Sevelameru carbonate synthon

Patient Information Leaflet

Sewelameru węglan Synthon, 800 mg, coated tablets
sewelameru węglan
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents

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

1. What Sewelameru węglan Synthon is and what it is used for

The active substance in Sewelameru węglan Synthon is sewelamer carbonate. This medicine binds dietary phosphate in the gastrointestinal tract, thereby reducing serum phosphate levels.
Sewelameru węglan Synthon is used to control hyperphosphataemia (high blood phosphate levels) in:

• adult patients undergoing dialysis (a blood-cleansing procedure). The medicine may be used in patients undergoing haemodialysis (using a blood-filtering machine) or peritoneal dialysis (where fluid is pumped into the abdominal cavity and the body's internal membrane filters the blood);
• patients with chronic (long-term) kidney disease who are not undergoing dialysis and whose serum (blood) phosphate level is equal to or greater than 1.78 mmol/l. This medicine should be used together with other medicines, such as calcium supplements and vitamin D, to prevent the development of bone disease. Elevated serum phosphate levels may lead to deposits in the body known as calcifications. Such deposits may stiffen blood vessels and impair blood circulation. High phosphate levels may also cause skin itching, redness of the eyes, bone pain, and fractures.

2. Important information before taking Sewelameru węglan Synthon

When not to take Sewelameru węglan Synthon:

• if the patient is allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• if the patient has low phosphate levels in the blood (this will be checked by the doctor)
• if the patient has intestinal blockage/obstruction

Warnings and precautions
In any of the cases listed below, consult a doctor before starting treatment with Sewelameru
węglan Synthon:

• problems with swallowing. In such a case, the doctor will prescribe Sewelameru węglan Synthon
  as an oral suspension powder.

• disorders of gastric and intestinal motility (movement)

• frequent vomiting

• active inflammatory bowel disease

• previous major gastrointestinal surgery of the stomach or intestines

• severe inflammatory bowel disease

While taking Sewelameru węglan Synthon, inform the doctor if the patient experiences severe abdominal pain, stomach pain, or intestinal disturbances, or blood in the stool (gastrointestinal bleeding). These symptoms may be caused by deposition of sewelamer crystals in the intestines. Contact the treating physician, who will decide whether treatment should be continued.

Additional treatment:
Due to kidney disease or dialysis treatment, the patient may:

• develop low or high calcium levels in the blood. Since this medicine does not contain calcium, the treating physician may prescribe additional calcium supplements in tablet form.
• develop low vitamin D levels in the blood. Therefore, the treating physician may monitor vitamin D levels and, if necessary, prescribe an additional vitamin D supplement. If the patient is not taking a multivitamin supplement, levels of vitamins A, E, K, and folic acid may also become reduced. Therefore, the physician may monitor levels of these vitamins and, if needed, prescribe a vitamin supplement.
• develop disturbances in bicarbonate levels in the blood, as well as increased blood and tissue acidity. The physician should monitor 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 procedures. This risk can be reduced by strictly adhering to aseptic techniques during bag exchanges. Inform the doctor immediately if new signs or symptoms affecting the abdominal area occur, such as swelling, pain, tenderness or rigidity of the abdomen, constipation, fever, chills, nausea, or vomiting.

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

Sewelameru węglan Synthon and other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.

• Do not take Sewelameru węglan Synthon at the same time as ciprofloxacin (an antibiotic).
• If the patient is taking antiarrhythmic or antiepileptic medicines, inform the doctor about the use of Sewelameru węglan Synthon.
• Sewelameru węglan Synthon may reduce the effectiveness of drugs such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system). The doctor will provide advice if the patient is taking such medicines.
• Hypothyroidism may occasionally occur in some patients taking Sewelameru węglan Synthon and levothyroxine (used to treat low thyroid hormone levels). Therefore, the doctor may more closely monitor thyroid-stimulating hormone (TSH) levels in the patient's blood.

Sewelameru węglan Synthon
The doctor will regularly monitor for possible interactions between Sewelameru węglan Synthon and other medicines.
In certain cases, Sewelameru węglan Synthon should be taken at the same time as another medicine. The doctor may recommend taking this medicine 1 hour before or 3 hours after taking Sewelameru węglan Synthon. The doctor may consider regular monitoring of blood levels of the concomitant medicine.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The risk of using Sewelameru węglan Synthon during pregnancy is unknown. Discuss with the doctor, who will decide whether treatment can be continued.
It is not known whether Sewelameru węglan Synthon passes into human milk and affects the breastfed infant. Discuss with the doctor, who will decide whether the woman can breastfeed or, if necessary, whether treatment with Sewelameru węglan Synthon should be discontinued.

Driving and operating machinery
It is unlikely that Sewelameru węglan Synthon affects the ability to drive or operate machinery.

Sewelameru węglan Synthon contains lactose
Sewelameru węglan Synthon contains lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking Sewelameru węglan Synthon.

3. How to take Sewelameru węglan Synthon

Sewelameru węglan Synthon should be taken according to the doctor's instructions. The doctor will adjust
the dose of the medicine according to the patient's serum phosphate concentration.
The recommended initial dose of Sewelameru węglan Synthon tablets in adults and elderly patients is one or two 800 mg tablets with meals, three times daily. If the patient is unsure, they should consult a doctor, pharmacist, or nurse.
Sewelameru węglan Synthon should be taken with food or immediately after a meal. Tablets should be swallowed whole. Do not crush, chew, or split the tablets.
Initially, the doctor will periodically check the patient's blood phosphate levels every 2–4 weeks and, if necessary, adjust the dose of Sewelameru węglan Synthon to achieve the appropriate phosphate concentration.
The patient should follow the diet recommended by the doctor.

Taking more than the recommended dose of Sewelameru węglan Synthon
In case of suspected overdose, contact the treating physician immediately.

Missing a dose of Sewelameru węglan Synthon
If the patient misses a dose, the next dose should be taken at the usual time with a meal. Do not take a double dose to make up for the missed dose.

Stopping Sewelameru węglan Synthon treatment
Taking Sewelameru węglan Synthon is important to maintain the appropriate level of phosphates in the patient's blood. Discontinuing the use of Sewelameru węglan Synthon may lead to serious consequences, such as vascular calcifications. If the patient is considering stopping treatment with Sewelameru węglan Synthon, they should first consult their doctor or pharmacist.

If there are further questions about the use of this medicine, contact a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Constipation is a very common adverse effect (may affect more than 1 in 10 people). It may be an early sign of intestinal obstruction. If constipation occurs, inform your doctor or pharmacist.
Some adverse effects may be serious. If any of the following adverse effects occur, seek medical help immediately.
Allergic reactions (symptoms: rash, hives, swelling, difficulty breathing). This is a very rare adverse effect (may affect less than 1 in 10,000 people).
Cases of intestinal obstruction have been reported (symptoms: severe bloating, abdominal pain, swelling or cramps, severe constipation). Frequency unknown (frequency cannot be estimated from available data).
Cases of intestinal wall perforation have been reported (symptoms: severe abdominal pain, chills, fever, nausea, vomiting or abdominal tenderness). Frequency unknown.

• Cases of gastrointestinal bleeding, colitis, and intestinal crystal deposits have been reported. Frequency unknown.

The following additional adverse effects have been observed in patients taking Sewelameru węglan Synthon:
Very common (may affect more than 1 in 10 people):
Vomiting • upper abdominal pain • nausea
Common (may affect 1 in 10 people):
Diarrhoea • dyspepsia • flatulence
Frequency unknown (cannot be estimated from available data):
Cases of itching, rash, and intestinal motility slowing have been reported.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sewelameru węglan Synthon

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and outer packaging after 'EXP'. The expiry date refers to the last day of the stated month.
No special storage instructions apply to this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sewelameru węglan Synthon contains

• The active substance is sevelamer carbonate. Each coated tablet of Sewelameru węglan Synthon contains 800 mg of sevelamer carbonate.
• Other components: monohydrate lactose, anhydrous colloidal silicon dioxide, zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.

What Sewelameru węglan Synthon looks like and contents of the pack
The Sewelameru węglan Synthon coated tablet is oval, white to off-white, with an 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.
Packages containing 1, 2 or 3 bottles are available.
Not all pack sizes may be marketed.
The HDPE bottles contain a desiccant to absorb moisture. Do not remove it from the bottle.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Manufacturers:
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 for marketing in 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, plėvele dengtos tabletės
Latvia Sevelamer carbonate Synthon 800 mg apvalkotās tabletes
Norway Sevelamercarbonat WH 800 mg film-coated tablets
Poland Sewelameru węglan Synthon