INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MICRO-NOVUM® Tablets

SCHEDULING STATUS:
Schedule 2.

PROPRIETARY NAME
(and dosage form):

MICRO-NOVUM® Tablets

COMPOSITION:
Each Micro-Novum tablet contains 0,35 mg of the progestational substance,
norethisterone.

PHARMACOLOGICAL CLASSIFICATION:
A.18.8 Medicines acting on genito-urinary system. Ovulation controlling agents.

PHARMACOLOGICAL ACTION:
Although Micro-Novum tablets' mode of action has not been clearly established, it appears to be mediated through suppression of pituitary gonadotrophins as well as through alteration of the cervical mucus and endometrium.

INDICATIONS:
Micro-Novum tablets are indicated for contraception.

CONTRA-INDICATIONS:
Oral contraceptives are contra-indicated in patients with:
Thrombophlebitis, thromboembolic disorders, cerebral vascular disease, myocardial infarction, or a past history of these conditions.
Markedly impaired liver function.
Known or suspected carcinoma of the breast.
Known or suspected oestrogen dependent neoplasia.
Undiagnosed abnormal genital bleeding.
Recurrent cholestatic jaundice. Patients with a history of cholestatic jaundice of pregnancy are more likely to develop cholestatic jaundice during oral contraceptive therapy.
Discontinue oral contraceptive medications if there is: gradual or sudden, partial or complete loss of vision; proptosis or diplopia; onset or aggravation of migraine, or when it becomes focal; development of headache of a new pattern which is recurrent, persistent or severe; papilloedema; any evidence of retinal vascular lesions, or an onset of unexplained chest pain.
Relative contra-indications include a history of diabetes mellitus, hypertension, depression, porphyria or states in which fluid retention occur. Conditions which might be influenced by this last factor include epilepsy, migraine, asthma, cardiac or renal dysfunction.
Combined oral contraceptives should be avoided in known or suspected pregnancy and in patients who are breast feeding.

WARNINGS:
The doctor should be alert to the earliest manifestations of thrombotic and thromboembolic disorders, thrombophlebitis, cerebrovascular disorders (including haemorrhage), myocardial infarction, pulmonary embolism and retinal thrombosis. Should any of these occur or be suspected, the medicine should be discontinued immediately.
An increased risk of thrombophlebitis, cerebrovascular disorders, myocardial infarction and pulmonary embolism associated with the use of oral contraceptives has been reported in several retrospective case control studies. The increased risk has been estimated in these studies to be approximately 4 to 11 times higher (for cerebral haemorrhage two times higher) for users when compared to nonusers. This reported risk according to two of the studies is not related to duration of use nor does it persist after discontinuance according to one of the studies. An interim report of a large-scale continuing prospective study has tended to confirm these retrospective studies for thrombophlebitis and possible cerebrovascular disorders. This study also reported that the risk of superficial and deep vein thrombosis was lower in women using, preparations containing 50 micrograms of oestrogen. Other prospective studies have not shown these risks.
The incidence of diseases of the circulatory system in women using combined oral contraceptives is significantly greater than those of controls, and the mortality is slightly increased. Coronary thrombosis, cerebrovascular accidents and venous thrombosis are more likely to occur in women aged 35 years or over, particularly if they have used the contraceptive for longer than five years, if they smoke, it they are obese or if they are hypertensive. Additional risk factors are diabetes, hypercholesterolaemia and familial hyperlipoproteinaemia. However, the risk of mortality due to oral contraceptives in women under 35 years who are in the high risk group is in general far less than the risk of mortality due to pregnancy.
Because of a possible increased risk of post-surgery thromboembolic complications in oral contraceptive users, the doctor should consider discontinuing therapy at least four weeks prior to elective surgery. Adequate precaution should be taken.
Foetal abnormalities have been reported to occur in the offspring of women who have taken oral contraceptives during pregnancy.
Pregnancy should be ruled out before initiating or continuing the oral contraceptive regimen.
Women on oral contraceptives should not breast feed, since small fractions of the active ingredients have been identified in the mother's milk.
Liver tumours, occasionally fatal, have been reported in women using oral contraceptives. These tumours may present as an abdominal mass, intra-abdominal bleeding and/or with signs and symptoms of an acute abdomen. These have been reported in short-term as well as long-term users of oral contraceptives. The treatment should be discontinued if persistent upper abdominal pain develops.

DOSAGE AND DIRECTIONS FOR USE:
Starting on the first day of a menstrual period, one tablet is taken at the same time every day continuously for as long as contraception is desired. A tablet must be taken regularly every day even during menstruation, or if bleeding occurs or if menstruation is delayed.
For the first 28 days an additional contraceptive method should be employed as an extra safe-guard against pregnancy.

How to use the Micro-Novum tablets pack.
Select the day of the week on the Micro-Novum tablets pack which corresponds to the first day of your menstrual cycle and take out the tablet by pressing down on the blister or bubble. Thereafter follow the direction indicated by the arrows on the pack for your next tablet.
A Micro-Novum tablet must be taken every day without interruption, including the period of menstruation. Your second and subsequent courses must follow the first without interruption.
When starting your second Micro-Novum tablets pack select a tablet corresponding to the day of the week following the day of the last tablet on your first pack.
Example: If the last tablet of your first Micro-Novum tablets pack is on a Wednesday, then start your second Micro-Novum tablets pack by selecting a tablet marked Thursday.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Under no circumstances should the oral contraceptive tablet be stopped without having adopted a satisfactory alternative method of contraception.

(a) Side-effects
Most commonly reported in early cycles of oral contraceptive therapy include breakthrough bleeding, spotting, nausea, vomiting and other gastrointestinal disturbances, and weight change. These frequently decrease with continued use. Other common side-effects include: change in menstrual flow, oedema, chloasma (which may persist post therapy), amenorrhoea, breast changes (tenderness, enlargement and secretion).
In addition to the conditions and disorders discussed above, the following have been reported as adverse reactions in patients using Micro-Novum tablets:

        Neuro-ocular lesions         Cystitis-like syndrome
        Rash         Headache
        Cervical erosion and secretion         Nervousness
        Suppression of lactation         Fatigue
        Premenstrual-like syndrome         Hirsutism
        Changes in libido         Loss of scalp hair
        Leg cramps         Erythema multiforme
        Relative pyridoxine deficiency         Erythema nodosum
        Haemorrhagic eruptions         Itching

(b) Special Precautions
The following are some of the medical conditions reported to be influenced by oral contraceptive therapy.
The doctor should be alert to these, carefully monitor the patient and exercise medical judgement to continue or discontinue therapy as appropriate.
Pre-existing uterine fibromyomata may increase in size.
Hypertension may occur in association with the use of oral contraceptives. Regular blood-pressure checks, including a pretreatment level, are advisable.
Prolonged amenorrhoea following the use of oral contraceptives may occur. The incidence is in the order of 1% of users. Caution is advised where oligomenorrhoea or amenorrhoea have occurred in the past. Women with a past history of oligomenorrhoea or secondary amenorrhoea or women with irregular cycles may be more likely to remain anovulatory or to become amenorrhoeic post oral contraceptive therapy.
Mood changes, weight gain, skin pigmentation, vaginal candidiasis, gastro-intestinal irritation and fluid retention may occur.
A decrease in glucose tolerance in a significant number of women may occur.
An increased risk of surgically confirmed gall-bladder disease associated with the use of oral contraceptives has been reported in a retrospective case control study.

Interaction with other medicines and efficacy:
The doctor should be aware of the fact that the reliability of oral contraceptive preparations decreases when a tablet is forgotten, or when other medicines such as rifampicin, barbiturates or anti-epileptic medicines are taken concurrently. With vomiting or diarrhoea the absorption of oral contraceptives may be diminished and women should be advised to use additional methods of contraception at the time of such disorders.
The concurrent use of oral contraceptives and barbiturates, rifampicin and anti-epileptic medicines can cause irregular cycles.

Effects on laboratory tests
Oral contraceptives may interfere with some laboratory estimations in patients using oral contraceptives.
Hepatic:
Increased BSP retention and other tests.
Coagulation:
Increased prothrombin Factors VII, VIII, IX and X; decreased antithrombin III, increased platelet aggregability.
Endocrine:
Increased PBI and butanol extractable protein bound iodine, decreased T3 uptake and increased glucose blood levels.
Other:
Increased serum phospholipids and triglycerides, decreased serum folate values and disturbance in tryptophan metabolism.
These altered test values usually return to pretherapy values after discontinuing oral contraceptive use. However, the doctor should he aware that these altered values may mask an underlying disease.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Accidental poisoning or overdosage has not been encountered and serious acute effects are unlikely. For massive overdosage it is recommended to perform gastric lavage and give symptomatic supportive treatment.

IDENTIFICATION:
Small round white tablet engraved with CO35 on both faces.

PRESENTATION:
Micro-Novum tablets are supplied in blister packs containing 28 tablets.

STORAGE INSTRUCTIONS:
Keep out of reach of children.
Store below 25°C.

REGISTRATION NUMBER:
B/18.8/135.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN-CILAG
Janssen Pharmaceutica (Pty) Ltd.,
(Reg. No. 80/11122/07)
15th Road,
Halfway House
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
16 July, 1979.

        Code No.:023887
        2000F
        Britepak

® = TRADEMARK

Updated on this site: January 2001
Current: April 2004
Source: Pharmaceutical Industry

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