PULMORIS ambrisentan 10 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ambrisentan, Quantity: 10 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

Ambrisentan

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; magnesium stearate; titanium dioxide; purified talc; allura red AC aluminium lake; polyvinyl alcohol; macrogol 3350; lecithin

Administration route:

Oral

Units in package:

10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ambrisentan is indicated for the treatment of: - idiopathic pulmonary arterial hypertension (PAH), - pulmonary artrial hypertension associated with connective tissue disease (PAH-CTD),,in patients with WHO functional class II, III or IV symptoms.

Product summary:

Visual Identification: Pink, oval shaped, biconvex, film coated tablets debossed with CL on one side and 10 on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-09-14

Patient Information leaflet

PULMORIS
1
PULMORIS
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Pulmoris?
Pulmoris contains the active ingredient ambrisentan.
Pulmoris is used to treat adults with pulmonary arterial hypertension
(PAH).
For more information, see Section 1. Why am I using Pulmoris? in the
full CMI.
2. What should I know before I use Pulmoris?
Do not use if you have ever had an allergic reaction to ambrisentan or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
Pulmoris? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Pulmoris and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4. How do I use Pulmoris?
•
The usual dose of Pulmoris is 5 mg, once a day
More instructions can be found in Section 4. How do I use Pulmoris? in
the full CMI.
5. What should I know while using Pulmoris?
Things you should do
• Remind any doctor, dentist or pharmacist you visit that you are
using Pulmoris.
• You must use reliable birth control (contraception) while using
Pulmoris and for 3 months
after you stop taking it. Use at least two reliable forms of birth
control (contraception).
• If you are a male, you should avoid exposing your partner to your
semen by use of
appropriate contraception e.g. condoms.
Things you should not do
• Do not stop using this medicine suddenly or lower the dosage
without checking with your
doctor.
Driving or using machines
• Do not drive or operate machines if you're feeling unwell.
Drinking alcohol
• Not applicable
Looking after your
medicine
• Keep your tablets in the pack until it is time to take them.
• Keep your tablets in a c

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – PULMORIS (ambrisentan)
TERATOGENICITY
Pulmoris may cause birth defects and is contraindicated in pregnancy
(see section 4.3
CONTRAINDICATIONS).
1
NAME OF THE MEDICINE
Ambrisentan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pulmoris 5 mg film-coated tablets
Each film-coated tablet contains 5 mg ambrisentan
Excipients with known effect:
Contain sugars as lactose
Pulmoris 10 mg film-coated tablets
Each film-coated tablet contains 10 mg ambrisentan
Excipients with known effect:
Contains lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pulmoris 5 mg film-coated tablets
Pulmoris 5 mg tablets are pale pink, square shaped, biconvex,
film-coated tablets debossed with “CL”
on one side and “5” on the other side.
Pulmoris 10 mg film-coated tablets
Pulmoris 10 mg tablets are pink, oval shaped, biconvex, film-coated
tablets debossed with “CL” on
one side and “10” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Pulmoris is indicated for the treatment of:

idiopathic pulmonary arterial hypertension (PAH),

pulmonary arterial hypertension associated with connective tissue
disease (PAH-CTD),
in patients with WHO functional class II, III or IV symptoms.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should only be initiated by a physician experienced in the
treatment of PAH. Pulmoris is for
oral use and can be administered with or without food.
Dose
Pulmoris as a single agent
Pulmoris should be taken orally at a dose of 5 mg once daily.
Additional benefit may be obtained by
increasing the dose to 10 mg [see sections 4.8 ADVERSE EFFECTS
(UNDESIRABLE EFFECTS)
and 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials].
Limited data suggest that the abrupt discontinuation of ambrisentan is
not associated with rebound
worsening of PAH.
Use with ciclosporin
When co-administered with ciclosporin, the dose of ambrisentan should
be limited to 5 mg once daily
(see sections 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER