ROYEN 2.5 g ORAL SUSPENSION POWDER

2. What you need to know before you take Royen 2.5 g

Do not take Royen 2.5 g

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

Warnings and precautions

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

Be particularly careful with Royen 2.5 g:

• 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 an increase in blood calcium levels, which can be serious. For the same reason, it is essential to control your daily intake of calcium-rich foods, such as dairy products and similar products.

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 ever occurred to you.

Other medicines and Royen 2.5 g

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Tell 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 in their composition, which may contribute to increased blood calcium levels.

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 medicine.

It is not known 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.

Royen 2.5 g contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per sachet; it is essentially "sodium-free".

3. How to take Royen 2.5 g

Follow your doctor's instructions for taking Royen 2.5 g exactly. If you are unsure, consult your doctor or pharmacist again.

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

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

Start treatment with Royen at a low dose. Do not increase the dose without first determining your blood calcium levels.

The dose of Royen should be adjusted based on your daily calcium intake. The recommended initial dose for a patient on dialysis is half a sachet at breakfast, lunch, and dinner. This dose may be gradually increased to achieve serum phosphorus levels below 6 mg/dl, while monitoring for increased 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, tell 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 taken.

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 your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Royen 2.5 g

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

If you stop taking Royen 2.5 g

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

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

4. Possible side effects

Like all medicines, Royen can cause side effects, although not everybody gets them.

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

• 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 patients treated, including isolated reports):

• Itching that may be due to allergic reactions.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Royen 2.5 g

No special storage conditions are required.

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

Do not use Royen after the expiration date stated on the pack. 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 medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Royen 2.5 g:

The active substance of this medicine is calcium acetate.

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

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

Appearance of the product and pack contents:

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

Marketing authorization holder and manufacturer:

LABORATORIOS RUBIÓ, S.A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal, Barcelona – Spain

Date of the last revision of this package leaflet:June 2012

Other sources of information

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