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Package Leaflet: Information for the user

OsvaRen® 435 mg/235 mg
film-coated tablets
(calcium acetate/magnesium carbonate, heavy)
The name of your medicine is OsvaRen 435 mg/235 mg film-coated tablets.
It will be referred to as OsvaRen throughout the remainder of this leaflet.

Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
• 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 only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:
1. What OsvaRen is and what it is used for
2. What you need to know before you take OsvaRen
3. How to take OsvaRen
4. Possible side effects
5. How to store OsvaRen
6. Contents of the pack and other information

1. What OsvaRen is and what it is used for

Warnings and precautions

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

Talk to your doctor before you are taking OsvaRen. Your doctor will talk to you about
any changes in diet because of the effect it has on the phosphate levels in your body
and depending on the kind of dialysis you receive.

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 phosphate and thereby
balances your phosphate levels.

2. What you need to know before you take OsvaRen
Do not take OsvaRen
• if you are allergic to calcium acetate, magnesium carbonate or any of
the other ingredients of this medicine (listed in section 6).
• if your phosphate blood levels are too low.

• OsvaRen is only to be taken with caution in view of calcium, magnesium and
phosphate blood values in the following cases:
- very high, non-treatable blood phosphate values
- high, difficult to treat potassium blood values
- low heart frequency or conduction defects of the heart, which are associated with
a slow heart beat (2nd degree AV-block).
Your doctor will regularly check your levels of phosphate, magnesium, calcium and the
calcium-phosphate-product in your blood.
If your calcium and magnesium blood values are too high, your doctor will lower the
OsvaRen dose according to the blood values or discontinue treatment. Adjustment of
the amount of calcium and magnesium in the dialysate may be necessary.

• if you have chronic kidney impairment because you may develop high levels of
calcium in the blood. Possible signs of high calcium levels are muscle weakness
and stomach problems such as bellyache, constipation, feeling and being sick.
Please talk to your doctor, if any of these signs occur.

- urso- and chenodesoxycholic acid, substances to treat gall stones

• be aware of possible symptoms of elevated calcium in your blood as given in section 4.

- digoxin (a cardiac glycoside), a medicine to enhance the performance of
the heart

• if you take OsvaRen for a long time because calcium deposits in tissue and hence
tissue hardening may occur.
• if you need medicine like digitalis glycosides (such as digoxin or digitoxin) your
doctor will do ECG monitoring and control your calcium level during administration
of OsvaRen.
• if you develop constipation.
• if you experience diarrhoea. In this case, please contact your doctor and take a
lower dose of OsvaRen.

- halofantrine, a medicine to treat malaria
- iron preparations

OsvaRen is to be taken with a meal.

- penicillamine, a medicine to treat chronic inflammation of the joints

Pregnancy and breast-feeding

• OsvaRen can increase the levels and hence the effect of the following
- levothyroxine, a medicine used in impaired function of the thyroid gland
• The calcium value in the blood is to be monitored if the following are being
- vitamin D, as it increases the level of calcium in your body

Tell your doctor or pharmacist if you are taking or have recently taken or might take
any other medicines.

- certain diuretic substances (water pills), such as hydrochlorothiazide, as
the calcium levels in your body may rise

• if you have raised calcium blood values.
This can arise due to vitamin D overdose, tumours of the lung, breast,
kidneys or blood, bone metastases, certain lung disorders (sarcoidosis) or
from bone loss as a consequence of lack of exercise.

Caution is advised:
• in case of simultaneous intake of vitamin D preparations and certain diuretic substances (water pills), such as hydrochlorothiazide, as they can increase the calcium
level in your body.

• OsvaRen can lower the levels and hence the effect of the following medicines:

• if you have raised magnesium values in the blood and/or corresponding

• if you take high doses of OsvaRen over a long time because your magnesium
blood values may rise. Possible signs of high magnesium levels are stomach
problems such as feeling sick, loss of appetite and constipation. If the magnesium
levels are very high you might experience muscle weakness, low blood pressure or
even fainting and coma.

- bisphosphonates, such as alendronate and risedronate, medicines to treat
bone diseases

- digitalis glycosides (cardiac glycosides such as digoxin) as a medicine to
enhance the performance of the heart

- fluorides to prevent and treat caries and bone disorders

- adrenaline, a substance to control allergic reactions and to treat shock
Possible consequences can even lead to severe disorders of heart rhythm.

• if you have the heart rhythm disturbance called 3rd degree AV-block.
• if you suffer from muscular fatigue, including that of the eye muscles
and weakness of the muscles used in swallowing, chewing and breathing
(myasthenia gravis).

• if you want to take antacids (used to relieve heartburn) that contain calcium or magnesium. Talk to your doctor before taking, because they might add to the amount of
calcium and magnesium you are already taking with OsvaRen.

- ketoconazole, a medicine to treat fungal infections
- estramustine, a medicine to treat prostate cancer
- anticholinergics, substances to treat Parkinson’s disease and irritable bladder
- zinc

Taking OsvaRen with food and drink

- nitrofurantoin, a substance to treat urinary tract infections

Other medicines and OsvaRen

- antibiotics, such as tetracycline, doxycycline, norfloxacin, some cephalosporins
like cefpodoxime, cefuroxim, and some quinolones like ciprofloxacin

None of the oral medicines mentioned in this leaflet should be taken within the
period 2 hours before and 3 hours after the intake of OsvaRen.
Even if you take OsvaRen as recommended, OsvaRen may influence the
effects of other medicines due its effect on the blood calcium levels.

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
There are no or limited amount of data on the use of OsvaRen during
pregnancy and breast-feeding.
You should only take OsvaRen if your doctor tells you that your clinical
condition required the treatment. Your calcium and magnesium levels will
be checked regularly.
Breast-feeding is not recommended if you take OsvaRen.

• Oestrogens, as female sex hormones, increase the calcium levels in your body

Driving and using machines

• OsvaRen can increase the calcium values and hence the effect of the
following agents:

Not relevant.

• OsvaRen can reduce the effect of the following medicine:
- Calcium antagonists, such as verapamil, an agent to lower blood

OsvaRen contains 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.

OsvaRen contains sodium.
This medicinal product contains 0.244 mmol (or 5.6 mg) - 0.976 mmol
(or 22.4 mg) sodium per dose (1 - 4 film-coated tablets). To be taken in
consideration by patients on a controlled sodium diet.

3. How to take OsvaRen
Always take this medicine exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
The dosage to be taken should be prescribed and monitored by your doctor
according to the level of your phosphate values in the blood.
The recommended dose is: 3 to 10 film-coated tablets
Maximum daily dose: 12 film-coated tablets
The recommended starting dose is 3 tablets daily. Take the tablets together with
the meals.
The dose is then increased gradually until the desired phosphate levels in the
blood are reached, unless you develop high blood calcium levels.

Use in children and adolescents
The safety and efficacy of OsvaRen in children and adolescence have not been
established. Therefore, the administration of OsvaRen is not recommended in
children and adolescents below 18 years of age.

Method of administration
Always take this medicine at mealtimes.
Do not crush or chew the tablets. If you cannot swallow the tablet in whole, you
may break it along the score line immediately before you take them.
The score line is only there to help you break the tablet if you have difficulty
swallowing it whole.
Breaking the tablets immediately before taking will avoid the development of an
unpleasant taste.

None of the oral medicines mentioned in this leaflet should be taken within the
period 2 hours before and 3 hours after the intake of OsvaRen.
OsvaRen can be used over a longer period, whereby your doctor should decide
the exact length of time.
Please talk to your doctor or pharmacist if you have the impression that the
effect of OsvaRen is too strong or too weak.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets

What OsvaRen looks like and contents of the pack

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:

White to weakly yellow, elongated, scored film-coated tablet. The score line only
serves to divide the tablet in order to make it easier to swallow and not to divide
it up into equal doses.
OsvaRen is available in a polyethylene container with 180 film-coated tablets.

- disturbed consciousness such as disorientation, unconsciousness (stupor) and
even coma

• gastro-intestinal disorders such as

- weakness

- soft stools
- nausea

Consult your doctor, as the calcium and magnesium blood values will go up and
can lead to serious side effects.

- loss of appetite
- feeling of fullness
- belching
- constipation
- diarrhoea
• increase in calcium blood level, which can occur without symptoms or in connection
with symptoms such as

If you forget to take OsvaRen

- constipation

If you miss a dose you should continue with the next dose. Do not take a double
dose of OsvaRen to make up for a forgotten dose.

- loss of appetite

If you stop taking OsvaRen

- being sick

Do not interrupt or stop taking OsvaRen without consulting your doctor.
If you have any further questions on the use of this medicine, ask your doctor or

Reporting of side effects

• moderate to severely increased calcium blood levels, which can be associated with
the following complaints:

common (may affect up to 1 in 10 people):

If you take more OsvaRen than you should

Typical signs of high calcium and magnesium blood values are gastric disorders,
muscle weakness, low blood pressure, nausea, loss of appetite, constipation,
heart rhythm disturbances and sleepiness. Typical signs of extremely high
calcium blood values are loss of energy, unconsciousness and even coma.
Typical signs of extremely high magnesium blood values are low blood pressure
and even coma.

uncommon (may affect up to 1 in 100 people):

- feeling sick
• increase in magnesium blood level, mostly without symptoms

- confusion
- increased excretion of calcium in the urine
- hypo-acidification of the blood
- heart rhythm disturbances
- high blood pressure
- hardening of tissues (deposit of calcium salts)
• moderate to severely increased magnesium blood levels, which can be associated
with the following complaints:
- tiredness
- muscle weakness

By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store OsvaRen
Keep out of the sight and reach of children.
Do not use OsvaRen after the expiry date which is stated on the container after ’EXP’.
The expiry date refers to the last day of that month.
After first opening of the container, use OsvaRen within 3 months.
Keep the container tightly closed in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.

- sleepiness ranging to diminished consciousness

6. Contents of the pack and other information

- lowered pulse

What OsvaRen contains

- drop in blood pressure

The active substances are calcium acetate and magnesium carbonate,

very rare (may affect up to 1 in 10,000 people):
• raised potassium blood levels
• disturbed mineral balance of the bones

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. Each film-coated tablet contains not more than 5.6 mg
sodium and 50 mg sucrose.
The other ingredients are
• Tablet core: Starch, pregelatinised (from maize), maize starch, sucrose,
gelatin, croscarmellose sodium and magnesium stearate

Fresenius Medical Care Deutschland GmbH
Else-Kroener-Strasse 1
Bad Homburg Vor der Hohe
Product Licence Holder
Procured from within the EU.
Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James`
House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
OsvaRen® 435 mg/235 mg film-coated tablets
PL 18067/0503
This leaflet was last revised on 9th May 2017.
Osvaren® is a trademark of Fresenius Medical Care Nephrologica Deutschland GmbH.

To request a copy of this leaflet in Braille,
large print or audio please call 01622

• Tablet film-coating: Castor oil, refined and hypromellose.

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