ORIPRO®

Progesterone 100mg, 200mg pessaries

Consumer Medicine Information
What is in this leaflet • a history of hormone associated • Disturbed cholesterol or lipid
thrombophlebitis or thrombo-embolic metabolism (hyperlipidemia) as
This leaflet answers some common questions disorder, progesterone may increase Low Density
about Oripro. Lipoproteins (LDL) and lower High
• liver dysfunction or disease
It does not contain all the available Density Lipoproteins (HDL) levels and
• malignancy or tumours, known or
information. worsen problems in controlling
suspected of breast or genital organs
It does not take the place of talking to your hyperlipidemia.
• pregnancy (when normal progesterone
doctor or pharmacist. • Active inflammation of a vein usually
levels are present)
All medicines have risks and benefits. Your with a clot (thrombophlebitis) or clotting
• missed abortion (thrombo-embolic) disorders or a history
doctor or pharmacist has weighed the risks of
you taking Oripro against the benefits they Do not use Oripro if you are pregnant and of hormone associated thrombophlebitis
expect it will have for you. have normal progesterone levels unless or thrombo-embolic disorders.
your doctor tells you to: Tell your doctor is you have any risk
If you have any concerns about taking this
Progesterone is not recommended for use in factors for preterm labor such as:
medicine, ask your doctor or pharmacist.
normal pregnancy unless your doctor
Keep this leaflet with the medicine. • pre-existing or gestational diabetes
prescribes it from your second trimester to
You may need to read it again. prevent preterm labour. • pre-existing conditions such as hepatitis
C, human papilloma virus and
Where progesterone levels are insufficient or
What Oripro is used for low and you and your doctor have discussed hyperthyroidism
Oripro is specially made to insert in your the risks and benefits involved, as in assisted • have a history of gynaecological
vagina. They contain a female hormone reproductive procedures, Oripro is used to conditions
called progesterone. support embryo implantation, to instigate and • vaginal infections and/or bleeding from
Oripro can be given to women undergoing maintain initial pregnancy. No adverse the vagina
fertility treatment. Progesterone is a hormone effects have been reported when used in this • smoke
essential for maintaining pregnancy. If you manner.
• drink alcohol
are having fertility treatment and your doctor Do not use Oripro if you are breast-
• overweight or obese
has determined your body does not produce feeding or plan to breast-feed:
Progesterone passes into the breast milk in • exposure to certain environmental
enough progesterone they may prescribe
variable amounts and may affect the quantity pollutants
Oripro.
of breast milk. The effect of the progesterone Safety and efficacy of Oripro in women with
The progesterone will help prepare your
on the breast feeding infant is not known. these risk factors have not been established.
uterus to receive and maintain a fertilized
egg. Once pregnancy occurs, Oripro may be Do not give or use Oripro to a child of any Tell your doctor or pharmacist if you are
used until production of progesterone by the age. pregnant or intend to become pregnant:
placenta is adequate. The safety and effectiveness of progesterone Your doctor or pharmacist will discuss the
use in children has not been established. possible risks and benefits of using Oripro
Your doctor may prescribe Oripro 200 mg
Do not use Oripro after the expiry date during pregnancy.
from the second trimester of your pregnancy,
to prevent you going into labour too early. printed on the pack. Tell your doctor or pharmacist if you are
Oripro will not be prescribed to prevent early Do not use Oripro if the packaging is breast-feeding or plan to breast-feed.
labour if you are expecting more than one damaged or shows signs of tampering or Oripro is not recommended while you are
baby. the product does not look quite right. breast-feeding. If there is a need to consider
If it has expired or is damaged, return it to Oripro while you are breast-feeding, your
Oripro is not addictive.
your pharmacist for disposal. doctor or pharmacist will discuss with you
This medicine is available only with a the benefits and risks of using them.
doctor’s prescription. If you are not sure whether you should
Progesterone passes into the breast milk in
Oripro is not recommended in children, as start using Oripro, talk to your doctor or
variable amounts and may affect the quantity
the safety and effectiveness of progesterone pharmacist.
of breast milk. The effect of the progesterone
in this age group has not been established. Before you start to use Oripro: on the breast feeding infant is not known.
Before starting or recommencing If you have not told your doctor or
Before you use Oripro progesterone therapy, a physical examination pharmacist about any of the above, tell
should have been performed, including them before you start using Oripro.
When you must not use Oripro:
special attention to the breasts, abdomen and Taking other medicine:
Do not use Oripro if you have an allergy to pelvic organs and a Papanicolaou (Pap)
progesterone or any of the ingredients smear. Tell your doctor or pharmacist if you are
listed at the end of this leaflet. taking/using any other medicines,
Tell your doctor or pharmacist if you have
Symptoms of an allergic reaction to including any that you buy without
allergies to:
progesterone may include: prescription from your pharmacy,
• any other medicines supermarket or health food shop.
• shortness of breath, wheezing or
• any other substances, such as foods, Some medicines and progesterone may
difficulty breathing
preservatives or dyes interfere with each other. These include:
• swelling of the face, lips, tongue or other
Tell your doctor if you have or have had • Carbamazepine, Phenobarbital, and
parts of the body
any medical conditions, especially the Phenytoin (medicines for epilepsy).
• skin rash, itching or hives following:
• Rifabutin, Rifampicin.
Do not use Oripro if you have or have had • Conditions that might be made worse by
any of the following medical conditions: • Aminoglutethimide.
a buildup of fluid (fluid retention), for
• undiagnosed vaginal bleeding example; asthma, seizure disorders These medicines may be affected by Oripro
(epilepsy), migraine, or cardiac or renal or may affect how well they work. You may
• undiagnosed urinary tract bleeding
dysfunction. need different amounts of your medicine, or
• active blood clotting (thrombophlebitis you may need to use different medicines.
or thrombo-embolic disorder), such as, • History of mental depression; stop use if Your doctor or pharmacist will advise you.
inflammation of a vein, deep vein blood serious depression recurs during therapy.
Use of other vaginal products should be
clotting (thrombosis), or a blood clot that • Diabetes as high doses of progesterone avoided during use of Oripro.
travelled to the lungs (pulmonary therapy can lower glucose tolerance in
embolism) some patients Your doctor and pharmacist may have more
information on medicines to be careful with
• History of liver disease or dysfunction as or avoid while using Oripro.
progesterone is metabolised in the liver.

ORIPRO®
Published by MIMS January 2020 1
How to use Oripro What to do if someone has • Acne, breast pain or tenderness, hot
swallowed some pessaries flushes.
Your doctor or pharmacist will tell you
accidentally. • Mild mood changes, nervousness,
how many pessaries you need to use each
If someone has swallowed some pessaries, changes in libido, and insomnia.
day.
there is no need for great concern. However, • Increased blood pressure in susceptible
Oripro is intended to be inserted into the
you should consult your doctor. Symptoms individuals.
vagina.
that may arise are euphoria, or nausea, • Loss or gain of body facial or scalp hair
Follow these steps to use a pessary: vomiting or dysmenorrhoea may develop. No or brown spots on exposed skin
1. Wash your hands thoroughly with soap specific antidote is known. Symptomatic and (melasma).
and water. supportive treatment can be given if These are the more common side effects of
2. Feel the pessary while it is still in the necessary. Oripro. (Mostly these are mild and short
wrapper. If it feels soft, keep it in the lived).
wrapper and chill it in the fridge for a While you are using Oripro Tell your doctor as soon as possible if you
few minutes. Do not remove the wrapper
Things you must do: notice any of the following:
while you are chilling it.
Tell any other doctors, dentists, and • Abnormal breakthrough uterine and/or
3. Put on a disposable glove, if desired.
pharmacists who are treating you that you vaginal bleeding or, spotting, or changes
These are available from pharmacies.
are using Oripro. in cervical secretions.
4. Remove wrapper from one pessary.
If you are about to be started on any new • Headache, dizziness, and drowsiness.
5. If you are particularly dry and insertion
medicine, tell you doctor, dentist or • Loss of menstruation (amenorrhoea).
feels uncomfortable you may need to
pharmacist that you are using Oripro. • Dry mouth, frequent urination, loss of
moisten the pessary by dipping it briefly
in cool water, before insertion. Either If you plan to have surgery that needs a appetite, and unusual thirst (diabetes,
using a squatting position or lying on general anaesthetic, tell your doctor or hyperglycaemia).
your back or side, insert the pessary dentist that you are using Oripro. • Mental depression.
deep into the vagina. If you become pregnant while using • Skin rash, itchiness (pruritus).
6. Depending on dosage, the best time for a Oripro, tell your doctor or pharmacist. These may be serious side effects. You may
pessary to be inserted may be before Things you must not do: need medical attention. (Serious side effects
retiring at night. But if more than one Do not give Oripro to anyone else, even if are rare).
dose is necessary, a second dose could they have the same conditions as you. If any of the following happen, stop using
be inserted in the morning. Oripro, and tell your doctor immediately
Do not use Oripro to treat any other
7. Throw away any used materials and complaints unless your doctor or or go to Accident and Emergency at your
wash your hands thoroughly. pharmacist tells you to. nearest hospital:
If you are not sure how to use a pessary, Do not stop using Oripro, or lower the • Migraine.
ask your doctor or pharmacist. dosage, without checking with your doctor • Loss of or change of speech,
When to use Oripro: or pharmacist. coordination or vision, pain or numbness
When undergoing fertility treatment: Use Things to be careful of: in chest, arm or leg; unexplained
Oripro at the same time each day as directed shortness of breath, any symptoms of
Be careful driving or operating machinery
by your doctor. blood clots (thrombosis).
until you know how Oripro affects you.
For the prevention of preterm labour: Use • Yellowing of skin or eyes (jaundice).
Oripro may cause dizziness or drowsiness in
Oripro 200 mg pessaries each night before some people. Make sure you know how you These are very serious side effects. You may
bed. react to Oripro before you drive a car, need urgent medical attention or
How long to use Oripro: operate machinery, or do anything else that hospitalisation. (These side effects are very
could be dangerous if you are dizzy or light- rare).
Do not stop using Oripro unless your
doctor or pharmacist tells you to. headed. If this occurs do not drive. If you Other side effects not listed above may
drink alcohol, dizziness or light-headedness occur in some patients. Tell your doctor or
If you forget to use Oripro: may be worse. pharmacist if you notice anything that is
If it is almost time for your next dose, making you feel unwell.
(within 4 hours), skip the dose you missed Side effects
and use your next dose when you are After using Oripro
meant to, as usual. Tell your doctor or pharmacist as soon as
Otherwise, use it as soon as you
possible if you do not feel well while you Storage
are using Oripro. Keep your pessaries in their original
remember, and then go back to using your
medicine as you would normally. Oripro helps most women with progesterone packaging until it is time to use them.
insufficiency, but it may have unwanted side If you take pessaries out of the packaging
Do not use a double dose to make up for
effects in a few women. All medicines can they will not keep well.
the dose that you missed.
have side effects. Sometimes they are Keep your pessaries in a cool dry place
This may increase the chance of you getting
serious, most of the time they are not. You where the temperature stays below 25°C.
unwanted side effects.
may need medical treatment if you get some
If you are not sure what to do, ask your Do not store Oripro or any other medicine
side effects.
doctor or pharmacist. in the bathroom or near a sink.
Ask your doctor or pharmacist to answer
If you have trouble remembering to use Do not leave Oripro on a window sill or in
any questions you may have.
your medicine, ask your pharmacist for the car on hot days.
Following is a list of possible side effects. Heat and dampness can destroy some
some hints.
Do not be alarmed by this list. medicines.
If you use too many pessaries You may not experience any of them.
(overdose): Keep Oripro where children cannot reach
Tell your doctor or pharmacist if you them.
Immediately telephone your doctor or notice any of the following and they worry A locked cupboard at least one-and-a-half
pharmacist or the Poisons Information you: metres above the ground is a good place to
Centre (telephone 13 11 26), or go to • Local irritation or itching may occur in store medicines.
Accident and Emergency at the nearest sensitive persons, at the site of insertion
hospital, if you think that you or anyone Disposal
when treatment is started.
else may have used too many pessaries. If your doctor or pharmacist tells you to
• Abdominal cramping, bloating, swelling stop using Oripro or they have passed
Symptoms of an overdose with Oripro face, ankles and feet (oedema).
include the side effects listed below in the their expiry date, ask your pharmacist
• Unusual tiredness, or weakness or what to do with any that are left over.
‘Side Effects’ section, but are usually of a
weight gain.
more severe nature.
• Nausea and vomiting.

ORIPRO®
Published by MIMS January 2020 2
Product Description
What it looks like
Opaque, bullet-shaped waxy, solid masses,
containing 100mg or 200mg progesterone
supplied either as blisters in a unit carton or
individual pessaries in a glass jar (not
marketed).
Pack size: 5 (strip pack only - samples) 15 or
30.
Ingredients
Active ingredient:
• 100mg or 200mg of progesterone.
Other ingredients:
• hard fat.
Manufacturer/Distributor
Orion Laboratories Pty Ltd T/A Perrigo
Australia
25-29 Delawney Street
Balcatta WA 6021
ARTG Numbers:
AUST R 21190, AUST R 21195, AUST R
165111 and AUST R 165112.
This leaflet was prepared in June 2019.

ORIPRO®
Published by MIMS January 2020 3