NORCOLUT TABLET 5 MG [SIN06679P]

Product Info

NORCOLUT TABLET 5 MG

[SIN06679P]

4.1 Therapeutic indications

Dysfunctional bleeding, primary and secondary amenorrhoea, premenstrual syndrome, mastopathy, timing of menstruation, endometriosis.

4.2 Dosage and method of administration

4.2.1 Method of administration

Oral use

4.2.2 Dosage regimen

The tablets are to be swallowed whole with some liquid.

If you forget a dose, wait until it is time to take the next prescribed dose. Do not take the missed dose. If you are worried, contact your doctor or pharmacist.

If contraceptive protection is required, additional non-hormonal (barrier) contraceptive methods should be used.

Unless otherwise prescribed by the doctor, the following dosages are recommended:

4.2.2.1 Dysfunctional bleeding

The administration of 1 tablet Norcolut 3 times daily over 10 days leads to the arrest of uterine bleeding not associated with organic lesions within 1–3 days. In individual cases, bleeding diminishes during the first few days after the commencement of tablet-taking and does not stop until about 5 days later. For the treatment to be successful, Norcolut administration should be continued regularly even after arrest of bleeding (up to a total of 30 tablets).

About 2–4 days after discontinuation of treatment, a withdrawal bleeding will occur resembling a normal menstruation in intensity and duration.

Slight bleeding during tablet-taking
Occasionally, slight bleeding may occur after initial arrest of bleeding. In these cases tablet-taking must not be interrupted.

Missing arrest of haemorrhage. Heavy break through bleeding
If the bleeding does not stop in spite of regular tablet taking, an organic cause must be considered. This applies also in cases where after initial arrest of haemorrhage, fairly heavy bleedings still occur during tablet-taking.

Prevention of recurrence
To prevent recurrence of dysfunctional bleeding, it is recommended to administer Norcolut prophylactically during the next three cycles. 1 tablet Norcolut 2–3 times daily from the 19^th to the 26^th day of the cycle (1^st day of the cycle – 1^st day of the last bleeding). The withdrawal bleeding occurs some days after administration of the last tablet.

Only the physician can decide whether this measure is necessary. His decision is then based on the course of the basal body temperature, which must be measured daily.

4.2.2.2 Primary and secondary amenorrhoea

In the case of secondary amenorrhoea, hormone treatment is to be given at the earliest 8 weeks after the last menstrual period.

In order to induce a menstruation-like bleeding, an estrogen is to be given before the administration of Norcolut.

However, before treatment is commenced, the presence of a prolactin-producing pituitary tumour should be excluded because, according to the present state of knowledge, the possibility cannot be ruled out that macroadenomas increase in size when exposed to higher doses of estrogen for prolonged periods of time.

Commencement of treatment
An equivalent of 20 mg estradiol valerate i.m. injection on the 1st day of treatment and equivalent of 10 mg estradiol valerate i.m. injection on the 14th day of treatment, followed by 1 tablet Norcolut 2–3 times daily from the 19^th to the 26^th day of treatment. Withdrawal bleeding starts about the 28^th day.

Continuation of treatment (over at least 2–3 cycles)
An equivalent of 10 mg estradiol valerate i.m. injection on the 6th and 16th days of the artificial cycle, followed by 1 tablet Norcolut twice daily from the 19^th to the 26^th day of the cycle (1^st day of bleeding = 1^st day of the cycle).

An attempt can then be made to stop the estrogen treatment and to induce a cyclical bleeding by the administration of 1 tablet Norcolut twice daily from the 19^th to the 26^th day of the cycle. Exception: Patients of whom it can be safely assumed that endogenous estrogen production is insufficient (primary amenorrhoea in gonadal dysgenesia).

PLEASE NOTE:
Contraception should be practised with non-hormonal methods (with the exception of the rhythm and temperature methods). If withdrawal bleeding at regular intervals of about 28 days fails to occur under the therapeutic scheme (see above), pregnancy must be considered despite the protective measures. The treatment must then be interrupted until the situation has been clarified by differential diagnosis.

4.2.2.3 Premenstrual syndrome, mastopathy

Premenstrual symptoms such as headaches, depressive moods, water retention, a feeling of tension in the breasts may be relieved or palliated by 1 tablet Norcolut 2–3 times daily from the 19^th to the 26^th day of the cycle.

The remarks under "Please note" for the indication "Primary and secondary amenorrhoea" apply also to this indication.

4.2.2.4 Timing of menstruation

The monthly bleeding can be advanced or postponed if particular circumstances require this. However, advancement with progestogen-estrogen combinations is definitely to be preferred, because the occurrence of a pregnancy is virtually ruled out by the inhibition of ovulation. As opposed to this, the postponement of menstruation calls for the use of Norcolut at a time when the necessary exclusion of pregnancy can be problematical since Norcolut must be given at a time when pregnancy cannot be excluded using the currently available examination methods. Therefore, this method remains restricted to those cases in which there is no possibility of early pregnancy in the cycle concerned.

Dosage: 1 tablet Norcolut 3 times daily for not longer than 10–14 days, beginning about 3 days before the expected menstruation. Bleeding will occur 2–3 days after having stopped medication. If it does not, the doctor must be consulted.

4.2.2.5 Endometriosis

Treatment is commenced on the 5th day of the cycle with 1 tablet Norcolut twice daily, increasing to 2 tablets twice daily in the event of spotting. When the bleeding ceases, the initial dose can be resumed. Duration of treatment at least 4–6 months. During treatment, ovulation and menstruation do not occur. After discontinuation of hormone treatment, a withdrawal bleeding will occur.

4.3 Contraindication

Norcolut should not be used in the presence of any of the conditions listed below, which are derived also from information on progestogen-only product and combined oral contraceptives (COCs).

Should any of the conditions appear during the use of Norcolut, the product should be stopped immediately.

• Known or suspected pregnancy

• Lactation

• Presence or a history of venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident.

• Presence or a history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)

• A high risk of venous or arterial thrombosis (see ‘Special warnings and precautions for use’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• History of migraine with focal neurological symptoms.

• Diabetes mellitus with vascular involvement

• Presence or history of severe hepatic diseases as long as liver function values have not returned to normal.

• Use of direct-acting antiviral (DAA) medicinal products containing ombitasvir, paritaprevir, or dasabuvir, and combinations of these (see ‘Interaction with other medicaments and other forms of interaction’ – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

• Presence or history of liver tumours (benign or malignant)

• Known or suspected sex hormone-dependent malignancies (e.g. of the genital organs or the breasts).

• Hypersensitivity to the active substances or any of the excipients

• Dublin Johnson syndrome

• Rotor syndrome

• History during pregnancy of idiopathic jaundice, severe pruritus or herpes gestations