Leaflet: information for the user

Fosquel 2.4 g powder for oral suspension

Sevelamer carbonate

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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.

1. What Fosquel is and what it is used for

2. What you need to know before you start taking Fosquel

3. How to take Fosquel

4. Possible side effects

5. Storage of Fosquel

6. Contents of the pack and additional information

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);
• adult 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;
• pediatric patients aged 6 years or older with chronic kidney disease (long-term) and a certain height and weight (with which their doctor will calculate their body surface area).

This medicationshould 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 calcifications. 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 also can produce itching skin, red eyes, bone pain, and fractures.

Do not takeFosquel

• 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:

• 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 severe abdominal pain, gastrointestinal or intestinal disorders, or gastrointestinal bleeding. 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 increased acidity in your blood and tissues. Your doctor must 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, or 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.

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 other 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 be observed with low frequency a deficiency of thyroid hormone in certain people who take levotiroxine (used to treat low levels of thyroid hormone) and Fosquel. Therefore, your doctor may monitor your thyroid-stimulating hormone levels in the blood more closely.
• 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 Fosquel. Your doctor must 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 must 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 or plan to become 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 if it is necessary to interrupt treatment with Fosquel.

Driving and operating machinery

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

Fosquel contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

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

To prepare a dose of 2.4 g, the oral powder for suspension should be dispersed in 60 ml of water. Drink within 30 minutes of preparation. It is essential to drink all the liquid, and it may be necessary to rinse the glass with water and drink it as well to ensure that all the powder is ingested.

Instead of water, the powder can be mixed with a small amount of cold drink (approximately 120 ml or half a glass) or food (about 100 grams), and taken within the next 30 minutes. Do not heat Fosquel powder (e.g., in the microwave) or add it to hot liquids or foods.

The recommended initial dose of this medication for adults and elderly patients is 2.4-4.8 g per day, divided into three meals. Your doctor will determine the exact initial dose and regimen. Consult with your doctor, pharmacist, or nurse if you are unsure.

Take Fosquel after a meal or with food.

Use in children and adolescents

The initial recommended dose of Fosquel for children is based on their height and weight (with which your doctor will calculate their body surface area). For children, it is preferred to use the powder presentation since tablets are not suitable for this population. This medication should not be administered on an empty stomach and should be taken with meals or snacks.

For doses less than 2.4 g, the powder packet can be divided. Fosquel powder can be measured by volume (ml) using a dosing device or a measuring spoon.

Preparation using a 1 ml dosing device:

For a dose of 0.4 g:

• Open the packet by tearing along the marked line.

• Insert the dosing device into the packet.
• Fill the dosing device to the top.
• Remove the dosing device from the packet to the top with the packet open to level the powder to the top of the dosing device. This allows any excess powder to fall into the packet.

• Mix 1.0 ml of powder from the dosing device in 60 ml of water. Drink within 30 minutes of preparation. It is essential to drink all the liquid to ensure that all the powder is ingested.
• Close the packet by folding it twice.
• The remaining powder can be used for the next dose within 24 hours.
• Discard the remaining powder if the packet has been open for more than 24 hours.

For a dose of 0.8 g:

• Follow the instructions above, filling the dosing device twice to obtain a total of 2.0 ml of powder.

For a dose of 1.2 g:

• Follow the instructions above, filling the dosing device three times to obtain a total of 3.0 ml of powder.

For a dose of 1.6 g:

• Follow the instructions above, filling the dosing device four times to obtain a total of 4.0 ml of powder.

Preparation using a measuring spoon:

For a dose of 0.4 g:

• Open the packet by tearing along the marked line.
• Hold the measuring spoon vertically.
• Pour the contents of the packet into the measuring spoon to fill it to 1.0 ml.
• Do not tap the measuring spoon to compact the powder.
• Mix 1.0 ml of powder from the measuring spoon in 60 ml of water. Drink within 30 minutes of preparation. It is essential to drink all the liquid to ensure that all the powder is ingested.
• Close the packet by folding it twice.
• The remaining powder can be used for the next dose within 24 hours.
• Discard the remaining powder if the packet has been open for more than 24 hours.

For a dose of 0.8 g:

• Follow the instructions above, filling the measuring spoon twice to obtain a total of 2.0 ml of powder.

For a dose of 1.2 g:

• Follow the instructions above, filling the measuring spoon three times to obtain a total of 3.0 ml of powder.

For a dose of 1.6 g:

• Follow the instructions above, filling the measuring spoon four times to obtain a total of 4.0 ml of powder.

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 moreFosquelthan you should

In case of a possible overdose, you should contact your doctor immediately.

If you forget to takeFosquel

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 Fosquel

Continuing your treatment with Fosquel is essential to maintain an appropriate level of phosphate in your blood. Stopping Fosquel treatment would lead to serious 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 all people 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:

• Allergic reaction (signs that include rash, hives, swelling, difficulty breathing). This is a very rare adverse effect (it 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). The frequency is unknown (it cannot be estimated from available data).
• Intestinal wall rupture has been reported (signs include: intense stomach pain, chills, fever, nausea, vomiting, or a painful or sensitive abdomen). The frequency is unknown.
• Intestinal bleeding, inflammatory bowel disease, and crystal deposition in the intestine have been reported. The frequency is unknown.

Other adverse effects have been reported in patients taking Fosquel:

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

vomiting, upper abdominal pain, nausea

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

diarrhea, stomach pain, indigestion, flatulence

Unknown frequency(it cannot be estimated from available data):

cases of itching, rash, slow intestinal motility.

Reporting Adverse Effects

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

Keepthis medicationout ofthe sight and reach ofchildren.

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

The medication does not require special storage conditions.The reconstituted suspension must be administered within 30 minutes of reconstitution.

Do not dispose of medications through the drainsor in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointof thepharmacy. If in doubt, ask your pharmacisthow to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofFosquel

• The active ingredient is sevelamer carbonate. Each sachet contains 2.4 g of sevelamer carbonate.
• The other components aremicrocrystalline cellulose (E460),sodium carmellose, sucralose (E955),lemon flavor, orange flavor, and yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Fosqueloral suspension powder is a white to yellowish powder supplied in an aluminium thermosellable sachet. The aluminium sachets are packed in an external box.

Packaging sizes:

60 sachets per box

90 sachets per box

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Laboratorios Rubió, S.A.

C/ Industria, 29. Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Manufacturer responsible:

Synthon Hispania S.L.

C/ Castelló, no 1, Pol. Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

Synthon BV

Microweg 22

6545 CM Nijmegen

The Netherlands

This medicinal product is authorized in the Member States of the EEA with the following names:

Spain:Fosquel 2.4 g oral suspension powder

Date of the last review of this leaflet:October 2019

Other sources of information

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