Livial 2.5mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Tibolone

から入手可能:

DE Pharmaceuticals

ATCコード:

G03CX01

INN（国際名）:

Tibolone

投薬量:

2.5mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 06040101

情報リーフレット

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
, contai

製品の特徴

OBJECT 1
LIVIAL 2.5MG TABLETS
Summary of Product Characteristics Updated 04-Apr-2016 | Merck Sharp &
Dohme Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
•
11. Legal category
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 86.8 mg 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