Lenzetto 1.53mg/spray, transdermal spray, solution

البلد: مالطا

اللغة: الإنجليزية

المصدر: Medicines Authority

العنصر النشط:

ESTRADIOL

متاح من:

Gedeon Richter Plc Gyomroi ut 19-21 1103 Budapest, Hungary

ATC رمز:

G03CA03

INN (الاسم الدولي):

ESTRADIOL 1.53 mg

الشكل الصيدلاني:

Transdermal spray, solution

تركيب:

ESTRADIOL 1.53 mg

نوع الوصفة الطبية :

POM

المجال العلاجي:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

الوضع إذن:

Authorised

تاريخ الترخيص:

2015-07-23

نشرة المعلومات

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
LENZETTO 1.53 MG/SPRAY TRANSDERMAL SPRAY, SOLUTION
estradiol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Lenzetto is and what it is used for
2.
What you need to know before you use Lenzetto
3.
How to use Lenzetto
4.
Possible side effects
5.
How to store Lenzetto
6.
Contents of the pack and other information
1.
WHAT LENZETTO IS AND WHAT IT IS USED FOR
Lenzetto is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogens.
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 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.
Lenzetto is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of the oestrogen 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 oestrogen deficiency symptoms after
menopause; when menstruation has
ceased following menopause. Symptoms of oestrogen deficiency include
hot flushes (sudden waves of
heat and sweating in the whole body), sleeping problems, irritabilit

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
Lenzetto 1.53 mg/spray, transdermal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each spray delivers 90 microliter of transdermal spray, solution
containing 1.53 mg of estradiol
(equivalent to 1.58 mg of estradiol hemihydrate).
Excipient with known effect: each spray contains 65.47 mg ethanol.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Transdermal spray, solution.
The solution is clear, colourless to pale yellow.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women
(in women at least 6-months since last menses or surgical menopause,
with or without a uterus).
The experience in treating women older than 65 years is limited.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Lenzetto is administered once daily, either as a monotherapy or as a
continuous sequential treatment
(when combined with a progestogen). One metered-dose spray is
administered once daily to the dry
and healthy skin of the forearm as a starting dose. The dose may be
increased to two metered-dose
sprays daily to the forearm based on clinical response. Dose increase
should be based on the degree of
the woman’s menopausal symptoms and should be made only after at
least 4 weeks of continuous
treatment with Lenzetto. The maximum daily dose is 3 metered-dose
sprays (4.59 mg/day) to the
forearm. Dose increase should be discussed with the physician. For
patients who have difficulty
applying the prescribed dose to distinct, non-overlapping areas of the
same forearm, Lenzetto may
also be applied to sites on the alternate forearm, or to sites on the
inner thigh.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose
for the shortest duration (see also section 4.4) should be used.
When the degree of the woman’s menopausal symptoms is not reduced
after a dose increase, the
patient should be back-titrated to the previous dose.
Patients should be