FOSQUEL 800 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Fosquel 800 mg Film-Coated Tablets

Sevelamer Carbonate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Fosquel and what is it used for

Fosquel contains sevelamer carbonate as the active substance. It binds to phosphate in the food in the digestive tract and thereby reduces the levels of phosphate in the blood.

This medicine is used to control hyperphosphataemia (high levels of phosphate in the blood) in:

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

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

High levels of phosphate in the blood can cause hard deposits in the body called calcifications. These deposits can harden in the blood vessels and make it more difficult for the blood to be pumped through the body. High phosphate levels in the blood can also cause itching of the skin, red eyes, bone pain, and fractures.

2. What you need to know before you take Fosquel

Do not take Fosquel:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you have low levels of phosphate in the 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:

• you have difficulty swallowing. Your doctor may prefer to prescribe Fosquel as an oral powder for suspension
• you have stomach or intestinal motility problems
• you vomit frequently
• you have active intestinal inflammation
• you have undergone major stomach or intestinal surgery.
• if you have severe inflammatory bowel disease.

Talk to your doctor while taking Fosquel:

• if you experience severe abdominal pain, stomach or intestinal disorders, or blood in your stools (gastrointestinal bleeding). These symptoms can 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 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 calcium supplements
• have low levels of vitamin D in your blood. Therefore, your doctor may monitor your vitamin D levels in your blood and prescribe a vitamin D supplement 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 bicarbonate levels in your blood and increased acidity in your blood and other body tissues. Your doctor should monitor your bicarbonate levels in your blood.

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 with careful use of sterile techniques during bag changes. You should immediately inform your doctor if you experience any new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness, or abdominal stiffness, constipation, fever, chills, nausea, or vomiting.

Children

The safety and efficacy of Fosquel in children (under 6 years) have not been studied. Therefore, the use of this medicine is not recommended in children under 6 years.

Using Fosquel with other medicines

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

• Fosquel should 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 talk to your doctor when taking Fosquel.
• The effects of medicines such as cyclosporin, 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 thyroid hormone deficiency may occasionally occur in certain individuals taking levothyroxine (used to treat low thyroid hormone levels) and Fosquel. Therefore, your doctor may monitor your thyroid-stimulating hormone levels in your blood more closely.
• Medicines for treating stomach acid and reflux in your stomach or oesophagus, such as omeprazole, pantoprazole, or lansoprazole, known as "proton pump inhibitors", may reduce the efficacy of Fosquel. Your doctor should monitor your phosphate levels in your blood.

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

In some cases, when Fosquel needs to be taken with another medicine, your doctor may tell you to take this medicine 1 hour before or 3 hours after taking Fosquel. Your doctor may also consider monitoring the levels of that medicine in your blood.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. The potential risk of Fosquel during human pregnancy is unknown. Talk to your doctor, who will decide whether you can continue treatment with Fosquel.

It is unknown whether Fosquel passes into breast milk and affects your baby. Talk to your doctor, who will decide whether you can breast-feed your baby or not and whether it is necessary to interrupt treatment with Fosquel.

Driving and using machines

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

Fosquel contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Fosquel

Fosquel should be taken as directed by your doctor. The doctor will determine the dose based on phosphate levels in the blood.

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. Talk to 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 them.

Initially, your doctor will check your phosphate levels in your blood every 2-4 weeks and may adjust the dose of Fosquel as needed to achieve an adequate phosphate 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 Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Fosquel

In case you forget to take a dose, it should be omitted, so the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for forgotten doses.

If you stop taking Fosquel

Taking your treatment with Fosquel is important to maintain an appropriate level of phosphate in your blood. Stopping treatment with Fosquel could have significant consequences, such as calcification in the blood vessels. If you consider stopping your treatment with Fosquel, contact your doctor or pharmacist first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Constipation is a very common side effect (may affect more than 1 in 10 patients). It can be an early symptom of intestinal obstruction. If you experience constipation, inform your doctor or pharmacist.

Some side effects can be serious. If you get any of the following side 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 side 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):

Diarrhoea, stomach pain, indigestion, flatulence

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

Reports of itching, rash, slow intestinal motility, intestinal obstruction (signs include severe distension, abdominal pain, swelling, or cramps, severe constipation), intestinal wall rupture (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal tenderness), gastrointestinal bleeding, large intestine inflammation, and crystal deposition in the intestine).

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at www.notificaRAM.es. By reporting side 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 which is stated on the bottle after the letters "EXP". The expiry date is the last day of the month shown.

Keep the bottle tightly closed to protect it from moisture.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 ingredients are lactose monohydrate, colloidal anhydrous silica, and zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.

Appearance of the product and pack contents

Fosquel film-coated tablets are oval, white to off-white tablets engraved 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.

Package sizes:

Each bottle contains 180 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 last revision of this leaflet:April 2020

Other sources of information

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