CHELSEA-35

Main information

  • Trade name:
  • CHELSEA-35 ED cyproterone acetate 2 mg and ethinylestradiol 35 micrograms tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CHELSEA-35 ED cyproterone acetate 2 mg and ethinylestradiol 35 micrograms tablet blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 210583
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

210583

CHELSEA-35 ED cyproterone acetate 2 mg and ethinylestradiol 35 micrograms tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Aspen Pharma Pty Ltd

Postal Address

34-36 Chandos Street,ST LEONARDS, NSW, 2065

Australia

ARTG Start Date

25/03/2014

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. CHELSEA-35 ED cyproterone acetate 2 mg and ethinylestradiol 35 micrograms tablet blister pack

Product Type

Composite Pack

Effective date

28/10/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Treatment of signs of androgenisation in women such as severe acne (involving inflammation or nodularity, or risk of scarring) where prolonged oral

antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. Chelsea-35 ED will also provide effective

oral contraception in this patient group.,If the hirsutism has only recently appeared, or has lately intensified to a considerable extent, the cause (which

might be an androgen producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Blister Pack

PVC/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 28 tablets (21 active + 7 placebo)

(S4) Prescription Only Medicine

3 x 28 tablets (21 active + 7 placebo)

(S4) Prescription Only Medicine

Components

1. placebo tablet

Dosage Form

Tablet, sugar coated

Route of Administration

Oral

Visual Identification

white, round tablet

2.

Dosage Form

Tablet, sugar coated

Route of Administration

Oral

Visual Identification

yellow, round tablet

Active Ingredients

cyproterone acetate

2 mg

ethinylestradiol

35 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 27.11.2017 at 09:22:36 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

Public Summary

Page 2 of

Produced at 27.11.2017 at 09:22:36 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

CHELSEA-35 ED

CHELSEA

®

-35 ED

Contraceptive tablets for women

Contains:

21 yellow tablets, each containing the active ingredients cyproterone acetate and ethinyloestradiol (2

mg/35 microgram (µg))

7 white placebo tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about CHELSEA

-35 ED.

It does not contain all of the available

information. It does not take the

place of talking to your doctor or

pharmacist.

All medicines have benefits and

risks. Your doctor has weighed the

risks of you taking CHELSEA

ED against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, talk to your

doctor or pharmacist.

Keep this leaflet with your

medicine.

You may need to read it again.

What this medicine is

used for

CHELSEA

-35 ED is a hormonal

preparation used to treat the

following androgen-dependent

conditions in women:

severe acne when other

treatments have failed

mild to moderate increased

growth of facial or body hair

(hirsutism).

Androgens are male sex hormones,

produced by women in small

amounts. If a woman's body

produces too much of these

hormones or is overly sensitive, then

androgen-dependent conditions

occur. CHELSEA

-35 ED works by

blocking the action of these

hormones.

CHELSEA

-35 ED is also an

effective oral contraceptive,

commonly known as the "Pill" or

"birth control pill".

As a contraceptive, CHELSEA

ED prevents pregnancy by:

preventing ovulation

thickening the cervical mucus to

act as a barrier to sperm

making the lining of the uterus

less suitable for implantation of

the fertilised egg.

Oral contraceptives such as

CHELSEA

-35 ED may have the

following theoretical benefits:

a decrease in the amount of blood

you lose each cycle during your

period

a decrease in anaemia

a decrease in period pain

a reduced risk of pelvic

inflammatory disease

a reduced risk of developing

ovarian cysts

an improvement in acne

a reduced risk of tubal (ectopic)

pregnancy

a reduced risk of benign breast

disease (breast lumpiness)

a reduced risk of getting cancer of

the uterus (womb) lining and

ovaries.

Ask your doctor if you have any

questions about why CHELSEA

®

-

35 ED has been prescribed for you.

Your doctor may have prescribed this

medicine for another reason.

CHELSEA

®

-35 ED is not for use in

men.

CHELSEA

-35 ED does not protect

against HIV infections (AIDS) or

other sexually transmitted diseases

(STDs). A barrier form of

contraception such as a condom or

diaphragm is needed.

CHELSEA

-35 ED is available only

with a doctor's prescription.

Before you take this

medicine

When you must not take it

Do not take CHELSEA

®

-35 ED if

you are allergic to:

any other medicines containing

cyproterone or ethinyloestradiol

any other oral contraceptive

any other medicine known as a

progestagen or oestrogen,

including injections and implants

any of the ingredients listed at the

end of this leaflet.

CHELSEA

-35 ED

Some of the symptoms of an allergic

reaction may include skin rash,

itching or hives; swelling of the face,

lips or tongue which may cause

difficulty in swallowing or breathing;

wheezing or shortness of breath.

Do not take CHELSEA

®

-35 ED if

you have or have had:

any condition affecting blood

circulation, in particular those

conditions relating to thrombosis,

(formation of blood clots in the

legs, lungs or other parts of the

body)

a heart attack, stroke or angina

(chest pain)

a migraine accompanied by visual

symptoms, speech disability or

weakness or numbness in any part

of the body

diabetes mellitus with blood

vessel complications

inflammation of the pancreas

associated with high triglyceride

(blood fats) levels in the blood

jaundice (yellowing of the skin)

or severe liver disease

benign or malignant liver tumours

cancer of the breast or genital

organs

unexplained vaginal bleeding.

Do not take CHELSEA

®

-35 ED if

you are pregnant or think you

might be pregnant.

This medicine may affect your

developing baby if you take it during

pregnancy.

Do not take it if you are

breastfeeding.

CHELSEA

-35 ED passes into

breast milk and may affect your

baby.

Do not take it after the expiry date

printed on the pack has passed.

If you take this medicine after the

expiry date, it may not work as well.

Do not take CHELSEA

®

-35 ED if

the packaging shows signs of

tampering or the tablets do not

look quite right.

If you are not sure whether you

should start taking this medicine, talk

to your doctor.

Before you start to take it

A complete medical check-up must

be done by your doctor before

starting CHELSEA

®

-35 ED.

This includes determining if you are

pregnant or not, a Pap smear, a blood

test, and a check of blood pressure,

breasts, abdomen and pelvic organs.

Your doctor will also note your

family medical history.

Tell your doctor if you are allergic

to any other medicines, foods, dyes

or preservatives.

Tell your doctor if you smoke.

The use of oral contraceptives like

CHELSEA

-35 ED by cigarette

smokers may increase the risk of

cardiovascular disease, especially if

you are over the age of 35. Your

doctor or pharmacist can advise you

about stopping smoking.

Tell your doctor if you have, or

have had, any medical conditions,

especially the following:

blood circulation problems,

including a positive family

history of blood clots, heart attack

or stroke

migraines

high blood pressure

a heart valve or rhythm disorder

varicose veins

diabetes mellitus

obesity

systemic lupus erythematosus, a

disease affecting the skin all over

the body

polycystic ovary syndrome

chronic inflammatory bowel

disease, e.g. Crohn's disease,

ulcerative colitis

sickle cell anaemia

haemolytic uraemic syndrome, a

blood clotting disorder causing

kidney failure

breast cancer including a family

history of breast cancer

liver or gall bladder problems

high blood triglyceride or

cholesterol levels, including a

family history

chloasma, dark patches on the

skin, especially the face. (If so,

avoid too much exposure to the

sun or UV radiation).

Your doctor may want to take special

care if you have any of these

conditions.

If you have not told your doctor

about any of the above, tell

him/her before you start taking

CHELSEA

®

-35 ED.

The Pill and Thrombosis

A thrombosis is the formation of a

blood clot, which may block a blood

vessel.

Serious health problems caused by

the Pill are rare and as with all

medications, the risks need to be

balanced against the benefits.

The most dangerous risk of the Pill is

a blood clot in the veins, usually in

the legs or lungs, known as deep vein

thrombosis (DVT) or venous

thromboembolism (VTE). Warning

signs are severe sudden chest pain,

shortness of breath, severe pain or

swelling in one leg, sudden blurred

vision or loss of sight, or sudden

severe headache. If you have any of

these symptoms contact your doctor

or go to your nearest Emergency

Department immediately.

It is important to put the risk of blood

clots into context.

A thrombosis sometimes occurs in

the deep veins of the legs (deep vein

thrombosis). If this blood clot breaks

away from the veins where it is

formed, it may reach and block the

arteries of the lungs (pulmonary

embolism). Deep vein thrombosis is

a rare occurrence. It can develop

whether or not you are taking the

Pill. It can also happen if you become

pregnant. The risk is higher in Pill

CHELSEA

-35 ED

users than in non-users but not as

high as the risk during pregnancy.

The risk of venous thromboembolism

(VTE) is increased 2-3 times in users

of combined hormonal contraception

methods compared to non-users. The

risk is highest in the first year of use

of a combined contraceptive and

gradually decreases with duration of

VTE with any combined hormonal

method of contraception is much less

common than VTE in pregnancy and

the immediate post-partum period.

Pills containing levonorgestrel or

norethisterone appear to have lower

VTE risk

Blood clots can also occur very

rarely in the blood vessels of the

heart (causing a heart attack) or the

brain (causing a stroke). Extremely

rarely blood clots can occur in the

liver, gut, kidney or eye.

Very occasionally thrombosis may

cause serious permanent disabilities

or may even be fatal.

Biochemical factors (hereditary or

acquired) that may indicate a

possible predisposition for blood clot

formation include having Activated

Protein C (APC) resistance,

hyperhomocysteinemia,

antithrombin-III deficiency, protein

C deficiency, protein S deficiency

and antiphospholipid antibodies.

The risk of having a heart attack or

stroke increases as you get older. It

also increases the more you smoke.

When using CHELSEA

-35 ED you

should stop smoking, especially if

you are older than about 35 years of

age.

If you develop high blood pressure

while using CHELSEA

-35 ED, you

may be told to stop using it.

It is recommended that if you are

concerned about blood clots speak

with your GP or Family Planning

clinic to discuss the risks and the full

range of available contraceptive

choices. Every woman needs to be

able to make an informed decision

with her doctor about the risks and

benefits of any method of

contraception. A risk assessment will

be based on personal and family

health history, age, family history of

blood clots and lifestyle factors such

as weight and smoking.

Tell your doctor if you:

plan to have surgery or be in

hospital.

have had recent surgery

have been confined to bed or

immobilized for a prolonged

period of time.

These situations may also increase

the risk of developing a blood clot.

Your doctor may tell you to stop

taking CHELSEA

-35 ED 4 weeks

before surgery or at the time of

immobilisation. Your doctor will

also tell you when you can start

taking CHELSEA

-35 ED again

after you are back on your feet.

If you notice possible signs of

thrombosis, stop taking

CHELSEA

®

-35 ED and consult

your doctor immediately (See 'Side

effects').

The Pill and Cancer

Breast cancer has been diagnosed

slightly more often in women who

use the Pill than in women of the

same age who do not use the Pill.

This slight increase in the numbers of

breast cancer diagnosis gradually

disappears during the course of the

10 years after stopping use of the

Pill. It is not known whether the

difference is caused by the Pill. It

may be that the women were

examined more often, so that breast

cancer was noticed earlier.

Cervical cancer has been reported to

occur more often in women using the

Pill for a long time. This finding

may not be caused by the Pill but

may be related to sexual behaviour

and other factors.

Contact your doctor immediately if

you have severe pain in your

abdomen.

In rare cases benign liver tumours

and even more rarely, malignant liver

tumours have been reported in users

of the Pill. These tumours may lead

to internal bleeding.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Some medicines reduce the

contraceptive effectiveness of

CHELSEA

-35 ED. These include:

certain medicines used in the

treatment of epilepsy, such as

barbiturates, primidone,

phenytoin, topiramate,

oxcarbazepine and

carbamazepine

antibiotics such as ampicillins,

tetracyclines

rifampicin, a medicine used in the

treatment of tuberculosis

griseofulvin, an antifungal

St John's wort, a herbal remedy.

If you are using any of the above

medicines on a short-term basis, use

an additional barrier method of

contraception (such as a condom or

diaphragm) while you are taking it

and for 7 days after finishing the

other medicine.

If you take rifampicin, use additional

contraception for four weeks after

finishing the course of rifampicin.

Your doctor may also advise you to

skip the 7 white placebo tablets.

If you are not sure whether you are

taking any of these medicines,

check with your doctor or

pharmacist.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

CHELSEA

-35 ED.

CHELSEA

-35 ED

How to take this

medicine

Follow all directions given to you

by your doctor and pharmacist

carefully.

If you do not understand the

instructions on the pack, ask your

doctor or pharmacist.

How much to take

Take one tablet each day, with some

water.

How to take it

CHELSEA

-35 ED can be taken

with or without food.

Take your medicine 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.

The CHELSEA

-35 ED pack

contains 28 tablets. On the pack each

tablet is marked with the day of the

week on which it is to be taken. The

ED in the name refers to the "every

day" presentation where 7 white

placebo tablets (also known as non-

active or sugar tablets) are also

included in the pack so that a tablet is

taken each day of the month instead

of having a break.

Take your first tablet from the red

section marked with the

appropriate day of the week, e.g., if

starting on Sunday - select SUN.

Follow the direction of the arrows

on the pack until all 28 tablets have

been taken.

Usually a menstrual period will start

within 2 to 4 days after taking the last

active tablet (i.e. while you are taking

tablets from the last row of your

pack).

Do not leave a gap between packs,

i.e. start taking your next pack on

the day after you have finished the

current one, even if your period

continues.

This means that you will always start

new packs on the same day of the

week, and also that you have your

withdrawal bleed on about the same

days, each month.

Additional contraceptive

methods

When additional contraceptive

methods are required, either do

not have sexual intercourse or use

a barrier method such as a condom

or diaphragm plus spermicide.

Rhythm methods are not advised as

the Pill disrupts the cyclical changes

associated with the natural menstrual

cycle, e.g. changes in temperature

and cervical mucus.

When to start taking it

After a natural cycle

Take the first tablet on the first

day of your period from the red

section of the pack. Additional

contraceptive methods must be

used for the next 14 days.

Switching from another

combined oral contraceptive

Start CHELSEA

®

-35 ED on the

day after the last active tablet from

the previous pill pack has been

taken.

If your present pill pack contains

placebo (sugar) tablets, you should

throw away the placebo tablets and

start CHELSEA

-35 ED on the day

after taking the last active tablet from

your present pack (if you are not sure

which this is, ask your doctor or

pharmacist). This means no tablet

free break. If you follow these

instructions, it is not necessary to use

an additional contraceptive method.

A withdrawal bleed may not occur

until the end of the first pack of

CHELSEA

- 35 ED. This is not

harmful.

Switching from

progestagen-only

contraceptives, e.g. minipill,

implant, injectable or a

progestogen-releasing

intrauterine device (IUD)

CHELSEA

-35 ED may be started

on any day when switching from the

minipill, or on the day when your

implant or IUD is removed or next

injection is due. Additional

contraceptive methods must be used

for the next 14 days.

After having a baby

Your doctor will advise you when it

is best to start CHELSEA

-35 ED. If

you are breastfeeding, you should

discuss this with your doctor first.

Additional contraceptive methods

must be used for the next 14 days.

After a miscarriage or

abortion

Your doctor will advise you.

Additional contraceptive methods

must be used for the first 14 days.

If you forget to take it

If you forget to take CHELSEA

®

-

35 ED, it may not work as well in

protecting you from becoming

pregnant.

Additional contraceptive

methods

When additional contraceptive

methods are required, either do

not have sexual intercourse or use

a barrier method such as a condom

or diaphragm plus spermicide.

If you are less than 12 hours late in

taking a tablet, take the missed

dose as soon as you remember, and

then go back to taking your tablets

as you would normally.

Additional contraceptive measures

are not necessary and contraceptive

protection is not reduced.

If you are more than 12 hours late

in taking an active (yellow) tablet,

take the missed tablet as soon as

you remember, even if this means

taking two tablets at the same time,

then continue to take the next

tablet at the normal time.

CHELSEA

-35 ED

Additional contraceptive methods

must be used for the next 7 days as

there is an increased risk of

becoming pregnant. If the 7 days

include taking any of the white

placebo (non-active) tablets,

discard the non-active tablets and

continue with the small yellow

active tablets of the next pack. You

are unlikely to have a period until

you reach the red section of the

second pack. This is not harmful.

See your doctor if you forget to

take more than one active tablet in

a pack or if you have missed one or

more active tablets within the first

week of the pack.

There is an increased risk of

becoming pregnant. An alternative

method of contraception should be

used until you are sure that you are

not pregnant.

If you have forgotten to take a

white placebo (non-active) tablet,

discard the missed tablet and

continue taking the tablets as you

would normally.

No additional contraceptive

precautions are needed.

If you are not sure what to do or

have any questions, ask your

doctor or pharmacist.

How long to take it for

Keep taking CHELSEA

®

-35 ED

for as long as your doctor tells you

to.

You will probably need to take

CHELSEA

-35 ED for about 6

months before you notice an

improvement in your condition. To

effectively treat your acne and excess

hair you will probably need to take it

for much longer. It is possible that

acne and excess hair may return

when treatment is stopped.

Repeat courses of CHELSEA

ED may be taken, however, it is

recommended that you have a "pill-

free" period.

If you take too much

(overdose)

Immediately telephone your

doctor, or the Poisons Information

Centre (telephone 13 11 26), or go

to Accident and Emergency at the

nearest hospital, if you think you

or anyone else may have taken too

much CHELSEA

®

-35 ED. Do this

even if there are no signs of

discomfort or poisoning.

You may experience nausea,

vomiting and vaginal bleeding.

While you are taking

this medicine

Things you must do

Before starting any new medicine,

tell your doctor or pharmacist that

you are taking CHELSEA

®

-35 ED.

Tell all the doctors, dentists and

pharmacists who are treating you

that you are taking CHELSEA

®

-35

ED.

Stop taking this medicine and tell

your doctor immediately if you fall

pregnant or think you are

pregnant while taking

CHELSEA

®

-35 ED.

Pregnancy must be ruled out before

you continue treatment. In the

meantime, use an alternative method

of contraception.

Tell your doctor if you plan to have

surgery or be immobilized for a

long period of time (eg. leg in

plaster).

Your doctor may advise you stop

taking it during this period.

Avoid excessive sun exposure and

use a SPF 30+ sunscreen if you

have a tendency to develop

chloasma (dark pigments on the

face or skin).

If you need to have any blood or

urine tests, tell your doctor that

you are taking CHELSEA

®

-35 ED.

This medicine may affect the results

of some tests.

Visit your doctor regularly so they

can check on your progress. .

In general, you should have a check-

up once every year, including a Pap

smear, breast examination and blood

pressure check.

Vomiting and Diarrhoea

Advice

If you vomit within 3 to 4 hours of

taking an active yellow tablet,

follow the advice under "If you

forget to take it" section. This is

like missing a tablet.

If you have severe diarrhoea,

please contact your doctor.

Vomiting or diarrhoea while taking

the white placebo tablets do not

reduce contraceptive reliability.

Unexpected bleeding

Like other contraceptive pills,

irregular vaginal bleeding

(spotting or break through

bleeding) may occur for the first

few months. Continue to take your

tablets as you would normally.

Irregular bleeding should stop

once your body adjusts to the pill

(usually after about 3 cycles). If

bleeding continues or becomes

heavy, see your doctor.

Missed period

If you have taken all your tablets

as directed, and you have not

vomited while taking an active pill,

or taken other medicines that

interfere with CHELSEA

®

-35 ED,

then you are very unlikely to be

pregnant. Continue to take

CHELSEA

®

-35 ED as usual.

If you miss your period twice in a

row stop taking CHELSEA

®

-35

ED and tell your doctor

immediately. Pregnancy must be

excluded before you start the next

pack of CHELSEA

®

-35 ED. In the

meantime, use another form of

contraception such as a condom or

diaphragm.

CHELSEA

-35 ED

Things you must not do

Do not use CHELSEA

®

-35 ED to

treat any other conditions unless

your doctor tells you to.

Do not give your medicine to

anyone else, even if they have the

same condition as you.

Possible side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

CHELSEA

®

-35 ED.

Like all other medicines,

CHELSEA

-35 ED may have

unwanted side effects in some

people. Sometimes they are serious,

most of the time they are not. You

may need medical treatment if you

get some of the side effects.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

nausea, vomiting

changes in vaginal secretion

breast tenderness, pain or

secretion

contact lens intolerance

headache, migraine

depressed mood

change in sex drive

fluid retention

change in body weight.

loss of head hair

acne

See your doctor as soon as possible

if you notice any of the following:

a lump in your breast

unusual, heavy vaginal bleeding

sudden increase in facial or body

hair

dark patches of the skin, in

particular the face

yellowing of the skin or eyes

severe diarrhoea.

The above list includes serious side

effects that may require medical

attention. Serious side effects are

rare.

See your doctor immediately or go

to Accident and Emergency at the

nearest hospital if you notice any

signs of a blood clot, heart attack

or stroke:

sudden severe chest pain that may

radiate down your left arm

severe pain and/or swelling in

either leg

sudden breathlessness

sudden onset of coughing

unusual or severe prolonged

headache

sudden partial or complete loss of

eyesight, double vision

dizziness or fainting

weakness or numbness suddenly

affecting any part of the body

problems with speech or

movement

severe stomach pain.

The symptoms above occur very

rarely and can happen whether or not

you are taking the pill. They are,

however, serious and require urgent

medical attention or hospitalisation.

If any of the following allergic

reactions occur, see your doctor

immediately, or go to Accident and

Emergency at the nearest hospital:

swelling of the face, lips, tongue

or throat causing difficulty

breathing

severe itch or rash on the body.

Tell your doctor if you notice

anything that is making you feel

unwell.

This is not a complete list of all

possible side effects. Other side

effects not listed above may also

occur in some people. Some of these

side effects (for example, high blood

pressure) can only be found when

your doctor does tests from time to

time to check your progress.

Storage and disposal

Storage

Keep your 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.

Keep your tablets in the pack until

it is time to take them.

If you take the tablets out of the pack

they will not keep well.

Keep your tablets in a cool dry

place where the temperature stays

below 25°C.

Do not store CHELSEA

®

-35 ED or

any other medicine in the

bathroom or near a sink.

Do not leave CHELSEA

®

-35 ED in

the car or on window sills.

Heat and dampness can destroy some

medicines.

Disposal

If your doctor tells you to stop

taking CHELSEA

®

-35 ED, or your

tablets have passed their expiry

date, ask your pharmacist what to

do with any that are left over.

Product description

What looks like

CHELSEA

-35 ED is available as a

calendar pack and contains 2

different tablets:

21 yellow round active tablets

7 white round placebo tablets.

On the pack each tablet is marked

with a day of the week on which it is

to be taken.

CHELSEA

-35 ED

Ingredients

The yellow active tablets contain two

active ingredients: cyproterone

acetate 2 mg and ethinyloestradiol 35

microgram (µg).

The white placebo tablets contain

lactose. These are also known as

"non-active" or "sugar tablets".

The tablets also contain:

lactose

maize starch

povidone

magnesium stearate

sucrose

macrogol 6000

calcium carbonate

purified talc

glycol montanate

glycerol

titanium dioxide

iron oxide yellow CI77492.

The tablets do not contain gluten,

tartrazine or any other azo dyes.

Australian Registration

Numbers

CHELSEA

-35 ED Tablet (Blister

pack): AUST R 210583

Sponsor

Aspen Pharma Pty Ltd

34-36 Chandos Street

St Leonards NSW 2065

Australia

Distributor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

Australia

CHELSEA and APOTEX are

trademarks of Apotex Pty Ltd

Date of preparation:

Aug 2016.

3-11-2018

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Issues Voluntary Nationwide Recall for one lot of ORTHO-NOVUM 1/35 and two lots of ORTHO-NOVUM 7/7/7 Due to Incorrect Veridate Dispenser Instructions

Janssen Pharmaceuticals, Inc. has initiated a voluntary recall of one lot of ORTHO-NOVUM 1/35 (norethindrone / ethinyl estradiol) Tablets and two lots of ORTHO-NOVUM 7/7/7 (norethindrone / ethinyl estradiol) Tablets to the pharmacy level. The patient information provided inside affected packages of ORTHO-NOVUM does not include the appropriate instructions for the Veridate dispenser.

FDA - U.S. Food and Drug Administration

30-10-2018

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes

FDA takes action to stop the use of lead acetate in hair dyes. FDA will no longer allow lead acetate to be used in certain hair coloring products based on data that demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive.

FDA - U.S. Food and Drug Administration

10-8-2018

FDA approves new vaginal ring for one year of birth control

FDA approves new vaginal ring for one year of birth control

FDA approved Annovera (segesterone acetate and ethinyl estradiol vaginal system), a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year.

FDA - U.S. Food and Drug Administration

29-5-2018

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules

Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal placebo capsules instead of active capsules. As a result of this packaging error, oral contraceptive capsules, that are taken out of sequence, may place the user at risk for contraceptive failure and unintended pregnancy. The reversing of the order may not be apparent to either new users or previous ...

FDA - U.S. Food and Drug Administration

29-5-2018

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan Issues Nationwide Voluntary Recall of TAYTULLA® Softgel Capsules 1mg/20mcg Sample Packs Due to Out of Sequence Capsules

Allergan plc (NYSE:AGN) today issued a voluntary recall in the US market of one lot (Lot# 5620706, Expiry May-2019) of TAYTULLA® (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1mg/20mcg, 6x28 physicians sample pack, indicated for use by women to prevent pregnancy. Allergan recently identified, through a physician report, that four placebo capsules were placed out of order in a sample pack of TAYTULLA. Specifically, the first four days of therapy had four non-hormonal...

FDA - U.S. Food and Drug Administration

15-3-2018

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids

OTTAWA - Health Canada is advising Canadians that it will be conducting a safety review of Fibristal (ulipristal acetate), a medication used to treat uterine fibroids in women. Health Canada's review is a result of Canadian and European reports of serious adverse events affecting the liver.

Health Canada

3-7-2014

More clinical trials to Denmark

More clinical trials to Denmark

The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the Danish Health and Medicines Authority's annual report 2013 on clinical trials of medicines in humans.

Danish Medicines Agency

28-5-2014

More than 10,000 websites shut down in global operation

More than 10,000 websites shut down in global operation

The recent global Operation PANGEA VII resulted in the shutdown of more than 10,000 websites. The operation focused on combating online sale of counterfeit medicines and making consumers aware that they need to take care of themselves when buying medicines online. Globally, the operation led to 237 arrests, some 540,000 parcels were inspected and over 9.4 million units containing potentially life-threatening medicines were seized – worth an estimated value of more than USD 35 million. More than 10,000 we...

Danish Medicines Agency

1-10-2018

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Shire Orphan Therapies GmbH)

EU/3/03/133 (Active substance: Icatibant acetate) - Transfer of orphan designation - Commission Decision (2018)6432 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/054/02/T/01

Europe -DG Health and Food Safety

29-8-2018

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Gedeon Richter Plc.)

Ulipristal Acetate Gedeon Richter (Active substance: Ulipristal Acetate) - Centralised - Authorisation - Commission Decision (2018)5779 of Wed, 29 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/5017

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (IQVIA RDS Ireland Limited)

EU/3/18/2058 (Active substance: 1-(3-methylbutanoyl)-L-aspartyl-L-threonyl-L-histidyl-L-phenylalanyl-L-prolyl-(L-cystinyl-L-isoleucyl-[(N6-(S)-4-carboxy-4-palmitamidobutanoyl)-L-lysinyl]-L-phenylalanyl-L-glutamyl-L-prolyl-L-arginyl-L-serinyl-L-lysinyl-L-glycinyl-L-cystinyl)-L-lysinamide, disulfide, acetate) - Orphan designation - Commission Decision (2018)5730 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/099/18

Europe -DG Health and Food Safety

6-8-2018

Cetrotide (Merck Europe B.V.)

Cetrotide (Merck Europe B.V.)

Cetrotide (Active substance: Cetrorelix (as acetate)) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5373 of Mon, 06 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/233/T/67

Europe -DG Health and Food Safety

12-6-2018

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/17/1834 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl]acetate salt) - Transfer of orphan designation - Commission Decision (2018)3797 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/244/16/T/01

Europe -DG Health and Food Safety

12-6-2018

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Santhera Pharmaceuticals (Deutschland) GmbH)

EU/3/13/1114 (Active substance: Cyclo[L-alanyl-L-seryl-L-isoleucyl-L-prolyl-L-prolyl-L-glutaminyl-L-lysyl-L-tyrosyl-D-prolyl-L-prolyl-(2S)-2-aminodecanoyl-L-alpha-glutamyl-L-threonyl] acetate salt) - Transfer of orphan designation - Commission Decision (2018)3798 of Tue, 12 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/166/12/T/01

Europe -DG Health and Food Safety

29-5-2018

Osurnia (Elanco Europe Ltd)

Osurnia (Elanco Europe Ltd)

Osurnia (Active substance: terbinafine / florfenicol / betamethasone acetate) - Centralised - Yearly update - Commission Decision (2018)3406 of Tue, 29 May 2018

Europe -DG Health and Food Safety

25-5-2018

Jakavi (Novartis Europharm Limited)

Jakavi (Novartis Europharm Limited)

Jakavi (Active substance: ruxolitinib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)3272 of Fri, 25 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2464/T/35

Europe -DG Health and Food Safety

3-5-2018

Perjeta (Roche Registration GmbH)

Perjeta (Roche Registration GmbH)

Perjeta (Active substance: pertuzumab) - Centralised - 2-Monthly update - Commission Decision (2018)2771 of Thu, 03 May 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2547/II/35

Europe -DG Health and Food Safety

17-4-2018

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Mallinckrodt Pharmaceuticals Ireland Limited)

EU/3/11/945 (Active substance: Ornithine phenylacetate) - Transfer of orphan designation - Commission Decision (2018)2355 of Tue, 17 Apr 2018 European Medicines Agency (EMA) procedure number: EMA/OD/105/11/T/03

Europe -DG Health and Food Safety

28-3-2018

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety