Lenzetto 1.53 mgspray transdermal spray solution

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ESTRADIOL HEMIHYDRATE

Available from:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

ESTRADIOL HEMIHYDRATE

Units in package:

6.5 ml

Manufactured by:

GEDEON RICHTER ROMANIA S.A

Patient Information leaflet

LENZETTO TRANSDERMAL SPRAY
®
Estradiol (1.53 mg/spray)
_Consumer Medication Information Leaflet (RiMUP)_
_ _
1
WHAT IS IN THIS LEAFLET
1.
What _Lenzetto _is used for
2.
How _Lenzetto_ works
3.
Before you use _Lenzetto_
4.
How to use _Lenzetto_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Lenzetto_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _LENZETTO_ IS USED FOR
_Lenzetto_ is a Hormone Replacement
Therapy (HRT). It contains the female
hormone estrogen. _Lenzetto_ is used in
postmenopausal women with at least
6 months since their last natural period.
_Lenzetto_ can also be used in women
who have had surgery to remove their
ovaries as this causes instant
menopause.
_Lenzetto_ is used for:
Relief of symptoms occurring after
menopause.
During the menopause, the amount of
the estrogen produced by a woman’s
body drops. This can cause symptoms
such as hot face, neck and chest (“hot
flushes”). _Lenzetto_ alleviates these
symptoms after menopause. You will
only be prescribed _Lenzetto_ if your
symptoms seriously hinder your daily
life.
_Lenzetto_ is indicated to treat estrogen
deficiency symptoms after menopause;
when menstruation has ceased
following menopause. Symptoms of
estrogen deficiency include hot flushes
(sudden waves of heat and sweating in
the whole body), sleeping problems,
irritability and dryness of the vagina.
The experience in treating women older
than 65 years is limited.
Lenzetto is not a contraceptive.
HOW _LENZETTO_ WORKS
_Lenzetto_ is a spray solution which
contains small amounts of a medicine
called estradiol. When sprayed onto the
skin as directed, it passes through the
skin into your bloodstream.
BEFORE YOU USE _LENZETTO _
-
_When you must not use it _
DO NOT USE _LENZETTO_ if any of the
following applies to you. If you are not
sure about any of the points below, TALK
TO YOUR DOCTOR before using _Lenzetto_.
_ _
DO NOT USE _LENZETTO_

if you have or have ever had BREAST
CANCER, or if you are suspected of
having

Summary of Product characteristics

PACKAGE INSERT
BRAND OR PRODUCT NAME
Lenzetto 1.53 mg/spray, transdermal spray, solution
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each spray delivers 90 microliter of transdermal spray, solution
containing 1.53 mg of estradiol
(equivalent to 1.58 mg of estradiol hemihydrate).
PRODUCT DESCRIPTION
Transdermal spray, solution.
The solution is clear, colourless to pale yellow.
Other ingredients: ethyl alcohol (96%) and octisalate
PHARMACODYNAMICS/PHARMACOKINETICS
Pharmacotherapeutic group: Sex hormones and modulators of the genital
system, Estrogens, Natural
and semisynthetic estrogens, plain; Estradiol, ATC Code: G03CA03
Lenzetto provides systemic estrogen replacement therapy by releasing
estradiol, the major estrogenic
hormone secreted by the ovaries. The active ingredient, synthetic
17beta-estradiol, is chemically and
biologically identical to endogenous human estradiol. It substitutes
for the loss of estrogen production
in menopausal women and alleviates menopausal symptoms.
Absorption
When Lenzetto was applied to the skin, the average drying time was 90
sec (median = 67 sec).
In a multiple-dose study, postmenopausal women were treated for 14
days with one, two or three 90-
microliter sprays of Lenzetto on the inner forearm. Serum
concentrations of estradiol appeared to
reach a steady-state after 7-8 days of application of Lenzetto.
Following morning administration, blood levels remained relatively
stable and within the therapeutic
range throughout the 24-hour period following administration with peak
levels between 2 AM and 6 AM.
In a clinical study, postmenopausal women were treated for 12 weeks
with one, two or three 90-
microliter sprays of Lenzetto on the inner forearm and blood levels of
estradiol were measured at
Week 4, 8 and 12. The estradiol exposure increased with increasing
dose (one, two, three sprays
respectively) but the increase was slightly less than proportional to
dose.
Pharmacokinetic parameters for estradiol and estrone from one, two or
three 90-microliter sprays of
Lenzetto were further exam