Leaflet: information for the user

Royen 2.5 g powder for oral suspension

calcium acetate

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Royen 2,5 g is presented in the form of single-dose sachets for oral administration in containers that contain 30 and 60 single-dose sachets.

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 2,5 g is indicated for:

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

Do not take Royen 2.5 g

• If you are allergic to calcium acetate or any of the other components of Royen 2.5 g (listed in section 6).
• If you have hypercalcemia (elevated calcium levels in the blood) or hypercalciuria (excessive calcium excretion in the urine).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Royen 2.5 g.

Be especially careful with Royen 2.5 g:

• At the beginning of treatment, as excessive dosing of Royen may cause an increase in blood calcium levels. Your doctor should determine blood calcium levels twice a week. Blood phosphorus levels should also be determined periodically.
• If you are being treated with digitalis, as an increase in blood calcium levels may cause cardiac arrhythmias.
• Do not take other calcium supplements with Royen, as this may cause an overdose and an increase in blood calcium levels that may be severe. 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 dialysed may reduce the incidence and severity of hypercalcemia induced by Royen.

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

Other medications and Royen 2.5 g

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Inform your doctor if you are taking any of the following medications, as they may interact with calcium acetate, so it may be necessary to adjust the dose or discontinue 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 and breastfeeding

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

The effects of Royen on the fetus are unknown when administered to pregnant women or may affect fertility.

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

Driving and operating machinery

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

Royen 2.5 g contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for Royen 2.5 g as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Royen 2.5 g can be taken before or during meals. Dissolve the contents of a packet in a glass of water and ingest immediately.

The normal dose is one packet with each meal (breakfast, lunch, and dinner), as recommended by your doctor.

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

The Royen dose should be adjusted based on the daily calcium intake calculation. The initial recommended dose for a patient on dialysis is half a packet at breakfast, lunch, and dinner. This dose can 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 it for longer 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 your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Royen 2.5 g

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

If you interrupt treatment with Royen 2.5 g

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

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

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

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

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

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

• Itching that may be due to allergic reactions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

No special storage conditions are required.

Keep this medication out of the sight and reach 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 drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Royen 2.5 g:

The active ingredient of this medication is calcium acetate.

Each single-dose sachet contains 2.5 g of calcium acetate (equivalent to 635 mg of calcium).

The other components are: cornstarch, mannitol (E-421), sodium saccharin, sodium cyclamate, povidone, citric acid, and orange flavor.

Appearance of the product and contents of the packaging:

Royen 2.5 g oral powder for suspension is presented in the form of single-dose sachets for oral administration in packaging containing 30 and 60 sachets.

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

Date of the last review of this leaflet:June 2012

Other sources of information

The detailed information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/.