Accrete D3 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calcium carbonate; Colecalciferol

Available from:

Thornton & Ross Ltd

ATC code:

A12AX

INN (International Name):

Calcium carbonate; Colecalciferol

Dosage:

1.5gram ; 400unit

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060400; GTIN: 5060222940053

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Accrete D3 film-coated tablets
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 D
3
)
Excipients with known effect:
Each film-coated tablet contains 0.3 mg hydrogenated soya-bean oil and
1.52 mg
sucrose.
For the full list of excipients, see 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet.
Ochre oval 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 doses.
4
CLINICAL PARTICULARS
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, primary hyperparathyroidism).
• Nephrolithiasis / nephrocalcinosis
• Severe renal impairment and renal failure
• Hypervitaminosis D
• Hypersensitivity to