SEVELAMER 800 mg Tabletki Powlekane

Andrei Popov

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Dr Andrei Popov jest lekarzem rodzinnym ze specjalistycznym przygotowaniem w zakresie leczenia bólu przewlekłego. Prowadzi konsultacje wideo dla dorosłych w Hiszpanii i w całej Europie: zarówno jeśli od miesięcy zmagasz się z bólem, którego nikt nie potrafił dobrze wyjaśnić, jak i wtedy, gdy potrzebujesz rozwiązać problem zdrowotny bez czekania tygodniami na wizytę.

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Jak stosować SEVELAMER SANDOTS

Treść ulotki

Sevelamer Sandoz 800 mg film-coated tablets

Sevelamer Sandoz 800 mg film-coated tablets

Sevelamer carbonate

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

1. What Sevelamer Sandoz is and what it is used for
2. What you need to know before you take Sevelamer Sandoz
3. How to take Sevelamer Sandoz
4. Possible side effects
5. How to store Sevelamer Sandoz
6. Contents of the pack and other information

1. What is Sevelamer Sandoz and what is it used for

Sevelamer Sandoz contains sevelamer carbonate as the active ingredient. This binds phosphate
present in food within the digestive system and in this way reduces serum phosphate
levels in the blood.
Sevelamer Sandoz is used to control hyperphosphataemia (high phosphate levels in the blood) in:

adult patients undergoing dialysis (blood purification technique). It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (fluid is pumped into the abdomen and an internal membrane filters the blood);
patients with chronic kidney disease (long-term) who are not undergoing dialysis and with serum (blood) phosphate levels equal to or greater than 1.78 mmol/l. Sevelamer Sandoz should be used with other treatments such as calcium and vitamin D supplements to prevent the development of bone disease.

Increased serum phosphate levels can cause hard deposits in the body, called
calcifications. These deposits can stiffen blood vessels and make it more difficult for blood to
be pumped throughout the body. Increased serum phosphate can also lead to itching, red eyes,
bone pain and fractures.

2. What you need to know before you take Sevelamer Sandoz

Do not take Sevelamer Sandoz if:

you have low levels of phosphatein your blood (your doctor will check this).
you suffer from intestinal obstruction.
you are allergic to sevelamer carbonate or any of the other ingredientsof this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Sevelamer Sandoz if any of the following apply to you:

problems with swallowing.
problems with motility (movement) in the stomach and intestines.
frequent vomiting.

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active inflammationof the intestines.
you have had major surgeryon your stomach or intestines.
you have a serious inflammatory bowel disease.

Further treatments:
Due to your kidney problems or dialysis treatment, you may:

experience low or high levels of calcium in your blood. Since sevelamer carbonate does not contain calcium, your doctor may prescribe you additional calcium-based tablets.
have a low level of vitamin D in your blood. As a result, your doctor may check the levels of vitamin D in your blood and prescribe you additional vitamin D as needed. If you do not take multivitamin supplements, you may also experience low levels of vitamin A, E, K and folic acid in your blood, and therefore your doctor may check these levels and prescribe vitamin supplements as needed.

Special note for patients undergoingperitoneal dialysis:
You may develop peritonitis (infection of the abdominal fluid) associated with peritoneal dialysis.
This risk can be reduced by adopting strict aseptic techniques when replacing the
bags. You must immediately inform your doctor if you experience new signs or symptoms of
abdominal discomfort, abdominal bloating, abdominal pain, abdominal tenderness or
abdominal 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 and folic acid occur.
Children
Safety and efficacy in children (under 6 years of age) have not been studied. Therefore, the use of
Sevelamer Sandoz is not recommended in children under 6 years of age.

Other medicines and Sevelamer Sandoz
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Sevelamer Sandoz must not be taken at the same time as ciprofloxacin(an antibiotic).
If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your
doctor when taking Sevelamer Sandoz.
Sevelamer Sandoz 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, a deficiency of thyroid hormones has been observed in some subjects taking levothyroxine(used to treat low levels of
thyroid hormones) and Sevelamer Sandoz. Consequently, your doctor may check your thyroid-stimulating hormone levels
in your blood more carefully.
If you are taking medicines to treat heartburn, gastroesophageal reflux disease
(GERD) or stomach ulcers such as omeprazole, pantoprazole, or lansoprazole, consult your doctor when
taking Sevelamer Sandoz.
Your doctor will check at regular intervals for any interactions between Sevelamer Sandoz and other
medicines.
In some cases, when Sevelamer Sandoz needs to 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 Sandoz, or consider checking the levels of
that medicine in your blood.
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Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine. It is not known if
Sevelamer Sandoz has effects on the fetus.
Tell your doctor if you wish to breastfeed your baby. It is not known whether Sevelamer Sandoz can
pass through breast milk and affect the baby.

Driving and using machines
It is unlikely that Sevelamer Sandoz will affect your ability to drive and operate
machinery.

Sevelamer Sandoz contains lactose
Sevelamer Sandoz contains lactose (a sugar from milk). If your doctor has diagnosed you with an
intolerance to certain sugars, contact him before taking this medicine.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

3. How to take Sevelamer Sandoz

Always take this medicine exactly as your doctor has instructed. Contact your doctor if
you are unsure. The doctor will base the dose on your serum phosphorus level.
The recommended initial dose of Sevelamer Sandoz tablets for adults and the elderly (over 65
years) is one or two 800 mg tablets to be taken with each meal, 3 times a day.

The tablets must be swallowed whole. Do not crush, chew, or break the tablets.
Initially, the doctor will check the phosphorus levels in your blood every 2-4 weeks and may adjust
the dose of Sevelamer Sandoz, if necessary, to achieve an adequate phosphate level.
Patients taking Sevelamer Sandoz must follow the prescribed diet.

If you take more Sevelamer Sandoz than you should
In the event of a possible overdose, you should contact your doctor immediately.

If you forget to take Sevelamer Sandoz
If you have forgotten 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 a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Because constipation can be an early symptom of a bowel obstruction, tell your doctor or
pharmacist if it occurs.
The following side effects have been reported in patients taking Sevelamer Sandoz:
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):
diarrhoea • abdominal pain • indigestion • flatulence
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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, skin rashes, slow intestinal (bowel) motility, bowel obstruction (signs include: severe
bloating; abdominal pain, swelling or cramps; severe constipation), perforation of the intestinal wall (signs
include: severe stomach pain, chills, fever, nausea, vomiting, or abdominal pain), intestinal bleeding,
inflammation of the large intestine and deposition of crystals in the intestine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or
nurse. You can also report side effects directly through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Sevelamer Sandoz

Keep this medicine out of the sight and reach of children.

[for HDPE bottles without a carton]
Do not use this medicine after the expiry date which is stated on the bottle and the carton after
“Exp”. The expiry date refers to the last day of that month.

[for HDPE bottles with a carton]
Do not use this medicine after the expiry date which is stated on the bottle and the carton after
“Exp”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sevelamer Sandoz contains

The active ingredient is sevelamer carbonate. Each film-coated tablet contains 800 mg of sevelamer carbonate.
The other ingredients are lactose monohydrate, silica (anhydrous colloidal), zinc stearate. The tablet coating contains hypromellose (E464) and monoacetylated glyceride.

Description of the appearance of Sevelamer Sandoz and contents of the pack
Sevelamer Sandoz is presented as film-coated tablets, of white to off-white colour, oval in shape
with ‘SVL’ imprinted on one side.
HDPE bottles with a polypropylene cap. Each bottle contains 30, 60, 180, 200 or 210 tablets.
Packs containing 1, 2 or 3 bottles are available.
<[Only for bottles containing a desiccant]:> HDPE bottles contain a desiccant. Do not remove
the desiccant from the bottle.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
4/5
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturers
Synthon Hispania SL
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Denmark Sevelamercarbonat “Sandoz”
Germany Sevelamercarbonat Hexal 800 mg Filmtabletten
Greece SEVELAMER/SANDOZ, 800 mg, επικαλυμμένα με λεπτό υμένιο δισκία
Italy Sevelamer Sandoz
5/5

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Kraj rejestracji
Włochy
Postać farmaceutyczna
Film-coated tablet, 800 MG
Kod ATC
V03AE02
Substancja czynna
sevelamer
Wymaga recepty
Tak
Producent
SANDOZ S.P.A.
Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
Zamienniki SEVELAMER SANDOTS
RENAJEL
Postać farmaceutyczna: Hard capsule, 403 MG
Substancja czynna: sevelamer
Producent: SANOFI WINTHROP INDUSTRIE
Wymaga recepty
RENVELA
Postać farmaceutyczna: Film-coated tablet, 800 MG
Substancja czynna: sevelamer
Producent: SANOFI WINTHROP INDUSTRIE
Wymaga recepty
SEVELAMER KARBONATO WINTROP
Postać farmaceutyczna: Oral suspension powder, 0.8
Substancja czynna: sevelamer
Producent: SANOFI WINTHROP INDUSTRIE
Bez recepty