Utrogestan 100 mg/200 mg Capsules

UTROGESTAN is a progesterone hormone treatment and is prescribed for disorders where you have too little progesterone:

• as an addition to postmenopausal oestrogen replacement therapy;
• a condition called dysovulation or anovulation (where you have irregularity in your menstrual cycle (period), which might even occur two times in a single month);
• a condition called premenstrual syndrome (complex of symptoms, including emotional tension, experienced by some women in the day immediately before menstruation (your period);
• a condition called mastopathy (a painful disorder of the breast);
• a condition called perimenopause (the time during which your body makes the natural transition to menopause, marking the end of your reproductive years.

Do not take UTROGESTAN:

• If you are hypersensitive (allergic) to progesterone or any of the other ingredients of UTROGESTAN listed in section 6).
• If you suffer from a severe liver disorder.
• If you experience any vaginal bleeding which a doctor has not diagnosed.
• If you have any mammary (breast) or genital cancer.
• If you suffer from any of the following disorders: herpes gestations (a type of skin rash with sores that starts during pregnancy), jaundice of pregnancy (yellowing of the skin), otosclerosis (an abnormal growth of bone near the middle ear, causing impaired hearing), severe itching, or porphyria (a condition that affects your blood).
• If you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis) or the lungs (pulmonary embolism).
• If you have thrombophlebitis (inflammation of your veins due to blood clot formation).
• If you have a blood clotting disorders (such as protein c, protein S, or antithrombin deficiency).
• If you have or recently have had a disease caused by blood clots in the arteries, such as a heart attack, stroke or angina.
• If you have bleeding on the brain (cerebral haemorrhage).
• If you are breastfeeding (see Pregnancy, breastfeeding and fertility).

Warnings and precautions

Take special care with UTROGESTAN:

• Treatment with UTROGESTAN should be stopped if your liver function test indicates any abnormalities or if you develop cholestatic jaundice (yellowing of the eyes and/or skin).
• Before starting UTROGESTAN treatment you should undergo a thorough examination and special care should be given to the breasts, pelvic organs and a “pap” smear should be conducted.
• UTROGESTAN should not be used as a contraceptive agent as the dosage is not sufficient.
• UTROGESTAN is not a treatment for the threat of premature birth.

Other medicines and UTROGESTAN:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor or pharmacist if you are currently taking:

• Griseofulvin (used in the treatment of fungal infections).
• Activated charcoal (usually used in the treatment of overdosing).
• Anti-epileptic medicines containing carbamazepine, phenobarbital or phenytoin.
• Tuberculosis treatment containing rifabutin or rifampicin.
• Ciclosporin used in cancer treatment.
• Theophylline (used in the treatment of asthma).
• Antibiotics such as ampicillins and tetracyclines (used to treat bacterial infections).
• Herbal remedies containing St John’s Wort (Hypericum perforatum) (used to assist with symptoms of depression).

UTROGESTAN with food and drink:

UTROGESTAN should be taken after food and preferably in the evening before going to bed.

Do not share medicines prescribed for you with any other person. Always take UTROGESTAN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual daily dose is 200 mg to 300 mg divided into one or two intakes. The dose of UTROGESTAN and duration of treatment will be determined by your doctor for your specific condition. Swallow the capsule whole with a glass of water. You should take UTROGESTAN sometime after eating, preferably in the evenings upon going to bed.

If you have the impression that the effect of UTROGESTAN is too strong or too weak, talk to your doctor or pharmacist.

If you take more UTROGESTAN than you should: In the event of overdosage, consult your doctor or pharmacist immediately. If he/she is unavailable, seek help at the nearest hospital or poison control centre.

If you forget to take UTROGESTAN: If you have been prescribed the 300 mg daily dosage and forget to take a morning or evening dose, do not take the missed dose. Continue to take the next dosage as prescribed. If you forget to take the 200 mg daily dose, skip the missed dose and carry on as before. Do not take more than one 200 mg dose daily. If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you stop taking UTROGESTAN: Do not stop taking UTROGESTAN unless instructed by your doctor. If you have any further questions on the use of UTROGESTAN, ask your doctor or pharmacist.

UTROGESTAN can have side effects. Not all side effects reported for UTROGESTAN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking UTROGESTAN, please consult your health care provider for advice. If any of the following happens, stop taking UTROGESTAN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• rash or itching.
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to UTROGESTAN. You may need urgent medical attention.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice the following:

Frequent:

• Passing more or less urine than is normal for you or if you experience pain while passing urine.

Less frequent:

• Unexplained shortness of breath, rapid breathing, chest pain, fast heart rate.

Frequency unknown:

• Yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems. This is a serious side effect. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:

Frequent:

• Dry mouth, frequent urination, loss of appetite, unusual thirst.
• Unusual or rapid weight gain.
• Dizziness, drowsiness, tiredness, headache, mood changes, nervousness.
• Unusual tiredness, or weakness, vertigo (sensation of spinning or swaying), sleeplessness.
• Abdominal pain or cramping, bloating of the stomach, nausea (feeling sick).
• Stopping of menstrual periods, medium to heavy uterine bleeding between your periods, increase amount of menstrual bleeding occurring at regular monthly periods.
• Joint pain.

Less frequent:

• Thin skin that bruises easily.
• Filling or rounding out of the face.
• Mental depression, sleeplessness.
• Hot flushes, low blood pressure.
• Skin rash, acne, darker patches of skin on the face, itching, loss or gain of body, facial or scalp hair.
• Unexpected or increased flow of breast milk.
• Breast pain or tenderness, loss of sexual desire.

Frequency unknown:

• Pain in back, pain that gets worse when you stand or walk, a curved, stooped shape of your spine, a bone that breaks much more easily than expected.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/health-products-vigilance/. By reporting side effects, you can help provide more information on the safety of UTROGESTAN.

• Store at or below 25 °C.

• Protect from light and excessive moisture.

• Do not remove from outer carton until use.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use the capsules after the expiry date printed on the blisters. Decomposed products may be toxic.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).