Royen 2,5 g powder for oral suspension
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Royen 2.5 g powder for oral suspension
calcium acetate
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Royen 2.5 g is and what it is used for
- What you need to know before taking Royen 2.5 g
- How to take Royen 2.5 g
- Possible adverse effects
- How to store Royen 2.5 g
- Contents of the pack and other information
1. What Royen 2.5 g is and what it is used for
Royen 2.5 g is presented in single-dose sachets for oral administration, in packaging containing 30 and 60 single-dose sachets.
Calcium acetate is a medicine belonging to a group of medicines called binders. It combines with dietary phosphate to form insoluble phosphates that are eliminated in the faeces, thereby helping to control blood phosphate levels.
Royen 2.5 g is indicated for:
- Control of hyperphosphataemia (elevated phosphate levels in the blood) in patients with advanced renal insufficiency.
2. What you need to know before taking 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 excretion of calcium in the urine).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Royen 2.5 g.
Take special care 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 measure blood calcium concentration twice a week. Blood phosphorus levels should also be monitored periodically.
- If you are being treated with digitalis, because increased blood calcium levels may cause cardiac arrhythmias.
- Do not take other calcium supplements together with Royen, as this could lead to overdose and elevated blood calcium levels, which may be serious. For the same reason, it is important that you monitor your daily intake of calcium-rich foods, such as dairy products and similar items.
If you are on dialysis, reducing the calcium concentration in the dialysate may reduce the incidence and severity of Royen-induced hypercalcemia.
Consult your doctor if any of the above circumstances have ever applied to you.
Other medicines and Royen 2.5 g
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 discontinue one of the treatments:
- Tetracyclines (a specific group of antibiotics).
- Zinc: zinc levels should be monitored, as Royen reduces its intestinal absorption.
- Antacids or other preparations containing high levels of calcium, which may contribute to increased blood calcium levels.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is unknown whether Royen may cause fetal harm when administered to pregnant women or may affect reproductive capacity.
Royen may be administered to pregnant or breastfeeding women only if strictly necessary.
Driving and operating machinery
Royen has no influence on the ability to drive or operate machinery.
Royen 2.5 g contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per dose; therefore, it is essentially “sodium-free”.
3. How to take Royen 2.5 g
Follow exactly the administration instructions for Royen 2.5 g provided by your doctor. If in doubt, 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 usual dose is one sachet with each meal (breakfast, lunch, and dinner), according to medical judgment.
Begin treatment with Royen at a low dose. Do not increase the dose without first determining blood calcium levels.
The dose of Royen should be adjusted based on the calculation of 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 phosphate levels below 6 mg/dL, while monitoring for increases in blood calcium levels.
Your doctor will determine how long your treatment with Royen should last. Do not stop treatment prematurely, as this may cause a sudden increase in blood phosphate levels. Likewise, do not use it for longer than prescribed by your doctor.
If you think that 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 prescribed, contact your doctor or pharmacist immediately, stating the medication and amount ingested.
The most common symptom in case of overdose is elevated blood calcium levels. If the increase is mild, it can be easily managed by reducing the dose of Royen or temporarily interrupting treatment. In case of severe hypercalcemia, hemodialysis should be performed and treatment temporarily discontinued until your doctor advises otherwise.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and amount ingested.
If you forget to take Royen 2.5 g
Do not take a double dose to make up for missed doses.
If you stop taking Royen 2.5 g
Consult your doctor, who will advise you on the dosing 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 adverse effects
Like all medicines, Royen may produce adverse effects, although not everybody experiences them.
Rare (less than 1 in 1,000 but more than 1 in 10,000 patients treated):
- Nausea, vomiting, diarrhoea, constipation, abdominal pain.
- Asthenia, fatigue.
- Mild increase in blood calcium.
- Severe increase in blood calcium which may cause confusion, delirium, stupor and coma.
Very rare (less than 1 in 10,000 patients treated, including isolated reports):
- Itching which may be due to allergic reactions.
Reporting of 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 leaflet.
You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging. The expiry 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 and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Royen 2.5 g:
The active substance in this medicine is calcium acetate.
Each single-dose sachet contains 2.5 g of calcium acetate (equivalent to 635 mg of calcium).
The other components are: maize starch, mannitol (E-421), sodium saccharin, sodium cyclamate, povidone, citric acid and orange flavouring.
Appearance of the product and contents of the pack:
Royen 2.5 g powder for oral suspension is available as single-dose sachets for oral administration, in packaging containing 30 and 60 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 most recent revision of this leaflet: June 2012
Other sources of information
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).