Thelin
sitaxentan sodium
Sitaxentan sodium
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.
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
Medicinal product no longer authorised
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.
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.
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.
The following two blood tests will be carried out before you first take Thelin and at intervals during treatment
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)
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.
Medicinal product no longer authorised
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).
Do not drive or use any tools or machines if you feel dizzy.
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.
Thelin tablets contain lactose monohydrate. If you are intolerant to some sugars, contact your doctor
before taking Thelin tablets.
Always take Thelin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
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 miss a dose, take the missed dose as soon as you remember but do not take two tablets in one
Talk to your doctor before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Medicinal product no longer authorised
Like all medicines, Thelin can cause side effects, although not everybody gets them.
headache
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
Liver damage
Rash
Anaemia (low blood count)
For more details on liver problems, see ‘Testing 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.
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.
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).
Medicinal product no longer authorised
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.
Pfizer Limited
Sandwich,
Kent, CT13 9NJ,
United Kingdom
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:
Pfizer S.A./N.V. Pfizer S.A.
Tél/Tel: +32 (0)2 554 62 11 Tél/Tel: +32 (0)2 554 62 11
Пфайзер Люксембург САРЛ, Клон България Pfizer Kft.
Тел.: +359 2 970 4333 Tel.: + 36 1 488 37 00
Pfizer s.r.o. V.J. Salomone Pharma Ltd.
Tel: +420-283-004-111 Tel : + 356 21 22 01 74
Pfizer ApS Pfizer bv
Tlf: +45 44 20 11 00 Tel: +31 (0)10 406 43 01
Pfizer Pharma GmbH Pfizer AS
Tel: +49 (0)30 550055 51000 Tlf: +47 67 52 61 00
Pfizer Luxembourg SARL Eesti filiaal Pfizer Corporation Austria Ges.m.b.H.
Tel: +372 6 405 328 Tel: +43 (0)1 521 15-0
Pfizer Hellas A.E. Pfizer Polska Sp. z o.o.,
Τηλ: +30 210 678 5800 Tel.: +48 22 335 61 00
Pfizer S.A. Laboratórios Pfizer, Lda.
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Tel: +34 91 490 99 00 Tel: +351 21 423 5500
Pfizer Pfizer România S.R.L.
Tél: +33 (0)1 58 07 34 40 Tel: +40 21 207 28 00
Pfizer Healthcare Ireland Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel: 1800 633 363 (toll free) Tel: + 386 (0) 1 52 11 400
+44 (0)1304 616161
Vistor hf. Pfizer Luxembourg SARL, organizačná zložka
Sími: + 354 535 7000 Tel: +421-2-3355 5500
Pfizer Italia S.r.l. Pfizer Oy
Tel: +39 06 33 18 21 Puh/Tel: +358 (0)9 43 00 40
GEO. PAVLIDES & ARAOUZOS LTD, Pfizer AB
Τηλ: +35722818087 Tel: + 46 (0)8 550 520 00
Pfizer Luxembourg SARL filiāle Latvijā Pfizer Limited
Tel: +371 670 35 775 Tel: +44 (0)1304 616161
Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514000
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