Tibolone 2.5mg tablets

Quốc gia: Vương quốc Anh

Ngôn ngữ: Tiếng Anh

Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)

Thành phần hoạt chất:

Tibolone

Sẵn có từ:

Aristo Pharma Ltd

Mã ATC:

G03CX01

INN (Tên quốc tế):

Tibolone

Liều dùng:

2.5mg

Dạng dược phẩm:

Oral tablet

Tuyến hành chính:

Oral

Lớp học:

No Controlled Drug Status

Loại thuốc theo toa:

Valid as a prescribable product

Tóm tắt sản phẩm:

BNF: 06040101; GTIN: 4251575902374 4251575902381

Tờ rơi thông tin

What is in this leaflet
1. What Tibolone tablets are and what they are used for
2. What you need to know before you take Tibolone tablets
3. How to take Tibolone tablets
4. Possible side effects
5. How to store Tibolone tablets
6. Contents of the pack and other information
1. What Tibolone tablets are and what they
are used for
Tibolone tablets are a Hormone Replacement Therapy
(HRT). They contain tibolone, a synthetic sex hormone.
Tibolone is used in postmenopausal women with at least
12 months since their last natural period.
Tibolone is used for the 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”).
Tibolone alleviates these symptoms after the menopause.
You will only be prescribed Tibolone if your symptoms
seriously hinder your daily life.
2. What you need to know before you take
Tibolone tablets
Medical History and regular check-ups
The use of HRT or Tibolone carries risks that need to be
considered when deciding whether to start taking it, or
whether to carry on taking it.
The experience in treating women with a premature
menopause (due to ovarian failure or surgery) is limited. If
you have a premature menopause the risks of using HRT or
Tibolone may be different. Please talk to your doctor.
Before you start taking (or restart) HRT or Tibolone, your
doctor will ask about your own and your family’s medical
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 Tibolone, 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 Tibolone.
Go for regular breast screening, as recommended by your
doctor.
Additionally, you are advised to join mammography
screening programs when offered to you. For
mammogram screening, it is importa

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tibolone 2.5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tibolone 2.5 mg tablets: each tablet contains 2.5 mg tibolone.
Excipient(s) with known effect: lactose monohydrate:
Tibolone 2.5 mg tablets: each tablet contains approximately 75 mg
lactose
monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White to whitish, flat round tablets of approximately 6 mm diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of oestrogen deficiency symptoms in women more than one year
after the
menopause.
For all women the decision to prescribe tibolone 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.
Method of administration
The tablets should be swallowed, with some water or other drink,
preferably at the
same time every day.
Elderly
No dose adjustment is necessary for the elderly.
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 Tibolone 2.5 mg
tablets treatment.
Starting Tibolone 2.5 mg tablets
Women experiencing a natural menopause should commence treatment with
Tibolone
2.5 mg tablets at least 12 months after their last natural bleed.
Women experiencing a
surgical menopause may commence treatment with Tibolone 2.5 mg tablets
immediately.
Any irregular/unscheduled vaginal bleeding, either on or off HRT, for
which there is
no obvious cause, should be investigated to exclude malignancy before
starting
Tibolone 2.5 mg tablets (see section 4.3).
_ _
Switching from a sequential or continuous combined HRT preparation
If changing from a sequential HRT preparation, treatment with_
_Tibolone 2.5 mg
tablets should start th