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SEVELAMER CARBONATE AMNEAL 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

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.

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 you doctor. This includes any
possible side effects not listed in this leaflet. See section 4.

Other medicines and Sevelamer
Tell your doctor if you are taking or have recently taken or might take any
other medicines.

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

The effects of medicines such as ciclosporin, mycophenolate mofetil and
tacrolimus (medicines used to suppress the immune system) may be
reduced by Sevelamer. Your doctor will advise you if you are taking these
medicines.

1. What Sevelamer is and what it is used for
Sevelamer 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
Do not take Sevelamer 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 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 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.

Sevelamer 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.

Thyroid hormone deficiency may uncommonly be observed in certain
people taking levothyroxine (used to treatment low thyroid hormone
levels) and Sevelamer. Therefore your doctor may monitor the levels of
thyroid stimulating hormone in your blood more closely.
Your doctor will check for interactions between Sevelamer and other
medicines on a regular basis.
Sevelamer with food and drink
You must take Sevelamer 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 has any affect on unborn babies.
Tell your doctor if you wish to breast-feed your baby. It is unknown
whether Sevelamer 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 contains lactose
Sevelamer 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
You must take Sevelamer as prescribed by your doctor. They will base the
dose on your serum phosphorus level.
The recommended starting dose of Sevelamer 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 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 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 when necessary to reach an
adequate phosphate level.

If you take more Sevelamer than you should
There are no reported overdoses in patients.
In the event of a possible overdose you should contact your doctor
immediately.

What Sevelamer looks like and contents of the pack

If you forget to take Sevelamer
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
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:
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.

Sevelamer are oval, white to off-white film-coated tablets with the
inscription ‘SVL’ on one side.

The HDPE bottles contain a desiccant. Do not remove this desiccant from
the bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder:
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2
Ireland
Manufacturer:
Synthon Hispania SL.
C/Castello No.1,
Pol. Las Salinis,
Sant boi de Llobregat,
Barcelona, 08830,
Spain
This leaflet was last revised in May 2016

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 MHRA 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
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 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.

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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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