| (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. |
| 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. |
| • |
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. |
EXLUTON tablets