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Tablets for oral use

Each pack Marvelon consists of 21 tablets.

Each tablet contains: desogestrel (a progestagen) 0,15 mg, ethinylestradiol (an estrogen) 0,03 mg

Marvelon is a combined oral contraceptive preparation containing as active substances the estrogen ethinylestradiol and the progestagen desogestrel. Clinical studies have revealed that oral contraceptive preparations containing ethinylestradiol and desogestrel lack undesirable metabolic effects which are considered to be due to the androgenic activity of some progestagens in oral contraceptives.

When taken according to the recommended dosage scheme Marvelon suppresses the hypophyseal gonadal function and thereby ovulation. In addition, it induces a regular uterine bleeding which, with respect to amount of flow and duration, resembles a normal menstrual bleeding. Usually this bleeding starts two or three days after the intake of the last tablet and is painless. In clinical trials, Marvelon showed a very low pregnancy rate, a good cycle control, a low incidence of side-effects and, as a result, a low dropout rate.

Oral contraception.

Dosage and administration
The first tablet of the first pack is taken on the first day of menstruation. This also applies when changing over from another brand of oral contraceptive. One tablet is taken daily at the same time, without interruption for 21 days, followed by a 7-day tablet-free period.
Each subsequent pack is started after the 7-day tablet-free period has elapsed.

After delivery administration can be started on the first day of the first spontaneous menstruation. If it is necessary to start earlier, e.g. immediately after delivery, additional contraceptive precautions are necessary for the first 14 days of tablet intake.

After a miscarriage or abortion administration should start immediately. In this way no additional contraceptive precautions are required.

N.B. Additional information on directions for use, changing from another oral contraceptive, missed tablets, delay of menstruation, etc. is given in the section: 'Information for the User'.

Cardiovascular or cerebrovascular disorders, e.g. thrombophlebitis and thromboembolic processes, or a history of these conditions.
Severe hypertension.
Severe liver disease or a history of this condition if the results of liver function tests have failed to return to normal; cholestatic jaundice; a history of jaundice of pregnancy or jaundice due to the use of steroids; Rotor syndrome and DubinJohnson syndrome.
Known or suspected estrogen-dependent tumours.
Endometrial hyperplasia.
Undiagnosed vaginal bleeding.
Hyperlipoproteinaemia, especially in the presence of other risk factors predisposing to cardiovascular disorders.
A history during pregnancy or previous use of steroids of severe pruritus or herpes gestationis.

Use during pregnancy and breast-feeding
This drug is contraindicated during pregnancy.
Estrogen/progestagen-containing oral contraceptives may affect the quality and reduce the quantity of milk produced. A small proportion of the active substances may be excreted in the milk.

Warnings and precautions
If any signs of thromboembolic processes occur, treatment should be discontinued immediately.
Smoking increases the risk of contracting vascular diseases, a risk increasing with age. In addition, this risk is probably slightly greater in users of estrogencontaining oral contraceptives than in non-users. Women over approximately 35 years of age should therefore be advised to stop smoking if they want to use this preparation.
In patients using estrogen-containing preparations, the risk of deep-vein thrombosis may be temporarily increased when undergoing major surgery or prolonged immobilization.
In the presence of severe varicose veins, the benefits of estrogen-containing preparations must be weighed against the possible risks.
Treatment should be discontinued if the results of liver function tests become abnormal.
Hepatic cell adenomas have been reported very rarely in women using oral contraceptives. The adenoma may present itself as an abdominal mass and/or with the signs and symptoms of acute abdominal pain. A bleeding hepatic cell adenoma should be considered if the patient has abdominal pain or signs of intra-abdominal bleeding.
Chloasma is occasionally seen during the use of estrogen and/or progestagencontaining preparations, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun while taking this preparation.
During the use of estrogen-containing oral contraceptives, depression may occasionally occur. If this is accompanied by a disturbance in tryptophan metabolism, administration of vitamin B6 might be of therapeutic value.
The use of steroids may influence the results of certain laboratory tests.
During prolonged treatment with estrogen and/or progestagen-containing preparations periodic medical examination is advisable.
Patients with any of the following conditions should be monitored: - latent or overt cardiac failure, renal dysfunction, hypertension, epilepsy or migraine (or a history of these conditions), since aggravation or recurrence may occasionally be induced. during infections or anoxia, estrogencontaining preparations may induce thromboembolic processes in patients with this condition; - estrogen-sensitive gynaecological disorders, e.g. uterine fibromyomata which may increase in size, and endometriosis which may become aggravated during estrogen treatment.

Reduced reliability
When this product is taken according to the directions for use the occurrence of pregnancy is highly unlikely. However, the reliability of oral contraceptives may be reduced when:
the tablets have not been taken in accordance with the directions for use e.g. one or more tablets have been missed.
gastro-intestinal disturbances with diarrhoea and/or vomiting have occurred within 4 hours of tablet-intake.
other drugs (see paragraph `Interactions') are used concomitantly.

If withdrawal bleeding fails to occur and none of the above mentioned events has taken place, pregnancy is highly unlikely and oral contraceptive use can be continued.

If, however, any of these events has occurred, tablet intake should be discontinued and pregnancy excluded before oral contraceptive use can be resumed.

Marvelon tablets should be taken orally. In view of this, chemical interaction of the active ingredients with other substances can be left out of consideration. Possible physiological incompatibilities are stated under 'Interactions'.

Irregular bleeding and reduced reliability may occur when oral contraceptives are used concomitantly with drugs such as anticonvulsants, barbiturates, antibiotics (e.g. tetracyclines, rifampicin, etc.), activated charcoal and certain laxatives. Oral contraceptives may diminish the glucose tolerance and increase the need for insulin or other antidiabetic drugs in diabetics.

Adverse reactions
The following adverse reactions have been associated with estrogen and/or progestagen therapy:
Genito-urinary tract

intermenstrual bleeding, post-medication amenorrhoea, changes in cervical secretion, increase in size of uterine fibromyomata, aggravation of endometriosis, certain vaginal infections, e.g. candidiasis.

tenderness, pain, enlargement, secretion.
Gastro-intestinal tract

nausea, vomiting, cholelithiasis, cholestatic jaundice.
Cardiovascular system

thrombosis, rise of blood pressure.

chloasma, erythema nodosum, rash.

discomfort of the cornea if contact lenses are used.

headache, migraine, mood changes.

fluid retention, reduced glucose tolerance, change in body weight.

The toxicity of both desogestrel and ethinylestradiol is very low. Therefore with Marvelon toxic symptoms are not expected to occur when, e.g. by young children, several tablets are taken simultaneously. Symptoms that possibly may occur in this case are: nausea, vomiting and in young girls slight vaginal bleeding. A specific treatment is probably not required, if necessary supportive treatment can be given.

The tablet bears the name 'Organon' on one side and the code 'TR 5' on the reverse side.











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