FOSQUEL 2.4 g ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the User

Fosquel 2.4 g Powder for Oral Suspension

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 from food in the digestive tract and thereby reduces serum phosphate levels in the blood.

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

• adult patients on dialysis (a blood cleaning technique). 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);
• adult 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;
• paediatric patients over 6 years of age with chronic kidney disease (long-term) and with a certain height and weight (which your doctor will use to calculate the body surface area).

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

High serum phosphate levels can cause hard deposits in the body called calcifications. These deposits can harden in the blood vessels and make it more difficult for blood to be pumped through the body. High serum phosphate levels 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 takeFosquel

• 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 phosphate levels 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:

• problems with stomach and intestinal motility (movement)
• you vomit frequently
• active inflammation of the intestine
• you have had major stomach or intestinal surgery.
• 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 the stool (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 calcium levels in your blood. As this medicine does not contain calcium, your doctor may prescribe calcium supplement tablets.
• have low vitamin D levels in your blood. Therefore, your doctor may check your vitamin D levels in the 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 necessary.
• have altered bicarbonate levels in the blood and increased acidity in the blood and other body tissues. Your doctor should check your bicarbonate levels in the blood.

Special note for patients on peritoneal dialysis

You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk may decrease with careful use of sterile techniques during bag changes. You should inform your doctor immediately 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 have not been studied in children (under 6 years). 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 use other medicines for heart rhythm problems or for epilepsy, you should consult 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 deficiency of the thyroid hormone has been rarely observed 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 the blood more closely.
• Medicines to treat 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 check your phosphate levels in the blood.

Your doctor will check for interactions between Fosquel and other medicines on a regular basis.

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or 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 can pass into breast milk and affect the 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 sodium

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

3. How to take Fosquel

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

For the 2.4 g dose of powder for oral suspension, the powder should be dispersed in 60 ml of water. Drink within 30 minutes of preparation. It is important to drink all the liquid and you may need to rinse the glass with water and drink it as well to ensure you take all the powder.

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 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 medicine 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. Talk to your doctor, pharmacist, or nurse if you are unsure.

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 (which your doctor will use to calculate the body surface area). For children, the powder formulation is preferred as tablets are not suitable for this population. This medicine should not be taken on an empty stomach and should be taken with meals or snacks.

For doses less than 2.4 g, the powder sachet can be divided. The 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 sachet by tearing along the marked line.

• Insert the dosing device into the sachet.
• Fill the dosing device to the top.
• Remove the dosing device from the sachet to the top to level the powder to the top of the dosing device. This allows excess powder to fall back into the sachet.

• Mix 1.0 ml of powder from the dosing device in 60 ml of water. Drink within 30 minutes of preparation. It is important to drink all the liquid to ensure you take all the powder.
• Close the sachet by folding it twice.
• The remaining powder can be used for the next dose within 24 hours.
• Discard the remaining powder in the sachet if it 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 get 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 get 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 get a total of 4.0 ml of powder.

Preparation using a measuring spoon:

For a dose of 0.4 g:

• Open the sachet by tearing along the marked line.
• Hold the measuring 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 in 60 ml of water. Drink within 30 minutes of preparation. It is important to drink all the liquid to ensure you take all the powder.
• Close the sachet by folding it twice.
• The remaining powder can be used for the next dose within 24 hours.
• Discard the remaining powder if it 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 get 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 get 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 get a total of 4.0 ml of powder.

Initially, your doctor will check your blood phosphate levels every 2-4 weeks and may adjust the dose of Fosquel as necessary 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, contact your doctor immediately.

If you forget to take Fosquel

If you miss 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 phosphate level in your blood. Stopping Fosquel treatment may 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:

• Allergic reaction (signs include rash, hives, swelling, difficulty breathing). This is a very rare side effect (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 (cannot be estimated from the available data).
• Intestinal wall rupture has been reported (signs include severe stomach pain, chills, fever, nausea, vomiting, or abdominal tenderness). The frequency is unknown.
• Gastrointestinal bleeding, inflammation of the large intestine, and crystal deposition in the intestine have been reported. The frequency is unknown.

Other side effects have been reported in patients taking Fosquel:

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

vomiting, pain in the upper abdomen, 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):

cases of itching, rash, slow intestinal motility.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: 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 sachet after the letters “EXP”. The expiry date is the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the 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 sachet contains 2.4 g of sevelamer carbonate.
• The other ingredients are microcrystalline cellulose (E460), sodium carmellose, sucralose (E955), lemon flavour, orange flavour, and yellow iron oxide (E172).

Appearance and packaging of the product

Fosquel powder for oral suspension is a white to yellowish powder supplied in an aluminium sachet. The aluminium sachets are packaged in an outer carton.

Package sizes:

60 sachets per carton

90 sachets per carton

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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 medicine is authorised in the Member States of the EEA under the following names:

Spain: Fosquel 2.4 g powder for oral suspension

Date of last revision of this leaflet:October 2019

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 Health Products (AEMPS) http://www.aemps.gob.es/.