SEASONIQUE levonorgestrel/ethinylestradiol 150 ug/30 ug film coated tablets and ethinylestradiol 10 ug film coated tablets blister composite pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

levonorgestrel, Quantity: 150 microgram; ethinylestradiol, Quantity: 30 microgram

Disponible depuis:

Theramex Australia Pty Ltd

DCI (Dénomination commune internationale):

ethinylestradiol,Levonorgestrel

forme pharmaceutique:

Tablet, film coated

Composition:

Excipient Ingredients: lactose; hypromellose; microcrystalline cellulose; magnesium stearate; polysorbate 80; titanium dioxide; macrogol 400; allura red AC aluminium lake; brilliant blue FCF aluminium lake

Mode d'administration:

Oral

Unités en paquet:

91 film coated tablets in a composite pack containing 84 levonorgestrel/ethinyloestradiol film coated tablets and 7 ethinyloestradiol film coated tablets

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Seasonique is indicated for use as an oral contraceptive.

Descriptif du produit:

Visual Identification: Pink, round, biconvex tablets embossed 172 on one side and T on the other side; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Statut de autorisation:

Licence status A

Date de l'autorisation:

2016-05-24

Notice patient

SEASONIQUE
®
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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 SEASONIQUE?
Seasonique contains the active ingredient Levonorgestrel and
Ethinylestradiol. Seasonique is used to prevent pregnancy.
For more information, see Section 1. Why am I using Seasonique? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SEASONIQUE?
Do not use if you have ever had an allergic reaction to Seasonique 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
Seasonique? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Seasonique 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 SEASONIQUE?
•
The daily dosing regimen should start with the first tablet (#1) of
Month 1 blister.
•
Take one tablet about the same time every day. Tablet taking is
continuous for 91 days. You may take the tablets with or
without food, and if necessary with a little liquid in the order shown
at the blister pack
•
More instructions can be found in Section 4. How do I use Seasonique?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SEASONIQUE?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using Seasonique.
•
If you become pregnant while taking Seasonique, see your doctor
immediately.
•
Use of Seasonique is generally not advisable when a woman is breast-
feeding. If you want to take the
pill while you are breast-feeding you should contact your doctor.
•
If you are about to have any blood tests, tell your doctor you are
taking Seasonique.
•
Have regular check ups from your doctor, including a Pap smear.
TH

Résumé des caractéristiques du produit

Theramex Australia Pty Ltd
Version 0.0
1
AUSTRALIAN PRODUCT INFORMATION
SEASONIQUE
®
(LEVONORGESTREL
AND
ETHINYLESTRADIOL)
FILM
COATED TABLET
1
NAME OF THE MEDICINE
Levonorgestrel and Ethinylestradiol
.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Seasonique is a 91-day extended-regimen oral contraceptive (OC)
tablet.
•
Each pink tablet contains 150 µg levonorgestrel and 30 µg
ethinylestradiol
•
Each white tablet contains 10 µg ethinylestradiol
LIST OF EXCIPIENTS WITH KNOWN EFFECT:
Lactose
For the full list of excipients, see Section 6.1
List of excipients.
3
PHARMACEUTICAL FORM
Film coated tablet
Each Seasonique composite pack contains:
•
84 round pink, round, biconvex film coated tablets embossed “172”
on one side and “T” on the other
side containing 150 µg levonorgestrel and 30 µg ethinylestradiol and
•
7 white, round, biconvex film-coated tablets embossed “173” on one
side and “T” on the other side
containing 10 µg ethinylestradiol
.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Seasonique is indicated for use as an oral contraceptive.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Seasonique is an extended-regimen oral contraceptive where tablets are
taken continuously for 91 days.
Each subsequent 91-day pack is started the day after the last tablet
of the previous pack. Seasonique pack
consists of 84 combination tablets of 150 µg levonorgestrel and 30
µg ethinylestradiol and 7 tablets of 10
µg ethinylestradiol.
_HOW TO USE SEASONIQUE _
Tablet taking is continuous for 91 days. One tablet is to be taken by
mouth at the same time every day in
the order shown at the blister pack.
One pink tablet containing levonorgestrel and ethinylestradiol is
taken daily for 84 consecutive days,
followed by one white ethinylestradiol tablet for 7 days, during which
time withdrawal bleeding usually
occurs.
Theramex Australia Pty Ltd
Version 0.0
2
_HOW TO START SEASONIQUE _
THE DAILY DOSING REGIME SHOULD START WITH THE FIRST TABLET (#1) OF _
MONTH 1 _BLISTER, CONSISTENT WITH THE
PACKAGING PRESENTAT