TIBOGEN

Main information

  • Trade name:
  • TIBOGEN tibolone 2.5 mg tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TIBOGEN tibolone 2.5 mg tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220602
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220602

TIBOGEN tibolone 2.5 mg tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Medi-Gen Pharma Pty Ltd

Postal Address

5 Sanctuary Place,

TEMPLESTOWE, VIC, 3106

Australia

ARTG Start Date

9/02/2015

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. TIBOGEN tibolone 2.5 mg tablet blister pack

Product Type

Single Medicine Product

Effective date

9/02/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

INDICATIONS

? Short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women.,? Second line therapy for the

prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated

for, other medicinal products approved for the prevention of bone mineral density loss.,After careful selection of users, TIBOGEN should be prescribed

for the shortest duration consistent with treatment goals. Review the need for continuation of treatment after 6 months, taking into account the

risk-benefit ratio for the individual user at the moment (including cardiovascular disease and breast cancer, refer CLINICAL TRIALS and

PRECAUTIONS). TIBOGEN should only be continued for as long as the benefit outweighs the risks.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

36 Months

Store below 25

degrees Celsius

Not recorded

Store in Original

Container

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 28 film coated tablets (1 blister strip per carton 28 tablets per blister

strip)

(S4) Prescription Only Medicine

Components

1. TIBOGEN tibolone 2.5 mg tablet blister pack

Dosage Form

Tablet, film coated

Route of Administration

Oral

Visual Identification

The formulation is presented as white to whitish round tablet, 6.0 mm +/-

0.2 mm in diameter.

Active Ingredients

Tibolone

2.5 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 02:16:28 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

TIBOGEN® TABLETS

Tibogen

®

tibolone 2.5mg tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Tibogen. It does not

contain all the available information.

It does not take the place of talking

to your doctor or pharmacist.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking Tibogen

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What is Tibogen used

for

Tibogen contains tibolone, a

substance that can replace the

natural sex hormones after

menopause.

The production of sex hormones by

the body decreases during and after

menopause. Women may then suffer

from complaints such as hot flushes,

night sweats, vaginal irritation,

depression and loss of sexual desire.

In addition, menopause may cause

thinning of the bones (osteoporosis).

Tibogen is used in postmenopausal

women at least 12 months since

their last natural period.

Tibogen is used for:

Relief of symptoms occurring

after menopause

During 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"). Tibogen

alleviates these symptoms after

menopause.

You will only be prescribed

Tibogen 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 take Tibogen to

prevent osteoporosis after

menopause.

Tibogen is not a contraceptive.

Tibogen has no effect on alertness

and concentration as far as is known.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

This medicine is available only with

a doctor’s prescription.

Before you use Tibogen

When you must not take it

Do not take Tibogen if:

you are pregnant or think you

may be pregnant. It may affect

your developing baby if you

take it during pregnancy.

you are breastfeeding

you have or have ever had

breast cancer, or if you are

suspected of having it

you have cancer which is

growth sensitive to oestrogens,

such as cancer of the womb

lining (endometrium), or if

you are suspected of having it

you have any unexplained

vaginal bleeding

you have excessive thickening

of the womb lining

(endometrial hyperplasia) that

is not being treated

you have or have ever had a

blood clot in a vein

(thrombosis), such as in the

legs (deep venous thrombosis)

or the lungs (pulmonary

embolism)

you have a blood clotting

disorder (such as protein C,

protein S, or antithrombin

deficiency)

you have or recently have had

a disease caused by blood

clots in the arteries, such as a

heart attack, stroke or angina

TIBOGEN® TABLETS

you have or have ever had

liver disease and your liver

function tests have not

returned to normal

you have a rare blood problem

called porphyria which is

passed down in families

(inherited)

Do not take Tibogen if you have

an allergy (hypersensitivity) to

tibolone or any of the ingredients

of Tibogen listed at the end of this

leaflet.

Some of the symptoms of an allergic

reaction may include:

shortness of breath

wheezing or troubled

breathing

swelling of the face, lips,

tongue or other parts of the

body

rash, itching or hives on the

skin.

If any of the above conditions

appear for the first time while taking

Tibogen, stop taking it at once and

consult your doctor immediately.

Do not take this medicine after the

expiry date printed on the pack or

if the packaging is torn or shows

signs of tampering.

If it has expired or is damaged,

return it to your pharmacist for

disposal.

If you are not sure whether you

should start taking this medicine,

talk to your doctor

Medical history and regular

check-ups

As well as benefits, HRT or

Tibogen has some risks which need

to be considered when deciding

whether to starting 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 Tibogen

may be different. Please talk to your

doctor. Before you start (or restart)

HRT or Tibogen, your doctor will

ask you 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 Tibogen,

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 Tibogen.

Go for regular breast screening, as

recommended by your doctor.

When to take special care with

Tibogen

Tell your doctor if you have ever

had any of the following conditions

before you start the treatment, as

these may return or become worse

during treatment with Tibogen. If so,

you should see your doctor more

often for check-ups:

fibroids inside your womb

growth of the womb lining

outside your womb

(endometriosis) or a history of

excessive growth of the womb

lining (endometrial hyperplasia)

increased risk of developing

blood clots (see "Blood clots in

a vein (thrombosis)")

increased risk of getting an

oestrogen-sensitive cancer

(such as having a mother, sister

or grandmother who has had

breast cancer)

high blood pressure

a liver disorder, such as a

benign liver tumour

diabetes

gallstones

migraine or severe headaches

a disease of the immune system

that affects many organs of the

body (systemic lupus

erythematosus, SLE)

epilepsy

asthma

a disease affecting the eardrum

and hearing (otosclerosis)

a very high level of fat in your

blood (triglycerides)

fluid retention due to cardiac or

kidney problems

Tell your doctor if you notice any

change in your condition whilst

using Tibogen.

Stop taking Tibogen and see a

doctor immediately if you notice

any of the following when taking

HRT or Tibogen:

any of the conditions mentioned

in the "Do not take Tibogen"

section

yellowing of your skin or the

whites of your eyes (jaundice).

These may be signs of a liver

disease

a large rise in your blood

pressure (symptoms may be

headache, tiredness, dizziness)

migraine-like headaches which

happen for the first time

if you become pregnant

if you notice signs of a blood

clot, such as:

painful swelling and

redness of the legs

sudden chest pain

difficulty in breathing

For more information, see "Blood

clots in a vein (thrombosis)"

TIBOGEN® TABLETS

HRT and cancer

Excessive thickening of the lining

of the womb (endometrial

hyperplasia) and cancer of the

lining of the womb (endometrial

cancer)

There have been reports and studies

of an increased cell growth or

cancer of the lining of the womb in

women using tibolone. The risk of

cancer of the lining of the womb

increases with the duration of use.

Irregular bleeding

You may have irregular bleeding or

drops of blood (spotting) during the

first 3-6 months of taking Tibogen.

However, if the irregular bleeding:

carries on for more than the

first 6 months

starts after you have been

taking Tibogen for more than

6 months

carries on after you have

stopped taking Tibogen;

see your doctor as soon as possible.

Breast cancer

Taking oestrogen, estrogen-

progesterone combined HRT or

Tibogen for several years slightly

increases the risk of breast cancer.

The risk increases with the duration

of HRT use and returns to normal

within about 5 years after stopping

HRT.

Women taking tibolone have a

lower risk than women using

combined HRT and a comparable

risk with oestrogen-only HRT.

Regularly check your breasts. See

your doctor if you notice any

changes such as:

dimpling or sinking of the skin

changes in the nipple

any lumps you can see or feel

Ovarian cancer

Ovarian cancer (cancer of the

ovaries) is very rare, but it is serious.

It can be difficult to diagnose,

because there are no obvious signs

of the disease.

Effects of HRT on heart or

circulation

Heart disease (heart attack)

Tibogen is not recommended for

women who have heart disease, or

have had heart disease recently. If

you have ever had heart disease, talk

to your doctor to see if you should

be taking Tibogen.

Studies with one type of HRT

(containing conjugated oestrogen

plus the progestogen

medroxyprogesterone acetate) have

shown that women may be slightly

more likely to get heart disease

during the first year of taking

medication. For other types of HRT

including Tibogen; the risk may be

similar, although this is not yet

certain.

See a doctor as soon as possible

and do not take any more Tibogen

if you get a pain in your chest that

spreads to your arm or neck.

This pain could be a sign of heart

disease.

Stroke

Recent research suggests that HRT

and Tibogen increases the risk of

having a stroke. This increased risk

has mainly been observed in elderly

postmenopausal women above 60

years of age.

If you are worried about any of

these things, or if you have had a

stroke in the past, talk to your doctor

to see if you should take Tibogen.

See a doctor as soon as possible

and do not take any more Tibogen

until your doctor says you can if

you get any unexplained

migraine-type headaches with or

without disturbed vision.

These headaches may be an early

warning sign of a stroke.

Blood clots in a vein (Thrombosis)

Oestrogen and oestrogen-

progestogen combined HRT may

increase the risk of blood clots in

the veins (also called deep vein

thrombosis, or DVT), especially

during the 1st year of taking it. It is

unknown if Tibogen increases the

risk in the same way.

Blood clots can be serious, and if

one travels to the lungs, it can cause

chest pain, breathlessness, fainting

or even death.

You are more likely to get a blood

clot in your veins as you get older

and if any of the following applies

to you. Inform your doctor if any of

these situations apply to you:

you are pregnant or recently

had a baby

you use oestrogens

you are unable to walk for a

long time because of major

surgery, injury or illness (see

also "If you need to have

surgery")

you are seriously overweight

(BMI greater than 30kg per

square metre.)

you have any blood clotting

problem that needs long-term

treatment with a medicine

used to prevent blood clots

if any of your close relatives

has ever had a blood clot in

the leg, lung or another organ

you have systemic lupus

erythematosus (SLE, a disease

of your immune system)

you have cancer

TIBOGEN® TABLETS

If any of these apply to you, talk to

your doctor about whether you

should use Tibogen.

For signs of a blood clot, see "Stop

taking Tibogen and see a doctor

immediately".

Other conditions

HRT will not prevent memory loss.

There is some evidence of a higher

risk of memory loss in women who

start using HRT after the age of 65.

Speak to your doctor for advice.

Tell your doctor if you become

pregnant or are breast-feeding.

Tibogen is for use in

postmenopausal women only. If you

are pregnant or breast-feeding or

think you may be pregnant, do not

take Tibogen.

Tell your doctor if you react badly

to lactose or milk before you start

taking Tibogen.

Tibogen tablets contain lactose.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including medicines

that you get without a

prescription, herbal medicines or

other natural products from your

pharmacy, supermarket or health

food shop.

Some medicines may interfere with

the effect of Tibogen. This applies

to the following medicines:

medicines against blood

clotting (such as warfarin)

medicines for epilepsy (such

as phenobarbitone, phenytoin

and carbamazepine)

medicines for tuberculosis

(such as rifampicin)

herbal remedies containing St

John's Wort (hypericum

perforatum)

You may need different amounts of

your medicine, or you may need to

take different medicines.

Ask your doctor or pharmacist

for advice before taking any

medicine.

How to take Tibogen

Follow all directions given to you

by your doctor or pharmacist

carefully. You should check with

your doctor or pharmacist if you

are unsure.

When to start it

Tibogen should not be taken until 12

months after your last natural

menstrual bleed. If Tibogen is taken

sooner than this, the chance of

irregular vaginal bleeding may be

increased.

Women who have undergone

premature menopause (surgical

removal of ovaries) can start taking

Tibogen immediately.

If you are already using a different

type of HRT, your doctor will

advise you when to switch to

Tibogen.

How to take it

Take one tablet daily, at about the

same time each day. Taking it at

the same time each day will have

the best effect. It will also help you

remember when to take it.

Swallow the tablet whole without

chewing with some water or other

nonalcoholic drink.

The Tibogen pack contains 28 white

tablets. The strips with Tibogen are

marked with the days of the week.

Start by taking the tablet marked

with that day. For example, if it is a

Monday, take a tablet marked

Monday on the upper row of the

strip. Follow the directions of the

arrows and continue taking one

tablet each day until the strip is

empty.

Do not leave a break between strips

or packs.

How long to use it

HRT should be prescribed at the

lowest effective dose and for the

shortest duration necessary. Your

doctor can advise you how long you

may need to take Tibogen.

In general, improvement of the

symptoms will occur within a few

weeks.

Optimum results are achieved when

treatment is continued for at least 3

months.

If you forget to take it

If you forget to take a tablet, take it

as soon as you remember, unless

you are more than 12 hours late. If

you are more than 12 hours late,

skip the dose you missed and take

your next dose when you are meant

Do not take a double dose to make

up for the forgotten dose.

If you take too much

(overdose)

If you have taken more tablets

than you have been prescribed,

immediately telephone your

doctor or for Australia the

Poisons Information Centre on 13

11 26, for New Zealand, the

National Poisons Centre on 0800

764 766 for advice.

Signs of an overdose may include

feeling sick or vomiting. Vaginal

TIBOGEN® TABLETS

bleeding may also occur after a few

days.

While you are using

Tibogen

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Tibogen.

Tell any other doctors, dentists

and pharmacists who treat you

that you are taking this medicine.

If you need to have surgery

Tell your doctor and your surgeon

that you are taking Tibogen if you

are going to have surgery.

You may need to stop taking

Tibogen about 4-6 weeks before the

operation to reduce the risk of a

blood clot (see "Blood clots in a

vein"). Ask your doctor when you

can start taking Tibogen again.

If you become pregnant while

taking this medicine, tell your

doctor immediately.

Things you must not do

Do not take Tibogen to treat any

other complaints unless your

doctor tells you to.

Do not give your medicine to

anyone, even if they have the same

condition as you.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking Tibogen.

The following diseases are reported

more often in women using HRT

compared to women not using HRT:

breast cancer

abnormal growth or cancer of

the lining of the womb

(endometrial hyperplasia or

cancer)

ovarian cancer

blood clots in the veins of the

legs or lungs (venous

thromboembolism)

heart disease

stroke

probable memory loss if HRT

is started over the age of 65

Tibogen helps most women with

menopausal symptoms, but it may

have unwanted side effects in a few

people. All medicines can have side

effects. Sometimes they are serious,

most of the time they are not. You

may need medical attention if you

get some side effects.

Do not be alarmed by the

following lists of side effects. You

may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following and

they worry you:

vaginal bleeding or spotting

abdominal pain

weight gain

breast pain

unnatural hair growth

vaginal symptoms, such as

discharge, itching, and

irritation.

Less common side effects may

include:

acne

Other side effects observed with

Tibogen in market use were:

dizziness, headache, migraine,

depression

rash or itching

visual disturbances

gastro-intestinal upset

fluid retention

joint pain, muscle pain

changes in liver function

There have been reports of breast

cancer and of an increased cell

growth or cancer of the lining of the

womb in women using Tibogen.

Please see "Medical history and

regular check-ups" for conditions

where Tibogen should be stopped.

The following side effects have

been reported with other HRTs:

gall bladder disease

various skin disorders:

discolouration of the skin

especially of the face or

neck known as

"pregnancy patches"

(chloasma)

painful reddish skin

nodules (erythema

nodosum)

rash with target-shaped

reddening or sores

(erythema multiforme)

Tell your doctor or pharmacist if

you notice any side effects not

mentioned in this leaflet.

After Using Tibogen

Storage

Keep your Tibogen tablets in a

safe place out of the reach of

children.

Keep your Tibogen tablets in the

original package in a cool dry

place where the temperature stays

below 25

°

C.

Do not use after the expiry date

stated on the blister and outer box.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

TIBOGEN® TABLETS

pharmacist what to do with any

medicine that is left over.

Product Description

What it looks like

Packs contain one or three blister

strip(s) of 28 white round flat tablets.

Ingredients

Tibogen tablet contains 2.5 mg of

the active ingredient called tibolone.

Tibogen also contains the following

inactive ingredients:

potato starch

lactose

ascorbyl palmitate

magnesium stearate

Do not use the product if the blister

pack or tablets are damaged or

appear unusual.

Sponsor

Tibogen is supplied in Australia by:

Medi-Gen Pharma Pty Ltd

Level 26, 530 Collins Street,

Melbourne, VIC 3000

Australia

AUST R 220602

This leaflet was prepared

24 August 2014