Package Insert: Information for the User

ROYEN 500 mg Hard Capsule

Calcium Acetate

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

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

2. Before taking ROYEN 500 mg

3. How to take ROYEN 500 mg

4. Possible adverse effects

5. Storage of ROYEN 500 mg

6. Additional information

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

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

ROYEN 500 mg hard capsule is indicated for:

• Control of hyperphosphatemia (elevated phosphate levels in the blood) in patients with advanced renal insufficiency.

Do not take ROYEN:

• If you are allergic to calcium acetate or any of the other components of ROYEN 500 mg.
• If you have hypercalcemia (elevated calcium levels in the blood) or hypercalciuria (excessive calcium excretion in the urine).

Be especially careful with ROYEN:

• At the beginning 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. Blood phosphorus levels should also be determined periodically.
• If you are being treated with digitalis, as increased blood calcium levels may cause cardiac arrhythmias.
• Do not take other calcium supplements with ROYEN, as this may cause an overdose and a potentially severe increase in blood calcium levels. It is also important to control your daily intake of calcium-rich foods, such as dairy products and similar items.

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

Consult your doctor if any of the circumstances mentioned above have occurred at any time.

Use of other medications:

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

Inform your doctor if you are taking any of the following medications, as they may interact with calcium acetate, requiring a dose adjustment or discontinuation of 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 in their composition, which may contribute to increased blood calcium levels.

Pregnancy:

Consult your doctor or pharmacist before using any medication.

The effects of ROYEN on the fetus are unknown, and it may affect reproductive capacity.

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

Driving and operating machines::

The influence of Royen on the ability to drive and operate machines is negligible.

Follow exactly the administration instructions for ROYEN 500 mg as indicated by your doctor. 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), as prescribed by your doctor.

Start treatment with ROYEN at a low dose. Do not increase the dose without first having a blood calcium level determination.

The ROYEN dose should be adjusted based on the daily calcium intake calculation. The initial recommended 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 discontinue treatment prematurely, as this may cause a sudden increase in blood phosphate levels. Similarly, do not use ROYEN for a longer period than indicated by your doctor.

If you estimate that the action 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 medication and the amount ingested.

The most common 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 ROYEN dose or temporarily interrupting treatment. In case of severe increase in blood calcium levels, hemodialysis should be performed and treatment temporarily interrupted until your doctor indicates otherwise.

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

If you forget to take ROYEN:

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with ROYEN:

Consult your doctor to determine the dosing schedule to follow until you reach your maintenance dose.

Like all medications, ROYEN can produce adverse effects, although not all people will experience them.

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

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

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

• Itching that may be due to allergic reactions.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, report to your doctor or pharmacist.

Do not store above 25°C.

Keep out of reach and sight of children.

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

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

Composition of ROYEN:

The active ingredient of this medication is calcium acetate.

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

The other components are: magnesium stearate and talc. The capsule is composed, in addition, by gelatin, titanium dioxide, and indigotina.

Appearance of the product and contents of the package:

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

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Rubió, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal, Barcelona – Spain

This prospectus has been approved in

June 2012