Product Description
Sevelamer carbonate is 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 is 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.
BEFORE YOU TAKE SEVELAMER TABLETS
Do not take Sevelamer if you:• have low levels of phosphate in your blood (your doctor will check this for you)
• have bowel obstruction
• 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 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
Tell your doctor if you are taking or have recently taken or might take any other medicines.
• 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.
• 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.
• 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 has been performed. If you are affected, do not drive and do not use any tools or machines.
HOW TO TAKE SEVELAMER TABLETS
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 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.
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.
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.
Since constipation may be an early symptom of a blockage in your intestine, please inform your doctor or pharmacist.
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
HOW TO STORE SEVELAMER 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”. Keep the bottle container tightly closed in order to protect from moisture. 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.
FURTHER INFORMATION
What Sevelamer tablet containsThe active substance is sevelamer carbonate.
Each tablet contains 400 mg sevelamer hydrochloride.
The other ingredients are silica colloidal anhydrous and stearic acid, hypromellose (E464), diacetylated monoglycerides, iron oxide black (E172) and propylene glycol.
Each Sevelamer film-coated tablet contains 800 mg of sevelamer carbonate
The other ingredients are microcrystalline cellulose, sodium chloride and zinc stearate. The tablet coating contains hypromellose (E464) and diacetylated monoglycerides. The printing ink contains iron oxide black (E172), isopropyl alcohol, propylene glycol and hypromellose (E464).
What Sevelamer looks like and contents of the pack
400mg tablets
Sevelamer tablets are film coated, off white, oval tablets imprinted on one side. The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and an induction seal. Pack sizes are: 1 bottle of 360 tablets multipacks containing 720 tablets (2 bottles of 360 tablets) multipacks containing 1080 tablets (3 bottles of 360 tablets)
800mg tablets
Sevelamer film-coated tablets are white tablets with SEVELAMER 800 imprinted on one side. The tablets are packed in high density polyethylene bottles with a polypropylene cap and an induction seal.
Pack sizes:
1 x 30 tablets per bottle
1 x 180 tablets per bottle
180 tablets (6 bottles of 30 tablets)
Not all pack sizes may be marketed.
No comments:
Post a Comment