Utrogestan 400 mg. 15 capsules

1. What Utrogestan is and what it is used for

The name of your medicine is Utrogestan. Utrogestan contains a hormone called progesterone.

What Utrogestan is used for

Utrogestan can be used to support pregnancy.

To support pregnancy

Utrogestan can be used to help reduce the risk of miscarriage in women who are experiencing bleeding during their current pregnancy and have a history of recurrent miscarriages.

2. What you need to know before you use Utrogestan

Do not use Utrogestan:

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 disorders;

if you have yellowing of the skin or eyes (jaundice);

if you experience undiagnosed vaginal bleeding;

if you have breast cancer or cancer of the genital tract;

if you have or have had blood clots in the veins (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 brain haemorrhage or stroke;

if you suffer from a rare blood disorder called porphyria, which is inherited. Warnings and precautions

Utrogestan should be used only during the first 3 months of pregnancy. Talk to your doctor, pharmacist, nurse, or midwife before using Utrogestan.

Utrogestan is not a contraceptive.

If you think you may have had a miscarriage, talk to your doctor, as you must stop using Utrogestan. You should contact your doctor if:

you experience vaginal bleeding

you feel unwell in the days following the use of the medicine.

Children and adolescents

Utrogestan is not intended for use in children.

Other medicines and Utrogestan

You must 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 necessary because Utrogestan can affect the way some other medicines work. Conversely, other medicines can also affect the way Utrogestan works.

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

ciclosporin (used to suppress the immune response);

bromocriptine, used for pituitary gland 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 hormonal problems.

Utrogestan with food and drink

Utrogestan is administered vaginally. Food and drink do not affect the treatment.

Pregnancy, breastfeeding, and fertility

Do not use Utrogestan if you are breastfeeding.

Driving and using machines

If this medicine makes you feel drowsy, do not drive or operate machinery.

Utrogestan contains soya lecithin

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

3. How to use Utrogestan

Always use this medicine exactly as your doctor has told you. If you experience side effects, consult your doctor, pharmacist, nurse, or midwife.

To reduce the risk of miscarriage in women with bleeding during the current pregnancy, Utrogestan treatment should be started at the first signs of vaginal bleeding during the first trimester and continued at least until the 16th week of pregnancy.

Using this medicine to reduce the risk of threatened or recurrent miscarriage

Insert this medicine deep into the vagina.

Do not swallow.

How much Utrogestan to use

Insert one Utrogestan capsule twice daily—one in the morning and one at bedtime—or as directed by your doctor. Continue with the same dosage regimen until your doctor tells you to stop.

If you have used more Utrogestan than required

If you have used more Utrogestan than required, speak to your doctor or go to the nearest hospital. Take the medicine with you.

The following side effects may occur: dizziness and fatigue.

If you have missed using Utrogestan

If you have missed a dose of the medicine, administer it as soon as you remember. However, if it is almost time for your next dose, do not administer the missed dose.

Do not administer a double dose to make up for a missed dose.

If you have stopped using Utrogestan

Speak to your doctor, pharmacist, nurse, or midwife before stopping the use of this medicine.

If you have any questions regarding the use of this medicine, consult your doctor, pharmacist, nurse, or midwife.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine:

Adverse reactions with unknown frequency (cannot be estimated from the available data):

Itching or a burning sensation

Oily vaginal discharge.

You may experience brief fatigue or dizziness within 1–3 hours of using the medicine.

If you notice any adverse reactions other than those listed above, inform your doctor, pharmacist, nurse, or midwife.

5. How to store Utrogestan

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.

Store in the original package.

Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Do not use this medicine if you notice visible changes in its appearance.

6. Contents of the pack and other information

What Utrogestan contains

The active substance is progesterone. One capsule contains 400 mg of progesterone.

The other ingredients in the capsule are refined sunflower oil, soya lecithin, gelatin, glycerol (E422), titanium dioxide (E171), and purified water.

What Utrogestan looks like and contents of the pack

The capsules are oblong, yellowish soft gelatin capsules containing an oily, whitish suspension. The dimensions of the 400 mg capsule are approximately 2.5 cm x 0.9 cm.

Pack type:

15 capsules in an HDPE bottle. The bottle is supplied in a cardboard box.

PVC/Alu blisters containing 15, 30, or 45 capsules in a cardboard box. Not all types of packaging may be placed on the market.