Thelin

Helstu upplýsingar

  • Heiti vöru:
  • Thelin
  • Lyf við lungum:
  • Mannfólk
  • Lyfjaform:
  • Allópatísk lyf

Skjöl

Staðsetning

  • Fáanlegt í:
  • Thelin
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • Antihypertensives,
  • Lækningarsvæði:
  • Hypertension, Pulmonary
  • Ábendingar:
  • Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.
  • Vörulýsing:
  • Revision: 13

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Withdrawn
  • Leyfisnúmer:
  • EMEA/H/C/000679
  • Leyfisdagur:
  • 09-08-2006
  • EMEA númer:
  • EMEA/H/C/000679
  • Síðasta uppfærsla:
  • 31-03-2019

Opinber matsskýrsla

7 Westferry Circus

Canary Wharf

London E14 4HB

United Kingdom

Telephone

+44 (0)20 7418 8400

Facsimile

+44 (0)20 7418 8416

E-mail

info@ema.europa.eu

Website

www.ema.europa.eu

An agency of the European Union

© European Medicines Agency, 2010. Reproduction is authorised provided the source is acknowledged.

EMA/474480/2010

EMEA/H/C/000679

EPAR summary for the public

Thelin

sitaxentan sodium

This document is a summary of the European public assessment report (EPAR) for Thelin. It explains

how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its

opinion in favour of granting a marketing authorisation and its recommendations on the conditions of

use for Thelin.

What is Thelin?

Thelin is a medicine that contains the active substance sitaxentan sodium. It is available as yellow-to-

orange, capsule-shaped tablets (100 mg).

What is Thelin used for?

Thelin is used to treat adults (aged 18 years or over) with pulmonary arterial hypertension (PAH) to

improve exercise capacity (the ability to carry out physical activity). PAH is abnormally high blood

pressure in the arteries of the lungs. Thelin is used in patients with class III disease. The ‘class’ reflects

the seriousness of the disease: ‘class III’ involves marked limitation of physical activity. Thelin has

been shown to be effective in PAH with no identified cause and PAH caused by connective tissue

disease.

Because the number of patients with pulmonary arterial hypertension is low, the disease is considered

‘rare’, and Thelin was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 21

October 2004.

The medicine can only be obtained with a prescription.

How is Thelin used?

Thelin should only be started and monitored by a doctor who has experience in the treatment of PAH.

Medicinal product no longer authorised

It is taken as one tablet a day, preferably at the same time of the day. This is the maximum dose. If

after 12 weeks the patient’s condition is getting worse, then the doctor should review the treatment.

How does Thelin work?

PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the

lungs. It causes high blood pressure in the vessels taking blood from the heart to the lungs. This

pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical

activity more difficult.

The active substance in Thelin, sitaxentan sodium, blocks the receptors for a hormone called

endothelin-1 (ET-1), which causes blood vessels to constrict. By blocking the effect of ET-1, Thelin

allows the vessels to dilate (expand), helping to lower the blood pressure and improving symptoms.

How has Thelin been studied?

Three doses of Thelin (50, 100 and 300 mg) have been compared with placebo (a dummy treatment)

in three main studies involving a total of 523 patients with PAH, most of whom had class II or III

disease. The study measured the improvement in exercise capacity by looking at the change in how far

the patients could walk in six minutes after 12 to 18 weeks of treatment.

What benefit has Thelin shown during the studies?

Thelin was more effective than placebo at improving exercise capacity. Before treatment, the patients

could walk around 366 metres in six minutes. After 12 to 18 weeks, this distance had increased by 33

metres more in the patients taking 100 mg Thelin than in the patients taking placebo. In the patients

with class III disease, this was around 46 metres.

What is the risk associated with Thelin?

The most common side effect with Thelin (seen in more than 1 patient in 10) is headache. For the full

list of all side effects reported with Thelin, see the package leaflet.

Thelin should not be used in people who may be hypersensitive (allergic) to sitaxentan sodium or any

of the other ingredients. It must not be used in patients who have mild to severe problems with their

liver or raised levels of some liver enzymes. The patient’s liver should be monitored before and during

the treatment. Thelin must not be taken with ciclosporin A (a medicine used to treat psoriasis and

rheumatoid arthritis, and to prevent rejection of liver and kidney transplants). Thelin must not be used

in women who are breastfeeding.

Caution is needed when Thelin is taken at the same time as some other medicines. See the package

leaflet for full details.

Why has Thelin been approved?

The CHMP concluded that Thelin had shown an effectiveness that was as expected for this class of

medicines. However, the effectiveness was only considered sufficient in patients with class III disease.

Therefore, the Committee decided that Thelin’s benefits are greater than its risks for patients with

class III disease and recommended that it be given marketing authorisation.

Thelin

EMA/474480/2010

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Thelin

EMA/474480/2010

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What measures are being taken to ensure the safe use of Thelin?

The company that makes Thelin will provide doctors and patients with educational material about the

medicine. The company will also set up a system to monitor Thelin’s side effects, suspected

interactions with other medicines and the outcome of any pregnancies that may happen in women

using the medicine.

Other information about Thelin:

The European Commission granted a marketing authorisation valid throughout the European Union for

Thelin on 10 August 2006. The marketing authorisation holder is Pfizer Limited. The marketing

authorisation is valid for five years, after which it can be renewed.

The full EPAR for Thelin can be found here

. For more information about treatment with Thelin, read the

package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

The summary of the opinion of the Committee for Orphan Medicinal Products for Thelin is available

here

This summary was last updated in 08-2010.

Medicinal product no longer authorised

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

Medicinal product no longer authorised

PACKAGE LEAFLET: INFORMATION FOR THE USER

Thelin 100 mg film-coated tablets

Sitaxentan sodium

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even

if their symptoms are the same as yours.

If any side effect becomes serious, or if you notice any side effects not listed in this leaflet,

please tell your doctor or pharmacist.

In this leaflet:

What Thelin is and what it is used for

Before you take Thelin

How to take Thelin

Possible side effects

How to store Thelin

Further information

1.

WHAT THELIN IS AND WHAT IT IS USED FOR

Thelin is used to help lower blood pressure in the blood vessels when this pressure is raised in

pulmonary arterial hypertension (PAH). Pulmonary arterial hypertension is the term used when the

heart struggles to pump blood to the lungs. Thelin lowers the blood pressure by widening these

vessels, so your heart can pump blood more effectively. This will make it easier for you to do more

activities.

2.

BEFORE YOU TAKE THELIN

Do not take Thelin:

If you are allergic (hypersensitive) to sitaxentan sodium or any of the other ingredients in these

tablets;

If you have or have had a serious liver problem;

If you have raised levels of some liver enzymes (detected by blood tests);

If you are taking Ciclosporin A (used to treat psoriasis and rheumatoid arthritis, and to prevent

rejection of liver or kidney transplants);

If you are breast-feeding (please read the section ‘Pregnancy and breast-feeding’ below);

If you are a child or adolescent under 18 years old.

Take special care with Thelin:

If you could get pregnant or are pregnant (please read the section “Pregnancy and breast-feeding”

below);

If you develop liver problems or symptoms that might relate to the liver (see ‘Testing for liver

problems’, below);

If you are taking or begin to take anticoagulants (e.g. warfarin, acenocoumarol, fenprocoumon

or fluindione) to prevent blood clots. The dose of these medicines may need to be adjusted by

your doctor.

If you are taking a statin (e.g. pravastatin or simvastatin).

If you are taking a high dose of nifedipine.

Medicinal product no longer authorised

If any of these apply to you, tell your doctor before you start taking Thelin.

The following two blood tests will be carried out before you first take Thelin and at intervals during

treatment

Testing for liver problems

Thelin may affect your liver. Your doctor will take blood tests to check that your liver is working

properly, before and during treatment with Sitaxentan sodium. It is important to have these tests every

month during treatment, even if you do not have any symptoms at all.

If you notice any of these signs:

feeling sick (nausea)

being sick (vomiting)

loss of appetite

fever

unusual tiredness

pain in the stomach (abdominal pain)

yellow colouring of the skin and eyes (jaundice)

Talk to your doctor immediately. These may be signs that your liver is not working properly.

Testing for anaemia

This blood test will be done before treatment, then one month and three months after you start taking

Thelin tablets. Following this, the test will continue to be done every three months to check for

anaemia (a reduced amount of red blood cells).

For your own safety, it is very important that you have regular blood tests.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

This includes medicines you bought without a prescription, herbal remedies and vitamins.

These medicines may interfere with the effect of Thelin.

Do not take Thelin if you are taking Ciclosporin A.

Thelin should be used with caution if you are taking or begin to take Vitamin K antagonists (e.g.

warfarin, acenocoumarol, fenprocoumon or fluindione).

Driving and using machines

Do not drive or use any tools or machines if you feel dizzy.

Pregnancy and breast-feeding

If you are able to get pregnant, you must use effective contraception while taking Thelin. Your doctor

will advise you about suitable contraception. Your doctor may recommend monthly pregnancy tests

while you are taking Thelin.

If you miss a period or think you may be pregnant, contact your doctor right away. He or she may

want you to stop taking Thelin. Tell your doctor at once if you are or plan to become pregnant in

the near future.

Do not breast-feed if you are taking this medicine, it is not known if it passes into breast milk.

Important information about some of the ingredients of Thelin

Thelin tablets contain lactose monohydrate. If you are intolerant to some sugars, contact your doctor

before taking Thelin tablets.

Medicinal product no longer authorised

3.

HOW TO TAKE THELIN

The usual dose is a 100 mg tablet once a day.

Always take Thelin exactly as your doctor has told you. Check with your doctor or pharmacist if you

are not sure.

Try to take the tablet at the same time each day to help you remember. Swallow the tablet

whole with water. It does not matter whether you take it with or without food.

Do not take more than one tablet each day. You may need to take Thelin for a month or two before

feeling any effect.

If you take more Thelin than you should

If you realise you have taken more Thelin tablets than your doctor has recommended (or if someone

else has taken some of your Thelin tablets), contact your doctor straight away. If you cannot reach

your doctor, go to the nearest hospital and take the pack with you.

If you forget to take Thelin

If you miss a dose, take the missed dose as soon as you remember but do not take two tablets in one

day.

If you stop taking Thelin

Talk to your doctor before stopping treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Thelin can cause side effects, although not everybody gets them.

Very common side effects (likely to affect more than 1 in 10 patients):

headache

Common side effects (likely to affect more than 1 in every 100 people):

swelling in the arms and legs

being unable to sleep

blocked nose and nosebleeds

bleeding from the gums

feeling and/or being sick, difficulty in passing stools, stomach ache, indigestion and diarrhoea

flushed

cramp in muscles

dizziness

feeling tired

your blood may take longer to clot.

yellowing of the skin or eyes ( jaundice) and persistent nausea and/or vomiting may indicate

changes in liver function

Rare side effects (likely to affect less than 1 in 1000 people):

Liver damage

Rash

Anaemia (low blood count)

For more details on liver problems, seeTesting for liver problems’ in section 2.

If any of the side effects become serious, or if you notice any other side effects not listed in this leaflet,

please tell your doctor or pharmacist.

Medicinal product no longer authorised

5.

HOW TO STORE THELIN

Keep out of the reach and sight of children.

Do not use Thelin after the expiry date which is stated on the blister pack, bottle or carton after EXP.

The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to

dispose of medicines you no longer require. These measures will help to protect the environment.

6.

FURTHER INFORMATION

What Thelin contains

The active substance is sitaxentan sodium.

The other ingredients are:

The tablet core contains cellulose, microcrystalline (E460), lactose monohydrate, hypromellose

(E464), sodium starch glycolate, magnesium stearate (E470b), anhydrous disodium phosphate

(E339), ascorbyl palmitate (E304), disodium edetate and monobasic sodium phosphate (E339).

The film-coat contains stearic acid (E570b), hypromellose (E464), microcrystalline cellulose

(E460), titanium dioxide (E171), yellow iron oxide dehydrate (E172), red iron oxide dehydrate

(E172) and talc (E553b).

What Thelin tablets look like and contents of the pack

Thelin 100 mg film-coated tablets are yellow-to-orange, capsule-shaped tablets, marked with T-100 on

one side.

Thelin comes in blister packs of 14, 28, 56, and 84 tablets and bottles of 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

Pfizer Limited

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Manufacturer:

Pfizer Service Company

Hoge Wei 10

B-1930

Zaventem

Belgium

For any information about this medicinal product, please contact the local representative of the

Marketing Authorisation Holder:

België /Belgique / Belgien

Luxembourg/Luxemburg

Pfizer S.A./N.V.

Pfizer S.A.

Tél/Tel: +32 (0)2 554 62 11

Tél/Tel: +32 (0)2 554 62 11

Medicinal product no longer authorised

България

Magyarország

Пфайзер Люксембург САРЛ, Клон България

Pfizer Kft.

Тел.: +359 2 970 4333

Tel.: + 36 1 488 37 00

Česká republika

Malta

Pfizer s.r.o.

V.J. Salomone Pharma Ltd.

Tel: +420-283-004-111

Tel : + 356 21 22 01 74

Danmark

Nederland

Pfizer ApS

Pfizer bv

Tlf: +45 44 20 11 00

Tel: +31 (0)10 406 43 01

Deutschland

Norge

Pfizer Pharma GmbH

Pfizer AS

Tel: +49 (0)30 550055 51000

Tlf: +47 67 52 61 00

Eesti

Österreich

Pfizer Luxembourg SARL Eesti filiaal

Pfizer Corporation Austria Ges.m.b.H.

Tel: +372 6 405 328

Tel: +43 (0)1 521 15-0

Ελλάδα

Polska

Pfizer Hellas A.E.

Pfizer Polska Sp. z o.o.,

Τηλ: +30 210 678 5800

Tel.: +48 22 335 61 00

España

Portugal

Pfizer S.A.

Laboratórios Pfizer, Lda.

Tel: +34 91 490 99 00

Tel: +351 21 423 5500

France

România

Pfizer

Pfizer România S.R.L.

Tél: +33 (0)1 58 07 34 40

Tel: +40 21 207 28 00

Ireland

Slovenija

Pfizer Healthcare Ireland

Pfizer Luxembourg SARL

Pfizer,

podružnica

svetovanje

področja

farmacevtske dejavnosti, Ljubljana

Tel: 1800 633 363 (toll free)

Tel: + 386 (0) 1 52 11 400

+44 (0)1304 616161

Ísland

Slovenská republika

Vistor hf.

Pfizer Luxembourg SARL, organizačná zložka

Sími: + 354 535 7000

Tel: +421-2-3355 5500

Italia

Suomi/Finland

Pfizer Italia S.r.l.

Pfizer Oy

Tel: +39 06 33 18 21

Puh/Tel: +358 (0)9 43 00 40

Κύπρος

Sverige

GEO. PAVLIDES & ARAOUZOS LTD,

Pfizer AB

Τηλ: +35722818087

Tel: + 46 (0)8 550 520 00

Latvija

United Kingdom

Pfizer Luxembourg SARL filiāle Latvijā

Pfizer Limited

Tel: +371 670 35 775

Tel: +44 (0)1304 616161

Medicinal product no longer authorised

Lietuva

Pfizer Luxembourg SARL filialas Lietuvoje

Tel. +3705 2514000

This leaflet was last approved in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu/. There are also links to other websites about rare diseases and treatments.

Medicinal product no longer authorised