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SEVELAMER CARBONATE 800 MG FILM-COATED TABLETS

Active substance(s): SEVELAMER CARBONATE

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TEVA UK Ref:

231-30-82301-A LEA SEVELAMER CARBONATE 800mg FC TABS TUK
Version:

2

15 September 2015

PACKAGE LEAFLET: INFORMATION FOR THE USER
Sevelamer carbonate 800 mg Film-coated Tablets
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 further questions, ask your doctor or your 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. This includes any
possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Sevelamer carbonate
is and what it is used for
2. What you need to know
before you take Sevelamer
carbonate
3. How to take Sevelamer
carbonate
4. Possible side effects
5. How to store Sevelamer
carbonate
6. Contents of the pack and
other information

1. WHAT SEVELAMER
CARBONATE IS AND
WHAT IT IS USED FOR
Sevelamer carbonate contains
sevelamer carbonate as the
active ingredient. It binds
phosphate from food in the
digestive tract and so reduces
serum phosphorus levels in
the blood.
Patients who have kidneys
that do not work properly are
not able to control the level of
serum phosphorus in their
blood. The amount of
phosphate then rises (your
doctor will call this
hyperphosphataemia).
Increased levels of serum
phosphorus can lead to hard
deposits in your body called
calcification. These deposits
can stiffen your blood vessels
and make it harder for blood
to be pumped around the
body. Increased serum
phosphorus can also lead to
itchy skin, red eyes, bone pain
and fractures.

2. WHAT YOU NEED TO
KNOW BEFORE YOU
TAKE SEVELAMER
CARBONATE
Do not take Sevelamer
carbonate if:
• you have low levels of
phosphate in your blood
(your doctor will check
this for you)
• you have bowel
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 carbonate if
any of the following applies to
you:
• swallowing problems
• problems with motility
(movement) in your
stomach and bowel
• being sick frequently
• active inflammation of the
bowel
• have undergone major
surgery on your stomach
or bowel.
The safety and efficacy in
children (below the age of
18 years) has not been
established. Therefore
Sevelamer carbonate is not
recommended for use in
children.
Additional treatments:
Due to either your kidney
condition or your dialysis
treatment you may:
• develop low or high levels
of calcium in your blood.
Since sevelamer carbonate
does not contain calcium
your doctor might
prescribe additional
calcium tablets.
• have a low amount of
vitamin D in your blood.
Therefore, your doctor
may monitor the levels of
vitamin D in your blood

REG0118893

Version 2.5

Approved

and prescribe additional
vitamin D as necessary. If
you do not take
multivitamin supplements
you may also develop low
levels of vitamins A, E, K
and folic acid in your
blood and therefore your
doctor may monitor these
levels and prescribe
supplemental vitamins as
necessary.
Special note for patients on
peritoneal dialysis:
You may develop peritonitis
(infection of your abdominal
fluid) associated with your
peritoneal dialysis. This risk
can be reduced by careful
adherence to sterile
techniques during bag
changes. You should tell your
doctor immediately if you
experience any new signs or
symptoms of abdominal
distress, abdominal
swelling, abdominal pain,
abdominal tenderness, or
abdominal rigidity,
constipation, fever, chills,
nausea or vomiting. You
should expect to be monitored
more carefully for problems
with low levels of vitamins A,
D, E, K and folic acid.
Other medicines and
Sevelamer carbonate
Tell your doctor if you are
taking or have recently taken
or might take any other
medicines.
Sevelamer carbonate should
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 carbonate.
The effects of medicines such
as ciclosporin, mycophenolate
mofetil and tacrolimus
(medicines used to suppress
the immune system) may be
reduced by Sevelamer
carbonate. Your doctor will
advise you if you are taking
these medicines.
Thyroid hormone deficiency
may uncommonly be
observed in certain people
taking levothyroxine (used to
treat low thyroid hormone
levels) and Sevelamer
carbonate. Therefore your
doctor may monitor the levels
of thyroid stimulating
hormone in your blood more
closely.
Your doctor will check for
interactions between
Sevelamer carbonate and
other medicines on a regular
basis.
Sevelamer carbonate with
food and drink
You must take Sevelamer
carbonate tablets with meals.
Pregnancy, breast-feeding
and fertility
If you are pregnant or
breast-feeding, think you may
be pregnant or are planning to
have a baby, ask your doctor
for advice before taking this
medicine.
It is unknown whether
Sevelamer carbonate has any
affect on unborn babies.
Tell your doctor if you wish to
breast-feed your baby. It is
unknown whether Sevelamer
carbonate may pass through
breast milk and affect your
baby.

Page 1 of 3

TEVA UK Ref:

231-30-82301-A LEA SEVELAMER CARBONATE 800mg FC TABS TUK
Ask your doctor or pharmacist
for advice before taking any
medicine.

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 carton after the
letters “EXP”. The expiry date
refers to the last day of that
month.
This medicinal product does
not require any special storage
conditions.

You must take Sevelamer
carbonate as prescribed by
your doctor. They will base the
dose on your serum
phosphorus level.

The tablets must be
swallowed whole. Do not
crush, chew or break into
pieces.

15 September 2015

5. HOW TO STORE
SEVELAMER
CARBONATE

3. HOW TO TAKE
SEVELAMER
CARBONATE

The recommended starting
dose of Sevelamer carbonate
tablets for adults and the
elderly (> 65 years) is one to
two tablets of 800 mg with
each meal, 3 times a day.

2

This includes any possible
side effects not listed in this
leaflet. You can also report
side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you
can help provide more
information on the safety of
this medicine.

Driving and using machines
No studies on the effects on
the ability to drive and use
machines have been
performed. If you are affected,
do not drive and do not use
any tools or machines.
Sevelamer carbonate
contains lactose
Sevelamer carbonate contains
lactose (milk sugar). If you
have been told by your doctor
that you have an intolerance
to some sugars, contact your
doctor before taking this
medicinal product.

Version:

Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to throw away
medicines you no longer use.
These measures will help
protect the environment.

6. CONTENTS OF THE
PACK AND OTHER
INFORMATION

In some cases where
Sevelamer carbonate should
be taken at the same time as
another medicine, your
doctor may advise you to take
this medicine 1 hour before or
3 hours after Sevelamer
carbonate intake, or they may
consider monitoring the blood
levels of that medicine.
Your doctor will check the
levels of phosphorus in your
blood periodically and they
may adjust the dose of
Sevelamer carbonate when
necessary to reach an
adequate phosphate level.
If you take more Sevelamer
carbonate than you should
There are no reported
overdoses in patients.
In the event of a possible
overdose you should contact
your doctor immediately.
If you forget to take
Sevelamer carbonate
If you have missed one dose,
this dose should be omitted
and the next dose should be
taken at the usual time with a
meal. Do not take a double
dose to make up for a
forgotten dose.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this
medicine can cause side
effects, although not
everybody gets them.
The following side effects have
been reported in patients
taking Sevelamer carbonate:

What Sevelamer carbonate
contains




The active substance is
sevelamer carbonate. Each
tablet contains 800 mg of
sevelamer carbonate
The other ingredients are
lactose monohydrate,
silica (colloidal
anhydrous), zinc stearate.
The tablet coating
contains hypromellose
(E464) and diacetylated
monoglycerides.

What Sevelamer carbonate
looks like and contents of
the pack
Sevelamer carbonate are oval,
white to off-white film-coated
tablets with the inscription
‘SVL’ on one side.
HDPE bottles with a
polypropylene cap.
Each bottle contains 30, 50 or
180 tablets.
Not all pack sizes may be
marketed.
Marketing Authorisation
Holder and Manufacturer
Marketing authorisation
holder:
TEVA UK Limited, Eastbourne,
BN22 9AG, UK
Manufacturer:
Merckle GmbH,
Ludwig-Merckle-Str. 3, 89143
Blaubeuren, Germany
This leaflet was last revised
in 09/2015.
PL 00289/1666

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
In clinical use, cases of
itching, rash, slow intestine
motility
(movement)/blockages in the
intestine and perforation in the
intestine wall have been
reported.
Since constipation may be an
early symptom of a blockage
in your intestine, please
inform your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, talk
to your doctor or pharmacist.

REG0118893

Version 2.5

Approved

82301-A
628 x 148

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