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

Logo EXLUTON tablets

SCHEDULING STATUS
S4

PROPRIETARY NAME
(and dosage form):

EXLUTON tablets

COMPOSITION
Each tablet contains 0,5 mg
lynoestrenol.

PHARMACOLOGICAL CLASSIFICATION
A/21.8.2 Progesterones with or without oestrogens.

PHARMACOLOGICAL ACTION
Inhibition of ovulation.

INDICATIONS
Fertility control.

CONTRA-INDICATIONS
Like all oral contraceptives Exluton is contra-indicated in the presence of the following conditions:
(a) Thrombophlebitis, thromboembolic processes, or a history of these disorders.
(b) Disturbances of the liver function, jaundice, Roter syndrome and Dubin-Johnson syndrome or a history of jaundice * in pregnancy.
(c) Undiagnosed genital bleeding.
* The use of oral contraceptives is not contra-indicated in patients with a history of hepatitis, whose liver function is normal.

DOSAGE AND DIRECTIONS FOR USE
One tablet is taken daily without interruption beginning on the first day of the cycle, i.e. the first day of menstruation. This starting day should be adhered to irrespective of whether another oral contraceptive has been used during the previous cycle or not.
The tablets are taken at the same time of the day, preferably at about the time of the evening meal.
When the pack of 35 tablets is empty, a new pack is started the following day, thus without interruption.
Post-partum and post-abortion treatment with Exluton should start preferably on the first day of the first spontaneous menstruation.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
(a) During the first few months of treatment irregular loss of blood may occur. Experience has shown that this is almost certainly a temporary problem. If it should occur, tablet taking should not be interrupted. If the irregular bleeding is severe or prolonged, the doctor should be consulted.
(b) Occasionally menstruation fails to occur. If the tablets have been taken as directed, this will almost certainly not mean that the patient is pregnant. Tablet-taking should not be interrupted. If the bleeding is more than one month late, the patient must consult her doctor in order to rule out the possibility of pregnancy. She may of course consult her doctor earlier, if wanted.
(c) Nausea, headache and breast tenderness may also be experienced during the initial months of treatment, but these are only temporary symptoms.
(d) During the use of oral contraceptives the body mass may increase. Experience has shown that the body mass stabilizes after some time and, in most cases, can be easily controlled by diet.
(e) Symptoms such as sudden and severe headache, pain in the chest, visual disturbances, and a swollen arm or leg require medical examination.
(f) By regular medical control it is possible to detect thromboembolic processes (thrombophlebitis; cerebrovascular disorders, pulmonary embolism and retinal thrombosis) in an earlier stage. The use of the preparation should be stopped immediately in these cases.
  Studies in England and in the United States have shown that women using oral contraceptives run a greater risk of thrombosis than non-users. As to how far this applies also to Exluton, which contains no oestrogenic substance, is not known. For the time being, it seems advisable to observe the same caution when using this preparation.
(g) If jaundice should occur during the use of the product, administration should be discontinued immediately.
(h) Since the glucose tolerance may diminish during the use of oral contraceptives, diabetic patients should be kept under strict control.
(i) Because fluid retention may sometimes be possible during the use of the product, conditions which might be influenced by this factor, such as cardiac or renal dysfunction, epilepsy, migraine and asthma, require careful observation.
(j) Caution should be observed in young women whose cycles are not yet established.
(k) Since oral contraceptives may cause an increase of blood pressure in predisposed women, this should be checked regularly. In case of serious hypertension, further administration of the preparation should be withheld.
(l) In case no withdrawal bleeding occurs it is advisable to rule out pregnancy. Important in this respect is, of course the question of whether tablets have been forgotten. If no bleeding has occurred in two consecutive cycles pregnancy should be ruled out anyway.
(m) It is advisable to perform periodic physical examination once every 3 months during the first year of treatment and once every 6 months thereafter. These examinations should include special reference to duration of the cycle, body mass, blood pressure, breasts, pelvic organs, legs and skin.

Remarks
Unless post-partum or post-abortion treatment with Exluton is started on the first day of the first spontaneous menstruation, the protection offered by this preparation cannot be relied upon.

Exluton appears to have no adverse effect on lactation, and the excretion of Lynoestrenol in the milk is negligible.

It must be emphasized that the absorption and accordingly also the effectiveness of the tablets may be reduced in the presence of conditions such as vomiting and diarrhoea.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Nausea, vomiting and slight vaginal bleeding may occur. Treatment is unlikely to be required.

CONDITIONS OF REGISTRATION
The product is to be advertised to the professions only.

IDENTIFICATION
35 white, round, flat tablets with bevelled edges; Organon embossed on one side, and TT above 2 on the reverse.

PRESENTATION
Press through strips containing 35 tablets.

STORAGE CONDITIONS
Store below 30°C. Protect from light.
Keep out of reach of children.

REGISTRATION NUMBER
E/21.8.2/181

In correspondence please quote packing number.

NAME OF APPLICANT
Organon (Pty) Limited
Benmore Gardens Shopping Centre
11th Street
Benmore
2010

DATE OF PUBLICATION OF THIS PACKAGE INSERT
13.9.73


INFORMATION FOR THE USER
Exluton is an oral contraceptive containing a small quantity of an active progestational substance: 0,5 mg lynoestrenol. It differs from the current oral contraceptives in that it contains no oestrogenic substance and must be taken daily even during your menstrual period. While it is being taken, normal menstruation goes on as usual.
The use of oral contraceptives is a reliable method for the prevention of pregnancy. To obtain the greatest possible certainty with regard to the contraceptive action of Exluton, it is absolutely essential that you follow precisely the directions for use given below. Taking the tablets irregularly and, above all, forgetting to take one or more of them, lessens the reliability of this method of contraception. Moreover, the reliability may also be reduced if, during the use of Exluton, severe gastro-intestinal disorders such as diarrhoea or vomiting occur.

DIRECTIONS FOR USE
1. How should you take Exluton?
  Next to each tablet is printed the day on which that particular tablet is to be taken. A tablet can be removed from the pack by pressing on the plastic bubble over the tablet. The tablet should be swallowed without chewing.
2. On which day do you start taking Exluton?
Wait until your next menstrual period.
On the day on which bleeding starts, take your first Exluton tablet. You take one tablet marked with that day of the week from the top row.
You continue to take one tablet a day until the pack is empty, always following the direction indicated by the arrows.
In this way you can easily check whether you have taken your daily tablet, because the day of the week on which a particular tablet should be taken is clearly indicated.
3. How to continue with the next Exluton pack?
  When a pack is empty, you begin the next day - thus without interruption and without waiting for your next menstrual period - with a new pack of Exluton. (Remember to ask your doctor in time for a prescription for a new pack.)
  Once again you take the first tablet from the top row, the one corresponding to the day of the week. Then you continue to take one tablet every day as before, following the direction indicated by the arrows.
4. What is meant by taking regularly?
  You should always take one tablet at the same time every day. It is best to do so about the time of the evening meal.
5. What must you do when you have forgotten to take a tablet?
  As soon as you notice that you have forgotten to take even a single tablet you must take one immediately. Naturally; you should then continue to take your daily tablet in the normal way. At the same time you should consult your doctor.

SIDE-EFFECTS
During the first months of use, you may have a bleeding at irregular times. Experience has shown that this is almost certainly a temporary problem. Just as you should continue to take your daily tablet during your normal menstrual period, you should also continue to take your daily tablet even if you experience an irregular bleeding. If the irregular loss of blood is serious or prolonged, you must inform your doctor.
In some rare cases menstruation fails to occur. Provided that you have taken your tablets correctly, this will almost certainly not mean that you are pregnant. Just continue to take the tablets. If your menstrual period is more than one month overdue, then you must consult your doctor in order to exclude the possibility of pregnancy, if you prefer to do this earlier you may of course do so.
In the first months of use you may experience some nausea, headache or swelling and painfulness of the breasts. These symptoms usually disappear rapidly, if not, you should consult your doctor.
You may put on mass when taking the tablets. Experience has shown that the mass after some time stabilizes and in most cases, can easily be controlled by a suitable diet.
If you should experience symptoms such as a sudden severe headache, pain in the chest, visual disturbances, or a swollen arm or leg, you must go to see your doctor.

N.B.
Consult your doctor whenever you are in doubt about; the directions for use.
If you are under medical treatment - no matter for what - you should tell the doctor treating you that you are taking Exluton.
In correspondence please quote packing number.

Organon

Organon (Pty) Limited
Benmore Gardens
11th street
2010 Benmore

Penrose 69271                10/86

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