Livial 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Tibolone

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

G03CX01

INN (International Name):

Tibolone

Dosage:

2.5mg

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

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIVIAL
® 2.5MG TABLETS
(TIBOLONE)
This medicine will be referred to as Livial throughout the remainder
of this leaflet.
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
menopau

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Livial 2.5mg 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.
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 befor