CIPLA AMBRISENTAN ambrisentan 5 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ambrisentan, Quantity: 5 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:

CIPLA 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: Pale pink, square shaped, biconvex film coated tablets debossed with CL on one side and 5 on 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

CIPLA AMBRISENTAN
1
CIPLA AMBRISENTAN
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 Cipla Ambrisentan?
Cipla Ambrisentan contains the active ingredient ambrisentan.
Cipla Ambrisentan is used to treat adults with pulmonary
arterial hypertension (PAH).
For more information, see Section 1. Why am I using Cipla Ambrisentan?
in the full CMI.
2. What should I know before I use Cipla Ambrisentan?
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
Cipla Ambrisentan? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Cipla Ambrisentan 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 Cipla Ambrisentan?
•
The usual dose of Cipla Ambrisentan is 5 mg, once a day
More instructions can be found in Section 4. How do I use Cipla
Ambrisentan? in the full CMI.
5. What should I know while using Cipla Ambrisentan?
Things you should do
• Remind any doctor, dentist or pharmacist you visit that you are
using Cipla Ambrisentan.
• You must use reliable birth control (contraception) while using
Cipla Ambrisentan 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
• N

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – CIPLA AMBRISENTAN (ambrisentan)
TERATOGENICITY
Cipla Ambrisentan may cause birth defects and is contraindicated in
pregnancy (see
section 4.3 CONTRAINDICATIONS).
1
NAME OF THE MEDICINE
Cipla Ambrisentan
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cipla Ambrisentan 5 mg film-coated tablets
Each film-coated tablet contains 5 mg ambrisentan
Excipients with known effect:
Contains sugars as lactose
Cipla Ambrisentan 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
Cipla Ambrisentan 5 mg film-coated tablets
Cipla Ambrisentan 5 mg tablets are pale pink, square shaped, biconvex,
film-coated tablets debossed
with “CL” on one side and “5” on the other side.
Cipla Ambrisentan 10 mg film-coated tablets
Cipla Ambrisentan 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
Cipla Ambrisentan 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. Cipla
Ambrisentan is for oral use and can be administered with or without
food.
Dose
Cipla Ambrisentan as a single agent
Cipla Ambrisentan 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