Utrogestan

• Female sex hormone (progesterone)
• Oral or vaginal capsule
• For fertility problems, PMS and irregular periods
• To prevent miscarriage or premature birth

UTROGESTAN capsules contain a female hormone called progesterone. Progesterone is closely linked to a woman’s fertility cycle.

• UTROGESTAN VAGINAL (soft capsules for vaginal use)is used in the following situations:

• To support pregnancy in women undergoing treatment for reduced fertility or infertility, in which the body does not produce enough progesterone to get pregnant or sustain pregnancy. UTROGESTAN VAGINAL is also used to support pregnancy during in vitro fertilization (IVF) cycles and/or egg cell donation.
• In pregnant women, to prevent repeated miscarriages or prevent premature birth due to inadequate progesterone production.
  
• UTROGESTAN ORAL (soft capsules for oral use) is used for various conditions, including:
• PMS (premenstrual syndrome), with symptoms such as breast tenseness, bloating (swollen belly or legs), fatigue, mood swings.
• Irregular periods (especially in menopausal women who suffer from PMS).
• Mastodynia, a benign condition causing pain, tenderness and swelling in the breast tissue, possibly with lumps.
• As part of Hormone Replacement Therapy (HRT) in combination with an oestrogen to reduce the symptoms of the menopause.
• Certain forms of infertility in women who need extra progesterone to fall pregnant.

Your doctor will recommend which variant of UTROGESTAN is suitable for you.

Use and dosage of UTROGESTAN will depend on the variant and the condition being treated. General guidelines for use are listed below.

• UTROGESTAN VAGINAL soft capsules

One 100-mg capsule in the morning and one in the evening to be inserted deep into the vagina, with or without the help of an applicator. (The daily dosage is 200 mg, i.e., two 100‑mg capsules a day, taken in two doses.) The doctor may increase this dose.

• UTROGESTAN ORAL soft capsules

Take one 200 mg-capsule or two 100-mg capsules in the evening AT BEDTIME and one 100‑mg capsule in the morning, if necessary. (The usual daily dosage is 200 mg to 300 mg of progesterone.) The capsules should be swallowed whole with a drink of water.

Dosage

Your dose should be determined by a doctor. In most cases, UTROGESTAN is not used daily but over certain days of your menstrual cycle. Your doctor will tell you when to use this medicine. For more information on use and dosage, please see the package leaflet.

Alcohol/driving

There are no dietary restrictions with UTROGESTAN.

You may feel sleepy or dizzy while taking UTROGESTAN. If this happens, do not drive or use any tools or machines.

Taken too much/forgot to take/stop using UTROGESTAN

If you have used more UTROGESTAN than you should, contact your doctor or pharmacist immediately.

If you have forgotten to take a dose, do not take a double dose to make up for a forgotten one.

Do not stop taking UTROGESTAN without consulting your doctor first. You will have a withdrawal bleed a few days after stopping UTROGESTAN.

UTROGESTAN is not suitable for everyone. Do not take this medicine if:

UTROGESTAN VAGINAL soft capsules:

• You have severe liver function problems.
• You have breast cancer or are suspected of having breast cancer, or have cancer of the sexual organs.
• You are allergic to the active ingredient or to any of the other ingredients in this medicine (see section 'What UTROGESTAN contains').

UTROGESTAN ORAL soft capsules:

• You are allergic to the active ingredient or to any of the other ingredients in this medicine (see section 'What UTROGESTAN contains').

When should this medicine be used with caution?

Pregnancy cannot be avoided with normal use. UTROGESTAN is not a contraceptive.

Pregnancy and breastfeeding

UTROGESTANcan be used during pregnancy, also during the first weeks of pregnancy.

There is insufficient clinical information to determine if progesterone passes into breast milk. Therefore, progesterone should be avoided while breastfeeding.

Always consult a doctor or pharmacist before taking this medicine.

Other medicines and UTROGESTAN

Some medicines for epilepsy and certain antibiotics can affect the way UTROGESTAN works. UTROGESTAN can also affect the way some antidiabetic medicines work. Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that do not require a prescription.

Like all medicines, UTROGESTAN can cause side effects, although not everybody gets them.

For both UTROGESTAN VAGINAL and UTROGESTAN ORAL: the menstrual cycle may be shortened and/or bleeding may occur if the treatment sequence is initiated too early, particularly before cycle day 15.

The following side effects may happen with UTROGESTAN ORAL soft capsules:

• Menstrual changes.
• No menstruation.
• Menstrual spotting.
• Breast pain.
• Sleepiness.
• Temporary dizziness.
• Problems affecting the stomach and intestines.
• Cholestatic jaundice.
• Itching.

For more information on possible side effects, see the package leaflet. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

The active substance in UTROGESTAN VAGINAL capsules is progesterone. Each soft capsule contains a micronised form equivalent to 100 or 200 mg.

• UTROGESTAN VAGINAL 100 mg soft capsules contain 100 mg progesterone per capsule.
• UTROGESTAN VAGINAL 200 mg soft capsules contain 200 mg progesterone per capsule.

Both capsule strengths contain an equal amount of other ingredients. These ingredients are: soybean lecithin, sunflower oil, titanium dioxide, gelatin, glycerol, purified water, q.s. for making a capsule.

The active substance in UTROGESTAN ORAL soft capsules is progesterone. Each soft capsule contains a micronised form equivalent to 100 or 200 mg.

• UTROGESTAN ORAL 100 mg soft capsules contain 100 mg progesterone per capsule.
• UTROGESTAN ORAL 200 mg soft capsules contain 200 mg progesterone per capsule.

Both capsule strengths contain an equal amount of other ingredients. These ingredients are: soybean lecithin, (purified) arachis oil, titanium dioxide, gelatin, glycerol, q.s. for making a capsule.

The manufacturer of UTROGESTAN is:

BESINS IMANUFACTURING BELGIUM N.V. Groot-Bijgaardenstraat 128
B-1620 DROGENBOS
BELGIUM

Read the package leaflet before use.