CYPROTERONE ACETATE

035 mg inhibits ovulation and thereby prevents conception. 035 mg should not therefore use an additional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and it is not necessary for effective contraception.

Posology First treatment course:

One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1). Women with amenorrhoea should start therapy immediately. In this case the first day of tablet intake is considered as the first day of the cycle.

Subsequent courses:

Each subsequent course is started after 7 tablet-free days have followed the preceding course. 035 mg is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started.

035 mg should be taken on the first day immediately after the end of the previous oral contraceptive course. Additional contraceptive precautions are not required. 035 mg should be started after taking the last active tablet from the Every Day Pill pack.

035 mg tablet is taken the next day. Additional contraceptive precautions are not then required. 035 mg should be taken on the first day of bleeding, even if a POP has already been taken on that day. Additional contraceptive precautions are not then required.

The remaining progestogen-only pills should be discarded. 035 mg can be started 21 days after a vaginal delivery, provided that the patient is fully ambulant and there are no puerperal complications. Additional contraceptive precautions will be required for the first 7 days of pill taking.

Since the first post-partum ovulation may precede the first bleeding, another method of contraception should be used in the interval between childbirth and the first course of tablets. 035 mg. 035 mg may be started immediately in which case no additional contraceptive precautions are required.

Duration of Use Time to relieve of symptoms is at least three months. The need to continue treatment should be evaluated periodically by the treating physician. The length of use depends on the severity of the clinical picture. Complete remission of acne is expected within a few months of commencing treatment, but in particularly severe cases treatment for longer may be necessary before the full benefit is seen.

035 mg are nausea, abdominal pain, increased weight, headache, depressed mood, altered mood, breast pain, breast tenderness. They occur in ≥ 1 % to <10% of the users. 4). Adverse reactions are listed according to MedDRA frequency convention and system organ class database.

4. 4: • Venous thromboembolic disorders • Arterial thromboembolic disorders • Hypertension • Liver tumours (benign and malignant) • Occurrence or deterioration of conditions for which association with COC use is not conclusive: Crohn's disease, ulcerative colitis, jaundice and/or pruritus related to cholestasis; gallstone formation; systemic lupus erythematosus; herpes gestationis; otosclerosis-related hearing loss; porphyria; cervical cancer; haemolytic uremic syndrome; Sydenham's chorea; epilepsy.

• Chloasma • Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal • In women with hereditary angioedema exogenous oestrogens may induce or exacerbate symptoms of angioedema The frequency of diagnosis of breast cancer is very slightly increased among OC users.

As breast cancer is rare in women under 40 years of age the excess number is small in relation to the overall risk of breast cancer. Causation with COC or cyproterone acetate/ethinylestradiol use is unknown. 4. 4). 5). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

Medical Examination Assessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. 4) for this product. The frequency and nature of these assessments should be based upon relevant guidelines and should be adapted to the individual woman, but should include measurement of blood pressure and, if judged appropriate by the clinician, breast, abdominal and pelvic examination including cervical cytology.

Exclude the likelihood of pregnancy before starting treatment. Undiagnosed vaginal bleeding that is suspicious for underlying conditions should be investigated. 035 mg is composed of the progestogen cyproterone acetate and the oestrogen ethinylestradiol and is administered for 21 days of a monthly cycle.

It therefore has a similar composition to that of a combined oral contraceptive (COC). Duration of use Time to relief of symptoms is at least three months. 2). 035 mg does not protect against HIV infections (AIDS) and other sexually transmitted diseases.

035 mg. In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. 035 mg should be discontinued. e. 035. 8). Depression can be serious and is a well-known risk factor for suicidal behaviour and suicide.

Women should be advised to contact their physician in case of mood changes and depressive symptoms, including shortly after initiating the treatment. 035 mg immediately: When stopping oral contraception non-hormonal contraception should be used to ensure contraceptive protection is maintained, if needed.

1. Occurrence for the first time, or exacerbation, of migrainous headaches or unusually frequent or unusually severe headaches. 2. Sudden disturbances of vision or hearing or other perceptual disorders. 3. g. unusual pains in or swelling of the leg(s), stabbing pains on breathing or coughing for no apparent reason).

3. 035 mg has not been specifically studied in renally impaired patients. Available data do not suggest a change in treatment in this patient population. Method of administration Oral use. 3 Contraindications Preparations containing oestrogen/progestogen combinations should not be used in the presence of any of the conditions listed below.

Should any of the conditions appear for the first time during their use, the product should be stopped immediately. g. g. g. g. 1. 035 mg is not for use in men.