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

Logo OVRAL® 28 tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

OVRAL® 28 tablets

COMPOSITION:
Each active tablet contains:

Norgestrel 500 micrograms
Ethinyl oestradiol 50 micrograms

PHARMACOLOGICAL CLASSIFICATION:
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:
OVRAL 28 is indicated for fertility control in women and for the control of certain menstrual irregularities.
NOTE: Ovral 28 does not protect against sexually transmitted diseases and the virus that causes AIDS.

CONTRA-INDICATIONS:
Ovral 28 is contra-indicated in patients with recurrent cholestatic jaundice, or markedly impaired liver-function, hormone dependent neoplasms, carcinoma of the breast, previous or active thromboembolic disorders, coronary artery disease, 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, 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 adverse 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, difficulty seeing or talking, numb or weak feeling in an arm or leg, if you become very sad or irritable, if you cough up blood, or have other unusual symptoms.
If you omit one or more pills and miss a menstrual period, see your doctor. Discontinue OVRAL 28 until he says you can resume. If, while on OVRAL 28 you develop an illness with vomiting and diarrhoea that lasts over 24 hours, the absorption of oral contraceptives may be diminished and women should be advised to use additional methods of contraception at a time of such disorders.
OVRAL 28 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 OVRAL 28 and will advise you about possible contra-indications (conditions in which you should not take this type of medication).

DOSAGE AND DIRECTIONS FOR USE:
1. Start by taking the white tablet in the circle on the package on the first day of your menstrual cycle (i.e. the day bleeding commences).
2. Take one white 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 white tablets are finished.
3. Then start taking one red coloured tablet each day (again following the arrows) until all the red tablets are finished.
4. On the following day start a new package taking the first white 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 white tablet in each package. The blood flow may be slightly less or more than you had before you started taking the tablets.

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, myocardial infarction and venous thrombosis are more likely to occur in smokers over the age of 35 years and nonsmokers over the age of 40, particularly if they have used the contraceptive for longer than five years, if they are obese or if they are hypertensive. Additional risk factors are diabetes, hypercholesterolaemia and familial hyperlipoprotelinaemia. However, with the exception of women 35 years and older who smoke and nonsmokers 40 and older, the risk of mortality associated with all methods of birth control is less than that associated with childbirth. Since cigarette smoking increases the risk of serious side-effects, women who use oral contraceptives should be strongly advised not to smoke.
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, ocular lesions, vaginal candidiasis, gall bladder disease, jaundice, 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 take only 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 drugs such as anti-epileptic agents (i.e. phenytoin and phenobarbital), 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 or prolonged periods of immobilisation are more likely to be associated with an increased incidence of thrombotic side-effects. Oral contraceptives should be discontinued four weeks prior to elective surgery or during periods of immobilisation.
9. Decreased glucose tolerance and increase in triglycerides and total phospholipids can be observed in patients on oral contraceptives. Diabetic and prediabetic patients should be monitored closely.
Under no circumstances should the oral contraceptive be stopped without having adopted a satisfactory alternative method of contraception.
Caution:
Omitted tablets:
OVRAL 28 is designed to 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 1 tablet, take it in the 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 oral contraceptive method until you finish the package.
Suppose you forget to take 2 tablets in a row; take the 2 pissed 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 1 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 seven days from the new OVRAL 28 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 he says you can.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment of overdosage is symptomatic and supportive. Nausea may occur and withdrawal bleeding may occur in females.

IDENTIFICATION:
Each course of OVRAL 28 comprises of 21 active white tablets and 7 red inert, sugar-coated tablets.

PRESENTATION:
OVRAL 28 is available in packs of 28 tablets (21 active and 7 inert tablets).

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H 1644 (ACT 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
AKROMED PRODUCTS (PTY) LTD
(Co. Reg. No. :05/13586/07)
Building 12
Healthcare Park
Woodlands Drive
Woodmead
Sandton        2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 1975

Product and Trademark under licence from WYETH-AYERST LABORATORIES USA.

308463 030437                Harry’s Printers K30945 K03

Updated on this site: April 2005
Source: Hospital Pharmacy

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