Fosquel 800 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fosquel 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 may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fosquel is and what it is used for
2. What you need to know before taking Fosquel
3. How to take Fosquel
4. Possible adverse effects
5. How to store Fosquel
6. Contents of the pack and other information

1. What Fosquel is and what it is used for

Fosquel 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 undergoing dialysis (a blood-cleaning technique). It can be used in patients receiving 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);
• patients with chronic kidney disease (long-term) who are not undergoing dialysis and who have a serum (in 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 calcifications. These deposits may harden blood vessels and make it more difficult for blood to be pumped through the body. Increased serum phosphate may also cause skin itching, red eyes, bone pain, and fractures.

2. What you need to know before taking Fosquel

Do not take Fosquel:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (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

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

• difficulty swallowing. Your doctor may prefer to prescribe Fosquel as a powder for oral suspension
• problems with stomach or intestinal motility (movement)
• frequent vomiting
• active inflammation of the intestine
• you have undergone major surgery of the stomach or intestine
• you have severe inflammatory bowel disease.

Talk to your doctor while taking Fosquel:

• if you experience severe abdominal pain, stomach or intestinal disturbances, or blood in your stools (gastrointestinal bleeding). These symptoms may be due to 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. Since 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 a vitamin D supplement if necessary. If you do not take multivitamin supplements, 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 bicarbonate levels in your blood and increased acidity in your blood and other body tissues. Your doctor should 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 may be reduced by careful use of sterile techniques during bag exchanges. You must inform your doctor immediately if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or 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.

Taking Fosquel with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

• Fosquel 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 Fosquel.
• The effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system) may be reduced by Fosquel. Your doctor will advise you if you are taking these medicines.
• A deficiency of thyroid hormone may rarely occur in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and Fosquel. Therefore, your doctor may monitor your thyroid-stimulating hormone (TSH) blood levels more closely.
• Medicines used to treat stomach acidity and reflux in your stomach or esophagus, such as omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors,” may reduce the effectiveness of Fosquel. Your doctor should monitor your blood phosphate levels.

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

In some cases, when Fosquel 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 Fosquel. Your doctor may also consider monitoring blood levels of that medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The potential risk of Fosquel during human pregnancy is unknown. Discuss with your doctor, who will decide whether you can continue treatment with Fosquel.

It is unknown whether Fosquel passes into breast milk and could affect your baby. Consult your doctor, who will decide whether you can breastfeed or not and whether treatment with Fosquel needs to be discontinued.

Driving and using machines

It is unlikely that Fosquel will affect your ability to drive or use machines.

Fosquel contains lactose

This medicine contains lactose. 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 Fosquel

Fosquel should be taken as directed by your doctor. Your doctor will determine the dose 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 must be swallowed whole. Do not crush, chew, or split them.

Initially, your doctor will monitor your blood phosphorus levels every 2 to 4 weeks and may adjust the dose of Fosquel as necessary to achieve an appropriate phosphorus level.

Follow the diet prescribed by your doctor.

If you take more Fosquel than you should

In case of a possible overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Fosquel

If you miss a dose, skip that dose 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 Fosquel

Taking Fosquel as prescribed is important to maintain an appropriate phosphate level in your blood. Stopping treatment with Fosquel may lead to serious consequences, such as calcification of blood vessels. If you are considering stopping treatment with Fosquel, 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 experiences them.

Constipation is a very common adverse effect (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 serious. If you experience any of the following adverse effects, seek medical attention immediately:

Very rare (may affect up to 1 in 10,000 patients):

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

Other adverse effects have been reported in patients taking Fosquel:

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

Vomiting, upper abdominal pain, nausea

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

Diarrhea, stomach pain, indigestion, flatulence

Frequency not known (cannot be estimated from available data):

Cases of itching, rash, slow intestinal motility (movement), intestinal obstruction (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation), intestinal wall rupture (signs include: severe stomach pain, chills, fever, nausea, vomiting, or tender/painful abdomen), gastrointestinal bleeding, inflammation of the large intestine, and crystal deposition in the intestine have been reported.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fosquel

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

Do not use this medicine after the expiry date stated on the bottle after the letters «EXP». The expiry date refers to the last day of the month indicated.

Keep the bottle tightly closed to protect it from moisture.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fosquel

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

Appearance of the product and contents of the pack

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

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

Pack sizes:

Each bottle contains 180 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Rubió, S.A.

Industria, 29. Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Manufacturer:

Synthon Hispania S.L.

C/ Castelló, no 1, Pol. Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

Date of the most recent revision of this leaflet: April 2020

Other sources of information

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.