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Tasermity (sevelamer hydrochloride) – Package leaflet - V03AE02

Updated on site: 10-Oct-2017

Medication nameTasermity
ATC CodeV03AE02
Substancesevelamer hydrochloride
ManufacturerGenzyme Europe BV

Package leaflet: Information for the user

Tasermity 800 mg film-coated tablets sevelamer hydrochloride

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.

Additional treatments:

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.

Changing treatment:

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.

Pregnancy and breast-feeding

The safety of Tasermity has not been established in pregnant or breast-feeding women. Tasermity should only be given to pregnant or breast-feeding women if clearly needed.

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.

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 2-3 weeks and may adjust the dose of Tasermity when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an adequate phosphate level.

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):

nausea, vomiting

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 film-coated, off-white, oval tablets with “SH800” imprinted on one side. The tablets are packed in high density polyethylene bottles with a child resistant polypropylene closure and an induction seal.

Pack size:

1 bottle of 180 tablets

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Genzyme Europe B.V.

Gooimeer 10

1411 DD Naarden

The Netherlands

Manufacturer:

Genzyme Ireland Ltd.

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

Genzyme Ltd.

37 Hollands Road

Haverhill, Suffolk

CB9 8PU

United Kingdom

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien/

Lietuva

Luxembourg/Luxemburg

UAB „SANOFI-AVENTIS LIETUVA“

Sanofi Belgium

Tel. +370 5 275 5224

Tél/Tel: + 32 2 710 54 00

 

България

Magyarország

sanofi-aventis Bulgaria EOOD

SANOFI-AVENTIS Zrt

Tел: +359 2 9705300

Tel: +36 1 505 0050

Česká republika

Malta

sanofi-aventis, s.r.o.

Sanofi Malta Ltd

Tel: +420 233 086 111

Tel: +356 21493022

Danmark

Nederland

sanofi-aventis Denmark A/S

sanofi-aventis Netherlands B.V.

Tlf: +45 45 16 70 00

Tel: +31 182 557 755

Deutschland

Norge

Zentiva Pharma GmbH

sanofi-aventis Norge AS

Tel: +49 (0) 180 20 200 10

Tlf: + 47 67 10 71 00

Eesti

Österreich

sanofi-aventis Estonia OÜ

sanofi-aventis GmbH

Tel. +372 6 273 488

Tel: + 43 1 80 185 - 0

Ελλάδα/Κύπρος

Polska

sanofi-aventis AEBE (Ελλάδα)

sanofi-aventis Sp. z o.o.

Τηλ: +30 210 900 1600

Tel.: +48 22 280 00 00

España

Portugal

sanofi-aventis, S.A.

Sanofi – Produtos Farmacêuticos, Lda.

Tel: +34 93 485 94 00

Tel: +351 21 35 89 400

France

România

sanofi-aventis France

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

 

Hrvatska

Slovenija

sanofi-aventis Croatia d.o.o.

sanofi-aventis d.o.o.

Tel: +385 1 600 34 00

Tel: +386 1 560 4800

Ireland

Slovenská republika

sanofi-aventis Ireland Ltd T/A SANOFI

sanofi-aventis Pharma Slovakia s.r.o.

Tel: +353 (0) 1 4035 600

Tel.: +421 2 33 100 100

Ísland

Suomi/Finland

Vistor hf.

Sanofi Oy

Sími: +354 535 7000

Puh/Tel: + 358 201 200 300

Italia

Sverige

Genzyme Srl

Sanofi AB

Tel: +39 059 349 811

Tel: +46 (0)8 634 50 00

Latvija

United Kingdom

sanofi-aventis Latvia SIA

Sanofi

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.

ANNEX IV

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE

TERMS OF THE MARKETING AUTHORISATION(S)

Scientific conclusions

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 non-listed gastrointestinal events such as colitis, ulcer, necrosis and peritonitis. Further evidence is still needed to demonstrate that sevelamer crystals are the causal agent for the gastrointestinal disorders. However, given the seriousness of these events and the number of reported cases, the risk of formation of sevelamer crystals associated with serious gastrointestinal disorders was considered relevance to the prescriber.

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.

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