Package leaflet: Information for the user

OsvaRen 435 mg/235 mg film-coated tablets

Calcium acetate/magnesium carbonate heavy
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What OsvaRen is and what it is used for
What you need to know before taking OsvaRen
How to take OsvaRen
Possible side effects
How to store OsvaRen
Contents of the pack and other information

1. What OsvaRen is and what it is used for

OsvaRen is used to treat high phosphate levels in the blood of adult patients with chronic kidney disease who are on dialysis (haemodialysis, peritoneal dialysis).
OsvaRen belongs to a group of medicines known as phosphate binders. Phosphate is a mineral that affects bone health. When kidney function is impaired, phosphate levels in the blood may become elevated. This may put you at risk of bone-related problems. OsvaRen binds phosphate and thereby helps balance phosphate levels.

2. What you need to know before taking OsvaRen

Do not take OsvaRen

if you are allergic to calcium acetate, magnesium carbonate, or any of the other excipients in this medicine (listed in section 6)
if your blood phosphate levels are too low
if you have high calcium levels in the blood
if you have high magnesium levels in the blood and/or corresponding symptoms
if you have heart rhythm disorders (third-degree AV block)
if you suffer from muscle fatigue, including eye muscles, and weakness of muscles involved in swallowing, chewing, and breathing (myasthenia gravis).

Warnings and precautions
Talk to your doctor or pharmacist before taking OsvaRen. Your doctor will advise you on
dietary changes, as the effect on phosphate levels in the body depends on the type of dialysis
you receive.
OsvaRen should be taken with particular caution considering blood levels of calcium, magnesium, and
phosphate in the following cases:

very high phosphate levels in the blood that cannot be treated
high potassium levels in the blood that are difficult to manage
slow heart rate or conduction defects of the heart associated with a slow heartbeat (second-degree AV block). Your doctor will regularly monitor your blood levels of phosphate, magnesium, calcium, and calcium phosphate products. If calcium and magnesium levels in the blood are too high, your doctor will reduce the dose of OsvaRen according to blood values or discontinue treatment. Adjustment of calcium and magnesium content in the dialysate may be necessary.

Use with caution:

when taking vitamin D preparations and certain diuretics (diuretics) such as hydrochlorothiazide simultaneously, as they may increase calcium levels in the body
if you take high doses of OsvaRen for a prolonged period, as magnesium levels in the blood may rise. Gastrointestinal problems such as nausea, loss of appetite, and constipation may be signs of high magnesium levels. If magnesium levels are very high, you may experience muscle weakness, low blood pressure, fainting, or even coma.
if you have chronic kidney damage, as high calcium levels in the blood may occur. Muscle weakness and gastrointestinal problems such as abdominal pain, constipation, nausea, and vomiting may be signs of high calcium levels. Contact your doctor if you notice any of these symptoms.
pay attention to possible symptoms of high calcium levels in the blood as described in section 4.
if you take OsvaRen for a long time, as calcium may deposit in tissues, potentially leading to tissue hardening.
if you require medications such as cardiac glycosides (e.g., digoxin or digitoxin), your doctor will perform an ECG check and monitor your calcium levels during OsvaRen treatment.
if constipation develops
if you experience diarrhea. In this case, contact your doctor and take a lower dose of OsvaRen.

Other medicines and OsvaRen
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
None of the oral medicines mentioned in this leaflet should be taken within 2 hours before and 3 hours after taking OsvaRen.
Even when taking OsvaRen as recommended, OsvaRen may affect the action of other medicines due to its effect on calcium and magnesium levels in the blood.

OsvaRen may reduce the levels and therefore the effect of the following medicines:
antibiotics, such as tetracycline, doxycycline, some cephalosporins like cefpodoxime and cefuroxime, some quinolones like ciprofloxacin and norfloxacin, nitrofurantoin
bisphosphonates, such as alendronate and risedronate, medicines for treating bone diseases
fluorides for preventing and treating dental caries and other bone disorders
ketoconazole, a medicine for treating fungal infections
estramustine, a medicine for treating prostate cancer
anticholinergics, substances for treating Parkinson's disease and overactive bladder
zinc
ursodeoxycholic and chenodeoxycholic acid, substances for treating gallstones
halofantrine, a substance for treating malaria
oral preparations containing iron
digoxin (a cardiac glycoside), a medicine to strengthen heart function
penicillamine, a medicine for treating chronic joint inflammation
levothyroxine, a substance used in case of impaired thyroid gland function
hypoxia-inducible factor prolyl-hydroxylase inhibitors (HIF-PHI), medicines for treating anemia, such as vadadustat, roxadustat, and molidustat
- Calcium levels in the blood should be monitored when taking OsvaRen together with the following medicines or preparations:
vitamin D preparations
some diuretics, such as hydrochlorothiazide
estrogens, such as female sex hormones
vitamin A preparations, as calcium levels may increase.
- OsvaRen may increase calcium or magnesium levels when taken simultaneously with antacids (used to relieve heartburn) and/or supplements containing calcium or magnesium.
- OsvaRen may increase calcium levels and thus the effect of the following medicines:
cardiac glycosides (cardiac glycosides such as digoxin), medicines to strengthen heart function
adrenaline, a substance to control allergic reactions and treat shock. Possible consequences may lead to severe heart rhythm disturbances.
- OsvaRen may reduce the effect of the following medicines:
calcium antagonists, medicines to lower blood pressure.

OsvaRen with food and drinks
OsvaRen should be taken during meals.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
There are no data or limited data on the use of OsvaRen in pregnant or breastfeeding women.
If you are pregnant, you should take OsvaRen only if your doctor determines that your clinical condition requires treatment. Calcium and magnesium levels should be monitored regularly.
OsvaRen must not be used during breastfeeding.
Driving and using machines
Not relevant.
OsvaRen contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
OsvaRen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e., essentially ‘sodium-free’.

3. How to take OsvaRen

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The dosage to be taken must be prescribed and monitored by your doctor according to your blood phosphate levels.
Recommended dose: 3 to 10 film-coated tablets
Maximum daily dose: 12 film-coated tablets
The recommended starting dose is 3 tablets per day.
The dose is then gradually increased until the desired blood phosphate levels are achieved, unless high levels of calcium in the blood occur.

Use in children and adolescents
The safety and efficacy of OsvaRen in children and adolescents has not been established. Therefore, OsvaRen must not be used in children and adolescents under 18 years of age.

Method of administration
Always take this medicine during meals.
Do not crush or chew the tablets. If you are unable to swallow the tablet whole, you may break it along the score line immediately before taking it. The score line is intended only to assist you in breaking the tablet if you have difficulty swallowing it.
Break the tablets immediately before ingestion to avoid the development of an unpleasant taste.
OsvaRen may be used for a long period, but the exact duration must be determined by your doctor.
If you feel that the effect of OsvaRen is too strong or too weak, speak to your doctor or pharmacist.

If you take more OsvaRen than you should
Contact your doctor, as blood levels of calcium and magnesium may increase and lead to serious adverse effects.
Typical signs of high calcium and magnesium levels in the blood include gastrointestinal disturbances, muscle weakness, low blood pressure, nausea, loss of appetite, constipation, cardiac rhythm disturbances, and drowsiness. Loss of strength, unconsciousness, and even coma are typical symptoms of extremely high calcium levels in the blood. Low blood pressure and even coma are typical symptoms of extremely high magnesium levels in the blood.

If you forget to take OsvaRen
If you miss a dose, continue with the next scheduled dose. Do not take a double dose to make up for the missed dose.

If you stop taking OsvaRen
Do not interrupt or stop taking OsvaRen without consulting your doctor.

If you have further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Common (may affect up to 1 in 10 people):
Gastrointestinal disorders such as:

soft stools
nausea
loss of appetite
feeling of fullness
belching
constipation
diarrhoea
- increased calcium levels in the blood, which may occur without symptoms or together with symptoms such as:
constipation
loss of appetite
nausea
vomiting
- increased magnesium levels in the blood, predominantly without symptoms

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

moderate to severe increase in calcium levels in the blood, which may be associated with the following disorders:
disturbances of consciousness such as lethargy, disorientation, state of unconsciousness (stupor), and even coma
muscle weakness and generalised weakness
confusion
increased excretion of calcium in the urine
reduced acidity of the blood (acid-base imbalance)
heart rhythm disorders
high blood pressure
tissue rigidity (calcium salt deposition)
- moderate to severe increase in magnesium levels in the blood, which may be associated with the following disorders:
fatigue
muscle weakness
drowsiness up to reduced consciousness
weak pulse
drop in blood pressure

Very rare (may affect up to 1 in 10,000 people):

increased potassium levels in the blood
disturbance of bone mineral balance

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Period of validity after first opening the container: 3 months.
Keep the container tightly closed to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What OsvaRen contains

The active substances are: calcium acetate and magnesium carbonate, heavy. Each film-coated tablet contains: Calcium acetate 435 mg, equivalent to 110 mg of calcium, and heavy magnesium carbonate 235 mg, equivalent to 60 mg of magnesium.
The other components are: Starch, pregelatinized (from maize), maize starch, sucrose, gelatin, sodium croscarmellose, magnesium stearate, castor oil, refined, hypromellose. Description of the appearance of OsvaRen and package contents Film-coated tablet, white-yellowish in color, oblong with a score line.

OsvaRen is available in polyethylene containers containing 180 film-coated tablets.
Marketing Authorization 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
Vifor Fresenius Medical Care Renal Pharma Italia S.r.l.,
Tel: +39-0373 977 321
This summary of product characteristics was last approved on .