Osvaren 435mg/235mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALCIUM, MAGNESIUM

Available from:

Fresenius Medical Care Nephrologica Deutschland GmbH D-61346 Bad Homburg, Germany

ATC code:

A12AA12

INN (International Name):

CALCIUM 110 mg MAGNESIUM 60 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

CALCIUM 110 mg MAGNESIUM 60 mg

Prescription type:

POM

Therapeutic area:

MINERAL SUPPLEMENTS

Authorization status:

Withdrawn

Authorization date:

2007-09-25

Patient Information leaflet

OSVAREN 
Fresenius Medical Care 
Film-coated tablets 
Nephrologica Deutschland GmbH

Module 1.3.1 PIL Engl_day_90_clean_clean_day_90_final 
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PACKAGE LEAFLET: INFORMATION FOR THE USER 

OSVAREN 435 MG / 235 MG FILM-COATED TABLETS 

Film-coated tablets 

Calcium acetate/Magnesium carbonate, heavy 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. 
• 
Keep this leaflet. You may need to read it again.  
• 
If you have any further questions, ask your doctor or pharmacist.  
• 
This medicine has been prescribed for you. Do not pass it on to
others. It may harm 
them, even if their symptoms are the same as yours.  
• 
If any of the side effects gets serious, or if you notice any side
effects not listed in this 
leaflet, please tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1. 
What OsvaRen is and what it is used for 
2. 
Before you take OsvaRen  
3. 
How to take OsvaRen 
4. 
Possible side effects 
5. 
  How to store OsvaRen  
6. Further 
information 

1.  WHAT OSVAREN IS AND WHAT IT IS USED FOR 

OsvaRen is used to treat high blood phosphate levels in patients with
chronic kidney impair-
ment who are on dialysis (haemodialysis, peritoneal dialysis). 

OsvaRen belongs to a group of medicines
known as phosphate binders. Phosphate is a mineral 
that affects the health of bones. When your kidney function
is impaired you tend to have high 
phosphate levels in the blood. This can put you at risk of
bone problems. OsvaRen binds phos-
phate and thereby balances your phosphate levels. 

2. BEFORE YOU TAKE OSVAREN 

DO NOT TAKE OSVAREN 
•  if you are HYPERSENSITIVE (allergic) to CALCIUM ACETATE,
MAGNESIUM CARBONATE or any of the 
other ingredients of OsvaRen. 
• if your phosphate blood levels are too low 

•  if you have RAISED CALCIUM BLOOD VALUES 
This can arise due to vitamin-D overdose, tumours of the lung,
breast, kidneys or blood, bone 
me

Summary of Product characteristics

Page 1 of 8 
SUMMARY OF PRODUCT CHARACTERISTICS 

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, 435.00 equivalent to 110 mg calcium and
Magnesium carbonate, heavy 235.00 mg 
equivalent to 60 mg magnesium 

Excipients: Each film-coated tablet contains max. 5.6 mg sodium and
50.00 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 INDICATION 

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. 
Page 2 of 8 
_ _
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 with