Kliovance tablets

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Estradiol; Norethisterone acetate

Dostępny od:

Novo Nordisk Ltd

Kod ATC:

G03CA53

INN (International Nazwa):

Estradiol; Norethisterone acetate

Dawkowanie:

1mg ; 500microgram

Forma farmaceutyczna:

Oral tablet

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 06040101; GTIN: 5017954000746

Ulotka dla pacjenta

1
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
KLIOVANCE
® 1 MG/0.5 MG FILM-COATED TABLETS
Estradiol/norethisterone acetate
READ ALL OF THIS 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 Kliovance
®
is and what it is used for
2.
What you need to know before you take Kliovance
®
3.
How to take Kliovance
®
4.
Possible side effects
5.
How to store Kliovance
®
6.
Contents of the pack and other information
1.
WHAT KLIOVANCE
® IS AND WHAT IT IS USED FOR
Kliovance
®
is a continuous combined Hormone Replacement Therapy (HRT). It
contains two types of
female hormones, an oestrogen and a progestagen. Kliovance
®
is used in postmenopausal women with at
least 1 year since their last natural period.
Kliovance
®
is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of oestrogen produced by a woman’s
body drops. This can cause
symptoms such as hot face, neck and chest (‘hot flushes’).
Kliovance
®
alleviates these symptoms after
menopause. You will only be prescribed Kliovance
®
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 Kliovance
®
to prevent osteoporosis after menopause.
Kliovance
®
is prescribed for women who have not had their womb removed, and whose
periods stopped
more th

Charakterystyka produktu

OBJECT 1
KLIOVANCE
Summary of Product Characteristics Updated 16-Mar-2016 | Novo Nordisk
Limited
1. Name of the medicinal product
Kliovance 1 mg/0.5 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains:
Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate
0.5 mg.
Excipient with known effect: lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets.
White film-coated, round, biconvex tablets with a diameter of 6 mm.
The tablets are engraved with
NOVO 288 on one side and the Apis bull on the other.
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.
The experience treating women older than 65 years is limited.
4.2 Posology and method of administration
Kliovance 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 also section 4.4) should be used.
A switch to a higher dose combination product could be indicated if
the response after 3 months is
insufficient for symptom relief.
In women with amenorrhoea and not taking HRT or women in transition
from another continuous
combined HRT product, treatment with Kliovance 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 h