Thelin

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

sitaxentan sodium

Available from:

Pfizer Ltd.

ATC code:

C02KX03

INN (International Name):

sitaxentan sodium

Therapeutic group:

Antihypertensives,

Therapeutic area:

Hypertension, Pulmonary

Therapeutic indications:

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.

Product summary:

Revision: 13

Authorization status:

Withdrawn

Authorization date:

2006-08-10

Patient Information leaflet

25
B. PACKAGE LEAFLET
Medicinal product no longer authorised
26
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:
1.
What Thelin is and what it is used for
2.
Before you take Thelin
3.
How to take Thelin
4.
Possible side effects
5.
How to store Thelin
6.
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 migh

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Thelin 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg sitaxentan sodium.
Excipients:
Also contains 166.3mg of lactose monohydrate.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
Capsule shaped yellow-to-orange film-coated tablets, debossed with
T-100 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should only be initiated and monitored by a physician
experienced in the treatment of PAH.
Thelin is to be taken orally as a dose of 100 mg once daily. It may be
taken with or without food and
without regard to the time of day.
In the case of clinical deterioration despite Thelin treatment for at
least 12 weeks, alternative therapies
should be considered. However, a number of patients who showed no
response by week 12 of
treatment with Thelin responded favourably by week 24, so an
additional 12 weeks of treatment may
be considered.
Higher doses did not confer additional benefit sufficient to offset
the increased risk of adverse
reactions, particularly liver injury (see section 4.4).
Discontinuation of treatment
There is limited experience with abrupt discontinuation of sitaxentan
sodium. No evidence for acute
rebound has been observed.
Dosage in hepatic impairment:
Studies in patients with pre-existing liver impairment have not been
conducted. Thelin is
contraindicated in patients with elevated liver aminotransferases
prior to initiation of treatment
(> 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin
> 2 x ULN prior to initiation of
treatment (see sect