Kliogest 2 mg/1 mg film-coated tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Estradiol; Norethisterone acetate

थमां उपलब्ध:

Novo Nordisk A/S

ए.टी.सी कोड:

G03FA; G03FA01

INN (इंटरनेशनल नाम):

Estradiol; Norethisterone acetate

डोज़:

2 mg/1 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Progestogens and estrogens, fixed combinations; norethisterone and estrogen

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

1987-11-18

सूचना पत्रक

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
KLIOGEST 2 MG/1 MG FILM-COATED TABLETS
estradiol/norethisterone acetate
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Kliogest is and what it is used for
2.
What you need to know before you take Kliogest
3.
How to take Kliogest
4.
Possible side effects
5.
How to store Kliogest
6.
Contents of the pack and other information
1.
WHAT KLIOGEST IS AND WHAT IT IS USED FOR
Kliogest is a continuous combined Hormone Replacement Therapy (HRT)
which is taken
every day without interruption. Kliogest is used in postmenopausal
women with at least
1 year since their last natural period.
The tablets contain 2 hormones: estradiol 2 mg (an oestrogen identical
to the one made in the
ovaries) and norethisterone acetate 1 mg (a progestagen that acts in a
similar way to the
body’s own hormone progesterone).
Kliogest 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’). Kliogest alleviates these
symptoms after menopause. You will only be prescribed Kliogest if your
symptoms seriously
hinder your daily life.
_ _
PREVENTION OF OSTEOPOROSIS
After the menopause some women may develop fragile bones
(osteoporosis). You should
discuss all available options with your doctor.
If you are at an increased risk of fractures due to osteoporosis and
other medicines are not
suitable for you, you can use Kliogest to prevent

उत्पाद विशेषताएं

Health Products Regulatory Authority
16 January 2024
CRN00F27K
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Kliogest 2 mg/1 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains estradiol 2 mg (as estradiol
hemihydrate) and norethisterone acetate 1 mg.
Excipient with known effect: lactose monohydrate.
Each white film-coated tablet contains lactose monohydrate 36.3 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White, film-coated, biconvex tablets, engraved with NOVO 281. Diameter
6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women with more than 1 year
since last menses.
Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are intolerant of or contraindicated
for other medicinal products approved for the prevention of
osteoporosis (see section 4.4).
The experience treating women older than 65 years is limited.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Kliogest is a continuous combined HRT product intended for use in
women with an intact uterus. One tablet should be taken
orally once a day without interruption, preferably at the same time
every day.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for the shortest duration
(see section 4.4) should be used.
In women with amenorrhoea and not taking HRT or women in transition
from another continuous combined HRT product,
treatment with Kliogest may be started on any convenient day. In women
in transition from a sequential HRT regimen,
treatment should start right after their withdrawal bleeding has
ended.
If the patient has forgotten to take a tablet, the tablet should be
taken as soon as possible within the next 12 hours. If more
than 12 hours have passed, the tablet should be discarded. Forgetting
a dose may increase the likelihood of breakthrough
bleeding an