Restafos 800 mg film-coated tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Restafos 800 mg film-coated tablets
Sevelamer carbonate
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 you should not give it 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, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Restafos is and what it is used for.
- What you need to know before taking Restafos.
- How to take Restafos.
- Possible side effects.
- How to store Restafos.
- Contents of the pack and other information.
1. What Restafos is and what it is used for
Restafos contains sevelamer carbonate as the active substance. It binds to dietary phosphate in the gastrointestinal tract, thereby reducing serum phosphate levels in the blood.
This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:
- adult patients on dialysis (a blood-cleaning technique). It can be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and an internal body membrane filters the blood).
- adult patients with chronic kidney disease (long-term) who are not on dialysis and who have a serum (blood) phosphate level equal to or above 1.78 mmol/L.
This medicine should be used together with other treatments such as calcium and vitamin D supplements to prevent the development of bone disease.
Elevated serum phosphate levels may lead to hard deposits in the body known as calcification. These deposits may harden blood vessels and make it more difficult for blood to be pumped around the body. Increased serum phosphate may also cause skin itching, red eyes, bone pain, and fractures.
2. What you need to know before taking Restafos
Do not take Restafos if:
- you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
- you have low levels of phosphate in the blood (your doctor will check this for you),
- you have intestinal obstruction.
Warnings and precautions
Talk to your doctor or pharmacist before taking Restafos if you are in any of the following situations:
- difficulty swallowing. Your doctor may prefer to prescribe the oral suspension powder available on the market,
- problems with gastrointestinal motility (movement of the stomach and intestines),
- you frequently experience vomiting,
- active intestinal inflammation,
- you have undergone major surgery of the stomach or intestine.
Contact your doctor while taking Restafos:
- If you experience severe abdominal pain, stomach or intestinal disturbances, or blood in the stool (gastrointestinal bleeding). These symptoms may be due to a serious inflammatory bowel disease caused by the deposition of sevelamer crystals in the intestine. Contact your doctor, who will decide whether to continue treatment or not.
Additional treatments:
Due to your kidney condition or dialysis treatment, you may:
- have low or high levels of calcium in your blood. As this medicine does not contain calcium, your doctor may prescribe additional calcium tablets,
- have low levels of vitamin D in your blood. Therefore, your doctor may monitor your blood vitamin D levels and prescribe vitamin D supplements if necessary. If you do not take multivitamin supplements, your blood levels of vitamins A, E, K, and folic acid may also decrease, so your doctor may monitor these levels and prescribe vitamin supplements as needed.
- have altered blood bicarbonate levels and increased acidity in the blood and other body tissues. Your doctor must monitor your blood bicarbonate levels.
Special note for patients on peritoneal dialysis:
You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced by carefully following sterile techniques during bag exchanges. You must inform your doctor immediately if you experience any new signs or symptoms of discomfort, swelling, pain, tenderness, abdominal rigidity, constipation, fever, chills, nausea, or vomiting.
Children
The safety and efficacy have not been studied in children (under 6 years of age). Therefore, the use of this medicine is not recommended in children under 6 years of age.
Other medicines and Restafos
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
Restafos must not be taken at the same time as ciprofloxacin (an antibiotic).
If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking Restafos.
The effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system) may be reduced by sevelamer carbonate. Your doctor will advise you if you are taking these medicines.
A deficiency in thyroid hormone may rarely occur in certain individuals taking levotiroxine (used to treat low thyroid hormone levels) and sevelamer carbonate. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) blood levels more closely.
Medicines used to treat stomach acid and reflux in the stomach or esophagus, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors," may reduce the effectiveness of sevelamer carbonate. Your doctor must monitor your blood phosphate levels.
Your doctor will regularly check for possible interactions between Restafos and other medicines.
In some cases, when Restafos must be taken at the same time as another medicine, your doctor may instruct you to take that medicine 1 hour before or 3 hours after taking Restafos. Your doctor should also consider monitoring blood levels of that medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. The potential risk of Restafos during human pregnancy is unknown. Consult your doctor, who will decide whether you can continue treatment with Restafos.
It is unknown whether Restafos is excreted in breast milk and may affect your baby. Consult your doctor, who will decide whether you can breastfeed or not and whether treatment with Restafos needs to be discontinued.
Driving and using machines
It is unlikely that Restafos will affect your ability to drive or use machines.
Restafos contains lactose monohydrate
This medicine contains lactose monohydrate (milk sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Restafos
Restafos should be taken as directed by your doctor. Your doctor will determine the dose based on your serum phosphorus levels.
The recommended starting dose of Restafos tablets for adults and elderly patients is one to two 800 mg tablets with each meal, three times a day. If you are unsure, consult your doctor, pharmacist, or nurse.
Take Restafos after a meal or with food.
The tablets must be swallowed whole. Do not crush, chew, or split the tablets.
Initially, your doctor will check your blood phosphorus levels every 2–4 weeks and may adjust the dose of Restafos as necessary to achieve an appropriate phosphorus level.
Follow the diet prescribed by your doctor. Patients taking Restafos must adhere to the prescribed diet.
If you take more Restafos than you should
In case of accidental ingestion or suspected overdose, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Restafos
If you miss a dose, skip it and take the next dose at the usual time with food. Do not take a double dose to make up for a missed dose.
If you stop taking Restafos
Taking Restafos as prescribed is important to maintain appropriate phosphate levels in your blood. Stopping treatment with Restafos may lead to serious consequences, such as vascular calcification. If you are considering stopping treatment with Restafos, contact your doctor or pharmacist first.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Constipation is a very common adverse effect (may affect more than 1 in 100 patients). It may be an early sign of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.
Some adverse effects may be serious. If you experience any of the following adverse effects, seek immediate medical attention:
- Allergic reaction (symptoms include rash, hives, swelling, difficulty breathing). This is a very rare adverse effect (may affect up to 1 in 10,000 patients).
- Intestinal obstruction has been reported (symptoms include: severe distension, abdominal pain, bloating or cramps, severe constipation). Frequency is unknown (cannot be estimated from available data).
- Rupture of the intestinal wall has been reported (symptoms include: severe stomach pain, chills, fever, nausea, vomiting, or tender or painful abdomen). Frequency is unknown.
- Severe inflammation of the large intestine has been reported (symptoms include: severe abdominal pain, gastrointestinal or intestinal disturbances, blood in stools [intestinal bleeding]) and crystal deposition in the intestine. Frequency is unknown.
Other adverse effects reported in patients taking Restafos:
Very common (may affect more than 1 in 10 patients):
- vomiting, upper abdominal pain, nausea.
Common (may affect up to 1 in 10 patients):
- diarrhoea, stomach ache, indigestion, flatulence.
Frequency not known (cannot be estimated from available data):
- cases of itching, rash, slow intestinal motility (movement).
Reporting of adverse effects
If you experience any adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this leaflet. You may 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 Restafos
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and packaging following the letters «EXP». The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Restafos
- The active substance is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.
- The other components are:
Core: lactose monohydrate, colloidal anhydrous silica, zinc stearate.
Tablet coating: hypromellose (E464) and diacetylated monoglycerides.
Appearance of the product and contents of the pack
Restafos are film-coated tablets, white to off-white in colour, oval-shaped, with "SVL" engraved on one side.
HDPE bottles with polypropylene cap.
Each bottle contains 180, 200 or 210 tablets.
Packs containing 1, 2 or 3 bottles are available.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SPA Società Prodotti Antibiotici S.p.A.
Via Biella, 8
20143 Milano
Italy
Manufacturer
Synthon Hispania S.L.
C/ Castelló nº1. Polígono Las Salinas, 08830 Sant Boi de Llobregat
Barcelona, Spain
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
SPA Farma Ibérica S.L.U.
Carrer de Roc Boronat, 147
08018 Barcelona
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark: Sevelamercarbonat Zentiva
Spain: Restafos 800 mg film-coated tablets
United Kingdom (Northern Ireland): Sevelamer carbonate
Date of the most recent revision of this leaflet: June 2022
“Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/”