TRI-REGOL coated tablets

Tri-Regol coated tablet is a hormonal oral contraceptive. The contraceptive action is achieved by inhibiting ovulation. Use exclusively if prescribed and under regular medical supervision.

General medical (blood pressure determination, measurement of blood sugar level) and gynaecological examinations are necessary before the use of the preparation is started.

The preparation should not be used in the case of pregnancy, severe liver disease, lipid metabolism disorders, severe hypertension, severe diabetes, vaginal bleeding of unknown origin, previous pregnancy jaundice, or gestational herpes, existing or previous -severe heart diseases,

-gallbladder diseases,

-thrombotic diseases or predisposition to them,

-liver tumour,

-malignant breast or uterus tumour,

Special care should be taken if the preparation is applied in diabetes, hypertension, venous phlebitis, varicosity, epilepsy, chorea and benign uterus tumours. Inform your physician if you have the above or any other disease before starting to use the preparation.

Owing to its milk secretion-decreasing effect, ask for your doctor's permission before using the preparation in the period of nursing.

During the use of the preparation rarely nausea, vomiting, headache, tension in the breast, changes in the body weight, depressed mood, chloasma problems in using contact lenses, intermenstrual bleeding, increased blood pressure and blood sugar levels, skin rash, thromboembolic diseases, hepatic and biliary diseases, unusual tiredness and diarrhoea may occur.

Regular medical control about every 6 months is recommended while the preparation is being used. Hormonal contraceptives should not be used for a period of 6 months after recovery from infectious hepatitis. The incidence of certain diseases (e.g. thromboembolic diseases, myocardial infarction and stroke) may increase among women using hormonal contraceptives. This risk is higher in older individuals (over the age of 30), especially in smokers, therefore women over 30 years are strongly advised to give up smoking.

The use of the preparation should be stopped and the physician consulted immediately:

-if pregnancy is suspected,

-if migraine-like or unusually strong headache occurs for the first time or becomes more severe,

-if visual disorders or sensory defects occur,

-if unusually strong pain is felt in the legs,

-if pain or gripping is felt in the chest,

-if Jaundice occurs and itching is felt all over the body,

-if blood pressure increases, or -in the case of seizure.

On rare occasions benign and very rarely malignant liver tumours leading sporadically to life-threatening intra-abdominal bleedings have been observed during long term treatment with sex hormones. Call your doctor immediately if you experience severe, continuous pain in the upper abdomen.

Dosage

Take one coated tablet daily (preferably always at the same hour of the day) from the first day of menstruation for 21 days which is followed by a pause of 7 days. Menstruation-like bleeding occurs during this period.

The ingestion of the next 21 coated tablets should be started on the 8th day after the 7-day pause has elapsed (even if bleeding has not stopped).

The beginning of the treatment and the correct sequence of taking the pills (6 pink, then 5 white, then 10 ochre coated tablets) are shown by numbering and arrows printed on the package.

If drug ingestion is missed at the usual time it should be made up within 12 hours.

Beyond 36 hours after taking the last coated tablet or if more than one pill is missed, reliable contraception cannot be guaranteed and other, supplementary, non-hormonal contraceptive measures should also be applied. The calendar method and temperature monitoring are not reliable. The administration of the preparation should be continued - by omitting the forgotten pills - from the package already in use. In the case of vomiting and diarrhoea the use of the preparation should be continued but other mechanical contraceptive measures should also be applied. The treatment should be continued. If intermenstrual bleeding occurs for it usually disappears spontaneously. Consult your doctor if you experience persisting or recurrent intermenstrual bleedings. If bleeding fails to occur during the 7-day pause, stop using the preparation until pregnancy is excluded. Following delivery or abortion, start using the preparation as prescribed by your doctor, but not sooner than on the first day of the second menstruation. If, due to medical reasons, the use of the preparation should be started sooner, then take the first coated tablet on the first day of the first menstruation cycle but apply other (non-hormonal) contraceptive measures too, during the first two weeks. Do not use other medicinal preparations (e.g. antibiotics, anticoagulants, antidepressants, antidiabetics) without prior consultation with your doctor. Do not use the preparation beyond the expiration date printed on the package.

Store below 25 °C.

Keep the drug out of the reach of children!

Date of preparation 18 July 2000

Package

1 x21 coated tablets

Gedeon Richter Pic. Budapest, Hungary