Skip to Content

SEVELAMER CARBONATE 800 MG FILM-COATED TABLETS

Active substance(s): SEVELAMER CARBONATE

View full screen / Print PDF » Download PDF ⇩
Transcript
TEVA UK Ref:

231-30-30147-B LEA SEVELAMER CARBONATE 800mg TAB TUK
Version:

2

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 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.
Ask your doctor or pharmacist for advice before
taking any 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.

3. HOW TO TAKE SEVELAMER
CARBONATE
You must take Sevelamer carbonate as
prescribed by your doctor. They will base the
dose on your serum phosphorus level.

05 November 2014

TEVA UK Ref:

231-30-30147-B LEA SEVELAMER CARBONATE 800mg TAB TUK
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.
The tablets must be swallowed whole. Do not
crush, chew or break into pieces.
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.



Version:

2

05 November 2014

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 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:
Synthon BV, Microweg 22, 6545 CM Nijmegen,
The Netherlands
This leaflet was last revised in 10/2014.
PL 00289/1666

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:
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. 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.

5. HOW TO STORE SEVELAMER
CARBONATE
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.
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
What Sevelamer carbonate contains
• The active substance is sevelamer
carbonate. Each tablet contains 800 mg of

30147-B
170 x 400
252246.01-GB

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide