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TRINOVUM tablets
SCHEDULING STATUS:
Schedule 3
PROPRIETARY NAME
(and dosage form):
TRINOVUM tablets
COMPOSITION:
TRINOVUM is a combination oral contraceptive regimen consisting of three different concentrations of oestrogen and progestogen plus placebo tablets as follows:
7 white tablets each contain 0,5 mg norethisterone and 0,035 mg ethinyl oestradiol.
7 pale peach tablets each contain 0,75 mg norethisterone and 0,035 mg ethinyl oestradiol.
7 peach tablets each contain 1,0 mg norethisterone and 0,035 mg ethinyl oestradiol.
7 green placebo tablets.
PHARMACOLOGICAL CLASSIFICATION:
A 18.8 Medicines acting on genito-urinary system. Ovulation-controlling agents.
PHARMACOLOGICAL ACTION:
In TRINOVUM therapy the low dose of the oestrogenic component, ethinyl oestradiol (0,035 mg), combined with successive weekly increased dosages of the low potency progestogenic component, norethisterone (0,5 mg-0,75 mg-10 mg) produces a hormonal pattern which resembles that of the normal physiological menstrual cycle. The primary effect is gonadotropin suppression with inhibition of ovulation but contraceptive effectiveness is enhanced through changes in the cervical mucous (which increase the difficulty of sperm penetration) and the endometrium (which reduce the likelihood of implantation).
(Smanjiti vjerojatnost implantacije znači osiromašiti stijenku maternice iznutra tako da ne bude dovoljno prokrvljena. Tako se već začeto dijete usađivanjem u tu stijenku neće moći hraniti niti doći do kisika. Ako dakle dva prethodna mehanizma ne 'upale', treći mehanizam će dijete ubiti gušenjem i izgladnjivanjem. Pa iz u sve to pilula ne djeluje 100% učinkovito, što znači da se dijete i tada može roditi.) Treba čitati upute.
Stopping the synthetic hormone administration produces a withdrawal bleeding, resembling menstruation, at average intervals of 28 days.
Pharmacokinetics
Norethisterone and ethinyl oestradiol are rapidly and well absorbed following oral administration and peak plasma levels occur within 1 - 4 hours. Norethisterone and ethinyl oestradiol are metabolised by first-pass metabolism. The mean bioavailability following first-pass metabolism is 65 - 80% for norethisterone and 40 - 50% for ethinyl oestradiol. Norethisterone is bound to both albumin and sex hormone binding globulin (SHBG). Ethinyl oestradiol is 98% bound to albumin, but is not bound to SHBG. The elimination half-life of norethisterone is 5 - 14 hours and 6 - 20 hours for ethinyl oestradiol. Both norethisterone and ethinyl oestradiol are eliminated via renal and faecal pathways.
INDICATIONS:
TRINOVUM is indicated for the prevention of pregnancy.
CONTRA-INDICATIONS:
Oral contraceptives are contra-indicated in patients with:
Markedly impaired liver function, benign or malignant liver tumour which developed during the use of oral contraceptives or other oestrogen-containing products, known or suspected carcinoma of the breast, known or suspected oestrogen-dependent neoplasia, undiagnosed abnormal genital bleeding, recurrent cholestatic jaundice. Thrombophlebitis, thromboembolic disorders (including deep thrombosis, pulmonary embolism and cerebrovascular accident), cerebral vascular disease, coronary artery disease, myocardial infarction, severe migraine, or a past history of these conditions. Medication should be discontinued immediately if migraine becomes focal or if there is a loss of vision or if there is an onset of unexplained chest pain.
TRINOVUM is contra-indicated in patients with a hypersensitivity to any component of this product.
Relative contra-indications include a history of diabetes mellitus, epilepsy, asthma, hypertension, depression, porphyria or states in which fluid retention occurs.
Combined oral contraceptives should be avoided in known or suspected pregnancy and in patients who are breast-feeding.
WARNINGS:
The following conditions may increase the risk of complications associated with oral contraceptive use:
Conditions, which may increase the risk of developing venous thromboembolic complications, e.g. prolonged immobilisation or major surgery.
Risk factors for arterial disease, e.g. smoking, hyperlipidemia, hypertension or obesity.
Migraine with aura.
Diabetes mellitus.
Severe depression or a history of this condition.
DOSAGE AND DIRECTIONS FOR USE:
The first white tablet should be taken on the first day of the menstrual cycle, i.e. the first day of menstrual bleeding. One white tablet is taken at the same time each day for 7 consecutive days; one light peach tablet is then taken daily for 7 days followed by one peach tablet daily for 7 days and then one green tablet daily for 7 days, during which time withdrawal bleeding usually occurs. During the FIRST cycle, it is important that an additional method of birth control be applied until all white and all pale peach tablets have been taken. After 28 tablets have been taken the first tablet (white) from the next package must be taken the following day whether or not bleeding is present. Use of oral contraceptives in the event of a missed menstrual period:
1.
If the patient has not adhered to the prescribed dosage regimen, the possibility of pregnancy should be considered after the first missed period and oral contraceptives should be withheld until pregnancy has been ruled out.
2.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.
Missed tablets:
If the patient forgets to take a tablet, she should take the tablet as soon as she remembers. Then she should take the next tablet at the regular time, even if it means taking two tablets on the same day. Should the patient miss more than one tablet, she should continue taking tablets on schedule and, in addition, use another method of contraception for the rest of that cycle.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
1.
The following side-effects have been reported in patients receiving oral contraceptives and are believed to be medicine-related:
Nausea and/or vomiting, abdominal cramps, bloating, colitis, gastro-intestinal irritation, spotting, chloasma or melasma which may persist; skin pigmentation, breast changes (tenderness, enlargement and secretion), change in appetite, change in body mass (increase or decrease), change in cervical erosion and cervical secretion, cholestatic jaundice, increase in size of uterine leiomyomata, rash (allergic), vaginal candidiasis, change in corneal curvature (steepening), intolerance to contact lenses, mood changes, irritability, changes in libido, pre-menstrual syndrome and temporary infertility after discontinuation of treatment.
2.
Hypertension may occur in association with the use of oral contraceptives. Regular blood-pressure checks, including a pre-treatment level, are advisable.
3.
A decrease in glucose tolerance has been observed in a significant percentage of patients on oral contraceptives. For this reason, pre-diabetic and diabetic patients should be carefully observed while receiving oral contraceptives.
4.
The onset or exacerbation of migraine or development of headache of a new pattern which is recurrent, persistent, or severe requires discontinuation of oral contraceptives and evaluation of the cause.
5.
In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, pathological causes should be borne in mind. In persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy.
6.
Patients with a history of psychic depression should be carefully observed and the medicine discontinued if depression recurs to a serious degree. Patients becoming significantly depressed while taking oral contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether this symptom is medicine-related.
7.
Since oral contraceptives may cause some degree of fluid retention, they should be prescribed with caution and with careful monitoring to patients with conditions which might be aggravated, such as convulsive disorders, migraine syndrome, asthma or cardiac or renal insufficiency.
8.
Patients with a history of jaundice during pregnancy have an increased risk of jaundice while receiving oral contraceptives. If jaundice recurs in such patients, oral contraceptives should be discontinued.
9.
Steroid hormones may be poorly metabolised in patients with impaired liver function and should be administered with caution in such patients.
10.
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.
11.
The doctor must take a complete medical and family history before prescribing oral contraceptives. At that time, and about once a year thereafter, the doctor should generally examine the patient's blood pressure, breasts, abdomen, and pelvic organs (including a Papanicolaou smear, i.e. test for cancer).
12.
If the decision is made to discontinue oral contraceptives alternate contraceptives should be offered.
13.
Women who use oral contraceptives should be strongly advised not to smoke.
14.
The use of oral contraceptives is associated with increased risk of ocular lesions, gall bladder disease, and congenital defects during early pregnancy (including heart defects and limb defects). Women who discontinue oral contraceptives with the intent of becoming pregnant should be recommended to use an alternate form of contraception for about three months before attempting to conceive.
15.
The incidence of disease of the circulatory system in women using combined oral contraceptives is significantly greater than those of controls, and mortality is slightly increased. Several reports suggest that this increased risk of cardiovascular disease may continue for a number of years after stopping oral contraceptives.
16.
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, if 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.
17.
Surgery is more likely to be associated with an increased incidence of thrombotic side-effects. Adequate precautions should be taken.
18.
Case reports have been published of benign hepatic tumours in women on oral contraceptives for a prolonged time, but a causal relationship has not been established. The preparation should be discontinued if persistent upper abdominal pain develops.
Interaction with other medicines and efficacy:
19.
The metabolism of oral contraceptives may be influenced by various drugs and herbal preparations including St John's wort. A decrease in hormonal effectiveness may occur with the induction of certain isoenzymes in the liver which enhance metabolic elimination (e.g. cytochrome P450 3A4), and interference with enterohepatic circulation of estrogens.
20.
Decreased effectiveness of the estrogenic component or oral contraceptives may result in spotting, breakthrough bleeding and possible oral contraceptive failure. It is possible that induction of these same isoenzymes might also lead to reductions in circulating levels of the progestational component of TRINOVUM. Of potential clinical importance are drugs and herbal supplements that are known to affect the induction of these enzymes (e.g. St John's wort, barbiturates, phenytoin sodium and especially rifampin).
21.
Oral contraceptive failure may occur with concomitant antibiotic therapy (e.g. ampicillin, neomycin) due to impairment of the enterohepatic circulation of estrogens which may result in hastened elimination and impaired effectiveness. For maximal protection, additional non-hormonal contraception should be recommended for the duration of antibiotic therapy and for 7 days afterwards. Those on long-term antibiotic therapy need only, take extra precautions for the first two weeks of antibiotic therapy.
22.
The efficacy of oestrogen containing contraceptives may be decreased by the concomitant administration of rifampicin and St John's wort. Reports have suggested interaction with topiramate, griseofulvin and troglitazone. A similar association has been suggested with concomitant use of barbiturates, phenylbutazone, phenytoin sodium, carbamazepine and tetracycline. 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.
23.
Oral contraceptives may interfere with some laboratory estimations, in particular hormones (decreased pregnanediol excretion), glucose tolerance (decreased), thyroid function (increased TBG, PB1), blood coagulation (increased prothrombin and factors II, VII, VIII, IX, X, XII, XIII and decreased antithrombin 3, increased noradrenaline-induced platelet aggregation), serum triglycerides and serum cholesterol (increased) and liver function tests (increased BSP retention). In addition, low density lipoprotein (LDL) cholesterol levels may be increased and high density lipoprotein (HDL) cholesterol levels may be decreased. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuation of oral contraceptives.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Serious ill effects have not yet been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, vomiting, and withdrawal bleeding may occur in females.
If the patient is intensely uncomfortable, emesis should be induced or gastric lavage performed. Otherwise, such symptomatic treatment as appears indicated should be instituted.
CONDITIONS OF REGISTRATION:
Advertising to the professions only.
IDENTIFICATION:
The TRINOVUM blister pack contains 7 white, 7 pale peach, 7 peach and 7 green coloured, small, round, odourless tablets with flat surfaces and bevelled edges. The tablets are engraved on both the upper and lower surfaces as follows: white - "C535", pale peach - "C735", peach - "C135" and green - "C-C".
PRESENTATION:
Carton containing a blister pack of 28 tablets.
STORAGE INSTRUCTIONS:
Protect from light and keep out of the reach of children. Store below 25°C.
REGISTRATION NUMBER:
S/18.8/124
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
JANSSEN - CILAG
Janssen Pharmaceutica (Pty) Ltd.
(Reg. No. 1980/011122/07)
15th Road
Halfway House
1685
DATE OF PUBLICATION OF THIS PACKAGE INSERT
4 March 1985
Code no.: 024166
2001K
Britepak
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