Ambrisentan Mylan

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

ambrisentan

Available from:

Mylan S.A.S

ATC code:

C02KX02

INN (International Name):

ambrisentan

Therapeutic group:

Antihypertensives,

Therapeutic area:

Hypertension, Pulmonary

Therapeutic indications:

Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.Ambrisentan Mylan is indicated for the treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III, including use in combination treatment. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH associated with connective tissue disease.

Product summary:

Revision: 4

Authorization status:

Authorised

Authorization date:

2019-06-20

Patient Information leaflet

49
B. PACKAGE LEAFLET
50
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMBRISENTAN MYLAN 5 MG FILM-COATED TABLETS
AMBRISENTAN MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you take Ambrisentan Mylan
3.
How to take Ambrisentan Mylan
4.
Possible side effects
5.
How to store Ambrisentan Mylan
6.
Contents of the pack and other information
1.
WHAT AMBRISENTAN MYLAN IS AND WHAT IT IS USED FOR
Ambrisentan Mylan 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 Mylan 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 Mylan may also be used in combination with other medicines
used to treat PAH.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMBRISENTAN MYLAN
DO NOT TAKE AMBRISENTAN MYLAN:
–
if you are
ALLERGIC
to ambrisentan or any of the other ingredients of this medicine
(listed in
section 6).
–
IF YOU

Summary of Product characteristics

ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ambrisentan Mylan 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of ambrisentan.
Excipients with known effect
Each tablet contains approximately 26 mg of lactose and 10 micrograms
of Allura red AC Aluminium
lake
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Pink, round, biconvex film-coated tablet with ‘M’ debossed on one
side and ‘AN’ on the other,
approximately 5.7 mm in diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ambrisentan Mylan is indicated for the 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 Mylan 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 Mylan 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.
3
Limited data suggest that the abrupt discontinuation of ambrisentan is
not associated with rebound
worsening of PAH.
When co-admini