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OSVAREN 435MG/235MG FILM-COATED TABLETS

Active substance(s): CALCIUM ACETATE / HEAVY MAGNESIUM CARBONATE

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Package Leaflet: Information for the user

1. What OsvaRen® is and what it is used for

Take special care with OsvaRen®

OsvaRen® 435 mg / 235 mg

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

film-coated tablets

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.

Before you take 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.

Calcium acetate/Magnesium carbonate, heavy
(this will be referred to as OsvaRen® throughout the leaflet)

Read all of this leaflet carefully before you start taking this
medicine.

2. Before you take OsvaRen®

• If you have any further questions, ask your doctor or pharmacist.

Do not take OsvaRen®

• 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 you are hypersensitive (allergic) to calcium acetate, magnesium
carbonate or any of the other ingredients of OsvaRen®

• 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.

• if your phosphate blood levels are too low

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1. What OsvaRen is and what it is used for
2. Before you take OsvaRen®
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3. How to take OsvaRen
4. Possible side effects

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5. How to store OsvaRen
6. Further information

- 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).

• Keep this leaflet. You may need to read it again.

In this leaflet:

• OsvaRen® is only to be taken with caution in view of calcium, magnesium and
phosphate blood values in the following cases:

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

magnesium. Talk to your doctor before taking antacids because they might add to
the amount of calcium and magnesium you are already taking with OsvaRen®.
• if you experience diarrhoea. In this case, please contact your doctor and take a
lower dose of OsvaRen®.
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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

• 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.

• The calcium value in the blood is to be monitored if the following are being taken:

• 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.

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

- vitamin D, as it increases the level of calcium in your body
- certain diuretic substances (water pills), such as hydrochlorothiazide, as the
calcium levels in your body may rise
• oestrogens, as female sex hormones, increase the calcium levels in your body
- antibiotics, such as tetracycline, doxycycline, ciprofloxacin, norfloxacin,
cefpodoxime, cefuroxime

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

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

• if you take OsvaRen® for a long time because calcium deposits in tissue and hence
tissue hardening may occur.

- fluorides to prevent and treat caries and bone disorders

• if you develop constipation.

- estramustine, a medicine to treat prostate cancer

• if you want to take antacids (used to relieve heartburn) that contain calcium or

- anticholinergics, substances to treat Parkinson’s disease and irritable bladder

- ketoconazole, a medicine to treat fungal infections

- zinc

Taking OsvaRen® with food and drink

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

OsvaRen® should be taken with meals.

- halofantrine, a medicine to treat malaria
- iron preparations

Pregnancy and breast-feeding

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

There are no data available on the use of OsvaRen® during pregnancy and
breast-feeding.

- nitrofurantoin, a substance to treat urinary tract infections

Ask your doctor or pharmacist for advice before taking any medicine.

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

Pregnancy
You should take OsvaRen® only if your treating physician believes that the
potential benefits outweigh the risk. Your calcium and magnesium levels will be
checked regularly.

• OsvaRen® can increase the levels and hence the effect of the following
medicines:
- levothyroxine, a drug used in impaired function of the thyroid gland
• OsvaRen® can increase the calcium values and hence the effect of the
following agents:
- digitalis glycosides (cardiac glycosides such as digoxin) as a medicine to
enhance the performance of the heart
- adrenaline, a substance to control allergic reactions and to treat shock
Possible consequences can even lead to severe disorders of heart rhythm.

Breastfeeding
Breastfeeding is not recommended if you take OsvaRen®.

Driving and using machines
No particular precautions are necessary.

If you need a medicine like digitalis glycosides (such as digoxin or digitoxin) your
doctor will do ECG monitoring.

Important information about some of the ingredients of
OsvaRen®

• OsvaRen® can reduce the effect of the following medicine:

This medicinal product contains sucrose.

- Calcium antagonists, such as verapamil, an agent to lower blood
pressure.
No other oral medicines mentioned in this leaflet should be taken within the
period 2 hours before and 3 hours after the intake of OsvaRen®.
Also if you take OsvaRen® as recommended, OsvaRen® may influence the
effects of other medicines due its effect on the blood calcium levels.

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 has to be taken into consideration by patients
on a controlled sodium diet.

3. How to take OsvaRen®
®

Always take OsvaRen exactly as your doctor has told you. You should check
with your doctor or pharmacist if you are not sure.

Please speak to you doctor or pharmacist if you have the impression that the
effect of OsvaRen® is too strong or too weak.

4. Possible side effects
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Like all medicines, OsvaRen can cause side effects, although not everybody gets
them. The following frequencies have been used for the assessment of side effects:

If you take more OsvaRen® than you should
Use in children and adolescents:
Insufficient information on the use of OsvaRen® is available in these patient
groups. Therefore, the administration of OsvaRen® is not recommended in
children and adolescents below 18 years of age (see section 2).

Adults
The dosage to be taken should be prescribed and monitored by your doctor
according to the level of phosphate values in your blood.

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

very common
common
uncommon
rare
very rare

- loss of appetite

Breaking the tablets immediately before taking will avoid the development of an
unpleasant taste.
No other 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.

- hypo-acidification of the blood

What OsvaRen® contains

In case of a missed dose, the next dose should be taken at the normal time (no
attempt should be made to make up for the missed dose).

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

- increased excretion of calcium in the urine

6. Further information

Maximum daily dose: 12 film-coated tablets

The film-coated tablets are to be taken at mealtimes. Do not crush or chew the
tablets. If you cannot swallow the tablets whole, you may break them along the
score line immediately before you take them.

- confusion

- high blood pressure

- nausea

If you stop taking OsvaRen®

- weakness

Keep out of the reach and sight 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 the
contents 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.

• gastro-intestinal disorders such as
- soft stools

Always take the medicine with food.

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

Marketing Authorisation Holder
®

- heart rhythm disturbances

If you forget to take OsvaRen®

The dose is then increased gradually until the desired phosphate levels in the
blood are reached, unless you develop high blood calcium levels.

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

5. How to store OsvaRen®

common

Recommended dose: 3 to 10 film-coated tablets
The recommended starting dose is 3 tablets daily. Take the tablets together with
food.

more than 1 in 10 people treated
less than 1 in 10, but more than 1 in 100 people treated
less than 1 in 100, but more than 1 in 1000 people treated
less than 1 in 1000, but more than 1 in 10 000 people treated
less than 1 in 10 000 people treated, not known (cannot be
estimated from the available data)

uncommon

- hardening of tissues (deposit of calcium salts)
• moderate to severely increased magnesium blood levels, which can be associated
with the following complaints:

The active substances are calcium acetate and magnesium carbonate,
heavy.

- feeling of fullness

- tiredness

- belching

- muscle weakness

- constipation

- sleepiness ranging to diminished consciousness

Each film-coated tablet contains 435 mg calcium acetate, equivalent to
110 mg calcium and 235 mg magnesium carbonate heavy, equivalent to
60 mg magnesium. Each film-coated tablet contains not more than 5.6 mg
sodium and 50 mg sucrose.

- diarrhoea

- lowered pulse

The other ingredients are

- drop in blood pressure

• Tablet core: Starch, pregelatinised (from maize), maize starch, sucrose,
gelatin, croscarmellose sodium and magnesium stearate

• increase in calcium blood level, which can occur without symptoms or in connection
with symptoms such as

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

- constipation

very rare

- loss of appetite,

• raised potassium blood levels

What OsvaRen® looks like and contents of the pack

- feeling sick

• disturbed mineral balance of the bones

- being sick

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.

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.

• increase in magnesium blood level, mostly without symptoms

Fresenius Medical Care Nephrologica Deutschland GmbH
61346 Bad Homburg v.d.H., Germany

Manufacturer
Fresenius Medical Care Deutschland GmbH
61346 Bad Homburg v.d.H., Germany

Further information on this medicine, including package
information in formats suitable for the blind and partiallysighted, is available from the local representative of the
Marketing Authorisation Holder:
Fresenius Medical Care (UK) Ltd., Nunn Brook Road, Huthwaite
Nottinghamshire NG17 2HU, England - Tel.: 0044 (0)1623 445100
Fresenius Medical Care (Ireland) Ltd
Grattan House, Malahide Road, Dublin 17, Ireland
Pharma-Cos Ltd., Pharma-Cos House, Triq C. Portanier,
Santa Venera SVR 1732, Malta, Tel: (+356) 21441870,
Fax: (+356) 21441388, Email: info@pharma-cos.com

This medicinal product is authorised in the Member States of
the EEA under the following names:
A, CY, CZ, D, DK, E, EST, F, FIN, GR, H, I, IRL, IS, L,
LT, LV, M, N, NL, P, PL, S, SK, SLO, UK: OsvaRen
B: Renepho
This leaflet was last revised
in 02/2011.

050M0203/01UK-IRL-M

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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