Ambrisentan Rowex 5 mg film-coated tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Ambrisentan

Saadav alates:

Rowex Ltd

ATC kood:

C02KX; C02KX02

INN (Rahvusvaheline Nimetus):

Ambrisentan

Annus:

5 milligram(s)

Ravimvorm:

Film-coated tablet

Terapeutiline ala:

Other antihypertensives; ambrisentan

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2019-12-20

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBRISENTAN ROWEX 5 MG FILM-COATED TABLETS
AMBRISENTAN ROWEX 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 Rowex is and what it is used for
2.
What you need to know before you take Ambrisentan Rowex
3.
How to take Ambrisentan Rowex
4.
Possible side effects
5.
How to store Ambrisentan Rowex
6.
Contents of the pack and other information
1.
WHAT AMBRISENTAN ROWEX IS AND WHAT IT IS USED FOR
Ambrisentan Rowex 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.
Ambrisentan Rowex 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 Rowex may also be used in combination with other medicines
used to treat
PAH.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMBRISENTAN ROWEX
DO NOT TAKE AMBRISENTAN ROWEX
-
if you are
ALLERGIC
to ambrisentan or any of the other ingredients of this medicine
(listed in
section 6)
-
IF YOU ARE PREGNANT
, if you are
PLANNING TO

Toote omadused

Health Products Regulatory Authority
02 October 2020
CRN009XHV
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ambrisentan Rowex 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of ambrisentan.
Excipients with known effect.
Each 5 mg tablet contains 91.7 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_ _
Approximately 6.5 mm pink, circular film-coated tablet with "5"
debossed on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ambrisentan Rowex 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 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 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, the