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OSVAREN 435MG/235MG FILM-COATED TABLETS

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

Warnings and precautions

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).

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.

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film-coated tablets

Calcium acetate/Magnesium carbonate, heavy

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
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2. What you need to know before you take OsvaRen

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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.
• 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.

3. How to take OsvaRen®

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

4. Possible side effects

• if you have the heart rhythm disturbance called 3rd degree AV-block.

5. How to store OsvaRen

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6. Contents of the pack and other information

• 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).

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• 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.
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.
• 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.
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• 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®.

• 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.
• be aware of possible symptoms of elevated calcium in your blood as given in section 4.
• if you take OsvaRen for a long time because calcium deposits in tissue and hence
tissue hardening may occur.
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• 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®.

Other medicines and OsvaRen®
Tell your doctor or pharmacist if you are taking or have recently taken or might take
any other medicines.
• OsvaRen® can lower the levels and hence the effect of the following medicines:
- antibiotics, such as tetracycline, doxycycline, norfloxacin, some cephalosporins
like cefpodoxime, cefuroxim, and some quinolones like ciprofloxacin
- bisphosphonates, such as alendronate and risedronate, medicines to treat
bone diseases
- fluorides to prevent and treat caries and bone disorders
- 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

OsvaRen_435mg_235mg_UK_PIL_2017-01_v11.indd 1

- urso- and chenodesoxycholic acid, substances to treat gall stones
- halofantrine, a medicine to treat malaria
- iron preparations
- digoxin (a cardiac glycoside), a medicine to enhance the performance of
the heart

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.

Taking OsvaRen® with food and drink

- nitrofurantoin, a substance to treat urinary tract infections

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
medicines:
- 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
taken:
- vitamin D, as it increases the level of calcium in your body
- c ertain 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
• OsvaRen® can increase the calcium values and hence the effect of the
following agents:
- d igitalis 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.
• OsvaRen® can reduce the effect of the following medicine:
-C
 alcium antagonists, such as verapamil, an agent to lower blood
­pressure.

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
medicine.
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®.

Driving and using machines
Not relevant.

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.

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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

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

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

Reporting of side effects

What OsvaRen® looks like and contents of the pack

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

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

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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

White to yellowish, oblong, scored film-coated tablets.

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

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

• gastro-intestinal disorders such as

- weakness

Maximum daily dose: 12 film-coated tablets

If you take more OsvaRen® than you should

- soft stools

- confusion

The recommended starting dose is 3 tablets daily. Take the tablets together with
the meals.

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

- nausea

- increased excretion of calcium in the urine

- loss of appetite

- hypo-acidification of the blood

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

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.

- feeling of fullness

- heart rhythm disturbances

- belching

- high blood pressure

- constipation

- hardening of tissues (deposit of calcium salts)

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.

OsvaRen_435mg_235mg_UK_PIL_2017-01_v11.indd 2

If you forget to take OsvaRen

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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.

If you stop taking OsvaRen®
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
pharmacist.

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

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

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

5. How to store OsvaRen®
Keep this medicine out of the sight and reach of children. Do not use this medicine 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. Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.

- constipation

- muscle weakness

- loss of appetite

- sleepiness ranging to diminished consciousness

- feeling sick

- lowered pulse

What OsvaRen® contains

- being sick

- drop in blood pressure

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

• increase in magnesium blood level, mostly without symptoms

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

OsvaRen® is available in a polyethylene container with 180 film-coated tablets.

Marketing authorisation holder:

Fresenius Medical Care Nephrologica Deutschland GmbH, Else-Kröner-Straße 1,
61352 Bad Homburg v.d.H., Germany

Manufacturer:

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1,
61352 Bad Homburg v.d.H., Germany

Local representative:

Fresenius Medical Care (UK) Ltd.
Tel: + 44 (0)1623 445 100
This leaflet was last approved in January 2017

6. Contents of the pack and other information

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.
The other ingredients are starch, pregelatinised (from maize), maize starch,
sucrose, gelatin, croscarmellose sodium and magnesium stearate; castor oil,
refined and hypromellose.

050M0203/03UK

28.03.17 16:30

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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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