PROMETRIUM 100 and 200 mg

Progesterone (micronised) 100 and 200 mg, soft capsule 
(For oral use)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Prometrium.

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 taking Prometrium against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Prometrium is used for

Prometrium is provided as a soft capsule that contains the natural female hormone, progesterone for oral use.

Prometrium is for women for the treatment of menstrual abnormalities or secondary amenorrhoea (no menstrual periods) and as hormone replacement therapy (HRT) in combination with oestrogen in postmenopausal women with an intact uterus (womb).

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

Prometrium is available only with a doctor’s prescription.

This medicine is not addictive.

This medicine is not a contraceptive.

Before you take Prometrium

When you must not take it

Do not take Prometrium 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 take Prometrium if you have or have had any of the following conditions:

  • unusual vaginal bleeding that has not been evaluated by your doctor
  • 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).

Do not take Prometrium if you are pregnant or intend to become pregnant. If you get pregnant while taking Prometrium, stop taking it straight away and tell your doctor.

Do not take Prometrium if you are breast-feeding.

Do not give Prometrium to a child of any age.

Do not take Prometrium after the expiry date printed on the pack.

Do not take Prometrium if the packaging is torn, shows signs of tampering, or if the product does not look quite right. If it has expired or if the packaging is damaged, return it to your pharmacist or doctor for disposal.

If you are not sure whether you should start taking Prometrium talk to your doctor.

Before you start to take it

Before starting or recommencing progesterone therapy, a physical examination should have been performed including special attention to the breasts, abdomen and pelvic organs.

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
  • high blood pressure
  • asthma
  • heart, liver or kidney disease
  • diabetes
  • skin sensitive to light
  • history of depression.

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