Kliofem tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estradiol; Norethisterone acetate

Available from:

Dowelhurst Ltd

ATC code:

G03CA53

INN (International Name):

Estradiol; Norethisterone acetate

Dosage:

2mg ; 1mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101

Patient Information leaflet

Code start
Code: 100% Direction
Length: Max. 29 mm (100%)
Code start
Code: 100% Direction
Length: Max. 29 mm (100%)
8-2850-01-001-4
PACKAGE LEAFLET:
INFORMATION FOR THE USER
KLIOFEM® 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.
history. Your doctor may decide to
perform a physical examination.
This may include an examination of
your breasts and/or an internal
examination, if necessary.
Once you have started on Kliofem®
you should see your doctor for
regular check-ups (at least once
a year). At these check-ups, discuss
with your doctor the benefits and
risks of continuing with Kliofem®.
Go for regular breast screening, as
recommended by your doctor.
DO NOT TAKE KLIOFEM®
If any of the following applies to
you. If you are not sure about any
of the points below, TALK TO YOUR
DOCTOR before taking Kliofem®.
Do not take Kliofem®:
• if you have, have had or suspect
having BREAST CANCER
• if you have, have had or suspect
having CANCER OF THE WOMB
LINING (endometrial cancer), or
any other oestrogen dependent
cancer
• if you have any UNEXPLAINED
VAGINAL BLEEDING
• if you have EXCESSIVE
THICKENING OF THE WOMB
LINING (endometrial hyperplasia)
that is not being treated
• if you have or have ever had
a BLOOD CLOT IN A VEIN (venous
thromboembolism), such as in
the legs (deep venous
thrombosis) or the lungs
(pulmonary embolism)
• if you have a BLOOD CLOTTING
DISORDER (such as protein C,
protein S or antithrombin
deficiency)
• if you have or previously have
had a disease caused by blood
clots in the arteries, such as
a HEART ATTACK, STROKE or ANGINA
• if you have or have ever had
a LIVER DISEASE and your

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Kliofem® 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
Kliofem 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 Kliofem 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 and spotting.
4.3
CONTRAINDICATIONS
−
Known, past or suspected breast cancer
−
Known