BIPHASIL* tablets

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

BIPHASIL* tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form)

BIPHASIL* tablets

COMPOSITION:
The eleven white tablets of BIPHASIL* contain 50 µg of levonorgestrel and 50 µg of ethinyl oestradiol.
The ten orange tablets contain 125 µg of levonorgestrel and 50 µg of ethinyl oestradiol.
The seven red tablets are inert.
The orange tablets contain TARTRAZINE.

PHARMACOLOGICAL CLASSIFICATION:
Category A, 18.8 Ovulation controlling agents

PHARMACOLOGICAL ACTION:
Oral contraceptives containing a progestogen and an oestrogen act by a multiplicity of mechanisms including inhibition of ovulation.

INDICATIONS:
BIPHASIL* is indicated for fertility control in women and for the control of certain menstrual irregularities.

CONTRAINDICATIONS:
There are no known contra-indications for normal healthy women. Oral contraceptives are contra-indicated in patients with recurrent cholestatic jaundice, or markedly impaired liver-function, hormone-dependent neoplasms, previous thromboembolic disorders, severe migraine or cerebrovascular insufficiency and undiagnosed vaginal bleeding. 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. Relative contra-indications include a history of diabetes mellitus, epilepsy, asthma, hypertension, depression, porphyria or states in which fluid retention occur. Combined oral contraceptives should be avoided in pregnancy and in patients who are breast feeding.

WARNINGS:
There are some effects of the pill that are very important. Even though they rarely occur, you should be aware of them. Stop taking tablets and see your doctor immediately if you have persistent vaginal bleeding or discomfort, constant leg or chest pain, breathing difficulties, severe headache or vomiting, dizziness or fainting, difficulty seeing or talking, numb or weak feeling in an arm or leg, it you become very sad or irritable, if you cough up blood or have other unusual symptoms. If you omit 1 or more pills and miss a menstrual period, see your doctor. Discontinue BIPHASIL* until he says you can resume. If while on BIPHASIL*, you develop an illness with vomiting and diarrhoea that lasts over 24 hours, your protection may be reduced. In such a case, see your doctor. BIPHASIL* tablets are to be used only on the advice, or on the recommendation of your doctor, who will give you more complete information on the use of BIPHASIL* and will advise you about possible contra - indications (conditions in which you should not take this type of medication).

The orange tablets of this product contain F D and C Yellow No 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of tartrazine-sensitivity in the general population is currently thought to be low, it is frequently seen in patients who also have aspirin-sensitivity.

DOSAGE AND DIRECTIONS FOR USE:
First Cycle:
New patients should begin by taking the first tablet on the first day of the menstrual cycle (i.e. the first day of bleeding.) The first tablet should be selected from those in the black circles in the shaded sector of the pack. The first tablet to be taken is that in the black circle marked with the appropriate day of the week. Thereafter, one tablet is taken daily, following the arrows marked on the package until all 28 tablets are finished.
Note:
New patients with a history of short menstrual cycles, i.e. less than 25 days, are advised to consult their doctor concerning alternative protection for the first 14 days of use in the first cycle only. After 28 tablets have been taken, the first cycle of BIPHASIL* will have been completed. Menstruation should occur two to four days after taking the last orange tablet.

Subsequent cycles:
A new pack should be started the day after completion of the previous pack by taking the tablet in the black circle in the shaded sector of the new pack indicated with the appropriate day of the week. There must be no interruption of treatment, i.e., the new pack is started immediately after completion of the previous pack and each new pack is started with the same tablet in the black circle in the shaded sector of the pack. This method should continue for as long as contraception is desired. Each cycle will begin on the same day of the week.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:

1.	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, 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 who are in the high-risk group is in general far less than the risk of mortality due to pregnancy.
2.	Hypertension may occur in association with the use of oral contraceptives. Regular blood pressure checks, including a pretreatment level, are advisable.
3.	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.
4.	Mood changes, mass gain, skin pigmentation, vaginal candidiasis, gall bladder disease, gastrointestinal irritation and fluid retention may occur.
5.	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.
6.	Interactions with other medicines and efficacy: The efficacy of the contraceptive pill may be decreased when it is administered concomitantly with other medicines such as the anti-epileptic agents, rifampicin, phenylbutazone and ampicillin. With vomiting and 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.
7.	Effects on laboratory tests: Oral contraceptives may interfere with some laboratory estimations, in particular hormones, glucose tolerance, thyroid function, blood coagulation, serum triglycerides and liver function tests.
8.	Surgery is more likely to be associated with an increased incidence of thrombotic side effects. Adequate precaution should be taken.

Under no circumstances should the oral contraceptive tablet be stopped without having adopted a satisfactory alternative method of contraception.

Changes the patient may expect:
The patient will probably have a menstrual period two to four days after taking the last active tablet in each package. In some women the amount of menstrual flow may change slightly after taking BIPHASIL*; however, this happens infrequently and should be of no major concern. Light intermenstrual bleeding might occasionally occur while taking BIPHASIL*; however, if this happens, the patient should continue taking her tablets as usual. Such light bleeding will usually disappear by itself. However, if heavier bleeding occurs and persists, the patient should consult her doctor. If the patient should miss one period completely, she should consult her doctor.

Cautions:
Omitted Tablets:
BIPHASIL* is designed to provide very small amounts of the substances that protect you from pregnancy. It will do this as long as you follow the schedule carefully. However, should you forget to take one or more pills, your body may not have enough of these substances left to prevent pregnancy. In such cases, use an additional birth-control method (other than oral contraceptive tablets). If you miss taking one tablet, take it the next morning or as soon as possible, then take the next tablet at the usual time and continue the course as before. Remember to use an additional contraceptive method until you finish the package. Suppose you forget two tablets in a row. Take the two missed pills when you remember, and the pill for that day at the regular time. in this case you take 3 pills on the day you remember. Continue your schedule until the package is finished. An additional contraceptive method is necessary until you finish the package. If you forget 3 or more tablets in a row, do NOT take them when you remember and do NOT finish the package. Wait 4 more days. This makes one week without tablets. Then begin a new package on DAY 8 even if you are still bleeding. During the 7 days without tablets and until you have taken a tablet daily for 7 days from the new BIPHASIL* package use an additional birth-control method. If you omit any of the pills in a package and do not menstruate when you expect to, see your doctor or health advisor. Do not take any more tablets until the doctor says you can.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The treatment of overdosage is symptomatic and supportive.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
The BIPHASIL* package contains 28 tablets (11 white, 10 orange and 7 red).

PRESENTATION:
Each course of BIPHASIL* comprises 11 white, 10 orange and 7 red tablets packed in a blister type package.

STORAGE INSTRUCTIONS:
Store in a cool place (below 25°C), dry place.
Keep out of reach of children.

REGISTRATION NUMBER:
H/18.8/10

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
AKROMED PRODUCTS (PTY) LTD.
(Co. Reg. no. 05/13586/07)
Electron Avenue, ISANDO 1600
* Registered Trademark
* Under licence from WYETH-AYERST LABORATORIES, U.S.A.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

20 August 1986	NDC 8-6045-B	012-534
		Davbar Dbn.