Ambrisentan Rowex Limited 10 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Ambrisentan

제공처:

Rowex Ltd

ATC 코드:

C02KX02

INN (International Name):

Ambrisentan

약제 형태:

Film-coated tablet

치료 영역:

ambrisentan

승인 상태:

Not marketed

승인 날짜:

2022-01-07

환자 정보 전단

SANDOZ
Business use only
Page 1 of 7
1.3.1 spc-label-pl - commom-pl - 9
(IE/H/1106+1112/001-002/DC D160 Response)
20210525
AMBRISENTAN 10 MG 5 MG FILM-COATED TABLET
722-4134.00 722-4135.00
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
5 MG FILM-COATED TABLETS
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR
_ _
contains the active substance ambrisentan. It belongs
to a group of medicines called
other antihypertensives (used to treat high blood pressure).
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.
widens the pulmonary arteries, making it easier for
the heart to pump blood through
them. This lowers the blood pressure and relieves the symptoms.
may also be used in combination with other medicines
used to treat PAH.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE

전체 문서 읽기

제품 특성 요약

Health Products Regulatory Authority
13 January 2022
CRN009L3M
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ambrisentan Rowex Limited 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of ambrisentan.
Excipient with known effect
Each film-coated tablet contains 183.4 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pink, oval shaped film-coated tablet (11.4 mm x 5.75 mm) with "10"
debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ambrisentan Rowex Limited 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 Rowex Limited 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 Rowex Limited
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 r