ROYEN 500 mg HARD CAPSULE

Introduction

Package Leaflet: Information for the User

ROYEN 500 mg Hard Capsule

Calcium Acetate

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

• 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects mentioned in this leaflet, or if you notice any other unusual effects not mentioned here, inform your doctor or pharmacist.

Contents of the Package Leaflet:

1. What is ROYEN 500 mg and what is it used for
2. Before taking ROYEN 500 mg
3. How to take ROYEN 500 mg
4. Possible side effects
5. Storage of ROYEN 500 mg
6. Further information

1. What is ROYEN 500 mg and what is it used for

ROYEN 500 mg is presented in the form of hard capsules for oral administration in containers containing 60 and 120 hard capsules.

Calcium acetate is a drug that belongs to the group of medicines called chelating agents. It combines with dietary phosphate and forms insoluble phosphates that are eliminated with the feces, which helps control blood phosphate levels.

ROYEN 500 mg hard capsule is indicated in:

• Control of hyperphosphatemia (high blood phosphate levels) in patients with advanced renal failure.

2. Before taking ROYEN 500 mg

Do not take ROYEN:

• If you are allergic to calcium acetate or any of the other components of ROYEN 500 mg.
• If you suffer from hypercalcemia (high blood calcium levels) or hypercalciuria (excessive elimination of calcium in the urine).

Be cautious with ROYEN:

• At the start of treatment, as excessive dosing of ROYEN may cause an increase in blood calcium levels. Your doctor should determine your blood calcium levels twice a week. Phosphorus levels in the blood should also be determined periodically.
• If you are being treated with digitalis, as increased calcium levels in the blood may cause cardiac arrhythmias.
• Do not take other calcium supplements with ROYEN, as this may cause an overdose and a serious increase in blood calcium levels. For the same reason, it is essential to control your daily intake of calcium-rich foods, such as dairy products and similar items.

If you are on dialysis, reducing the concentration of calcium in the dialysate may reduce the incidence and severity of ROYEN-induced hypercalcemia.

Consult your doctor if any of the above circumstances have occurred to you.

Use of other medicines:

Inform your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

Inform your doctor if you are taking any of the following medicines, as they may interact with calcium acetate, and it may be necessary to adjust the dose or interrupt one of the treatments:

• Tetracyclines (a specific group of antibiotics).
• Zinc: zinc levels should be monitored, as ROYEN decreases intestinal zinc absorption.
• Antacids or other preparations containing high concentrations of calcium, which may contribute to increased blood calcium levels.

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

It is unknown whether ROYEN can cause fetal harm when administered to pregnant women or affect reproductive capacity.

ROYEN should only be administered to pregnant or breastfeeding women in cases of strict necessity.

Driving and using machines:

ROYEN has no influence on the ability to drive and use machines.

3. How to take ROYEN 500 mg

Follow your doctor's instructions for taking ROYEN 500 mg exactly. Consult your doctor or pharmacist if you have any doubts.

ROYEN is taken orally. Swallow the capsules with a glass of water.

The normal dose is 3 to 5 capsules with each meal (breakfast, lunch, and dinner), according to medical criteria.

Start treatment with ROYEN at a low dose. Do not increase the dose without previously determining blood calcium levels.

The dose of ROYEN should be adjusted based on the calculation of daily calcium intake. The recommended initial dose of ROYEN for a patient on dialysis is 2 capsules at breakfast, lunch, and dinner. This dose may be gradually increased to achieve serum phosphate levels below 6 mg/dl, while controlling the increase in blood calcium levels.

Your doctor will indicate the duration of your treatment with ROYEN. Do not stop treatment before this, as it may cause a sudden increase in blood phosphate levels. Similarly, do not use it for longer than indicated by your doctor.

If you think the effect of ROYEN is too strong or too weak, inform your doctor or pharmacist.

If you take more ROYEN than you should:

If you have taken more ROYEN than you should, consult your doctor or pharmacist immediately, indicating the medicine and the amount ingested.

The most frequent symptom in case of overdose is an increase in blood calcium levels. If the increase is mild, it can be easily controlled by reducing the dose of ROYEN or temporarily interrupting treatment. In case of severe hypercalcemia, hemodialysis should be performed, and treatment should be temporarily interrupted until your doctor indicates otherwise.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to take ROYEN:

Do not take a double dose to make up for forgotten doses.

If you stop taking ROYEN:

Consult your doctor to indicate the dosage to follow until you reach your maintenance dose.

4. Possible side effects

Like all medicines, ROYEN can cause side effects, although not everyone gets them.

Rare (less than 1 in 1,000 but more than 1 in 10,000 treated subjects):

• Nausea, vomiting, diarrhea, constipation, abdominal pain.
• Asthenia, fatigue.
• Mild increase in blood calcium levels.
• Severe increase in blood calcium levels that can cause confusion, delirium, stupor, and coma.

Very rare (less than 1 in 10,000 treated subjects, including isolated reports):

• Itching that may be due to allergic reactions.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of ROYEN 500 mg

Do not store above 25°C.

Keep out of the reach and sight of children.

Do not use ROYEN after the expiration date stated on the container. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Further information

Composition of ROYEN:

The active ingredient of this medicine is calcium acetate.

Each capsule contains 500 mg of calcium acetate (equivalent to 127 mg of calcium).

The other ingredients are: magnesium stearate and talc. The capsule is also composed of gelatin, titanium dioxide, and indigo carmine.

Appearance of the product and container contents:

ROYEN 500 mg hard capsule is presented in the form of capsules for oral administration in containers containing 60 and 120 capsules.

Marketing authorization holder and manufacturer:

LABORATORIOS RUBIÓ, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal, Barcelona – Spain

This leaflet was approved in

June 2012