Osvaren 435mg/235mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calcium acetate; Magnesium carbonate heavy

Available from:

Vifor Fresenius Medical Care Renal Pharma UK Ltd

ATC code:

V03AE04

INN (International Name):

Calcium acetate; Magnesium carbonate heavy

Dosage:

435mg ; 235mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09050202; GTIN: 4046241074796

Summary of Product characteristics

OBJECT 1
OSVAREN 435 MG / 235 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 06-Jun-2011 | Vifor
Fresenius Medical Care Renal Pharma
UK Ltd
1. Name of the medicinal product
Osvaren 435 mg / 235 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains:
Calcium acetate, 435 mg equivalent to 110 mg calcium and Magnesium
carbonate, heavy 235 mg
equivalent to 60 mg magnesium
Excipients: Each film-coated tablet contains max. 5.6 mg sodium and 50
mg sucrose.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet.
White to yellowish, oblong film-coated tablet with a single score
line.
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
Treatment of hyperphosphatemia associated with chronic renal
insufficiency in patients undergoing
dialysis (haemodialysis, peritoneal dialysis).
4.2 Posology and method of administration
_Adults:_
3 to 10 film-coated tablets per day, depending on the serum phosphate
level. The daily dose should be
subdivided according to the number of meals taken over the day
(usually three a day).
The recommended starting dose is three tablets daily.
If necessary, the dosage may be raised to maximally 12 film-coated
tablets per day.
To achieve the maximum phosphate binding effect, Osvaren should be
taken only together with the meal
and should not be crushed or chewed.
For easy swallowing, the tablets should be taken together with some
liquid.
In case the tablets are too large to be swallowed by the patient, the
tablets should be broken along the
score line immediately before swallowing in order to avoid the
development of taste of acetic acid.
Because the rate and/or extent of absorption of other oral medicinal
products may vary when used
concurrently with OsvaRen no other oral medicinal products should be
taken within the period 2 hours
before and 3 hours after administration of OsvaRen (see section 4.5).
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