Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Cyclogest?
Cyclogest contains the active ingredient progesterone. Cyclogest is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme.
For more information, see Section 1 Why am I using Cyclogest? in the full CMI.
2. What should I know before I use Cyclogest?
Do not use if you have ever had an allergic reaction to Cyclogest or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2 What should I know before I use Cyclogest? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Cyclogest and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI
4. How do I use Cyclogest?
A 400 mg pessary is administered vaginally twice a day.
More instructions can be found in Section 4 How do I use Cyclogest? in the full CMI
5. What should I know while using Cyclogest?
Things you should do |
|
Things you should not do |
|
Driving or using machines | Do not drive or use machines if you feel dizzy after using Cyclogest. |
Drinking alcohol | Tell your doctor if you drink alcohol |
Looking after your medicine | Store Cyclogest in a cool, dry place where the temperature is below 25°C. |
For more information, see Section 5 What should I know while using Cyclogest? in the full CMI.
6. Are there any side effects?
The most common side effects are fatigue and drowsiness, hot flushes, swelling or pain in your abdomen, constipation and breast pain. Serious side effects include allergic reactions.
For more information, including what to do if you have any side effects, see Section 6 Are there any side effects? in the full CMI.
CYCLOGEST®
Active ingredient(s): progesterone
Consumer Medicine Information (CMI)
This leaflet provides important information about using Cyclogest. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Cyclogest.
Where to find information in this leaflet:
1. Why am I using Cyclogest?
2. What should I know before I use Cyclogest?
3. What if I am taking other medicines?
4. How do I use Cyclogest?
5. What should I know while using Cyclogest?
6. Are there any side effects?
7. Product details
1. Why am I using Cyclogest?
Cyclogest contains the active ingredient progesterone. Progesterone is a natural, female sex hormone, produced in the body. Progesterone is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme.
Progesterone acts on the lining of the womb and it helps you to become and to stay pregnant when you are treated for infertility.
2. What should I know before I use Cyclogest?
Warnings
Do not use Cyclogest if you:
- are allergic to progesterone or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine. - have unusual vaginal bleeding that has not been evaluated by your doctor.
- have a known or suspected tumour that is hormone sensitive.
- have porphyria disorders (a group of inherited or acquired disorders of certain enzymes).
- have or have had blood clots in the legs, lungs, eyes or elsewhere in your body.
- currently have or have had severe liver problems.
- have had a miscarriage and your physician suspects some tissue is still in the uterus or have had a pregnancy outside of the womb.
Check with your doctor if you:
- have any other medical conditions
- take any medicines for any other condition
- have or have had:
– Depression
– Liver problems
– Epilepsy
– Migraine
– Asthma
– Cardiac or renal dysfunction
– Diabetes.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6 Are there any side effects?
Pregnancy and breastfeeding
Cyclogest can be used during the first trimester of pregnancy for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) programme.
The risks of congenital (conditions present at birth) anomalies, including genital abnormalities in male or female infants, from exposure to exogenous progesterone during pregnancy have not been fully established.
Do not use Cyclogest if you are breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Cyclogest and affect how it works.
The list of medicines may decrease the effectiveness of Cyclogest:
- Carbamazine (used to prevent fits, treat certain types of pain or mood disorders)
- Rifampicin (to treat infections)
- Phenytoin (to prevent fits or treat certain types of pain)
Ketoconazole may increase the effectiveness of Cyclogest.
Use of other vaginal products should be avoided during use of Cyclogest.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Cyclogest.
4. How do I use Cyclogest?
How much to use
- Each dose is one pessary.
When to use Cyclogest
- Cyclogest should be used twice a day. Start using the medicine on the day of egg retrieval. If pregnancy is confirmed, continue using Cyclogest for 38 days from the start of therapy or as recommended by your doctor. If pregnancy has not occured, the administration of Cyclogest should be discontinued.
How to use Cyclogest
- Cyclogest is inserted into your vagina
- Always wash your hands throrougly before inserting
- To insert the pessary into the vagina, place the pessary between the lips of the vagina and push the pessary upwards and backwards. You may find it easier to do this if you are lying down or squatting.
- Throw away any used material and wash your hands thoroughly.
If you forget to use Cyclogest
If you forget to insert a pessary at the usual time, do so as soon as you remember.
If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to.
Do not use a double dose to make up for the dose you missed.
If you use too much Cyclogest
If you (or someone else) has accidentally swallowed any of the pessaries or you use too many, you may need urgent medical attention.
- You should immediately:
- phone the Poisons Information Centre
- (by calling 13 11 26), or
- contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Cyclogest?
Things you should do
Call your doctor straight away if you:
- experience any of the side effects listed below and they worry you.
Remind any doctor, dentist or pharmacist you visit that you are using Cyclogest.
Things you should not do
- Do not stop using Cyclogest suddenly
Ask your doctor or pharmacist for advice if you intend to stop or have stopped using Cyclogest. Stopping the medicine suddenly may cause increased anxiety, moodiness and increased chance of seizures.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Cyclogest affects you.
Cyclogest may cause dizziness in some people. If you feel dizzy you should not drive or use machines until you feel better.
Drinking alcohol
Tell your doctor if you drink alcohol.
Looking after your medicine
Store Cyclogest below 25°C
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date located on the carton. The expiry date refers to the last day of that month.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
General
Gastrointestinal
Pain
Renal
Vaginal
|
Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
General
Pain
Gastrointestinal
Reproductive
Bleeding-related
|
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor’s prescription.
What Cyclogest contains
Active ingredient (main ingredient) |
Progesterone |
Other ingredients (inactive ingredients) |
Hard fat |
Do not take this medicine if you are allergic to any of these ingredients.
What Cyclogest looks like
Cyclogest is an off-white, torpedo-shaped pessary containing 400 mg of the active ingredient progesterone.
It is supplied in strip packs of 15 pessaries.
The Australian registration number is AUST R 348691
Who distributes Cyclogest
Cyclogest is supplied in Australia by:
Gedeon Richter Australia Pty Ltd
Suite 902/15 Blue Street
North Sydney NSW 2060
AUSTRALIA
Phone: 1300 GEDEON (1300 433 366)
Cyclogest is supplied in New Zealand by:
Pharmacy Retailing (NZ) t/a Healthcare Logistics
58 Richard Pearse Drive
Airport Oaks Mangere, Auckland
NEW ZEALAND
Phone: 0800 GEDEON (0800 433 366)
This leaflet was prepared in July 2023.
Published by MIMS October 2023