in faeces and urine.


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5.3 Preclinical safety data

At doses far higher than the human therapeutic range teratogenicity has been observed in animal studies. There is further no information of relevance to the safety assessment in addition to what is stated in other parts of the SPC.


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6. Pharmaceutical particulars

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6.1 List of excipients

Tablet core: Magnesium stearate Crospovidone (Type A) Copovidone (K-value: 25.2-30.8) Microcrystalline cellulose Sucrose Gelatin all-rac -α-Tocopherol (E307) Hydrogenated soya-bean oil Maize starch

Coating (Sepifilm 4202 yellow): Yellow iron oxide (E172) Hypromellose (15 mPa s) Titanium dioxide (E171) Macrogol 400

Talc


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

2 years.


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6.4 Special precautions for storage

Do not store above 25°C. Store in the original package in order to protect from moisture.


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6.5 Nature and contents of container

The film-coated tablets are packed in PVC/Al blister and cardboard box. Pack size: 30, 60 tablets. Not all pack sizes may be marketed.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. Marketing authorisation holder

Jenson Pharmaceutical Services Ltd. Carradine House, 237 Regent's Park Road, London, N3 3LF, UK.


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8. Marketing authorisation number(s)

PL 17871/0150


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9. Date of first authorisation/renewal of the authorisation

19/01/2011


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10. Date of revision of the text

19/01/2011



More information about this product

Link to this document from your website: http://www.medicines.org.uk/emc/medicine/25530/SPC/


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