Livial 2.5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TIBOLONE

Available from:

Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

ATC code:

G03CX01

INN (International Name):

TIBOLONE 2.5 mg

Pharmaceutical form:

TABLET

Composition:

TIBOLONE 2.5 mg

Prescription type:

POM

Therapeutic area:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Authorization status:

Withdrawn

Authorization date:

2005-07-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIVIAL®
2.5 MG TABLETS
TIBOLONE
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, pharmacist or
nurse.

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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
WHAT LIVIAL IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LIVIAL
3.
HOW TO TAKE LIVIAL
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LIVIAL
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT LIVIAL IS AND WHAT IT IS USED FOR
Livial 2.5 mg tablet
The active substance is: tibolone.
This medicine is a Hormone Replacement Therapy (HRT). It contains
tibolone, a substance that has
favourable effects on different tissues in the body, such as brain,
vagina and bone. This medicine is
used in postmenopausal women with at least 12 months (1 year) since
their last natural period.
This medicine 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").
Livial alleviates these symptoms
after menopause. You will only be prescribed this medicine 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 Livial to prevent osteoporosis after menopause.
There are three different kinds of HRT:

OESTROGEN-ONLY HRT

COMBINED HRT, contain

Summary of Product characteristics

Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
Livial 2.5 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of tibolone.
Excipient(s) with known effect:
Each tablet contains approximately 86.8mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, round and flat tablets with beveled edges and a diameter of 6
mm and coded “MK” above
“2” on one side and “Organon

” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Treatment of oestrogen deficiency symptoms in postmenopausal women,
more than one year
after menopause.

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 also Section 5.1).
For all women the decision to prescribe Livial should be based on an
assessment of the individual
patient’s overall risks and, particularly in the over 60s, should
include consideration of the risk of
stroke (see sections 4.4 and 4.8).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
The dosage is one tablet per day. The tablets should be swallowed with
some water or other drink,
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 separate progestogen should not be added with Livial treatment.
STARTING LIVIAL
Women experiencing a natural menopause should commence treatment with
Livial at least 12
months after their last natural bleed. In case of a surgical
menopause, treatment with Livial may
commence immediately.
2
Women being treated with gonadotrophin releasing hormone (GnRH)
analogues, for example, for
endometriosis, may commence treatment with Livial immediately.
Any irregular/unscheduled vaginal bleeding, either on or off HRT,
should be investigated to
exclude malignancy before starting Livi