Fosquel 2.4 g powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fosquel 2.4 g powder for oral suspension

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 effects, consult your doctor, even if they are adverse effects 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 side 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 phosphorus in the gastrointestinal tract and thereby reduces serum phosphorus levels in the blood.

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

• adult patients on dialysis (a blood-cleansing technique). It can be used in patients undergoing 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);
• adult patients with chronic kidney disease (long-term) who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l;
• paediatric patients over 6 years of age with chronic kidney disease (long-term) and with a certain height and weight (from which your doctor will calculate the body surface area).

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

Elevated serum phosphorus levels may cause hard deposits in the body known as calcifications. These deposits can harden blood vessels and make it more difficult for blood to be pumped through the body. Increased serum phosphorus 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:

• problems with stomach and 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 stool (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 other 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 in 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) levels in blood more closely.
• Medicines used to treat stomach acid 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 should also consider monitoring blood levels of that medicine.

Pregnancy and lactation

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. Consult your doctor, who will decide whether you can continue treatment with Fosquel.

It is unknown whether Fosquel can pass into breast milk and affect the baby. Consult your doctor, who will decide whether you can breastfeed your baby or not, and whether it is necessary to interrupt treatment with Fosquel.

Driving and use of machines

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

Fosquel contains sodium

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

3. How to take Fosquel

Fosquel should be taken exactly as prescribed by your doctor. Your doctor will determine the dose based on your serum phosphorus levels.

For the 2.4 g dose, the oral suspension powder in the sachet must be dispersed in 60 ml of water. It should be drunk within 30 minutes of preparation. It is important to drink all the liquid, and it may be necessary to rinse the glass with water and drink it as well to ensure the entire powder is ingested.

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

The recommended initial dose of this medicine for adults and elderly patients is 2.4–4.8 g per day, divided equally into three doses with meals. Your doctor will determine the exact initial dose and dosing regimen. If you are unsure, consult your doctor, pharmacist, or nurse.

Take Fosquel after a meal or with food.

Use in children and adolescents

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

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

Preparation using a 1 ml dosing scoop:

For a 0.4 g dose:

• Open the sachet by tearing along the marked line.

• Insert the dosing scoop into the sachet.

• Fill the dosing scoop up to the upper edge.

• Remove the dosing scoop filled to the upper edge from the sachet while keeping the sachet open, to level the powder to the top of the scoop. This allows excess powder to fall back into the sachet.

• Mix 1.0 ml of powder from the scoop with 60 ml of water. Drink within 30 minutes of preparation. It is important to drink all the liquid to ensure complete ingestion of the powder.

• Close the sachet by folding it over twice.

• The remaining powder may be used for the next dose within the following 24 hours.

• Discard any remaining powder if the sachet has been open for more than 24 hours.

For a 0.8 g dose:

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

For a 1.2 g dose:

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

For a 1.6 g dose:

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

Preparation using a measuring spoon:

For a 0.4 g dose:

• Open the sachet by tearing along the marked line.
• Hold the spoon vertically.
• Pour the contents of the sachet 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 with 60 ml of water. Drink within 30 minutes of preparation. It is important to drink all the liquid to ensure complete ingestion of the powder.
• Close the sachet by folding it over twice.
• The remaining powder may be used for the next dose within the following 24 hours.
• Discard any remaining powder if the sachet has been open for more than 24 hours.

For a 0.8 g dose:

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

For a 1.2 g dose:

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

For a 1.6 g dose:

• Follow the instructions above, filling the 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 your Fosquel dose as needed 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, you must contact your doctor immediately.

If you forget to take Fosquel

If you miss a dose, skip it 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 Fosquel treatment may lead to serious consequences, such as calcification of blood vessels. If you are considering stopping Fosquel treatment, 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 every 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, seek immediate medical attention:

• Allergic reaction (symptoms include rash, hives, swelling, difficulty breathing). This is a very rare adverse effect (may affect up to 1 in every 10,000 patients).
• Intestinal obstruction has been reported (symptoms include: severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency is unknown (cannot be estimated from available data).
• Perforation of the intestinal wall has been reported (symptoms include: severe stomach pain, chills, fever, nausea, vomiting, or tender or painful abdomen). Frequency is unknown.
• Cases of intestinal bleeding, inflammation of the large intestine, and crystal deposition in the intestine have been reported. Frequency is unknown.

Other adverse effects reported in patients taking Fosquel:

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

vomiting, upper abdominal pain, nausea

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

diarrhea, stomach pain, indigestion, flatulence

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

cases of itching, rash, slow intestinal motility (movement).

Reporting of adverse effects

If you experience any 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 Medicines: 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 sight and reach of children.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fosquel

• The active substance is sevelamer carbonate. Each sachet contains 2.4 g of sevelamer carbonate.
• The other components are microcrystalline cellulose (E460), sodium carboxymethylcellulose, sucralose (E955), lemon flavour, orange flavour, and yellow iron oxide (E172).

Appearance of the medicine and contents of the pack

Fosquel oral suspension powder is a white to yellowish powder supplied in heat-sealed aluminum sachets. The aluminum sachets are packed in an outer carton.

Pack sizes:

60 sachets per carton
90 sachets per carton

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorios Rubió, S.A.
C/ 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

or

Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands

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

Spain: Fosquel 2.4 g powder for oral suspension

Date of the most recent revision of this leaflet: October 2019

Other sources of information

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