NORDIOL® tablets

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

NORDIOL® tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

NORDIOL^® tablets

COMPOSITION:
The 21 pink tablets contain:
Levonorgestrel 250 µg
Ethinyl oestradiol 50 µg
The 7 red tablets are inactive

PHARMACOLOGICAL CLASSIFICATION:
Category A, 18.8 Ovulation Controlling Agents.

PHARMACOLOGICAL ACTION:
Oral contraceptives of the combination type act by a multiplicity of mechanisms including inhibition of ovulation.

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

CONTRA-INDICATIONS:
There are no known contra-indications for normal healthy women. Oral contraceptives are contraindicated 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 local, 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, if you become very sad or irritable, it you cough up blood, or have other unusual symptoms. It you omit one or more tablets and miss a menstrual period, see your doctor. Discontinue NORDIOL until he says you can resume. If, while on NORDIOL 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.
NORDIOL tablets are to be used only on the advice, or on the recommendation of your doctor. He will give you more complete information on the use of NORDIOL and will advise you about possible contraindications (conditions in which you should not lake this type of medication).

DOSAGE AND DIRECTIONS FOR USE:

1.	Start by taking the pink tablet, in the circle of the package on the first day of your menstrual cycle (i.e. the day menstruation commences).
2.	Take one pink tablet each day, immediately after the evening meal or at bedtime, as nearly as possible at the same time each day, for 21 days, following the arrows until all 21 pink tablets are finished.
3.	Then start taking one red tablet each day (again following the arrows) until all the red tablets are finished.
4.	The following day start a new package, taking the first pink tablet in the circle to commence the next course.
	NOTE: There must be no interval between finishing one course and starting the next.

THE CHANGES YOU CAN EXPECT:
You will probably have a menstrual period two or three days after taking the last pink tablet in each package. The blood flow may be slightly less or more than you had before you started taking the tablets, but this happens infrequently.

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 it they have used the contraceptive for longer than five years, if they smoke, if they are obese or it 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 mortally 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 drugs and efficacy:
	Oral contraceptive failure may occur with concomitant antibiotic therapy. For maximal protection, additional non-hormonal contraception should be recommended for the duration of antibiotic therapy and for seven days afterwards. Those on long term antibiotic therapy need only take extra precautions for the first two weeks of antibiotic therapy.
	Spotting and breakthrough bleeding are possible signs of diminished contraceptive effectiveness.
	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 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.
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.

PRECAUTIONS:
Omitted tablets:
NORDIOL 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 1 or more tablets, 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 2 tablets in a row: take the 2 missed tablets when you remember, and the tablet for that day at the regular time. In this case, you take 3 tablets 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 seven days without tablets and until you have taken a tablet daily for 7 days from the new NORDIOL package, use an additional birth-control method. If you omit any of the tablets in a package and do not menstruate when you expect to, see your doctor or health advisor. Do not take any more tablets until he says you can.

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

IDENTIFICATION:
Each course of NORDIOL comprises 21 active pink and 7 red inactive, sugar coated tablets.

PRESENTATION:
NORDIOL is available in blister packs of 28 tablets (21 active and 7 inactive tablets).

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

REGISTRATION NUMBER:
C/18.8/197

NAME AND BUSINESS ADDRESS OF APPLICANT:
AKROMED PRODUCTS (PTY) LTD.
Electron Avenue, ISANDO 1600
Trademark and product under licence from
WYETH-AYERST LABORATORIES. U S A

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 OCTOBER 1985.

24660 BR311

Davbar Dbn.