Package leaflet: Information for the user
Tasermity 800 mg
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 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 Tasermity is and what it is used for
2.What you need to know before you take Tasermity
3.How to take Tasermity
4.Possible side effects
5.How to store Tasermity
6.Contents of the pack and other information
1.What Tasermity is and what it is used for
Tasermity contains sevelamer as the active ingredient. It binds phosphate from food in the digestive tract and so reduces serum phosphate levels in the blood.
Tasermity is used to control the levels of phosphate in the blood of adult kidney failure patients on haemodialysis or peritoneal dialysis treatment.
Adult patients whose kidneys have failed and who are undergoing haemodialysis or peritoneal dialysis are not able to control the level of serum phosphate 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.
Tasermity may be used with other medicines which include calcium or vitamin D supplements to control the development of renal bone disease.
2. What you need to know before you take Tasermity
Do not take Tasermity:
if you have low levels of phosphate in your blood (your doctor will check this for you).
if you have bowel obstruction.
if you are allergic to sevelamer or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Tasermity if any of the following applies to you:
if you are not on dialysis
if you have swallowing problems
if you have problems with motility (movement) in your stomach and bowel
if you have symptoms of delayed emptying of stomach contents such as feeling of fullness, nausea and/or vomiting
if you have prolonged diarrhoea or pain in the abdomen (symptoms of active inflammatory bowel disease)
if you have undergone major surgery on your stomach or bowel.
Due to either your kidney condition or your dialysis treatment you may:
develop a low or high level of calcium in your blood. Since Tasermity 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.
When you switch from another phosphate binder to Tasermity, your doctor might consider monitoring the levels of bicarbonate in your blood more closely because Tasermity may decrease the levels of bicarbonate.
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.
Children and adolescents
The safety and efficacy in children (below the age of 18 years) have not been studied. Therefore Tasermity is not recommended for use in this population.
Other medicines and Tasermity
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Tasermity 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 before taking Tasermity.
The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Tasermity. Your doctor will advise you if you are taking these medicines.
In certain people taking levothyroxine (a thyroid hormone) and Tasermity, increased levels of thyroid stimulating hormone (TSH, a substance in your blood which helps control your body’s chemical functions) may very rarely be observed. Therefore your doctor may monitor the levels of TSH in your blood more closely.
If you are taking medicine such as omeprazole, pantoprazole, or lansoprazole to treat heartburn, gastroesophageal reflux disease (GERD), or gastric ulcers, you should consult your doctor when taking Tasermity.
Your doctor will check for interactions between Tasermity and other medicines on a regular basis.
In some cases where Tasermity 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 Tasermity intake, or he/she may consider monitoring the blood levels of that medicine.
The safety of Tasermity has not been established in pregnant or
If you are pregnant or
Driving and using machines
Tasermity is unlikely to affect your ability to drive or to use machines.
3.How to take Tasermity
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. He/she will base the dose on your serum phosphate level. The recommended starting dose of Tasermity for adults and the elderly (> 65 years) is one or two tablets with each meal 3 times a day.
Initially your doctor will check the levels of phosphate in your blood every
The tablets must be swallowed whole. Do not crush, chew or break into pieces prior to swallowing.
Patients taking Tasermity should adhere to their prescribed diet and liquid intake.
If you take more Tasermity than you should
In the event of a possible overdose you should contact your doctor immediately.
If you forget to take Tasermity
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.
4.Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Since constipation may be a preceding symptom in very rare cases of blockages in your intestine, it is important to inform your doctor or pharmacist of this symptom before or during the use of Tasermity.
The following side effects have been reported in patients taking Tasermity: Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
diarrhoea, indigestion, abdominal pain, constipation, flatulence. Uncommon (may affect up to 1 in 100 people):
increased acidity of the blood.
Very rare (may affect up to 1 in 10000 people): hypersensitivity.
Not known (frequency cannot be estimated from the available data):
cases of itching, rash, abdominal pain, slow intestine motility (movement), blockages in the intestine, inflammation of abnormal small pouches (called diverticula) in the large intestine and perforation in the intestine wall have been reported.
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 national reporting system listed in Appendix V.
By reporting side effects you can help provide more information on the safety of this medicine.
5.How to store Tasermity
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle after “EXP”. The expiry date refers to the last day of that month.
Do not store this medicine above 25 C. Keep the bottle tightly closed in order to protect from moisture.
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 to protect the environment.
6. Contents of the pack and other information
What Tasermity contains
-The active substance is sevelamer hydrochloride. Each tablet contains 800 mg sevelamer hydrochloride.
-The other ingredients are silica colloidal anhydrous and stearic acid, hypromellose (E464), diacetylated monoglycerides, iron oxide black (E172) and propylene glycol.
What Tasermity looks like and contents of the pack
Tasermity tablets are
1 bottle of 180 tablets
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Genzyme Europe B.V.
1411 DD Naarden
Genzyme Ireland Ltd.
IDA Industrial Park
Old Kilmeaden Road
37 Hollands Road
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Tel. +370 5 275 5224
Tél/Tel: + 32 2 710 54 00
Tел: +359 2 9705300
Tel: +36 1 505 0050
Sanofi Malta Ltd
Tel: +420 233 086 111
Tel: +356 21493022
Tlf: +45 45 16 70 00
Tel: +31 182 557 755
Zentiva Pharma GmbH
Tel: +49 (0) 180 20 200 10
Tlf: + 47 67 10 71 00
Tel. +372 6 273 488
Tel: + 43 1 80 185 - 0
Τηλ: +30 210 900 1600
Tel.: +48 22 280 00 00
Sanofi – Produtos Farmacêuticos, Lda.
Tel: +34 93 485 94 00
Tel: +351 21 35 89 400
Sanofi Romania SRL
Tél : 0 800 222 555
Tel: +40 (0) 21 317 31 36
Appel depuis l’étranger : +33 1 57 63 23 23
Tel: +385 1 600 34 00
Tel: +386 1 560 4800
Tel: +353 (0) 1 4035 600
Tel.: +421 2 33 100 100
Sími: +354 535 7000
Puh/Tel: + 358 201 200 300
Tel: +39 059 349 811
Tel: +46 (0)8 634 50 00
Tel: +371 67 33 24 51
Tel: +44 (0) 845 372 7101
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu.
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE
TERMS OF THE MARKETING AUTHORISATION(S)
Taking into account the PRAC Assessment Report on the PSUR(s) for sevelamer, the scientific conclusions of CHMP are as follows:
During the reporting period, a total of 8 new cases of serious gastrointestinal disorders associated with the presence of sevelamer crystals were reported. In those cases, sevelamer crystals appeared to have been associated with several
Therefore, in view of the data presented in the reviewed PSURs, the PRAC considered that changes to the product information of medicinal products containing sevelamer hydrochloride and carbonate were warranted.
The CHMP agrees with the scientific conclusions made by the PRAC.
Grounds for the variation to the terms of the marketing authorisation(s)
On the basis of the scientific conclusions for sevelamer the CHMP is of the opinion that the benefit- risk balance of the medicinal product(s) containing sevelamer is unchanged subject to the proposed changes to the product information
The CHMP recommends that the terms of the marketing authorisation(s) should be varied.