Sevelameru vemglan Sinthon

B. PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Sevelamer Carbonate Synthon, 800 mg, film-coated tablets

Sevelamer carbonate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sevelamer Carbonate Synthon and what is it used for
• 2. Important information before taking Sevelamer Carbonate Synthon
• 3. How to take Sevelamer Carbonate Synthon
• 4. Possible side effects
• 5. How to store Sevelamer Carbonate Synthon
• 6. Contents of the packaging and other information

1. What is Sevelamer Carbonate Synthon and what is it used for

The active substance of Sevelamer Carbonate Synthon is sevelamer carbonate. The medicine binds to phosphate in the gastrointestinal tract and thereby reduces phosphate levels in the blood. The medicine is used to control hyperphosphataemia (high phosphate levels in the blood) in:

• adult patients undergoing dialysis (a technique for cleaning the blood). The medicine may be used in patients undergoing haemodialysis (using a machine to filter the blood) or peritoneal dialysis (where fluid is pumped into the abdominal cavity and the inner lining of the body filters the blood);
• patients with chronic (long-term) kidney disease who are not undergoing dialysis and who have a blood phosphate level of 1.78 mmol/l or higher. This medicine should be used with other medicines, such as calcium supplements and vitamin D, to prevent the development of bone disease. High phosphate levels in the blood can lead to the formation of deposits in the body, known as calcification. These deposits can stiffen blood vessels and make it difficult for blood to circulate in the patient's body. High phosphate levels can also lead to itching of the skin, redness of the eyes, pain, and bone fractures.

2. Important information before taking Sevelamer Carbonate Synthon

When not to take Sevelamer Carbonate Synthon:

• if the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6).
• if the patient has low phosphate levels in the blood (the doctor will check this)
• if the patient has bowel obstruction or intestinal blockage

Warnings and precautions

In any of the following cases, the patient should consult their doctor before starting to take Sevelamer Carbonate Synthon:

• swallowing problems. In such cases, the doctor will prescribe Sevelamer Carbonate Synthon powder for oral suspension.

Sevelamer Carbonate Synthon powder for oral suspension.

• gastrointestinal motility disorders (movement disorders of the stomach and intestines)
• frequent vomiting
• active gastrointestinal inflammation
• recent major gastrointestinal surgery.
• severe inflammatory bowel disease

While taking Sevelamer Carbonate Synthon, the patient should tell their doctor if they experience severe stomach, abdominal, or gastrointestinal pain, or blood in their stool (gastrointestinal bleeding). These symptoms may be due to the deposition of sevelamer crystals in the intestines. The patient should contact their doctor, who will decide whether to continue treatment.
Additional treatment:
In relation to kidney disease or dialysis treatment, the patient may experience:

• low or high calcium levels in the blood. Since this medicine does not contain calcium, the doctor may prescribe additional calcium supplements in the form of tablets.
• low vitamin D levels in the blood. In this case, the doctor may check the patient's vitamin D levels and prescribe additional vitamin D supplements if necessary. If the patient is not taking a multivitamin supplement, they may also experience a decrease in levels of vitamins A, E, K, and folic acid. In this case, the doctor may check the levels of these vitamins and prescribe a vitamin supplement if necessary.
• disorders of bicarbonate levels in the blood and increased acidity of the blood and other body tissues. The doctor should monitor the patient's bicarbonate levels in the blood.

Special information for patients undergoing peritoneal dialysis
The patient may develop peritonitis (infection of the fluid in the abdominal cavity) related to peritoneal dialysis. This risk can be reduced by strictly following the rules of asepsis during bag changes. The patient should immediately inform their doctor if they experience new signs or symptoms of abdominal disorders, swelling, pain, tenderness, or tension of the abdomen, constipation, fever, chills, nausea, or vomiting.

Children and adolescents

The safety and efficacy of Sevelamer Carbonate Synthon 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.

Sevelamer Carbonate Synthon and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• The patient should not take Sevelamer Carbonate Synthon and ciprofloxacin (an antibiotic) at the same time.
• If the patient is taking anti-arrhythmic or anti-epileptic medicines, they should inform their doctor about taking Sevelamer Carbonate Synthon.
• Sevelamer Carbonate Synthon may reduce the effectiveness of medicines such as cyclosporin, mycophenolate mofetil, and tacrolimus (immunosuppressant medicines). The doctor will advise if the patient is taking these medicines.
• Hypothyroidism (underactive thyroid) may occasionally occur in patients taking Sevelamer Carbonate Synthon and levothyroxine (used to treat underactive thyroid). In this case, the doctor may closely monitor the patient's thyroid-stimulating hormone levels.

Sevelamer Carbonate Synthon
The doctor will regularly check for possible interactions between Sevelamer Carbonate Synthon and other medicines.
In some cases, Sevelamer Carbonate Synthon should be taken at the same time as another medicine. The doctor may advise taking this medicine 1 hour before or 3 hours after taking Sevelamer Carbonate Synthon. The doctor may consider regular monitoring of the levels of this medicine in the patient's blood.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The risk of taking Sevelamer Carbonate Synthon during pregnancy is unknown. The patient should discuss this with their doctor, who will decide whether to continue treatment.
It is not known whether Sevelamer Carbonate Synthon passes into breast milk and affects the breastfed child. The patient should discuss this with their doctor, who will decide whether the woman can breastfeed or whether it is necessary to stop treatment with Sevelamer Carbonate Synthon.

Driving and using machines

It is unlikely that Sevelamer Carbonate Synthon will affect the patient's ability to drive or use machines.

Sevelamer Carbonate Synthon contains lactose

Sevelamer Carbonate Synthon contains lactose (milk sugar). If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Sevelamer Carbonate Synthon.

3. How to take Sevelamer Carbonate Synthon

Sevelamer Carbonate Synthon should be taken as advised by the doctor. The doctor will adjust the dose according to the patient's blood phosphate levels.
The recommended initial dose of Sevelamer Carbonate Synthon tablets for adults and the elderly is one or two 800 mg tablets with meals, three times a day. The patient should consult their doctor, pharmacist, or nurse if they are unsure.
Sevelamer Carbonate Synthon should be taken with food or after a meal. Tablets should be
swallowed whole.Do not break, chew, or divide the tablets.
Initially, the doctor will periodically check the patient's phosphate levels in the blood every 2-4 weeks and adjust the dose of Sevelamer Carbonate Synthon if necessary to achieve the correct phosphate levels.
The patient should follow the diet prescribed by their doctor.

Taking a higher dose of Sevelamer Carbonate Synthon than recommended

In case of possible overdose, the patient should immediately contact their doctor.

Missing a dose of Sevelamer Carbonate Synthon

If the patient misses a dose, they should take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

Stopping treatment with Sevelamer Carbonate Synthon

Taking Sevelamer Carbonate Synthon is important to maintain the correct phosphate levels in the patient's blood. Stopping treatment with Sevelamer Carbonate Synthon may lead to serious consequences, such as calcification in blood vessels. If the patient is considering stopping treatment with Sevelamer Carbonate Synthon, they should first consult their doctor or pharmacist.
If the patient has any further questions about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sevelamer Carbonate Synthon can cause side effects, although not everybody gets them.
Constipation is a very common side effect (may affect more than 1 in 10 people). It may be an early sign of bowel obstruction. If constipation occurs, the patient should inform their doctor or pharmacist.
Some side effects may be serious. If the patient experiences any of the following side effects, they should seek medical attention immediately.
Allergic reactions (symptoms: rash, hives, swelling, difficulty breathing). This is a very rare side effect (may affect less than 1 in 10,000 people).
There have been reports of bowel obstruction (symptoms: severe bloating, abdominal pain, swelling, or cramps, severe constipation). The frequency of this side effect is unknown (cannot be estimated from the available data).
There have been reports of perforation of the intestinal wall (symptoms: severe abdominal pain, chills, fever, nausea, vomiting, or abdominal tenderness). The frequency of this side effect is unknown.

• There have been reports of gastrointestinal bleeding, colitis, and crystal deposits in the intestine. The frequency of this side effect is unknown.

In patients taking Sevelamer Carbonate Synthon, the following other side effects have been observed:
Very common(may affect more than 1 in 10 people):
Vomiting • abdominal pain • nausea
Common(may affect up to 1 in 10 people):
Diarrhoea • indigestion • bloating
Frequency unknown(cannot be estimated from the available data):
There have been reports of itching, rash, and slowed gastrointestinal motility

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02 222 Warszawa, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, e-mail: [email protected]
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Sevelamer Carbonate Synthon

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the bottle and packaging after 'EXP'. The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Sevelamer Carbonate Synthon contains

• The active substance is sevelamer carbonate. Each Sevelamer Carbonate Synthon film-coated tablet contains 800 mg of sevelamer carbonate.
• Excipients: lactose monohydrate, colloidal silica anhydrous, zinc stearate. The tablet coating contains hypromellose (E464) and mono- and diacetylated monoglycerides.

What Sevelamer Carbonate Synthon looks like and contents of the pack

Sevelamer Carbonate Synthon film-coated tablets are oval, white to off-white, with the imprint "SVL" on one side.
Pack sizes:
HDPE bottle with a PP cap in a cardboard box.
Each bottle contains 180, 200, or 210 tablets.
Packs containing 1, 2, or 3 bottles are available.
Not all pack sizes may be marketed.
HDPE bottles contain a desiccant. Do not remove it from the bottle.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:
Synthon BV
Microweg 22
6545 CM Nijmegen
Netherlands
Manufacturer:
Synthon Hispania SL
Castelló 1, Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain
Pharmakapothiki ALFA-OMEGA S.A.
Lakko Kyrillo, PO Box 152
Aspropyrgos Attiki 193 00
Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Cyprus
Sevelamer Ledpharm
Denmark
Sevelamercarbonat Synthon
Estonia
Sevelamer Auxilia
Finland
Sevelamer Avansor 800 mg
Greece
SEVELAMER/FARAN
Hungary
Szevelamer-karbonát Synthon 800 mg
Lithuania
Sevelamer Synthon 800 mg, apvalkotų tabletės
Latvia
Sevelamer carbonate Synthon 800 mg apvalkotās tabletes
Norway
Sevelamercarbonat WH 800 mg film-coated tablets
Poland
Sewelameru węglan Synthon
Date of last revision of the leaflet:04.05.2020