RENAGEL. 800 mg. 180 tablets
RENAGEL. 800 mg. 180 tablets
What Renagel is and what it is used
Renagel contains sevelamer as the active ingredient . It binds dietary phosphate in GI tract and thus reduce the serum level of phosphate in the blood.
Adult patients who develop renal failure who are not on dialysis or peritoneal dialysis , are unable to control serum phosphate levels in the blood. In this case the amount of phosphate increases (your doctor will call this hyperphosphataemia ) . Elevated levels of serum phosphorus can lead to hard deposits in your body called calcification . These deposits can " harden " the blood vessels and impede blood pumped around the body. Increased serum phosphorus can lead to itchy skin, red eyes, bone pain and fractures .
Renagel is used to control the level of phosphate in the blood of adult patients with renal failure treated with hemodialysis or peritoneal dialysis.
You may have with Renagel to use other drugs that may include calcium and vitamin D, to control the development of renal bone disease.
2 . What you should know before you take Renagel
Do not take Renagel, if:
have low levels of phosphate in the blood ;
suffer from bowel obstruction ;
you are allergic to sevelamer or to any other ingredients of this medicine (listed in Section 6) .
Warnings and Precautions
Talk to your doctor before taking Renagel, if any of the following apply to you :
are not on dialysis ;
swallowing disorders ;
problems with motility (movement ) in your stomach or intestines ;
delayed gastric emptying ;
active inflammatory bowel disease ;
have undergone major surgery on your stomach or intestines .
Safety and efficacy have not been established in children ( under 18 years). Therefore not recommended for use Renagel in this population.
Upon your kidney disease or dialysis treatment can :
develop a low or high level of calcium in the blood. Since Renagel does not contain calcium , your doctor may prescribe additional calcium tablets ;
have low levels of vitamin D in the blood. Therefore, your doctor may monitor the levels of vitamin D in your blood and prescribe additional vitamin D as necessary. In the event that multivitamin supplements can develop low levels of vitamins A, E , K and folic acid in the blood and therefore your doctor may monitor these levels and prescribe supplemental .
When you switch from another phosphate binder to Renagel, your doctor may consider stricter monitoring of bicarbonate levels in your blood because Renagel may reduce the levels of bicarbonate .
Special note for patients on peritoneal dialysis
You may develop peritonitis ( infection of your abdominal fluid) associated with peritoneal dialysis. This risk can be reduced by strict adherence to sterile techniques during bag changes . You must tell your doctor immediately if you experience any new signs or symptoms of abdominal discomfort , bloating , abdominal pain , abdominal tenderness, or abdominal rigidity , constipation , fever , chills, nausea or vomiting.
Moreover , 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 Renagel
Please tell your doctor if you are taking , have recently taken or taking other medicines.
Renagel should not be given concomitantly with ciprofloxacin ( an antibiotic).
If you are taking medicines for heart rhythm disorders or epilepsy , you should consult with your doctor when taking Renagel.
Action of drugs such as cyclosporine , mycophenolate mofetil and tacrolimus ( medicines used in transplant patients) may be reduced by Renagel. Your doctor will advise you if you are taking these drugs.
Very rarely can be observed elevated levels of thyroid stimulating hormone (TSH - a substance in the blood which stimulates the thyroid gland to produce thyroid hormone , which helps control the metabolism of the body) in certain people taking levothyroxine ( thyroid hormone ) and Renagel. Therefore, your doctor may monitor more closely the levels of TSH in your blood .
Your doctor will regularly check for interactions between Renagel and other medicines.
Renagel c Food and Beverage
You should take Renagel with food. However, you should stick to your prescribed diet and fluid intake .
Do not chew . The tablets should be swallowed whole.
Pregnancy, lactation and fertility
Safety of Renagel has not been established in pregnant or lactating women. Renagel should be administered to pregnant or lactating women only if clearly needed.
If you are pregnant or breast-feeding, you may be pregnant or planning to become pregnant , talk to your doctor before taking this medicine.
Driving and using machines
No studies on the effects on ability to drive and use machines. If you are affected , do not drive or use any tools or machines.
3 . How to take Renagel
You should take Renagel as prescribed by your doctor. The doctor will determine the dose based on your serum phosphate level . The usual starting dose for adults and the elderly (> 65 years) is one or two tablets with each meal three times a day.
Your doctor will check the levels of phosphate in your blood and he / she may adjust the dose of Renagel, if necessary (between 1 and 5 tablets of 800 mg per meal ) to reach a sufficient level of phosphate.
In some cases where Renagel should be used together with other medicines , your doctor may advise you to take this medicine 1 hour before or 3 hours after Renagel, or may consider monitoring blood levels of that drug.
If you take more Renagel than
No cases of overdose in patients.
In the event of a possible overdose you should immediately contact your doctor.
If you forget to take Renagel
If you miss a dose, this dose should be skipped and the next dose should be taken at the usual time . Do not take a double dose to make up for a missed dose.
4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
The following adverse reactions have been reported in patients taking Renagel.
Very common ( may affect more than 1 in 10 people): nausea , vomiting ;
Common ( may affect up to 1 in 10 people ): diarrhea , indigestion , abdominal pain , constipation, flatulence .
In clinical use of Renagel, cases of pruritus, rash, abdominal pain, delayed intestinal motility ( bowel movements ) , bowel obstruction , inflammation, abnormal small pouches (called diverticula ) in the colon and perforation of the intestinal wall.
Since constipation may be a preceding symptom in very rare cases of bowel obstruction , please tell your doctor or pharmacist.
If you get any side effects , tell your doctor. This includes all listed in this leaflet .
5 . How to store Renagel
Keep out of reach of children.
Do not store above 25 ° C. Keep the bottle tightly closed in order to protect from moisture.
Do not use this medicine after the expiry date stated on the carton and / or bottle after " EXP" .
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . Contents of the pack and other information
Contents of Renagel
The active substance is sevelamer .
The other ingredients are silica colloidal anhydrous and stearic acid.
The tablet film coating contains hypromellose and diacetylated monoglycerides . The printing ink contains black iron oxide ( E172 ), hypromellose and propylene glycol.
Renagel looks like and contents of the pack
Renagel tablets are film-coated , off-white, oval tablet, one side of which is imprinted "Renagel 800" .
The tablets are packaged in bottles of high density polyethylene with a child resistant polypropylene cap and induction seal .