OSVAREN 435 mg / 235 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

OsvaRen 435 mg / 235 mg film-coated tablets

Calcium, acetate / Magnesium, heavy carbonate

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet

1. What OsvaRen is and what it is used for
2. What you need to know before taking OsvaRen
3. How to take OsvaRen
4. Possible side effects
   1. Storage of OsvaRen

1. Package contents and additional information

1. What OsvaRen is and what it is used for

This medication is used to treat high levels of phosphate in the blood in adult patients with chronic kidney failure who are on 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 kidney function is damaged, you tend to have high levels of phosphate in your blood. This can put you at risk of bone problems. OsvaRen binds to phosphate and therefore balances your phosphate levels.

2. What you need to know before taking OsvaRen

Do not take OsvaRen

• if you are allergicto calcium acetate, magnesium carbonate, or any of the other components of this medication (listed in section 6).
• if your phosphate levels in the bloodare too low.
• if you have high levels of calcium in the blood.
• if you have high levels of magnesiumin the blood and/or corresponding symptoms.
• if you have a heart rhythm disordercalled third-degree AV block.

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

Warnings and precautions

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

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

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

Your doctor will regularly monitor your blood levels of phosphate, magnesium, calcium, and the calcium-phosphate product. If your calcium and magnesium levels in the blood are too high, your doctor will reduce the dose of OsvaRen according to the blood values or interrupt treatment. It may be necessary to adjust the amount of calcium and magnesium in the dialysate.

Cautions are recommended:

• in the case of simultaneous intake 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, as they may increase your magnesium levels in the blood. Possible symptoms of high magnesium levels are stomach problems such as nausea, loss of appetite, and constipation. If magnesium levels are very high, you may experience muscle weakness, low blood pressure, or even fainting and coma.
• if you have chronic kidney failure, as it may cause high levels of calcium in the blood. Possible signs of high calcium levels in the 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, as it may cause 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 calcium level during the administration of OsvaRen.
• if you start to experience constipation.
• if you suffer from diarrhea. In this case, contact your doctor and take a lower dose of OsvaRen.

Other medications and OsvaRen

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

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

Although you take OsvaRen according to the recommendations, OsvaRen may influence the effects of other medications due to its effect on calcium and magnesium levels in the blood.

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

• antibioticssuch as tetracycline, doxycycline; some cephalosporins such as cefpodoxime and cefuroxime; and some quinolones such as ciprofloxacin and norfloxacin, nitrofurantoin.
• bisphosphonates, such as alendronate and risedronate, medications for the treatment of bone diseases.
• fluoridesfor the prevention and treatment of caries and bone disorders.
• ketoconazole, a medication for the treatment of fungal infections.
• estramustine, a medication for the treatment of prostate cancer.
• anticholinergics, substances for the treatment of Parkinson's disease and irritable bladder.
• zinc
• ursodeoxycholic acidand chenodeoxycholic acid, substances for the treatment of gallstones.
• halofantrine, a medication for the treatment of malaria.
• oral iron preparations.
• digoxin(a cardiac glycoside), a medication to increase heart performance.
• penicillamine, a medication for the treatment of chronic joint inflammation.

• levothyroxine, a medication used in thyroid function disorders.
• hypoxia-inducible factor inhibitors, prolyl hydroxylase inhibitors (HIF-PHI), medications for the treatment of anemia, such as vadadustat, roxadustat, and molidustat.

• The calcium value in the blood should be monitored if OsvaRen and the following medications or preparations are taken:

• Vitamin D preparations,
• certain substances that help eliminate water (diuretics), such as hydrochlorothiazide, as they may increase calcium levels in your body.
• estrogens, such as female sex hormones.
• Vitamin A preparations, as they may increase calcium levels in the body.

OsvaRen may increase calcium or magnesium values in case of simultaneous intake with antacids(used to relieve stomach acidity) and/or supplementscontaining calcium or magnesium.

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

• digitalis glycosides(cardiac glycosides such as digoxin) as a medication that increases heart performance.
• adrenaline, a substance for controlling allergic reactions and treating shock.

The possible consequences can even lead to serious heart rhythm disorders.

• OsvaRen may reduce the effect of the following medications:

• Calcium antagonists, an agent to lower blood pressure.

Taking OsvaRen with food and drinks

OsvaRen should be taken with meals.

Pregnancy and breastfeeding

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

There are no data or limited data on the use of OsvaRen during pregnancy and breastfeeding.

If you are pregnant, you should only take OsvaRen if your doctor indicates that your clinical situation requires treatment. Your calcium and magnesium levels will be regularly monitored.

Driving and using machines

Not relevant.

OsvaRencontains sucrose.

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

OsvaRen contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet, which is essentially "sodium-free".

3. How to take OsvaRen

Follow the instructions for administration of this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

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

The recommended dose is:3 to10 film-coated tablets

Maximum daily dose: 12 film-coated tablets.

The recommended starting dose is 3 tablets per day. The dose is gradually increased until the desired phosphate levels in the blood are reached, unless high calcium levels in the blood occur.

Use in children and adolescents

The safety and efficacy of this medication have not been established in children and adolescents. Therefore, it should not be used in children and adolescents under 18 years of age.

Method of administration

Always take this medication with meals.

Do not crush or chew the tablets. If you cannot swallow the tablets whole, you can split them at the score line immediately before taking them. The score line is only for splitting the tablet if you find it difficult to swallow it whole.

If you split the tablets immediately before taking them, you will avoid the formation of an unpleasant taste.

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

Consult your doctor or pharmacist if you think the effect of this medication is too strong or too weak.

If you take more OsvaRen than you should

Consult your doctor, as the levels of calcium and magnesium in the blood will increase and may cause serious side effects.

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

The typical signs of high calcium and magnesium levels in the blood are gastrointestinal disorders, muscle weakness, low blood pressure, nausea, loss of appetite, constipation, heart rhythm disorders, and drowsiness. The typical signs of very high calcium levels in the blood are loss of energy, unconsciousness, and even coma. The typical signs of very high magnesium levels in the blood are decreased blood pressure and even coma.

If you forget to take OsvaRen

If you forget a dose, continue with the next one. Do not take a double dose to make up for the forgotten doses.

If you stop taking OsvaRen

Do not stop or discontinue this medication without consulting your doctor.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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
• diarrhea

• increased calcium level in the blood, which may occur without symptoms or related to symptoms such as

• constipation
• loss of appetite
• nausea
• vomiting

• increased magnesium level in the blood, mainly 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 discomfort:

• changes in consciousness such as lethargy, disorientation, unconsciousness (stupor), and even coma.
• muscle weakness and general weakness.
• confusion.
• increased excretion of calcium in the urine.
• acidosis of the blood.
• heart rhythm disorders.
• high blood pressure.
• hardening of tissues (calcium deposits).

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

• fatigue.
• muscle weakness.
• drowsiness leading to decreased consciousness.
• slower pulse.
• decreased blood pressure.

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

• high levels of potassium in the blood.
• mineral imbalance in the bones.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of OsvaRen

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

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

Expiration: after opening the packaging, 3 months.

Keep the packaging tightly closed to protect it from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

OsvaRen composition

• The active ingredientsare calcium 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 ingredients are pregelatinized starch (corn), cornstarch, sucrose, gelatin, sodium croscarmellose, magnesium stearate, refined castor oil, and hypromellose.

Appearance of OsvaRen and package contents

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

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

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

Date of the last revision of this package leaflet:December 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.