Patient Information Leaflet: Information for the User

SEVELAMER DOC Generici 800 mg film-coated tablets

Read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet

What SEVELAMER DOC Generici is and what it is used for
What you need to know before taking SEVELAMER DOC Generici
How to take SEVELAMER DOC Generici
Possible side effects
How to store SEVELAMER DOC Generici
Contents of the pack and other information

1. What SEVELAMER DOC Generici is and what it is used for

SEVELAMER DOC Generici contains the active substance sevelamer carbonate, which works by preventing
the absorption of phosphate from food in the digestive tract, thereby reducing phosphate levels
in the blood.
SEVELAMER DOC Generici is used to control hyperphosphataemia (high phosphate levels in the blood)
in:

adult patients on dialysis (a blood purification technique). The medicine 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);
patients with chronic kidney disease who are not on dialysis and who have a serum phosphate level equal to or greater than 1.78 mmol/l. SEVELAMER DOC Generici should be used together with other treatments, such as calcium and vitamin D supplements, to prevent the development of bone disease. Elevated phosphate levels in the blood may lead to the formation of solid deposits in the body called calcifications. These deposits can stiffen blood vessels and make it more difficult for blood to circulate throughout the body. In addition, increased phosphate levels in the blood can cause skin itching, red eyes, bone pain, and fractures.

2. What you need to know before taking SEVELAMER DOC Generici

Do not take SEVELAMER DOC Generici if:

you have low levels of phosphate in the blood (your doctor will monitor this).
you suffer from intestinal obstruction.
you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking SEVELAMER DOC Generici if any of the following conditions apply to you:

problems with swallowing.
problems with motility (movement) in the stomach and intestines.
frequent vomiting.
active inflammation of the intestine.
you have undergone major surgical procedures on the stomach or intestines.

Children and adolescents
The safety and efficacy in children (under 18 years of age) have not been established. Therefore, the use of SEVELAMER DOC Generici is not recommended in children.
Additional treatments
Due to your kidney problems or your dialysis treatment, you may:

experience low or high levels of calcium in the blood. Since SEVELAMER DOC Generici does not contain calcium, your doctor may prescribe additional calcium tablets.
have low levels of vitamin D in the blood. Consequently, your doctor may monitor your vitamin D levels and prescribe additional vitamin D as needed. If you do not take multivitamin supplements, you may also develop low levels of vitamin A, E, K, and folic acid in the blood; therefore, your doctor may monitor these levels and prescribe vitamin supplements as necessary.

Special note for patients undergoing peritoneal dialysis
You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis. This risk can be reduced by strictly following aseptic techniques when changing dialysis bags. You must inform your doctor immediately if you experience new signs or symptoms of abdominal discomfort, abdominal swelling, abdominal pain, abdominal tenderness or rigidity, constipation, fever, chills, nausea, or vomiting. You should expect more careful monitoring if problems related to low levels of vitamin A, D, E, K, or folic acid occur.

Other medicines and SEVELAMER DOC Generici
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

SEVELAMER DOC Generici must not be taken concomitantly with ciprofloxacin (an antibiotic).
If you are taking medicines for heart rhythm disorders or for epilepsy, you must consult your doctor when taking SEVELAMER DOC Generici.
SEVELAMER DOC Generici may reduce the effects of medicines such as cyclosporine, mycophenolate mofetil, and tacrolimus (medicines used to suppress the immune system). Your doctor will advise you on how to proceed if you are taking these medicines.
In rare cases, in some individuals taking levothyroxine (used to treat low thyroid hormone levels) and SEVELAMER DOC Generici, thyroid hormone deficiency has been observed. Consequently, your doctor may monitor your thyroid-stimulating hormone levels more closely.
If you are taking medicines such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease, or gastric ulcer, consult your doctor when taking SEVELAMER DOC Generici.

Your doctor will regularly check for possible interactions between SEVELAMER DOC Generici and other medicines.
In some cases, when SEVELAMER DOC Generici must be taken at the same time as another medicine, your doctor may advise you to take that medicine 1 hour before or 3 hours after taking SEVELAMER DOC Generici, or may consider monitoring blood levels of that medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. It is not known whether SEVELAMER DOC Generici has effects on the fetus.
Inform your doctor if you intend to breastfeed. It is not known whether SEVELAMER DOC Generici passes into breast milk and may affect the infant.

Driving and using machines
It is unlikely that SEVELAMER DOC Generici affects the ability to drive vehicles or operate machinery.

SEVELAMER DOC Generici contains lactose
SEVELAMER DOC Generici contains lactose (a milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take SEVELAMER DOC Generici

You must take SEVELAMER DOC Generici exactly as directed by your doctor.
Your doctor will determine your dose based on your blood phosphate levels.
The recommended starting dose of SEVELAMER DOC Generici tablets for adults and elderly patients (over 65 years of age) is one or two 800 mg tablets taken with each meal, three times daily.
The tablets must be swallowed whole. Do not crush, chew, or break the tablets.
Initially, your doctor will monitor your blood phosphate levels every 2–4 weeks and may adjust the dose of SEVELAMER DOC Generici as necessary to achieve the appropriate phosphate level.
Patients taking SEVELAMER DOC Generici must follow the prescribed diet.

If you take more SEVELAMER DOC Generici than you should
In case of possible overdose, contact your doctor immediately.

If you forget to take SEVELAMER DOC Generici
If you miss a dose, skip it and take the next dose at the usual time with a meal. Do not take a double dose to make up for the missed dose.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since constipation may be an early symptom of intestinal obstruction, inform your doctor or pharmacist.
The following side effects have been reported in patients taking SEVELAMER DOC Generici:

Very common (may affect more than 1 in 10 people):
vomiting, constipation, upper abdominal pain, nausea.

Common (may affect up to 1 in 10 people):
diarrhea, abdominal pain, indigestion, flatulence.

Very rare (may affect up to 1 in 10,000 people):
hypersensitivity.

Not known (frequency cannot be estimated from the available data):
cases of itching, rash, slow intestinal motility / intestinal obstruction, and intestinal wall perforation have been reported.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SEVELAMER DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and the outer packaging after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What SEVELAMER DOC Generici contains

The active substance is sevelamer carbonate. Each film-coated tablet of SEVELAMER DOC Generici contains 800 mg of sevelamer carbonate.
The other components are monohydrate lactose, anhydrous colloidal silicon dioxide, zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides.

Description of the appearance of SEVELAMER DOC Generici and package contents
SEVELAMER DOC Generici is available as white/whitish, oval, film-coated tablets, marked with the letters 'SVL' on one side.
Packaging:
HDPE bottles with polypropylene caps. Each bottle contains 180, 200 or 210 tablets.
Packages containing 1, 2 or 3 bottles are available.
<[Only for bottles containing desiccant]:> The HDPE bottles contain a desiccant. Do not remove the desiccant from the bottle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan – Italy.
Manufacturers:

Synthon Hispania SL - Castelló 1, Polígono Las Salinas - 08830 Sant Boi de Llobregat - Spain.
Medice Arzneimittel Pütter GmbH & Co. KG - Kuhloweg 37 - 58638 Iserlohn - Germany.

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark Sevelamercarbonat Genthon
Austria Sevelamercarbonat Medice 800 mg Filmtabletten
Belgium Sevelamer-carbonaat Genthon 800 mg filmomhulde tabletten
Germany Sevemed 800 mg Filmtabletten
Greece SEVELAMER / DEMO Επικαλυμμένo με λεπτό υμένιο δισκίo 800 mg/TAB
Spain Sevelámero Kern Pharma 800 mg comprimidos recubiertos con película
France Sevelamer carbonate Biogaran 800 mg, comprimés pelliculés
Ireland Sevelamer carbonate Genthon 800 mg
Italy SEVELAMER DOC Generici 800 mg film-coated tablets
Netherlands Sevelamer-carbonaat Genthon, filmomhulde tabletten
Portugal Sevelâmero Genthon 800 mg comprimido revestido por pelicula
United Kingdom Sevelamer carbonate Genthon 800 mg film-coated tablets