INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
NORINYL 1/28 (Tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

NORINYL 1/28 (Tablets)

COMPOSITION:
Each white tablet contains:

	Norethisterone	1 mg
	Mestranol	0,05 mg

Each orange tablet contains:

Lactose

PHARMACOLOGICAL CLASSIFICATION:
A 18.8 Ovulation controlling agent

PHARMACOLOGICAL ACTION:
The mode of action of NORINYL 1/28 tablets is similar to that of other oestrogen/progesterone oral contraceptives; its activity is exerted through a combined effect on one or more of the following: hypothalamus, anterior pituitary, ovary, endometrium and cervical mucus.

INDICATIONS:
Oral contraception

CONTRA-INDICATIONS:
Oral contraceptives are contra-indicated in patients with the following conditions:

1.	Thrombophlebitis or thromboembolic disorders, cerebrovascular or coronary artery disease, or a history of these conditions.
2.	Acute or severe chronic liver disease, Dubin-Johnson or Rotor syndrome, history during pregnancy of idiopathic jaundice or severe pruritus.
3.	Known or suspected oestrogen-dependant neoplasia of the breast or endometrium.
4.	Undiagnosed, abnormal vaginal bleeding.
5.	Severe migraine.
6.	Pregnancy.
7.	Breast feeding: small amounts of hormone have been found in mother’s milk and the effect upon infants is not yet known. Reduction of milk supply may occur.
8.	The use of this product in patients suffering from diabetes mellitus, epilepsy, asthma, hypertension, depression, migraine or cardiac dysfunction may result in exacerbation of these disorders, because of fluid retention. The onset of exacerbation of migraine or development of headache of a new pattern which is recurrent, persistent or severe requires discontinuation of oral contraceptives and immediate investigation of the cause.
9.	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.

DOSAGE AND DIRECTIONS FOR USE:
Take your first tablet on the first day of your next period (the day your bleeding starts) by pressing out the appropriate tablet from the red strip. For example, if your first day of bleeding is a Tuesday, you should take the tablet marked “Tue” from the red strip of the pack. Then take one tablet every day following the arrows until the pack is empty. When you have finished your first pack, start the next pack on the following day. Remember to start every pack with a tablet from the red strip. Continue taking the tablets even during your period.
Each pack lasts four weeks. Always ensure that you have a new pack ready, so that you can continue taking the tablets without interruption. Your period will usually occur while you are taking the tablets from the red strip.
It is advisable to use additional precautions during the first two weeks of your first course, also if you suffer from gastro-intestinal upset which results in vomiting or diarrhoea.
Take the tablets regularly at a set time, such as before going to bed. If you miss a tablet, take it as soon as you remember and continue as before. If you forget your tablet on two days you should use additional precautions until you have finished the pack. If more than two tablets have been missed, do not take any more tablets but use an alternative method of contraception until your next menstrual period or until the possibility of pregnancy has been excluded.
Bleeding: Slight spotting or bleeding may occur during the first few cycles. If such bleeding persists or if heavier bleeding occurs, medical advice must be sought. If you have missed more than one period tell your doctor.
Changing from another oral contraceptive: NORINYL 1/28 tablets should be started immediately after completing the last course of the other product, starting with a tablet from the red strip labelled with the appropriate day of the week.
You should use additional precautions during the first two weeks of your first course of NORINYL 1/28 tablets.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
As with all oral contraceptives, there may be slight nausea at first, weight gain or breast discomfort, which will soon disappear.
Spotting or bleeding may occur during the first few cycles. Usually menstrual bleeding becomes light and occasionally there may be no bleeding while taking tablets from the red strip of NORINYL 1/28 tablets.
The incidence of disease 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 thirty five 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 mellitus, hypercholesterolaemia and familial hyperlipoproteinaemia. However, the risk of mortality due to oral contraceptives in women under the age of thirty five who are in the high-risk group is in general far less than the risk of mortality due to pregnancy.
Hypertension associated with the use of oral contraceptives occurs in approximately 5% of users. It is usually mild and reversible, but regular blood pressure checks including a pre-treatment 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.
Mood changes, weight gain, skin pigmentation, vaginal candidiasis, gall-bladder disease, gastro-intestinal irritation and fluid retention may occur. Case reports have been published of benign hepatic tumours in women taking oral contraceptives for a prolonged time, but a causal relationship has not been established. The preparation should be discontinued if sudden upper abdominal pain develops.
A decreased glucose tolerance may occur in diabetic patients on this treatment, and their control must be carefully supervised.
An increased risk of congenital anomalies including heart defects and limb defects, has been reported following the use of sex hormones, including oral contraceptives, in pregnancy. If the patient does not adhere to the prescribed schedule the possibility of pregnancy should be considered at the time of the first missed period and further use of oral contraceptives should be withheld until pregnancy has been ruled out. It is recommended that for any patient who has missed two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen. If pregnancy is confirmed the patient should be apprised of the potential risk to the foetus and the advisability of continuing the pregnancy should be discussed in the light of these risks.
Women taking oral contraceptives require careful observation if they have or have had any of the following conditions: breast nodules; fibrocystic disease of the breast or an abnormal mammogram; a history of severe depressive states; varicose veins; sickle-cell anaemia; diabetes; hypertension; high blood cholesterol levels; epilepsy; asthma; otosclerosis; multiple sclerosis; porphyria; tetany; disturbed liver functions; gallstones; cardiovascular disease; kidney disease; chloasma; herpes of pregnancy. The worsening or first appearance of any of these conditions may indicate that the oral contraceptive should be stopped.
Women with a history of oligomenorrhoea or secondary amenorrhoea or young women without regular cycles may have a tendency to remain anovulatory or to become amenorrhoeic after discontinuation of oral contraceptives. Women with these pre-existing problems should be advised of this possibility and encouraged to use other contraceptive methods. Cardiovascular problems related to cigarette smoking may be exacerbated by the simultaneous use of oral contraceptives. Women who take oral contraceptives should not smoke.
Interaction with other drugs and efficacy: The efficacy of the contraceptive pill may be decreased when it is administered concomitantly with other drugs such as anti-epileptic agents, rifampicin, sedatives and anti-arthritic drugs. 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 efficacy of NORINYL 1/28 tablets may be decreased by the concomitant administration of aminopenicillins.
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.
Surgery: Women undergoing surgery or prolonged bedrest should stop these preparations two months prior to elective surgery. Alternatively, and in situations requiring emergency surgery, prophylactic anti-coagulants should be given.
Under no circumstances should the oral contraceptive tablets be stopped without having adopted a satisfactory alternative method of contraception.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may be manifested by nausea, vomiting, breast enlargement and vaginal bleeding. Gastric lavage may not be necessary, but demulcents such as milk, egg white or bismuth hydroxide may be useful.

IDENTIFICATION:
21 white, round, flat tablets with bevelled edges, approximately 5 mm diameter, engraved “SEARLE” on one side and “1” on the other plus 7 orange, round, flat tablets with bevelled edges, approximately 5 mm diameter, engraved “SEARLE” on one side and “P” on the other.

PRESENTATION:
Push through blister pack containing 21 white tablets and 7 orange tablets.

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

REFERENCE NUMBER:
H 1648 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd
Alphen West G
George Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
1 February 1976

Updated on this site: January 2005
Source: Pharmaceutical Industry
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