Prospecto: Information for the User

OsvaRen 435 mg / 235 mg Film-Coated Tablets

Calcium Acetate/Magnesium Carbonate Heavy

Read this prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is OsvaRen and for what it is used

2.What you need to know before starting to take OsvaRen

3.How to take OsvaRen

4.Possible adverse effects

1. Storage of OsvaRen

6.Contents of the package and additional information

OsvaRen is used to treat elevated levels of phosphate in the blood in patients with chronic kidney failure undergoing dialysis (hemodialysis, peritoneal dialysis).

OsvaRen belongs to a group of medications that bind to phosphate. Phosphate is a mineral that affects bone health. When your renal function is impaired, you tend to have elevated levels of phosphate in the blood. This can put you at risk of developing bone problems. OsvaRen binds to phosphate and therefore balances your phosphate levels.

Do not take OsvaRen

• if you areallergictocalcium acetate,magnesium carbonate, or any of the other ingredients of this medication (listed in section 6).
• if yourblood phosphate levelsaretoo low.
• if you havehigh levels of calcium in your blood.

This may increase due to a vitamin D overdose, lung, chest, kidney, or blood tumors, bone metastases, some lung changes (sarcoidosis), or bone loss due to lack of exercise.

• if you havehigh levels of magnesium in your blood and/or corresponding symptoms.
• if you have theheart rhythm disordercalled third-degree AV block.

• if you havemuscle fatigue, including eye muscle fatigue and weakness of muscles used for swallowing, chewing, or breathing (myasthenia gravis).

Warnings and precautions

Consult your doctor before starting to take OsvaRen. Your doctor will explain any changes in your diet due to the effect it has on your phosphate levels in your body and depending on the type of dialysis you receive.

• Given the levels of calcium, magnesium, and phosphate in your blood, OsvaRen will be taken with caution in the following cases:

• very high levels of phosphate in your blood that cannot be treated
• high levels of potassium in your blood that are difficult to treat
• low heart rate or heart conduction defects associated with a slow heart rate (second-degree AV block).

Your doctor will regularly monitor your blood levels of phosphate, magnesium, calcium, and the phosphate-calcium product. If your calcium and magnesium levels in your blood are too high, your doctor will reduce your OsvaRen dose according to your blood values or stop treatment. You may need to adjust the amount of calcium and magnesium in your dialysis.

Precautions are recommended:

• in the case of simultaneous ingestion of vitamin D preparations and certain diuretics, such as hydrochlorothiazide, as they may increase the level of calcium in your body.

• if you take high doses of OsvaRen for a long period of time, as they may increase your magnesium levels in your blood. Possible symptoms of high magnesium levels are stomach problems such as nausea, loss of appetite, and constipation. If your magnesium levels are very high, you may experience muscle weakness, low blood pressure, or even coma.
• if you want to take antacids (used to relieve stomach burning) that contain calcium or magnesium. Consult your doctor before taking antacids, as they may add to the amount of calcium and magnesium you are already taking with OsvaRen.
• if you have chronic kidney disease, as it may produce high levels of calcium in your blood. Possible signs of high calcium levels in your blood are muscle weakness and stomach problems such as abdominal pain, constipation, nausea, and vomiting. Inform your doctor if you have any of these signs.
• be aware of the possible symptoms of high calcium levels in your blood as indicated in section 4.
• if you take OsvaRen for a long period of time, as it may produce calcium deposits in tissues and therefore hardening.
• if you need medications from the group of digitalis glycosides (such as digoxin or digitoxin), your doctor will monitor your electrocardiogram and control your calcium levels during OsvaRen administration.
• if you start to experience constipation.
• if you have diarrhea. In this case, contact your doctor and take a lower dose of OsvaRen.

Use of OsvaRen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

?OsvaRen may decrease the levels, and therefore the effect, of the following medications:

• antibioticssuch as tetracycline, doxycycline, and norfloxacin; some cephalosporins such as cefpodoxime and cefuroxime; and some quinolones such as ciprofloxacin
• bisphosphonates, such as alendronate and risedronate, medications for the treatment of bone diseases
• fluoridesto prevent and treat caries and bone changes
• ketoconazole, a medication to treat fungal infections
• estramustine, a medication to treat prostate cancer
• anticholinergics, substances to treat Parkinson's disease and irritable bladder
• zinc
• ursodeoxycholic acidandchenodeoxycholic acid, substances to treat gallstones
• halofantrine, a medication to treat malaria
• preparations ofiron
• digoxin(a cardiac glycoside), a medication to increase heart performance
• nitrofurantoin, a substance to treat urinary tract infections
• penicillamine, a medication to treat chronic joint inflammation

• OsvaRen may increase the levels and therefore the effect of the following medications:

• levotiroxine, a medication used in thyroid function disorders

• vitamin D, as it increases the level of calcium in your body
• determined substances that help eliminate water(diuretics), such as hydrochlorothiazide, as they may increase the levels of calcium in your body

• OsvaRen may increase the levels of calcium and therefore the effect of the following substances:

• digitalis glycosides(digitalis cardiac glycosides such as digoxin) as a medication that increases heart performance
• adrenaline, a substance to control allergic reactions and treat shock

The possible consequences may lead to severe heart rhythm disorders.

• OsvaRen may reduce the effect of the following medications:

• calcium channel blockers, such as verapamil, an agent to reduce blood pressure.

None of the medications mentioned in this prospectus should be taken orally within 2 hours before and 3 hours after taking OsvaRen.

Although you take it as recommended, OsvaRen may influence the effects of other medications due to its effects on calcium levels in your blood.

Taking OsvaRen with food and drinks

OsvaRen should be taken with meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

There are no data or these are limited regarding the use of OsvaRen during pregnancy and breastfeeding. Only take OsvaRen if your doctor indicates that your clinical situation requires treatment. Your calcium and magnesium levels will be regularly monitored.

It is not recommended to breastfeed while taking OsvaRen.

Driving and operating machinery

Not relevant.

OsvaRen contains sucrose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

OsvaRen contains sodium

This medication contains 0.244 mmol (or 5.6 mg) – 0.976 mmol (or 22.4 mg) of sodium per dose (1 – 4 tablets), which should be taken into account in patients with low-sodium diets.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dose to be taken must be prescribed and monitored by your doctor according to your blood phosphate levels.

The recommended dose is: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 increased gradually until the desired blood phosphate levels are reached, unless high blood calcium levels occur.

Use in children and adolescents

The safety and efficacy of OsvaRen in children and adolescents have not been established. Therefore, OsvaRen is not recommended for children and adolescents under 18 years old.

Administration form

Take this medication with meals every time.

Do not crush or chew the tablets. If you cannot swallow the tablets whole, you can break them through the notch immediately before taking them. The notch is only for breaking the tablet if it is difficult to swallow it whole.

Breaking the tablets immediately before taking them will prevent an unpleasant taste from forming.

None of the medications mentioned in this leaflet should be taken orally within 2 hours before and 3 hours after taking OsvaRen.

OsvaRen can be used for a long period, so your doctor will decide exactly how long.

Consult your doctor or pharmacist if you consider that the effect of OsvaRen is too strong or too weak.

If you take more OsvaRen than you should

Consult your doctor, as blood calcium and magnesium levels will increase and may cause severe adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

The typical signs of high blood calcium and magnesium levels are gastrointestinal disorders, muscle weakness, low blood pressure, nausea, loss of appetite, constipation, cardiac rhythm alterations, and drowsiness. The typical signs of extremely high blood calcium levels are loss of energy, unconsciousness, and even coma. The typical signs of extremely high blood magnesium levels are low blood pressure and even coma.

If you forgot to take OsvaRen

If you forgot a dose, you should continue with the next one. Do not take a double dose of OsvaRen to compensate for the missed doses.

If you interrupt the treatment with OsvaRen

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

If you have any other doubts about the use of this medication, consult your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

• Gastrointestinal alterations such as

• soft stools
• nausea
• loss of appetite
• feeling of fullness
• eructation
• constipation
• diarrhea

• Increased calcium levels in the blood, which may occur without symptoms or associated with symptoms such as

• constipation
• loss of appetite
• nausea
• vomiting

• Increased magnesium levels in the blood, mainly without symptoms

Less frequent (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 discomforts:

• Alterations in consciousness such as disorientation, stupor, and even coma
• weakness
• confusion
• Increased excretion of calcium in the urine
• hypochloremia of the blood
• Alterations in heart rhythm
• high blood pressure
• Hardening of tissues (calcium salt deposition)

• Moderate to severe increase in magnesium levels in the blood, which may be associated with the following discomforts:

• fatigue
• muscle weakness
• sleepiness leading to a decrease in consciousness
• slower pulse
• drop in blood pressure

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

• Elevated potassium levels in the blood
• Alteration of the mineral balance of the bones

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

After the first opening of the packaging, use OsvaRen within 3 months.

Keep the packaging perfectly closed to protect it from moisture.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of OsvaRen

• Theactive principlesarecalcium acetate and heavy magnesium carbonate.

Each film-coated tablet contains:

435 mg of calcium acetate, equivalent to 110 mg of calcium and 235 mg of heavy magnesium carbonate, equivalent to 60 mg of magnesium.

• The other components are pregelatinized cornstarch (corn), cornstarch, sucrose, gelatin, sodium croscarmellose, magnesium stearate, refined ricin oil, and hypromellose.

Appearance of the product and content of the container

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

OsvaRen is available in polyethylene containers with 180 film-coated tablets.

Marketing authorization holder

Fresenius Medical Care Nephrologica Deutschland GmbH

Else-Kröner-Straße 1,
61352 Bad Homburg v.d.H., Germany

Responsible 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 España, S.L.

Avenida Diagonal 613

Barcelona 08028 - Spain

Last review date of this leaflet: March 2017

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/.