This salt alternative could help reduce blood pressure. So why are so few people usingit?

Active ingredient(s): Progesterone (micronised)

Consumer Medicine Information (CMI)

This leaflet provides important information about using UTROGESTAN. 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 UTROGESTAN.

Where to find information in this leaflet:

1. Why am I using UTROGESTAN?
2. What should I know before I use UTROGESTAN?
3. What if I am taking other medicines?
4. How do I use UTROGESTAN?
5. What should I know while using UTROGESTAN?
6. Are there any side effects?
7. Product details

1. Why am I using UTROGESTAN?

UTROGESTAN contains the active ingredient micronised progesterone. UTROGESTAN is provided as a soft capsule to be inserted deep into the vagina and contains the natural female hormone progesterone. Progesterone is a hormone essential for maintaining pregnancy.

UTROGESTAN is used for:

• Women who need extra progesterone while undergoing fertility treatment (e.g. ART)
  If you are having fertility treatment and your doctor has determined your body does not produce enough progesterone your doctor may prescribed UTROGESTAN.
  The progesterone will help prepare your uterus (womb) to receive and maintain a fertilised egg.
  Once pregnancy occurs UTROGESTAN may be used until production of progesterone by the placenta is adequate.
• Prevention of preterm birth in women with singleton pregnancy who have a short cervix (midtrimester sonographic cervix ≤ 25 mm) and/or a history of spontaneous preterm birth.
  There is limited evidence supporting the use of progesterone with twin/multiple pregnancies.
  There is insufficient evidence to recommend the use of progesterone in women with preterm labour or ‘other’ risk factors for preterm birth.
• Reducing the risk of miscarriage in women with bleeding in the current pregnancy and a history of three or more previous miscarriages.
  The benefit of this medicine was shown to be limited to women who have had three or more previous miscarriages. However, your doctor may consider it appropriate to use in women with less than three miscarriages, who have a reduced chance of future pregnancy.
  Other known causes of potential miscarriage should be ruled out before starting treatment.

Your doctor may have prescribed UTROGESTAN for another purpose. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before I use UTROGESTAN?

Always check the ingredients to make sure you can use this medicine.

Do not use UTROGESTAN if:

• you are allergic to progesterone, or any of the ingredients listed at the end of this leaflet.
• you have or have had any of the following conditions:
  – Unusual vaginal bleeding that has not been evaluated by your doctors;
  – Known missed abortions or ectopic pregnancy;
  – Severe liver problems;
  – Known or suspected cancer of the breast or genital tract;
  – Blood clots (thrombophlebitis or thromboembolic disorder), such as inflammation of a vein, deep vein blood clotting (thrombosis) or a blood clot that travelled to the lungs (pulmonary embolism);
  – Bleeding on the brain;
  – Porphyria disorder (a blood disease).

Warnings

Check with your doctor if you:

• have or have had any medical conditions, especially the following:
  – Epilepsy
  – Migraine
  – High blood pressure
  – Asthma
  – Heart, liver or kidney diseases
  – Diabetes
  – History of depression
• Tell your doctor or pharmacist if you have allergies to:
  – Any other medicines
  – Soya (UTROGESTAN contains soya lecithin which may cause hypersensitivity reactions)
  – Any other substances, such as foods, preservatives or dyes

If you have not told your doctor or pharmacist about any of the above, tell them before you use UTROGESTAN.

• If you think you have miscarried, you should speak to your doctor as you will need to stop using UTROGESTAN.

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?

UTROGESTAN is not suitable for use as a contraceptive.

Pregnancy and breastfeeding

During fertility treatment UTROGESTAN should only be used during the first three months of pregnancy, unless your doctor has recommended otherwise.

For treatment to reduce the risk of miscarriage in women with bleeding in the current pregnancy UTROGESTAN should be initiated at the first sign of vaginal bleeding during the first trimester and should continue at least until the 16th week of pregnancy.

For the prevention of preterm birth UTROGESTAN may be prescribed by your Doctor during the second trimester (16 – 24 weeks gestation) and should be continued to the end of the 36th week of your pregnancy or until delivery.

Do not use UTROGESTAN if you are breast-feeding.

Children and adolescents

Do not give UTROGESTAN to a child of any age. UTROGESTAN has not been evaluated in adolescents with childbearing potential.

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 UTROGESTAN and affect how it works or how these medicines work. These include:

• Carbamazepine, Phenobarbital and Phenytoin (medicines for epilepsy)
• Rifampicin
• Phenylbutazone
• Spironolactone
• Griseofulvin
• Some antibiotics including Ampicillins and Tetracyclines
• Bromocriptine
• Cyclosporin
• Ketoconazole

These medicines may be affected by UTROGESTAN or may affect how well they work. You may need different amounts of your medicine or you may need to use different medicines. Your doctor or pharmacist will advise you.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect UTROGESTAN.

4. How do I use UTROGESTAN?

How much to use

Your doctor will tell you how many capsules you need to use each day.

• For supplementation during Assisted Reproductive Technology, the recommended dosage is 600 mg/day, in three divided doses from the day of embryo transfer until at least the 7th week of pregnancy and not later than the 12th week of pregnancy.
• For treatment to reduce the risk of miscarriage in women with bleeding in the current pregnancy, the usual dose is 400 mg twice daily from the first sign of vaginal bleeding until at least the 16th week of pregnancy.
• For the prevention of preterm birth the usual dose is 200 mg/day recommended at bedtime, during the second trimester (16-24 weeks gestation) and should be continued until the end of the 36th week of your pregnancy or until delivery.

When to take / use UTROGESTAN

• UTROGESTAN is intended to be inserted into the vagina.
• Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.
• Do not stop using UTROGESTAN or lower the dosage without checking with your doctor.
• UTROGESTAN should not be used at the same time as other vaginal preparations.

If you forget to use UTROGESTAN

UTROGESTAN should be used as instructed by your doctor for the recommended timeframes for each use.

If you miss a dose, use it as soon as you remember, and then go back to using your medicine as you would normally.

If it is almost time for your next dose, skip the dose you missed and go back to using your medicine when you are meant to.

Do not use a double dose to make up for the dose you missed.

If you use too much UTROGESTAN

If you think that you or anyone else may have used too much UTROGESTAN, 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.

Symptoms of an overdose with UTROGESTAN include feeling dizzy or feeling tired.

5. What should I know while using UTROGESTAN?

UTROGESTAN contains soya lecithin. If you are allergic to soya do not use UTROGESTAN.

Things you should do

Call your doctor straight away if you:

• Experience swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing
• Hives

You may have had a very serious reaction to UTROGESTAN and may need urgent medical attention or hospitalization.

Remind any doctor, dentist or pharmacist you visit that you are using UTROGESTAN.

Things you should not do

• Do not stop using this medicine or lower the dosage without checking with your doctor or pharmacist.
• UTROGESTAN should not be used at the same time as other vaginal preparations.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how UTROGESTAN affects you.

UTROGESTAN may cause drowsiness or dizziness in some people. Make sure you know how you react to UTROGESTAN 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.

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may increase the effect of UTROGESTAN.

Looking after your medicine

Store below 30°C. Do not refrigerate.

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.

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

Serious side effects

Systemic side effects of tiredness and dizziness observed with the oral form have not been reported at the recommended dosages for vaginal use.

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. This medicine is not addictive.

What UTROGESTAN contains

Do not take this medicine if you are allergic to any of these ingredients.

What UTROGESTAN looks like

UTROGESTAN 200 is an ovoid, slightly yellow soft capsule, containing a whitish oily suspension.

UTROGESTAN 200 is supplied in blister strips packaged in an outer carton. Each carton contains 7 (trade or starter pack), 14, 15, 21, 28, 30, 42, 45, 56, 84 or 90* capsules.

* Not all pack sizes may be marketed

AUST R 232824

Who distributes UTROGESTAN

Besins Healthcare Australia Pty Ltd
Level 16, Tower 2, Darling Park,
201 Sussex Street,
Sydney NSW 2000

This leaflet was prepared in February 2022.

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