Restafos 800 mg comprimidos recubiertos con pelÍcula

Leaflet: information for the user

Restafos 800 mg film-coated tablets

Sevelamer carbonate

Read this 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 must not give it 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,even if they are not listed in this leaflet.See section 4.

Restafoscontains sevelamer carbonate as the active ingredient. It binds to the phosphorus in food in the digestive tract and thereby reduces serum phosphorus levels in the blood.

This medication is used to control hyperphosphatemia (high levels of phosphate in the blood) in:

• adult patients undergoing dialysis (a blood cleansing technique). It can be used in patients undergoing hemodialysis (using a machine to filter the blood) or peritoneal dialysis (where fluid is pumped into the abdomen and a membrane filters the blood).
• patients with chronic kidney disease (long-term) who are not undergoing dialysis and have a serum (in the blood) phosphate level of 1.78 mmol/L or higher.

This medication should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.

The increase in serum phosphorus levels can produce hard deposits in the body called calcification. These deposits can harden in blood vessels and make it more difficult for blood to be pumped throughout the body. The increase in serum phosphorus can also produce itching skin, red eyes, bone pain, and fractures.

Do not take Restafos if:

• You are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)
• You have low levels of phosphorus in your blood (your doctor will check this for you),
• You have intestinal obstruction,

Warnings and precautions

Consult your doctor or pharmacist before starting to take Restafos if you are in any of the following situations:

• You have difficulty swallowing. Your doctor may prefer to prescribe you oral suspension powder available on the market
• You have problems with the motility (movement) of your stomach and intestines,
• You have frequent vomiting,
• Active intestinal inflammation,
• You have undergone major surgery of the stomach or intestines.

Consult with your doctor while taking Restafos:

• If you experience intense abdominal pain, gastrointestinal or intestinal disorders, or blood in your stool (gastrointestinal hemorrhage). These symptoms may be due to a severe intestinal inflammatory 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 disease or dialysis treatment, you may:

• Have low or high levels of calcium in your blood. Since this medication does not contain calcium, your doctor may prescribe you calcium supplements
• Have low levels of vitamin D in your blood. Therefore, your doctor may monitor your vitamin D levels in the blood and prescribe a vitamin D supplement if necessary. If you do not take multivitamin supplements, your levels of vitamins A, E, K, and folic acid in the blood may also decrease, so your doctor will monitor these levels and prescribe vitamin supplements as needed.
• Have altered bicarbonate levels in your blood and increased acidity in your blood and other body tissues. Your doctor should monitor your bicarbonate levels in the blood.

Special note for patients on peritoneal dialysis:

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk may decrease with careful observation of sterile techniques during bag changes. You shouldinform your doctor immediately if you experience any new signs or symptoms of discomfort, swelling, pain, sensitivity, or abdominal rigidity, constipation, fever, chills, nausea, or vomiting.

Children

This medication has not been studied in children (under 6 years). Therefore, it is not recommended for use in children under 6 years.

Other medications and Restafos

Inform your doctor if you are taking, have taken, or may need to take any other medication.

Restafos should not be administered at the same time asciprofloxacin (an antibiotic).

If you usemedications for heart rhythm problems or epilepsy,consult your doctor when taking Restafos.

The effects of medications such as ciclosporin, micofenolato mofetil, and tacrolimus (medications used to suppress the immune system) may be reduced by sevelamer carbonate. Your doctor will advise you if you are taking these medications.

You may occasionally experience a deficiency of thyroid hormone in people takinglevotiroxine (used to treat low levels of thyroid hormone) and sevelamer carbonate. Therefore, your doctor may closely monitor your levels of thyroid-stimulating hormone in the blood.

Medications to treat stomach acid and reflux in your stomach or esophagus, such as omeprazol, pantoprazol, or lansoprazol, known as "proton pump inhibitors," may reduce the effectiveness of sevelamer carbonate. Your doctor should monitor your phosphorus levels in the blood.

Your doctor will regularly check for interactions between Restafos and other medications.

In some cases, when Restafos must be taken at the same time as another medication, your doctor may instruct you to take that medication 1 hour before or 3 hours after taking Restafos.Your doctor should also consider monitoring the levels of that medication in your blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. The potential risk of Restafos during human pregnancy is unknown. Consult with your doctor, who will decide whether to continue treatment with Restafos.

The excretion of Restafos in breast milk and its potential effect on your baby is unknown. Consult with your doctor, who will decide whether to breastfeed your baby or not and whether to interrupt treatment with Restafos.

Driving and operating machinery

It is unlikely that Restafos will affect your ability to drive or operate machinery.

Restafos contains lactose monohydrate

This medication containslactose monohydrate (milk sugar). If your doctor has told you that you have anintolerance to certain sugars,consult with them before taking this medication.

Restafos should be taken as indicated by your doctor. The doctor will establish the dose based on serum phosphate levels.

The recommended initial dose of Restafos tablets for adults and elderly patients is one to two 800 mg tablets with each meal, three times a day.Consult with your doctor, pharmacist, or nurse if you are unsure.

Take Restafos after a meal or with food.

The tablets must be swallowed whole..Do not crush, chew, or break.

Initially, your doctor will check your blood phosphate concentrations every 2-4 weeks and may adjust the Restafos dose as needed to achieve an adequate phosphate level.

Follow the diet prescribed by your doctor. Patients taking Restafos must follow the diets prescribed for them.

If you take more Restafos than you should

In case of a possible 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 Restafos

If you forget to take a dose, omit it, and take the next dose at the usual time with a meal. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Restafos

It is essential to continue your treatment with Restafos to maintain an appropriate level of phosphate in your blood. Stopping treatment with Restafos would have significant consequences, such as vascular calcification. If you consider stopping your treatment with Restafos, contact your doctor or pharmacist first.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Constipation is a very frequent 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 severe. If you experience any of the following adverse effects, seek medical attention immediately:

• Allergic reaction (signs 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 (signs include: severe distension, abdominal pain, swelling or cramps, severe constipation). Frequency is unknown (cannot be estimated from available data).
• Intestinal wall rupture has been reported (signs include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain or tenderness). Frequency is unknown.
• Severe inflammation of the large intestine has been reported (symptoms include: severe abdominal pain, gastrointestinal or intestinal disturbances, blood in the stool [intestinal bleeding]) and crystal deposition in the intestine. Frequency is unknown.

Other adverse effects have been reported in patients taking Restafos:

Very frequent(may affect more than 1 in 10 patients):

• Vomiting, upper abdominal pain, nausea.

Frequent(may affect up to 1 in 10 patients):

• Diarrhea, stomach pain, indigestion, flatulence.

Unknown frequency(cannot be estimated from available data):

• Cases of itching, rash, slow intestinal motility (movement).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle and on the packaging after the letters «CAD».The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medications should not be thrown into the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Restafos

• The active principle is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.
• The other components are: The core: lactose monohydrate, anhydrous colloidal silica, zinc stearate. The tablet coating contains hypromellose (E464) and diacetyl monoglycerides.

Appearance of the product and contents of the packaging

Restafos are white to off-white, oval-shaped, film-coated tablets with "SVL" engraved on one side.

HDPE bottles with polypropylene caps.

Each bottle contains 180, 200, or 210 tablets.

Packs containing 1, 2, or 3 bottles are available.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

SPA Società Prodotti Antibiotici S.p.A.

Via Biella, 8

20143 Milano

Italy

Responsible for manufacturing

Synthon Hispania S.L.

C/ Castelló nº1. Polígono Las Salinas, 08830 Sant Boi de Llobregat

Barcelona. Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

SPA Farma Ibérica S.L.U.

Carrer de Roc Boronat, 147

08018 Barcelona

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Denmark: Sevelamercarbonat Zentiva

Spain: Restafos 800 mg film-coated tablets

United Kingdom (Northern Ireland): Sevelamer carbonate

Last review date of this leaflet:June 2022

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