APO-CABERGOLINE

Main information

  • Trade name:
  • APO-CABERGOLINE cabergoline 500 micrograms tablets bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • APO-CABERGOLINE cabergoline 500 micrograms tablets bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218126
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218126

APO-CABERGOLINE cabergoline 500 micrograms tablets bottle

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

20/11/2015

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. APO-CABERGOLINE cabergoline 500 micrograms tablets bottle

Product Type

Single Medicine Product

Effective date

29/07/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

· Inhibition of physiological lactation ,Cabergoline is indicated for the prevention of the onset of physiological lactation in the puerperium for clearly

defined medical reasons. ,· Treatment of hyperprolactinaemic disorders ,Cabergoline is indicated for the treatment of pathological hyperprolactinaemia.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

Glass Type III

Coloured

21 Months

Store below 25

degrees Celsius

Child resistant closure

Protect from Light

Protect from Moisture

Protect from Heat

Pack Size/Poison information

Pack Size

Poison Schedule

8 tablets

(S4) Prescription Only Medicine

2 tablets

(S4) Prescription Only Medicine

Components

1. APO-CABERGOLINE cabergoline 500 micrograms tablets bottle

Dosage Form

Tablet

Route of Administration

Oral

Visual Identification

White coloured, capsule shaped, flat, scored tablets with debossed "APO"

on one side and "CA" bisect "0.5" on the other side.

Active Ingredients

Cabergoline

500 microgram

© 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 05:25:50 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

APO-Cabergoline

Tablets

Contains the active ingredient cabergoline

Consumer Medicine Information

For a copy of a large print leaflet, Ph: 1800 195 055

What is in this leaflet

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about cabergoline. It does

not contain all the available

information. It does not take the

place of talking to your doctor or

pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want to read it again.

What this medicine is

used for

The name of your medicine is APO-

Cabergoline tablets. It contains the

active ingredient cabergoline.

It is used to:

treat abnormally high levels of

prolactin (hyperprolactinaemia).

prevent the production of milk in

women after birth, if breast

feeding is to be prevented for

medical reasons.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you. Your

doctor may have prescribed this

medicine for another reason.

This medicine is available only with

a doctor's prescription.

How it works

Cabergoline works by stimulating the

receptors which inhibit the secretion

of hormone known as prolactin, thus

reducing your body's level of

prolactin

Abnormally high prolactin may cause

menstrual changes in women,

impotence in men and breast changes

in both sexes

There is no evidence that this

medicine is addictive.

Use in children

This medicine should not be used in

children under the age of 16 years.

The safety and effectiveness in

children less than 16 years of age has

not been established.

Before you take this

medicine

Before starting treatment with

cabergoline, your doctor will need to

do some tests to detect any

underlying heart, lung or kidney

disease. These tests include chest x-

rays, physical examinations, blood

tests and heart monitoring.

Your doctor will repeat these tests

regularly if you are taking

cabergoline for a long period of time.

While you are taking cabergoline,

report anything unusual to your

doctor such as difficulty in breathing,

chest pain, swelling of your hands or

feet, or anything else that is making

you feel unwell.

When you must not take it

Do not take this medicine if:

You have or have had any of

the following:

Any scarring or thickening of

the lungs with shortness of

breath

Heart valve disorder

Any swelling or inflammation

around the heart or lungs

Any abnormal formation of

tissue outside the stomach wall

APO-CABERGOLINE TABLETS

You are hypersensitive to, or

have had an allergic reaction to,

cabergoline, any of the

ingredients listed at the end of

this leaflet or other ergot

alkaloids (medicines used to

treat migraines).

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

Before you start to take it

Before you start taking this

medicine, tell your doctor if:

You have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

Kidney, heart and liver problems

Lung disease or problems with

your breathing

Raynaud's syndrome (associated

with extreme numbness, tingling

and colour changes in the fingers

due to cold)

Ulcer or bleeding in the stomach

or intestines

Low blood pressure

High blood pressure after

childbirth

History of severe mental illness

You are currently pregnant or you

plan to become pregnant.

Do not take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

It is recommended that women

who plan to become pregnant

stop taking cabergoline at least

one month before becoming

pregnant.

You are currently breastfeeding

or you plan to breast-feed.

Do not take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

This medicine prevents the flow

of breast milk.

You are planning to have surgery

or an anaesthetic.

You are currently receiving or are

planning to receive dental

treatment.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

cabergoline. These include:

Medicines used to treat mental

illness, e.g. antipsychotic

medicines for schizophrenia

Medicines used to treat high

blood pressure

Ergot alkaloids, medicines used

to treat migraine

Medicines used to prevent nausea

and vomiting (e.g.

metoclopramide)

Medicines called macrolide

antibiotics which are used to treat

bacterial infections (e.g.

erythromycin)

If you are taking any of these you

may need a different dose or you

may need to take different medicines.

Other medicines not listed above

may also interact with cabergoline.

How to take this

medicine

Follow carefully all directions given

to you by your doctor. Their

instructions may be different to the

information in this leaflet.

How much to take

Your doctor will tell you how much

of this medicine you should take.

This will depend on your condition

and whether you are taking any other

medicines.

Do not stop taking your medicine or

change your dosage without first

checking with your doctor.

To treat high levels of prolactin

(hyperprolactinaemia), the

recommended starting dose is 250

micrograms (half a 500 microgram

tablet) taken twice a week. Your

doctor will generally start you on a

low dose and may gradually increase

your dose.

To prevent the production of breast

milk, the recommended dose is 1mg

(two 500 microgram tablets) taken

once, on the first day after delivery of

your baby.

How to take it

Swallow cabergoline tablets with a

glass of water.

When to take it

Take this medicine on the same day

each week. Taking it on the same day

each week will have the best effect

and will also help you remember

when to take it.

Take your medicine with food or a

meal.

How long to take it for

Continue taking your medicine for as

long as your doctor tells you.

Make sure you have enough to last

over weekends and holidays.

If you forget to take it

If it is almost time to take your next

dose, skip the missed dose and take

APO-CABERGOLINE TABLETS

your next dose at the usual time.

Otherwise, take it as soon as you

remember and then go back to taking

your medicine as you would

normally.

Do not take a double dose to make

up for missed doses.

This may increase the chance of you

experiencing side effects.

If you have trouble remembering to

take your medicine, ask your

pharmacist for some hints to help you

remember.

If you take too much

(overdose)

If you think that you or anyone

else may have taken too much of

this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

The symptoms of taking too much

cabergoline may include nausea,

vomiting, stomach pains and

dizziness.

While you are taking

this medicine

Things you must do

Tell your doctor that you are taking

this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breast-feed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Use barrier methods of

contraception, such as condoms,

to prevent pregnancy during and

for at least one month after taking

cabergoline.

Your doctor may recommend

routine pregnancy tests during

long periods of treatment.

Stop taking cabergoline

immediately if you become

pregnant and consult your doctor.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side

effects. These tests may include

chest x-rays, physical

examinations, blood tests and

heart monitoring.

Follow your doctor's requests for

tests and report anything unusual

to your doctor such as difficulty

in breathing, chest pain or

swelling of your hands or feet.

Keep all your doctor's

appointments while taking

cabergoline so that your progress

can be checked.

Tell any other doctors, dentists

and pharmacists who are treating

you that you take this medicine.

Things you must not do

Do not:

Give this medicine to anyone

else, even if their symptoms seem

similar to yours.

Take your medicine to treat any

other condition unless your

doctor tells you to.

Stop taking your medicine, or

change the dosage, without first

checking with your doctor.

Things to be careful of

Be careful when driving or operating

machinery until you know how this

medicine affects you.

Cabergoline may cause dizziness or

affect your ability to respond quickly.

If you feel sleepy while taking

cabergoline, do not drive or operate

machinery.

If you feel light-headed, dizzy or

faint when getting out of bed or

standing up, get up slowly.

See your doctor if you notice changes

in your behaviour that result in a

strong desire to either gamble, shop,

eat or use medicines to excess, or you

notice an increase in your sex drive.

Such compulsive behaviours have

been seen with this class of medicine,

including cabergoline.

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking cabergoline or if you have any

questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

Dizziness, fainting

Headache

Nausea or vomiting

Unusual sleepiness

Abdominal pain or heartburn or

pain in the stomach

Constipation

Nosebleed

Weakness or tiredness

Temporary impairment of vision

Breast pain

Hot flushes

Rash

Hair loss

These side effects listed above are

usually mild and short lived.

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention:

Irregular heart beat

APO-CABERGOLINE TABLETS

Leg cramps or pain in the fingers

or toes

Aggressive behaviour

Depression, feelings of deep

sadness

Changes in behaviour such as

increased sex drive, a compelling

desire to gamble, shop, eat or take

medicines

Any breathing problems

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

Chest pain

Sudden signs of allergy (see

Allergic reactions section below)

Tell your doctor if you notice

anything else that is making you

feel unwell when you are taking,

or soon after you have finished

taking cabergoline.

Other side effects not listed above

may occur in some patients.

Some of these side effects (e.g.

changes in liver function) can

only be found when your doctor

does tests from time to time to

check your progress.

Allergic reactions

If you think you are having an

allergic reaction to cabergoline, do

not take any more of this medicine

and tell your doctor immediately

or go to the Accident and

Emergency department at your

nearest hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Keep your medicine in its original

packaging until it is time to take it.

If you take your medicine out of its

original packaging it may not keep

well.

Keep your medicine in a cool dry

place where the temperature will stay

below 25°C. Protect from heat, light

and moisture.

Do not store your medicine, or any

other medicine, in the bathroom or

near a sink. Do not leave it on a

window sill or in the car. Heat and

dampness can destroy some

medicines.

Keep this medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop taking

this medicine or it has passed its

expiry date, your pharmacist can

dispose of the remaining medicine

safely.

Product description

What APO- Cabergoline

Tablets looks like

0.5mg tablets: white coloured,

capsule shaped, flat, scored tablet,

embossed "APO" on one side and

"CA" bisect '0.5" on the other side

Bottles of 2 and 8 tablets.

* Not all pack sizes may be available.

Ingredients

Each tablet contains 500 micrograms

of cabergoline as the active

ingredient.

It also contains the following inactive

ingredients:

lactose anhydrous

magnesium stearate

This medicine is gluten-free, sucrose-

free, tartrazine-free and free of other

azo dyes.

Australian Registration

Numbers

APO-Cabergoline 500 microgram

tablets : AUST R 218126.

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trade marks of Apotex Inc.

This leaflet was last updated in:

May 2014.

APO-CABERGOLINE TABLETS

10-11-2018

Pest categorisation of Popillia japonica

Pest categorisation of Popillia japonica

Published on: Thu, 08 Nov 2018 00:00:00 +0100 The Panel on Plant Health performed a pest categorisation of Popillia japonica(Coleoptera: Scarabaeidae) for the EU. P. japonica is a distinguishable species listed in Annex IAII of Council Directive 2000/29/EC. It is native to Japan but established in the USA in the early 20th century. It spreads from New Jersey to most US states east of the Mississippi, some to the west and north into Canada. P. japonica feeds on over 700 plant species. Adults attack folia...

Europe - EFSA - European Food Safety Authority Publications

9-11-2018

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

First Choice Vapor recalls Unflavoured 100 mg Nicotine Base E-Liquids

These vaping products do not meet requirements of the Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001) under the Canada Consumer Product Safety Act.

Health Canada

20-7-2016

Marketing authorisation for medicine for cows suspended in the EU/EEA

Marketing authorisation for medicine for cows suspended in the EU/EEA

On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.

Danish Medicines Agency

18-3-2008

Warning about Power 1 Walnut

Warning about Power 1 Walnut

The Danish Medicines Agency has been made aware that the Health Sciences Authority in Singapore has confiscated large quantities of the illegal medicinal product Power 1 Walnut, which has been marketed as a potency-enhancing product containing only herbs.

Danish Medicines Agency

10-9-2018

Silapo (STADA Arzneimittel AG)

Silapo (STADA Arzneimittel AG)

Silapo (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5944 of Mon, 10 Sep 2018

Europe -DG Health and Food Safety