Package Leaflet: Information for the User

Fosquel 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. Do 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, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Fosquel contains 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) phosphorus 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.

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

Do not take Fosquel:

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

Warnings and precautions

Consult your doctor before taking Fosquel if you are in any of the following situations:

• difficulty swallowing. Your doctor may prefer to prescribe Fosquel in powder form for oral suspension
• problems with stomach and intestinal motility
• you frequently vomit
• you have active intestinal inflammation
• you have had major surgery on your stomach or intestines.
• you have a severe inflammatory bowel disease.

Consult your doctor while taking Fosquel:

• if you experience intense abdominal pain, gastrointestinal or intestinal disorders, or blood in your stool (gastrointestinal hemorrhage). These symptoms may be due to 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 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 doctor may also monitor your blood levels of vitamins A, E, K, and folic acid, and prescribe vitamin supplements as needed
• have altered bicarbonate levels in your blood and elevated acidity in your blood and tissues. Your doctor should monitor your bicarbonate levels in your blood.

Special note for peritoneal dialysis patients

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk may decrease with the careful use of sterile techniques during bag changes. Inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, 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.

Use of Fosquel with other medications

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

• Fosquel should not be administered at the same time as ciprofloxacin (an antibiotic).
• If you are taking medications for heart rhythm problems or epilepsy, consult your doctor when taking Fosquel.
• The effects of medications such as ciclosporin, micofenolato mofetilo, and tacrolimus (medications used to suppress the immune system) may be reduced by Fosquel. Your doctor will advise you if you are taking these medications.
• It may occasionally be observed that certain individuals taking levotiroxine (used to treat low levels of thyroid hormone) and Fosquel may experience a deficiency of thyroid hormone. Therefore, your doctor may closely monitor your levels of thyroid-stimulating hormone in the blood.
• Medications for treating 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 Fosquel. Your doctor should monitor your phosphate levels in your blood.

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

In some cases, when Fosquel must be taken at the same time as another medication, your doctor may instruct you to take this medication 1 hour before or 3 hours after taking Fosquel. Your doctor should 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 Fosquel during human pregnancy is unknown. Consult your doctor, who will decide whether to continue treatment with Fosquel.

The safety of Fosquel for use during breastfeeding is unknown. Consult your doctor, who will decide whether you can breastfeed your baby or not and whether you need to stop treatment with Fosquel.

Driving and operating machinery

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

Fosquel contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Fosquel should be taken as directed by your doctor. Your doctor will determine the dosage based on your serum phosphorus levels.

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

Take Fosquel after a meal or with food.

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

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

Follow the diet prescribed by your doctor.

If you take more Fosquel than you should

In case of a possible overdose, you should immediately contact your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fosquel

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 make up for the missed dose.

If you interrupt treatment with Fosquel

Continuing your treatment with Fosquel is important to maintain an appropriate level of phosphate in your blood. Stopping Fosquel treatment would have significant consequences, such as calcification in blood vessels. If you consider stopping your Fosquel treatment, 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 everyone will experience them.

Constipation is a very frequent adverse effect (it may affect more than 1 in 10 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 have any of the following adverse effects, seek medical attention immediately:

Very Rare(it may affect up to 1 in 10,000 patients:

Allergic reaction (signs that include rash, hives, swelling, difficulty breathing).

Other adverse effects have been reported in patients taking Fosquel:

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):

Pruritus, rash, slow intestinal motility (movement), intestinal obstruction (signs include: severe distension; abdominal pain, swelling or cramps; severe constipation), intestinal perforation (signs include: severe abdominal pain, chills, fever, nausea, vomiting or abdominal tenderness or sensitivity), intestinal bleeding, colonic inflammation, and crystal deposition in the intestine).

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 for Pharmacovigilance of Medicinal Products for Human Use: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 in the bottle after the letters «CAD». The expiration date is the last day of the month indicated.

Keep the bottle perfectly closed to protect it from moisture.

This medication does not require special storage conditions.

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

Composition of Fosquel

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

Appearance of the product and contents of the packaging

Fosquel film-coated tablets are oval-shaped, white to off-white tablets with "SVL" printed on one side. The tablets are packaged in HDPE bottles with a polypropylene cap.

The HDPE bottles contain a desiccant. Do not remove the desiccant from the bottle.

Packaging sizes:

Each bottle contains 180 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Laboratorios Rubió, S.A.

29 Industria Street. Comte de Sert Industrial Estate

08755 Castellbisbal (Barcelona)

Spain

Responsible manufacturer:

Synthon Hispania S.L.

1 Castelló Street, Las Salinas Industrial Estate

08830 Sant Boi de Llobregat (Barcelona)

Spain

Last review date of this leaflet:April 2020

Other sources of information

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