PREME Tablet

Oral contraception for the treatment of signs of androgenization in women.

For the treatment of androgen-dependent diseases in women, such as acne, especially pronounced forms and those which are accompanied by seborrhea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgenetic alopecia, mild forms of hirsutism and also for oral contraception in women with these diseases. If the hirsutism has only recently appeared or has lately intensified to a considerable extent the doctor must be expressly informed of this because of the necessity to clarify the cause.

Dosage and administration

Before starting PREME, a thorough general medical and gynaecological examination (including the breasts) should be carried out and the family case history carefully noted. In addition, disturbances of the clotting system must be ruled out if any members of the family have suffered from thromboembolic diseases (e.g. deep vein thrombosis, stroke, myocardial infarction) already at a young age. Pregnancy must be excluded. As a precaution, control examinations should be conducted at intervals of about 6 months during long-term treatment with the tablets.

* Start of treatment

Wait for your next period to occur. Start taking the tablets on the 1st day of the cycle (=1st day of bleeding). You may also start on days 2-5 of your cycle, but in that case make sure you also use an additional contraceptive method.

The first cycle will be somewhat shorter than usual, whereas all following cycle will last 4 weeks.

* Use of the memo-pack

Take your first tablet from the memo-pack out of the section marked with the corresponding day of the week, press it through the aluminium foil, and swallow it whole with some liquid. It does not matter at what time of the day you take the tablet, but once you have selected a particular time-preferably after your breakfast or evening meal- you should keep to it every day.

* 1 tablet daily for 21 days

From now on you must take a tablet every day in the direction indicated by the arrows on the pack until the pack is empty. If, at any time, you are not sure whether you have taken your tablet for that day or not, a glance at the memo-pack will tell you.

* Tablet-free interval of 7 days

After all 21 tablets have been taken, a tablet-free interval of 7 days follows during which time a menstruation-like bleeding will occur.

* Continuation of treatment

After this 7 days interval, tablet-taking is resumed from the next pack-regardless of whether your bleeding has already ceased (which it usually has) or is still continuing.

Thus, you will be following a simple scheme of 3 weeks tablet-taking, 1 week off, and each new pack will start on the same day of the week as the previous one.

Please note

Irregular tablet-taking, vomiting or intestinal disorders with diarrhoea, very rate individual metabolic disturbances or prolonged simultaneous use of certain medical preparations can affect the contraceptive action (possible first symptom: intermenstrual bleeding). Mild laxatives do not impair the action of the tablets.

* Length of use

The length of use depends on the severity of the clinical picture; in general, treatment should be carried out over several months.

It is recommended to take PREME for at least another 3-4 cycles after the signs have subsided. Should there be a recurrence, weeks or months after discontinuation of tablet-taking, treatment with PREME may be resumed.

* If intermenstrual bleeding occurs

If “unscheduled” bleeding occurs during the 3 weeks in which PREME is being taken, tablet-taking should not be interrupted. Slight bleeding will usually stop spontaneously. However, if the bleeding is heavy, similar to menstrual bleeding, you should consult your doctor.

* If a period is missed

If, in exceptional cases, bleeding fails to occur during the tablet-free interval, tablet-taking is provisionally not to be resumed (no new pack) and the doctor must be consulted.

* What to do in case of irregular tablet-taking (if you forget to take your daily tablet); vomiting or diarrhoea

See the package insert about the details.

Pregnancy, lactation, severe disturbances of liver function, jaundice or persistent itching during a previous pregnancy. Dubin-Johnson syndrome, Rotor syndrome, previous or existing liver tumors, existing or previous thromboembolic process in arteries or veins and states which predispose to such diseases (e.g. disturbances of the clotting system with a tendency towards thrombosis, certain heart diseases), sickle-cell anaemia, existing or treated cancer of the breast or the endometrium, severe diabetes with vascular changes, disturbances of lipometabolism, a history of herpes of pregnancy, otosclerosis with deterioration during pregnancy.

In rare cases, headaches, gastric upsets, nausea, a feeling of tension in the breasts, changes in body weight and libido, or depressive moods can occur. In predisposed women, long-term use of the tablets can sometimes cause brownish patches on the face which are made worse by long exposure to the sun. Women who have this tendency, should therefore avoid spending too long in the sun.

Individual cases of poor tolerance of contact lenses have been reported.

barbiturates, phenylbutazone, hydantoins, rifampicin, ampicillin, oral antidiabetics, insulin

Contraindicated.

PREME is not for use in men.

According to the present state of knowledge, an association between the use of progestogen-estrogen combinations and an increased risk of venous and arterial thromboembolic diseases cannot be ruled out. The relative risk of arterial thrombosis (e.g. stroke, myocardial infarction) appears to increase further when heavy smoking, increasing age and the use of combined oral contraceptives coincide.

In rare cases benign and in even rarer cases malignant liver tumors leading in isolated cases to life-threatening intraabdominal haemorrhage have been observed after the use of hormonal substances such as those contained in PREME. The doctor must therefore the informed of the occurrence of unusual upper abdominal complaints which do not disappear spontaneously within a short time as it may then be necessary to withdraw the preparation.

The substance cyproterone acetate contained in PREME inhibits the influence of the androgens which are also produced by the female organism. It is thus possible to treat diseases, the cause of which is either an increased production of androgens or a particular sensitivity to these hormones.

While PREME is being taken, the increased sebaceous gland function, which plays an important role in the development of acne and seborrhea, is reduced. This leads-usually after 3-4 months of therapy - to the healing of existing acne efflorescences. The excessive greasiness of the hair and skin generally disappears earlier. The loss of hair which frequently accompanies seborrhea likewise diminishes. Treatment with PREME is indicated in women of child-bearing age who exhibit mild forms of hirsutism, and in particular in slightly increased facial hair; results do not, however, become apparent until after several months of use.

Apart from the described antiandrogen effect, cyproterone acetate has also a pronounced progestational action. The sole administration of cyproterone acetate would thus lead to cycle disturbances which are avoided by its combination with ethinylestradiol in PREME. This holds true as long as the preparation is taken cyclically according to the instructions. During treatment with PREME, ovulation will not take place. In addition, the cervical mucus remains thick which makes it difficult for the man’s sperms to ascend. Furthermore, the uterine membrane is not prepared for the nidation of a fertilized egg. PREME thus offers multiple protection against pregnancy.