1. What Renapat is and what it is used for
Renapat contains Sevelamer carbonate as the active substance. It binds phosphate from food in the
digestive tract and so reduces serum phosphorus levels in the blood.
This medicine is used to control hyperphosphataemia (high blood phosphate levels) in:
• adult patients on dialysis (a blood clearance technique). It can be used in patients
undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis
(where fluid is pumped into the abdomen and an internal body membrane filters the
blood);
• patients with chronic (long-term) kidney disease who are not on dialysis and have a
serum(blood) phosphorus level equal to or above 1.78 mmol/l.
This medicine should be used with other treatments such as calcium supplements and vitamin D
to prevent the development of bone disease.
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 Renapat
Do not take Renapat if:
• you are allergic to the active substance or to any of the other ingredients of this medicine.
• you have low levels of phosphate in your blood (your doctor will check this for you)
• you have bowel obstruction
Warnings and precautions
Talk to your doctor before taking Renapat if any of the following applies to you:
• swallowing problems. Your doctor can rather prescribe Renapat powder for oral
suspension
• 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.
• serious inflammatory bowel disease
Talk to your doctor while taking Renapat:
• if you experience severe abdominal pain, stomach or intestine disorders, or blood in the
stool (gastrointestinal bleeding). These symptoms can be due to Sevelamer crystals deposit
in your bowel. Contact your doctor who will decide on continuing the treatment or not.
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 this medicine 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.
• have disturbed level of bicarbonate in your blood and increased acidity in the blood
and other body tissue. Your doctor should monitor the level of bicarbonate in your
blood.
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.
Children
The safety and efficacy in children (below the age of 6 years) have not been studied. Therefore this
medicine is not recommended for use in children below the age of 6 years.
Other medicines and Renapat
Tell your doctor if you are taking, have recently taken or might take any other medicines.
• Renapat 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 Renapat.
• The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus
(medicines used to suppress the immune system) may be reduced by Renapat. 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 Renapat. Therefore your
doctor may monitor the levels of thyroid stimulating hormone in your blood more
closely.
• Medicines treating heartburn and reflux from your stomach or oesophagus, such as
omeprazole, pantoprazole, or lansoprazole, known as “proton pump inhibitors”, may
reduce the efficacy of Renapat. Your doctor may monitor the phosphate level in your
blood.
Your doctor will check for interactions between Renapat and other medicines on a regular basis.
In some cases where Renapat 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 Renapat intake. Your doctor may also
consider monitoring the levels of that medicine in your blood.
Pregnancy and breast-feeding
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.
The potential risk of Renapat during human pregnancy is unknown. Talk to your doctor who will decide
if you can continue the treatment with Renapat.
It is unknown whether Renapat is excreted in breast milk and may affect your baby. Talk to your doctor
who will decide if you can breastfeed your baby or not, and if it is necessary to stop Renapat treatment.
Driving and using machines
Sevelamer Carbonate is unlikely to affect your ability to drive or to use machines.
3. How to take Renapat
You must take Renapat as prescribed by your doctor. They will base the dose on your serum phosphorus
level.
The recommended starting dose of Renapat tablets for adults and elderly is one to two tablets of 800
mg with each meal, 3 times a day. Check with your doctor or health care provider if you are not sure.
Take Renapat after your meal or with food.
The tablets must be swallowed whole. Do not crush, chew or break into pieces.
Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust
the dose of Renapat when necessary to reach an adequate phosphate level.
Follow the diet prescribed by your doctor.
If you take more Renapat than you should
In the event of a possible overdose you should contact your doctor immediately.
If you forget to take Renapat
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.
If you stop taking Renapat
Taking your Renapat treatment is important to maintain an appropriate phosphate level in your blood.
Stopping Renapat would lead to important consequences such as calcification in the blood vessels. If
you consider stopping your Renapat treatment, contact your doctor or pharmacist first. If you have any
further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Constipation is a very common side effect (may affect more than 1 in 10 people). It can be an early
symptom of a blockage in your intestine. In case of constipation, please inform your doctor or
pharmacist.
Some side effects could be serious. If you get any of the following side effects, seek immediate medical
attention:
- Allergic reaction (signs including rash, hives, swelling, trouble breathing). This is a very rare side
effect (may affect up to 1 in 10,000 people).
- Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps;
severe constipation) has been reported. Frequency is not known (frequency cannot be estimated
from the available data).
- Rupture in the intestinal wall (signs include: severe stomach pain, chills, fever, nausea, vomiting,
or a tender abdomen) has been reported. Frequency is not known.
- Intestinal bleeding, inflammation of the large bowel and crystal deposit in the intestine have
been reported. Frequency is not known.
Other side effects have been reported in patients taking Renapat:
Very common:
vomiting, upper abdominal pain, nausea
Common (may affect up to 1 in 10 people):
diarrhoea, stomach ache, indigestion, flatulence
Not known:
cases of itching, rash, slow intestine motility (movement)
5. How to store Renapat
Store Below 30°C
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.
Keep the bottle container tightly closed in order to protect from moisture. This medicine 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.