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					Scheduling status Proprietary name (and dosage form) Marvelon® 150/30 (tablets) Composition

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21 larger white tablets containing 0,15 mg desogestrel and 0,03 mg ethinyl oestradiol. 7 smaller white tablets that do not contain any active ingredients. Pharmacological classification A/18.8/Ovulation controlling agents Pharmacological action Marvelon 150/30 is an oestrogen/progestogen combination oral contraceptive which inhibits ovulation. Indications Oral contraception. Contra-indications Thrombophlebitis, thromboembolic processes, or a history of these complaints. Disturbances of the liver function, jaundice, Rotor syndrome and the Dubin-Johnson syndrome. NB: The use of MARVELON 150/30 is not contra-indicated in patients with a history of hepatitis whose liver functions are normal. Known or suspected mammary carcinoma. Known or suspected hormone dependant tumours. Sickle cell anaemia. Undiagnosed genital bleeding. Porphyria. Pregnancy. Pregnancy must be excluded before therapy is started. Marvelon 150/30 is contra-indicated in hyperlipoproteinaemia, especially in the presence of other risk factors which may indicate a predisposition for cardiovascular disorders. Marvelon 150/30 is contra-indicated in patients with severe migraine or cerebrovascular insufficiency. Medication should be discontinued immediately if migraine becomes focal or 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, depression or states in which fluid retention occurs. Marvelon 150/30 should be avoided in patients who are breast feeding.

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Dosage and directions for use The tablets should be taken orally without chewing. One tablet is taken daily without interruption for 28 days beginning on the first day of the cycle, ie. the first day of menstruation, with a tablet from the green starting zone which is marked with the appropriate day of the week. When the pack of 28 tablets is empty, a new pack is started the following day with a tablet from the green starting zone of the new pack, thus without interruption.

Switch over Women may change without inconvenience from any other oral contraceptive to Marvelon 150/30. Use of the current pack must first be completed before administration of Marvelon 150/30 is started. The first Marvelon 150/30 tablet is taken from the green starting zone on the first day of the withdrawal bleeding following the intake of the last active tablet of the previous pack, provided that this bleeding starts within 7 days after taking the last active tablet. Tablet intake of Marvelon 150/30 is then continued as listed in the information for the user. If no bleeding has occurred within 7 days of taking the last active tablet of the previous pack, pregnancy should be ruled out before starting to use Marvelon 150/30 . Note: When a 28 tablet preparation is being used the withdrawal bleeding occurs while (non-active) tablets are still being taken. After Marvelon 150/30 use has been started from the green starting zone on the first day of this bleeding, the remaining tablets of the previous pack can be thrown away. Side-effects and special precautions Occasionally menstruation fails to occur during the intake of the placebo tablets especially during the first few treatment cycles. If the tablets have been taken as directed, it is unlikely that the patient will be pregnant. However, the patient must consult her doctor in order to rule out the possibility of pregnancy. - During the first few months of treatment, irregular bleeding may occur. If it does occur, tablet-taking should not be interrupted. If the irregular bleeding resembles a normal menstruation the patient should consult her doctor. - Nausea, headache and breast tenderness may also be experienced during the first cycles. If these symptoms do not disappear spontaneously the doctor should be informed. - Symptoms such as sudden and severe headaches, pain in the chest, visual disturbances and a swollen leg or arm require medical examination. - If jaundice occurs during the use of the product - which is not necessarily treatment related administration should be discontinued immediately. - Vaginal candidiasis, skin pigmentation, gall bladder disease, gastrointestinal irritation and fluid retention may occur. - Depression may occur. In a number of these women there may be a disturbance of tryptophan metabolism, and in such cases the administration of Vitamin B6 is of therapeutic value. During the use of Marvelon 150/30 the body mass may increase. Chloasma is occasionally seen during the use of Marvelon 150/30 especially in women with a previous history of chloasma gravidarum. Women with a tendency to chloasma should avoid excessive exposure to the sun while taking this preparation. The incidence of disease 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 incidents and venous thrombosis are more likely to occur in women aged 35 years or over, particularly if they have used the contraceptive for longer than 5 years, if they smoke, if they are obese, or if they are hypertensive. Additional risk factors are diabetes, hypercholesterolaemia and familial hyperlipoproteinaemia. However, the risk of mortality due to oral contraceptives in women under 35 who are in the high risk group is in general far less than the risk of mortality due to pregnancy.

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It is advisable to perform periodic physical examinations once every three months during the first year of treatment and every six months thereafter. These examinations should pay particular attention to the duration of the cycle, body mass, blood pressure, breasts, pelvic organs, legs and skin. If any signs of thromboembolic processes occur, the use of the preparation should be stopped immediately. Marvelon 150/30 may increase the risk of thrombosis and this should be taken into account when surgery is to be performed on patients using this preparation. Patients with myocardial or renal dysfunction or epilepsy require careful observation. Caution should be observed in young women whose cycles are not yet stabilised. Marvelon 150/30 may cause an increase in blood pressure in women who are prone to hypertension, and this should be checked regularly, including pretreatment level. In case of a significant increase in blood pressure, the use of the preparation should be stopped immediately. The physician should be aware of the fact that the reliability of MARVELON ®150/30 is reduced when a tablet is forgotten, other medications such as rifampicin, barbiturates or anti-epileptics are used concomitantly, or when gastro-intestinal disturbances occur during tablet taking. Therefore, if no withdrawal bleeding occurs, it is advisable to make sure that these conditions have not played a role. If the possibility cannot be excluded, tablet taking must be stopped immediately, because the chance of pregnancy is then very high. If a patient has missed two consecutive withdrawal bleeds, pregnancy should be ruled out before resuming tablet taking. With vomiting or diarrhoea, the absorption of Marvelon 150/30 may be diminished and women should be advised to use additional methods of contraception at the time of such disorders. Whenever there is reason to suspect the presence of pregnancy, this must be checked. As soon as the presence of pregnancy has been established, tablet taking must be discontinued immediately. Administration after delivery should start preferably on the first day after the spontaneous menstruation. If it is necessary to start treatment earlier, e.g. immediately after delivery, other contraceptive measures should also be used during the first 14 days of tablet taking. Suppression of lactation may occur when administration is started immediately post-partum. Caution should be exercised in prescribing Marvelon 150/30 to women with a previous history of herpes gestationis. Prolonged amenorrhoea following the use of oral contraceptives may occur. The incidence is small. Caution is advised where oligomenorrhoea or amenorrhoea have occurred in the past. 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. MARVELON 150/30 should be discontinued if persistent upper abdominal pain develops.

Effects on laboratory tests: Marvelon 150/30 may interfere with some laboratory estimations, in particular hormones, glucose tolerance, thyroid function, blood coagulation, serum triglycerides and liver function tests. Under no circumstances should Marvelon 150/30 be stopped without having adopted a satisfactory alternative method of contraception. 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 only take extra precautions for the first two weeks of antibiotic therapy. Spotting and breakthrough bleeding are possible signs of diminished contraceptive effectiveness.

Known symptoms of overdosage and particulars of its treatment When large doses are swallowed, nausea and possible withdrawal bleeding in females above the age of 4 years may occur. Treatment is supportive and symptomatic. Conditions of registration Product to be advertised to the professions only. Identification Marvelon 150/30 consists of two types of tablets distinguished by mark and size. The 21 larger white tablets contain the active ingredients and are round and biconvex. They have bevelled edges, coded ORGANON and a star on one side and the tablet code TR above 5 on the reverse. The 7 smaller white tablets are round and flat with bevelled edges coded KH above 2 on one side and a square on the reverse. Presentation Push-through strips contain 21 active white tablets and 7 smaller white placebo tablets, the latter being circled in red. Storage instructions Store below 30 °C. Protect from light and moisture. Keep out of reach of children. Registration number Q/18.8/324 Name and business address of the applicant Donmed Pharmaceuticals (Pty) Ltd Donmed House Cambridge Place cnr Kirkby & Oxford Roads Bedfordview 2007 Date of publication of this package insert 26 May 1986
Under license of NV Organon, The Netherlands


				
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