Cidolut nor for Dysfunctional bleeding, primary and secondary amenorrhoea and premenstrual syndrome

Cidolut Nor                                                                                                Oral progestogen
Important informations, please read carefully

Composition :

Each tablet contains 5 mg norethisterone acetate.

Properties :

Cidolout Nor is a progestogen derived from nortesterone have weak estrogenic and androgenic properties used commonly as hormonal contraceptive and in menopausal HRT to oppose the effect of estrogens on the endometrium.

Indications & Usage :

Dysfunctional bleeding, primary and secondary amenorrhoea, premenstrual syndrome, mastopathy, uterine hypoplasia, timing of menstruation, endometriosis, progressive carcinoma of the breast.

Contra-Indications :

Pregnancy, severe disturbances of liver function, Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumours (in progressive carcinoma of the breast only if these are not due to metastases), a history of jaundice or severe pruritus during pregnancy, a history of herpes of pregnancy, thromboembolic

Side Effects :

In rare cases nausea may occur.

Drug Interactions :

The doctor should be informed if other medicines are being taken regularly ( e.g. barbiturates, phenylbutazone, hydantoins, ri(pmpicin, ampicillin ), since these may impair the action of steroid
hormones like norethisterone. Insulin and antidiabetic requirements may change.

Warnings & Precautions :

– Before starting the treatment with the drug, be sure that the pregnancy has been excluded, and the pregnant mother must be warned about the risk of effect of the drug on her fetus.
– This drug is not used as a pregnancy test.
– This drug should not be given in missed or incomplete abortion.
The doctor must be informed if the patient suffers from diabetes, since this disease requires careful supervision. .
It has been conduded from epidemiological surveys that the use of oral estrogen I progestogen containing ovulation inhibitors is attended by an increased incidence of thromboembolic diseases.
thromboembolic risk in mind, particularly where there is a history of thromboembolic diseases or in the presence of severe diabetes with vascular changes or sickle-cell anaemia.
In rare cases benign and in even rare cases malignant liver tumours leading in isolated cases to life threatening intraabdominal hemorrhage have been observed after the use of hormonal substances such as the one contained in cidolut nor 5 mg. The doctor must therefore be informed of the occurrence of unusual upper abdominal complaints which do not disappear spontaneously within a short time as it may then be necessary to withdraw the preparation. The scientific brochure contains further information for the doctor.

Reasons for immediate discontinuation of the tablets :

Occurrence for the first time of migrainous headaches or more frequent occurrence usually severe headaches, sudden perceptual disorders ( e.g. disturbances of vision or hearing) first signs of
thrombophlebitis or thromboembolic symptoms (for examilli!. unusuaLPains in or . of the leg, stabbing pains on breathing or coughing for no apparent reason). Afeeling of paman htness in
the chest, pending operations ( six weeks beforehand) and immobilization ( for instance, llowing accidents ), onset of jaundice, onset of hepatitis, itching of the whole body, significant rise in blood
pressure, pregnancy, hypercalcaemia ( in women with carcinoma of the breast).

Dosage & Administration :

Before starting cidolut nor 5 mg a thorough general medical and gynaecological examination ( including the breasts) should be carried out and pregnancy must be excluded.
As precaution, control examinations should be conducted at intervals of about 6 months during long- term treatment with cidolut nor 5 mg. The tablets are to be swallowed as whole with some liquid. Unless otherwise prescribed by the doctor the following dosage schemes are recommended:                                   Dysfunctional bleeding:The administration of 1 tablet cidolut nor 5 mg twice daily over 10 days leads to the arrest of uterine
bleeding not associated with organic lesions within 1-4 days. In individual cases, bleeding diminishes during the first few days after the commencement of tablet-taking and does not stop until about 5-7 days later. For the treatment to be successful, cidolut nor 5 mg administration must be continued regularly even after arrest of bleeding ( up to a total of 20 tablets cidolut nor 5 mg ).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 blee<iing may occur after initial arrest of bleeding. In these cases tablet-taking must not be interrupted.
Missing arrest of hemorrhage. heavy breakthrough bleeding:cidolut nor 5 mg can givevaluable “hints concerning differential diagnosis 01 uterine bleeding. If the bleeding does not stop inspite of regular tablet-taking, an organic cause must be considered. The attending physician must te informed immediately, because further measures are then mostly required. This applies also in cases where after initial arrest of hemorrhage heavier bleedings still occur during

Prevention of recurrence :

To prevent recurrence of dysfunctional bleeding, it is recommended to administer cidolut nor 5 mg prophylactically during the next three cycles, i.e. 1 tablet cidolut nor 5 mg twice daily from the 19th to the 26th day of the cycle ( 1st day of the cyde = 1st 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.
Primary and secondary amenorrhoea:
In the case of secondary amenorrhoea 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 (e.g. Estradiol valerate Depot 10 mg ) is to be given before the administration of cidolut nor 5 mg. 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:
2 ampoules Estradiol valerate Depot 10 mg i.rn, on the 1 st day of treatment and 1 ampoule Estradiol valerate 10 mg i.rn. on the 14th day of treatment, followed by 1 tablet cidolut nor 5 mg twice daily from the 19th to the 26th day of the treatment. Withdrawal bleeding starts about the 28th day.
Continuation of treatment ( over at least 2 .. 3 cycles) :
1 ampoule Estradiol valerate 10 mg i.rn. on the 6th day and 16th day of the artificial cycle followed by 1 tablet cidolut nor 5 mg daily from the 19th to the 26th day of the cycle ( 1 st day of bleeding = 1 st day
of the cycle ). An attempt can then be made to stop estrogen treatment and to induce a cyclical bleeding by the administration of 1 tablet cidolut nor 5 mg daily from the 19th to the 26th 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:
During treatment pregnancy must not occur. 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 intemupted until the situation has been clarified by differential diagnosis.
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 cidolut nor omg once or twice daily from the 19th to the 26th day of the cycle.
The remarks under “please note” for the indication “Primary and secondary amenorrhoea” apply also to this indication.
Uterine hypoplasia:
Treatment should commence directly after menstruation on the 5th day of the cycle.
Estradiol valerate 10 mg          Cidolut Nor 5 mg
1 st & 2nd weeks   1-2 ampoules i.m. weekly      1 tablet twice daily
3rd to 7th week     1-2 ampoules i.m. weekly   2 tablets twice daily
8th week                                                                 2 tablets twice daily
After the 8-week therapy a withdrawal bleeding will occur.

Timing of menstruation :

The monthly bleeding can be advanced or postpone i particu ar circumstances require IS. oweve, 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 cidolut nor 5 mg at a time when the necessary
exclusion of pregnancy can be problematical, since cidolut nor 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 & Administration :

1 tablet cidolut nor 5 mg twice 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.

Endometriosis :

Treatment is commenced on the 5th day of the cycle with 1 tablet cidolut nor 5 mg twice daily, increasing to two 5 mg 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. Progressive carcinoma of the breast clinical trials have shown that cldolut nor 5 mg can have a favourable influence on progressive carcinoma of breast. The dosage determined by the doctor can vary considerably from case to case and has to be adhered to strictly.

Packing :

Tablets of 5 mg. Box of 20 tablets.

Storage :

Store below 30’C and R.H. below 70 %.
Store all drugs properly and keep them out of reach of children.
– Keep medicament out of children reach

Produced by :

Chemical Industries Development (CID) ” Glza “A.R.E