VISANNE dienogest 2 mg tablets blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

dienogest, Quantity: 2 mg

Tilgjengelig fra:

Bayer Australia Ltd

INN (International Name):

Dienogest

Legemiddelform:

Tablet

Sammensetning:

Excipient Ingredients: crospovidone; purified talc; microcrystalline cellulose; povidone; potato starch; lactose monohydrate; magnesium stearate

Administreringsrute:

Oral

Enheter i pakken:

12 blisters of 14 tablets, 6 blisters of 14 tablets, 2 blisters of 14 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Treatment of endometriosis

Produkt oppsummering:

Visual Identification: White to off white, 7 mm diameter round, flat-faced, bevelled edged tablet embossed "B" on one side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Registered

Autorisasjon dato:

2010-06-11

Informasjon til brukeren

200226 Visanne CMI
Page 1 of 6
VISANNE
®
(VIZ- AHN)
_dienogest _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have
prescribed it for another reason.
DO NOT TAKE VISANNE IF YOU ARE
CONCERNED ABOUT AN INCREASED
RISK OF BLOOD CLOTS.
Blood clots are rare. Very
occasionally blood clots may
cause serious permanent
Visanne. It does not contain all
disability, or may even be fatal.
the available information. It does
not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the risks of you taking
Visanne against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS, OR
ARE UNSURE ABOUT TAKING THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST FOR MORE ADVICE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT IS VISANNE
USED FOR
Visanne is used for the treatment
of the painful symptoms of
endometrial lesions (displaced
tissue of the lining of the womb).
Visanne contains a progestogen
hormone, dienogest.
Taking one Visanne tablet every
day leads to the shrinking of the
endometrial tissue and reduces
associated complaints such as
pelvic pain and painful monthly
bleedings.
BEFORE YOU TAKE
VISANNE
_WHEN YOU MUST NOT TAKE _
_IT _
DO NOT TAKE VISANNE IF YOU
HAVE AN ALLERGY TO:
•
dienogest (the active
ingredient in Visanne)
•
any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty in
breathing
•
swelling of the face, lips,
tongue or other parts of the
body
•
rash, itching or hives on the
skin.
DO NOT TAKE VISANNE IF YOU
HAVE OR HAVE HAD A BLOOD CLOT
IN:
•
the blood vessels of the legs
(deep vein thrombosis -
DVT)
•
the lungs (pulmonary
embolism - PE)
•
the heart (heart attack)
•
the brain (stroke)
•
other parts of the body.
DO NOT TAKE V

Preparatomtale

AUSTRALIAN PRODUCT INFORMATION
VISANNE® (DIENOGEST) TABLETS
1 NAME OF THE MEDICINE
dienogest
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Visanne tablet contains 2 mg of dienogest.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
The tablets are white to off-white, round, flat-faced, bevelled edge
marked with the letter “B”
on one side and have a diameter of 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of endometriosis
4.2 DOSE AND METHOD OF ADMINISTRATION
Tablet taking can start on any day of the menstrual cycle. The dosage
of Visanne is one
tablet daily without any break, taken preferably at the same time each
day with some liquid
as needed. Tablets must be taken continuously without regard to
vaginal bleeding. When
a pack is finished the next one should be started without
interruption.
The efficacy of Visanne may be reduced in the event of missed tablets,
vomiting and/or
diarrhoea (if occurring within 3-4 hours after tablet taking). In the
event of missed tablet(s),
the woman should take one tablet only, as soon as she remembers, and
should then
continue on the next day to take the tablet at her usual time. A
tablet not absorbed due to
vomiting or diarrhoea should likewise be replaced by one tablet.
If a short acting, e.g. oral, hormonal treatment was prescribed before
starting treatment
with dienogest, treatment may be started on the first day of menstrual
bleeding after
cessation of treatment.
If a long-acting, i.e. injectable, hormonal treatment was administered
before starting
treatment with dienogest, then dienogest may be started once
metabolism/excretion of the
previously administered drug is expected to be completed.
There is no experience with Visanne treatment for more than 15 months
in patients with
endometriosis.
_ _
4.3 CONTRAINDICATIONS
Visanne should not be used in the presence of any of the conditions
listed below, which
are partially derived from information on other proge