Prometrium 400mg soft vaginal capsules

Use this medicine exactly as described in this package leaflet or as your doctor, pharmacist or nurse have instructed.

• Keep this leaflet. You may need to read it again.
• If you have questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you notice any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Prometrium is and what it is used for
2. What you need to know before you use Prometrium
3. How to use Prometrium
4. Possible side effects
5. How to store Prometrium
6. Contents of the pack and other information

Prometrium can be used to help pregnancy.

To help pregnancy

Prometrium can be used to help women reduce the risk of miscarriage in women with bleeding in the current pregnancy and a history of recurrent miscarriages.

• if you are allergic (hypersensitive) to soya or peanuts
• if you are allergic to progesterone or any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems
• if you have yellowing of the skin or eyes (jaundice)
• if you have undiagnosed vaginal bleeding
• if you have breast cancer or cancer of the genitals
• if you have or have had blood clots in a vein (thrombosis), which can sometimes be painful (thrombophlebitis), for example in the leg (deep vein thrombosis) or the lungs (pulmonary embolism)
• if you have had a cerebral haemorrhage or stroke
• if you have a rare blood disease called porphyria, which is passed down in families (inherited).

Prometrium should only be used during the first 3 months of pregnancy. Talk to your doctor or pharmacist or nurse or mid-wife before using Prometrium.

Prometrium is not a contraceptive.

If you believe that you have had a miscarriage, you must speak with your doctor, because you must stop using Prometrium .

You must contact your doctor if you:

• experience any vaginal bleeding
• feel unwell within a few days of taking the medicine.

Prometrium is not for use in children.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Prometrium can affect the way some other medicines work. Also some other medicines can affect the way Prometrium works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• ciclosporin (used to reduce the immune response).
• bromocriptine, which is used in the treatment of pituitary gland-related problems or Parkinson’s disease.
• Rifamycin medicines such as rifampicin (used to treat infections).
• Ketoconazole (used for fungal infections).

If you have recently been tested for liver or hormone problems.

Prometrium should be inserted into the vagina. Food and drinks do not affect the treatment.

Do not use Prometrium if you are breast-feeding.

If this medicine makes you feel drowsy then do not drive or use machinery.

If you are allergic to peanut or soya, do not use this medicinal product.

• Insert this medicine deep into the vagina.
• Do not swallow.

• Take one Prometrium capsule twice daily, one in the morning and one at bedtime, or as instructed by your doctor.
• Continue with the same dose regimen until your doctor tells you to stop.

If you have used too much Prometrium, you should talk to your doctor or got to a hospital. Take the medicine pack with you.

The following effects may happen: feeling dizzy or feeling tired.

• If you forget to insert a dose, insert it as soon as you remember. However, if it is nearly time for your next dose, you can skip the missed dose.
• Do not take a double dose to compensate for a forgotten dose.

Talk to your doctor, pharmacist or nurse or mid-wife before stopping this medicine.

If you get any side effects, talk to your doctor or pharmacist or nurse or mid-wife. This includes any possible side effects not listed in this leaflet. You can also report side effects via the website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• Active substance is progesterone. One capsule contains 400mg of progesterone.
• The other ingredients in the capsule are sunflower oil, soyabean lecithin, gelatine, glycerol (E422), titanium dioxide (E171) and purified water.

The capsules are yellowish, soft gelatin capsules, that contain a whitish oily suspension. The dimensions of the 400mg capsule are approximately 2.5 cm x 0.9 cm.

Pack size: 15 capsules per bottle (HDPE). The bottle is supplied in a cardboard carton.