Ambrisentan betapharm 10 mg film-coated tablets.

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Ambrisentan

Beszerezhető a:

Betapharm Arzneimittel GmbH

ATC-kód:

C02KX; QC02KX02

INN (nemzetközi neve):

Ambrisentan

Adagolás:

10 milligram(s)

Gyógyszerészeti forma:

Film-coated tablet

Terápiás terület:

Other antihypertensives; ambrisentan

Engedély dátuma:

2019-12-20

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBRISENTAN BETAPHARM 5 MG FILM-COATED TABLETS
AMBRISENTAN BETAPHARM 10 MG FILM-COATED TABLETS
Ambrisentan
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 any further questions, ask your doctor, pharmacist or
nurse
-
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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ambrisentan betapharm is and what it is used for
2.
What you need to know before you take Ambrisentan betapharm
3.
How to take Ambrisentan betapharm
4.
Possible side effects
5.
How to store Ambrisentan betapharm
6.
Contents of the pack and other information
1.
WHAT AMBRISENTAN BETAPHARM IS AND WHAT IT IS USED FOR
Ambrisentan betapharm contains the active substance ambrisentan. It
belongs to a group of
medicines called other antihypertensives (used to treat high blood
pressure).
Ambrisentan betapharm it is used to treat pulmonary arterial
hypertension (PAH) in adults.
PAH is high blood pressure in the blood vessels (the pulmonary
arteries) that carry blood from
the heart to the lungs. In people with PAH, these arteries get
narrower, so the heart has to
work harder to pump blood through them. This causes people to feel
tired, dizzy and short of
breath.
Ambrisentan betapharm widens the pulmonary arteries, making it easier
for the heart to pump
blood through them. This lowers the blood pressure and relieves the
symptoms.
Ambrisentan betapharm may also be used in combination with other
medicines used to treat
PAH.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMBRISENTAN BETAPHARM
DO NOT TAKE AMBRISENTAN BETAPHARM
-
if you are ALLERGIC to ambrisentan or any of the other ingredients of
this medicine

Termékjellemzők

Health Products Regulatory Authority
20 December 2019
CRN008K7C
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ambrisentan betapharm 10 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of ambrisentan.
Excipients with known effect.
Each 10 mg tablet contains 183.4 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Approximately 11.4 mm pink, oval shaped film-coated tablet with "10"
debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ambrisentan betapharm is indicated for treatment of pulmonary arterial
hypertension (PAH) in adult patients of WHO
Functional Class (FC) II to III, including use in combination
treatment (see section 5.1). Efficacy has been shown in idiopathic
PAH (IPAH) and in PAH associated with connective tissue disease.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment must be initiated by a physician experienced in the
treatment of PAH.
Posology
_Ambrisentan monotherapy_
Ambrisentan betapharm is to be taken orally to begin at a dose of 5 mg
once daily and may be increased to 10 mg daily
depending upon clinical response and tolerability.
_Ambrisentan in combination with tadalafil_
When used in combination with tadalafil, Ambrisentan betapharm should
be titrated to 10 mg once daily.
In the AMBITION study, patients received 5 mg ambrisentan daily for
the first 8 weeks before up titrating to 10 mg, dependent
on tolerability (see section 5.1). When used in combination with
tadalafil, patients were initiated with 5 mg ambrisentan and 20
mg tadalafil. Dependent on tolerability the dose of tadalafil was
increased to 40 mg after 4 weeks and the dose of ambrisentan
was increased to 10 mg after 8 weeks. More than 90% of patients
achieved this. Doses could also be decreased depending on
tolerability.
Limited data suggest that the abrupt discontinuation of ambrisentan is
not associated with rebound worsening of PAH.
When co-administered with cyclosporine A, t