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SEVELAMER CARBONATE GENTHON 800 MG FILM-COATED TABLETS

Active substance(s): SEVELAMER CARBONATE

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Package leaflet: Information for the USER
Sevelamer carbonate 800 mg film-coated tablets
sevelamer carbonate

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 any further questions, ask your doctor or 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet
1. What Sevelamer carbonate 800 mg film-coated tablets are and what
it is used for
2. What you need to know before you take Sevelamer carbonate 800 mg
film-coated tablets
3. How to take Sevelamer carbonate 800 mg film-coated tablets
4. Possible side effects
5. How to store Sevelamer carbonate 800 mg film-coated tablets
6. Contents of the pack and other information

1. What Sevelamer carbonate 800 mg filmcoated tablets are and what it is used for
Sevelamer carbonate 800 mg film-coated tablets contain 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 800 mg film-coated
tablets
Do not take Sevelamer carbonate 800 mg film-coated
tablets 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 800 mg filmcoated tablets 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.



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 800 mg filmcoated tablets
Tell your doctor if you are taking or have recently taken or might take
any other medicines.
Sevelamer carbonate 800 mg film-coated tablets 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 800 mg film-coated tablets.
The effects of medicines such as ciclosporin, mycophenolate mofetil and
tacrolimus (medicines used to suppress the immune system) may
be reduced by Sevelamer carbonate 800 mg film-coated tablets. 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 treatment low thyroid hormone
levels) and Sevelamer carbonate 800 mg film-coated tablets. 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
800 mg film-coated tablets and other medicines on a regular basis.
Sevelamer carbonate 800 mg film-coated tablets with food
and drink
You must take Sevelamer carbonate 800 mg film-coated tablets with
meals.

The safety and efficacy in children (below the age of 18 years) has not
been established. Therefore Sevelamer carbonate 800 mg film-coated
tablets are not recommended for use in children.

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 800 mg
film-coated tablets have any effect on unborn babies.

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.

Tell your doctor if you wish to breast-feed your baby. It is unknown
whether Sevelamer carbonate 800 mg film-coated tablets 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 800 mg film-coated tablets contain
lactose
Sevelamer carbonate 800 mg film-coated tablets contain 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 800 mg
film-coated tablets
You must take Sevelamer carbonate 800 mg film-coated tablets as
prescribed by your doctor. They will base the dose on your serum
phosphorus level.
The recommended starting dose of Sevelamer carbonate 800 mg
film-coated 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 800 mg film-coated
tablets 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 800 mg film-coated tablet 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 800 mg filmcoated tablets when necessary to reach an adequate phosphate level.
If you take more Sevelamer carbonate 800 mg film-coated
tablets than you should
There are no reported overdoses in patients.
In the event of a possible overdose you should contact your doctor
immediately.

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. This includes any
possible side effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme Website: 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
800 mg film-coated tablets
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 800 mg film-coated tablets
contain
• 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 macrogol poly
(vinyl alcohol) grafted copolymer, talc.
What Sevelamer carbonate 800 mg film-coated tablets look
like and contents of the pack
Sevelamer carbonate 800 mg film-coated tablets are oval, white to
off-white film-coated tablets with the inscription ‘SVL’ on one side.

If you forget to take Sevelamer carbonate 800 mg film-coated
tablets
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.

HDPE bottles with a polypropylene cap.
Each bottle contains 180, 200 or 210 tablets.
Packs containing 1, 2 or 3 bottles are available.

4. Possible side effects

Not all pack sizes may be marketed.

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 800 mg film-coated tablets:
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.

The HDPE bottles contain a desiccant. Do not remove this desiccant from
the bottle.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Genthon B.V.
Microweg 22
6545 CM Nijmegen,
The Netherlands
Manufacturer:
Synthon Hispania S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat, Spain
Distributed by:
Consilient Health (UK) Ltd.,
No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.

This leaflet was last revised in 09/2014
P0298

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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.

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