Consumer medicine information

Intrarosa 6.5 mg Pessaries

Prasterone

BRAND INFORMATION

Brand name

Intrarosa

Active ingredient

Prasterone

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Intrarosa 6.5 mg Pessaries.

1. Why am I using Intrarosa?


Intrarosa contains the active ingredient prasterone. Intrarosa is used to treat vulvar and vaginal atrophy in postmenopausal women with moderate to severe symptoms.
For more information, see Section 1. Why am I using Intrarosa? in the full CMI.

2. What should I know before I use Intrarosa?


Do not use if you have ever had an allergic reaction to Intrarosa or any of the ingredients listed at the end of the CMI or if you have or have had any of the conditions listed in Section 2. What should I know before I use Intrarosa?.
Talk to your doctor before you use Intrarosa 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 Intrarosa? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Intrarosa 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 Intrarosa?

  • One pessary once a day at bedtime.
  • You place it in your vagina with the provided applicator, or with your fingers. Do not use any other applicator.

More instructions can be found in Section 4. How do I use Intrarosa? in the full CMI.

5. What should I know while using Intrarosa?

Things you should do
  • Remind any doctor, dentist, or pharmacist you visit that you are using Intrarosa.
  • Go for regular Pap tests, gynaecological and breast exams. Do this as per your healthcare professional's directions.
  • If you become pregnant, stop taking Intrarosa. Talk with your healthcare professional.
Things you should not do
  • Do not stop using this medicine without telling your doctor.
  • Do not change the dose unless your doctor tells you to.
  • Do not use this medicine if you have vaginal bleeding that has not been diagnosed.
  • Do not use this medicine if you still have periods. This drug is for postmenopausal women only.
Driving or using machines
  • No effects on ability to drive and use machines have been observed.
Drinking alcohol
  • There is no potential interaction with alcohol.
Looking after your medicine
  • Store Intrarosa in a cool, dry place, out of direct light where the temperature is below 30°C. Do not freeze.
  • Keep Intrarosa in the original packaging, in a safe place, away from children.

For more information, see Section 5. What should I know while using Intrarosa? in the full CMI.

6. Are there any side effects?


The most common side effect is vaginal discharge. A change in your breast exam or Pap test results can occur while you take Intrarosa. Your healthcare professional will decide when to perform breast exams and Pap tests and will interpret the results.
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.

BRAND INFORMATION

Brand name

Intrarosa

Active ingredient

Prasterone

Schedule

S4

 

1 Name of Medicine

Prasterone.

2 Qualitative and Quantitative Composition

Each pessary contains 6.5 mg of prasterone in hard fat.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Intrarosa is a white to off-white, bullet-shaped pessary, approximately 28 mm long and 9 mm in diameter at its widest end.

4 Clinical Particulars

4.9 Overdose

No experience of overdosage is available. In the event of overdose, vaginal douching is recommended.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Prasterone was not genotoxic in an in vitro bacterial mutagenicity assay (Ames test), an in vitro chromosomal aberration assay (performed in human lymphocytes) or in vitro in the mouse bone marrow micronucleus test.
Carcinogenicity. Long-term studies in animals to determine carcinogenic potential have not been performed with prasterone. Oestradiol and testosterone, two metabolites of prasterone, are carcinogenic in animals.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical name: 3β-hydroxyandrost-5-en-17-one, 5-androstene-3β -ol-17-one.
Molecular formula and molecular mass: C19H28O2 (288.43 g/mol).
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSINTRAR.gif CAS number. 53-43-0.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (Schedule 4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/INTRARST.gif