ENDOMETRIN PESSARIES progesterone 100mg vaginal tablet blister pack

Main information

  • Trade name:
  • ENDOMETRIN PESSARIES progesterone 100mg vaginal tablet blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ENDOMETRIN PESSARIES progesterone 100mg vaginal tablet blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 189948
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

189948

ENDOMETRIN PESSARIES progesterone 100mg vaginal tablet blister pack

ARTG entry for

Medicine Registered

Sponsor

Ferring Pharmaceuticals Pty Ltd

Postal Address

PO Box 315,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

19/09/2012

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. ENDOMETRIN PESSARIES progesterone 100mg vaginal tablet blister pack

Product Type

Single Medicine Product

Effective date

25/10/2017

Permitted Indications

No Permitted Indications included on Record

Indication Requirements

No Indication Requirements included on Record

Standard Indications

No Standard Indications included on Record

Specific Indications

ENDOMETRIN PESSARIES are indicated for luteal support as part of an Assisted Reproductive Technology (ART) treatment programme for infertile

women.

Warnings

See Product Information and Consumer Medicine Information for this product

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

3 Years

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

21 pessaries with one applicator

(S4) Prescription Only Medicine

Components

1. ENDOMETRIN PESSARIES progesterone 100mg vaginal tablet blister pack

Dosage Form

Pessary, compressed

Route of Administration

Vaginal

Visual Identification

White to off-white convex and oblong tablets debossed with "FPI" on one

side and "100" on the other side. Nominal size approximately 22 mm x 13

Active Ingredients

progesterone

100 mg

Public Summary

Page 1 of

Produced at 22.05.2019 at 08:24:27 AEST

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

© 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 2 of

Produced at 22.05.2019 at 08:24:27 AEST

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: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ENDOMETRIN

®

Pessaries

Progesterone 100 mg

Vaginal Tablets

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Endometrin

Pessaries.

The leaflet 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 using Endometrin

against the benefits they expect it

will have for you.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Endometrin is

used for

Endometrin is provided as a pessary

(or vaginal tablet) that contains the

natural female hormone,

progesterone.

Endometrin is for women who need

extra progesterone while undergoing

treatment in an Assisted

Reproductive Technology (ART)

programme (e.g. IVF).

Progesterone acts on the lining of the

uterus (womb) and it helps you to

become and to stay pregnant when

you are treated for infertility.

Your doctor may have prescribed

Endometrin for another purpose. Ask

your doctor if you have any questions

why this medicine has been

prescribed for you.

Endometrin is available only with a

doctor's prescription.

This medicine is not addictive.

Before you use

Endometrin

When you must not use it

Do not use Endometrin if you have

an allergy to:

any medicine containing

progesterone

any of the ingredients listed at

the end of this leaflet.

Symptoms of an allergic reaction

may include:

skin rash, itching or hives

swelling of the face, lips, tongue

or other parts of the body

shortness of breath, wheezing or

difficulty breathing.

Do not use Endometrin if you have

or have had any of the following

conditions:

unusual vaginal bleeding that has

not been evaluated by your doctor

missed abortion or ectopic

pregnancy (pregnancy outside of

the womb)

severe liver problems

known or suspected cancer of the

breast or genital tract

blood clots in the legs, lungs,

eyes or elsewhere in the body

porphyria disorder (a blood

disease).

Do not use Endometrin if you are

breast-feeding.

If you take this medicine after the

expiry date has passed, it may not

work.

Do not use Endometrin after the

expiry date on the pack has passed.

Do not use Endometrin if the

packaging is torn or shows signs of

tampering or the product does not

look quite right.

If it has expired or is damaged, return

it to your pharmacist or doctor for

disposal.

If you are not sure whether you

should start using Endometrin talk

to your doctor.

Before you start to use it

Tell your doctor or pharmacist if

you have allergies to:

any other medicines

any other substances, such as

foods, preservatives or dyes.

You must tell your doctor or

pharmacist if you have or have had

any of the following problems:

epilepsy

migraine

asthma

heart, liver or kidney disease

diabetes

history of depression.

ENDOMETRIN

PESSARIES

If you have not told your doctor

about any of the above, tell them

before you use Endometrin.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including

medicines that you buy without a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines may affect the way

other medicines work.

Some medicines may interfere with

progesterone if taken at the same

time. These include:

rifampicin

carbamazepine

St John's Wort (herbal product)

ketoconazole.

Endometrin should not be used at

the same time as other vaginal

preparations.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while using

Endometrin.

How to use

Endometrin

How much to use

Your doctor or pharmacist will tell

you how many tablets you need to

use each day.

The usual dosage is one 100 mg

tablet placed directly into the vagina

three times daily starting on the day

of egg retrieval.

Follow all directions given to you

by your doctor carefully.

They may differ from the

information contained in this leaflet.

Endometrin tablets are intended to

be placed directly into the vagina.

An applicator is provided in the pack

to help administer the tablets.

Follow the directions on how to

administer the tablet below:

wash your hands thoroughly with

soap and water

unwrap the applicator and remove

one vaginal tablet from the blister

put one tablet in the space

provided at the end of the

applicator. The tablet should fit

securely and not fall out

the applicator with the tablet may

be inserted into the vagina while

you are standing, sitting, or when

lying on your back with your

knees bent. Gently insert the thin

end of the applicator well into the

vagina

push the plunger to release the

tablet

remove the applicator and rinse it

thoroughly in warm running

water, wipe dry with a soft tissue

and keep the applicator for

subsequent use.

The directions on how to administer

the tablet are also provided with each

pack of Endometrin.

If you do not understand the

instructions, ask your doctor or

pharmacist for help.

How long to use it

The use of Endometrin may be

continued for up to 10 weeks if

pregnancy is confirmed (12 week of

gestation).

If you forget to use it

If it is almost time for your next

dose, skip the dose you missed and

use your next dose when you are

meant to, as usual.

Otherwise, use it as soon as you

remember, and then go back to

using your medicine as you would

normally.

Do not use a double dose to make

up for the dose that you missed.

If you are not sure what to do, talk

to your doctor or pharmacist.

If you have trouble remembering to

use your medicine, ask your

pharmacist for some hints.

If you use too much

(overdose):

Immediately telephone your doctor

or Poisons Information Centre

(telephone 13 11 26), or go to

accident and emergency at your

nearest hospital, if you think that

you or anyone else may have used

too much Endometrin. Do this even

if there are no signs of discomfort

or poisoning.

While you are using

Endometrin

Things you must do

Tell any other doctors or

pharmacists who are treating you

that you are using Endometrin.

If you are about to start taking any

new medicines, tell your doctor or

pharmacist that you are using

Endometrin.

Take special care and tell your doctor

straight away if you experience any

of these symptoms during treatment

or even a few days after the last

dosage:

pains in your calves or chest, a

sudden shortness of breath or

coughing blood indicating

possible clots in the legs, heart or

lungs

severe headache or vomiting,

dizziness, faintness or changes in

vision or speech, weakness or

numbness of an arm or leg

indicating possible clots in the

brain or eye

worsening symptoms of

depression.

Things you must not do

Do not give Endometrin to anyone

else, even if they have the same

condition as you.

Do not use Endometrin to treat any

other complaints unless your

doctor has told you to.

ENDOMETRIN

PESSARIES

Do not stop using Endometrin or

lower the dosage, without checking

with your doctor or pharmacist.

Things to be careful of

Be careful driving or operating

machinery until you know how

Endometrin affects you.

Some people may experience

drowsiness or dizziness. Make sure

you know how you react to

Endometrin before you drive a car,

operate machinery or do anything

else that could be dangerous if you

are dizzy or light-headed. If this

occurs, do not drive.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using

Endometrin.

Endometrin helps most people with

low progesterone levels, 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 treatment if you get some of

the side effects.

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:

headache

vaginal disorders (such as

discomfort, burning sensation,

discharge, dryness and bleeding)

uterine cramping

abdominal pain or bloating

(swelling)

nausea.

The above list includes the more

common side effects of your

medicine. They are usually mild and

short-lived.

Tell your doctor as soon as possible

if you notice any of the following:

dizziness

insomnia

diarrhoea

constipation

urticaria (allergic rash)

rash

vaginal disorders (e.g. vaginal

discomfort, burning sensation,

discharge, dryness and bleeding)

fungal infections in the vagina

(e.g. vaginal thrush)

breast disorders (e.g. breast pain,

breast swelling and breast

tenderness)

itching in the genital area

swelling of the limbs.

The above list includes serious side

effects which may require medical

attention. Serious side effects are

rare.

Other side effects not listed above

may also occur in some patients. Tell

your doctor if you notice anything

that is making you feel unwell.

Ask your doctor or pharmacist if

you do not understand anything in

this list.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

After using

Endometrin

Storage

Keep this medicine in its original

packaging until it is time to use

them.

Keep this medicine in a cool dry

place where the temperature stays

below 25°C.

Do not store it or any other

medicine in the bathroom or near a

sink.

Do not leave it in the car or on

window sills.

Keep it 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

using this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that are left over.

Product description

What it looks like

Endometrin Pessaries are white to

off-white, flat and oval tablets with

the inscriptions "FPI" on one side

and "100" on the other side.

Endometrin Pessaries are supplied in

blister strips packaged in an outer

carton. Each carton contains 21

tablets and one vaginal applicator.

Ingredients

Active ingredient:

progesterone.

Inactive ingredients:

colloidal anhydrous silica

lactose

pregelatinised maize starch

povidone

adipic acid

sodium bicarbonate

sodium lauryl sulphate

magnesium stearate.

Sponsor

Endometrin Pessaries are supplied in

Australia by:

Ferring Pharmaceuticals Pty Ltd

Suite 2, Level 1, Building 1,

20 Bridge Street

Pymble, NSW 2073

This leaflet was prepared in August

2012.

Endometrin Pessaries 100 mg

AUST R 189948

ENDOMETRIN

PESSARIES