NORGESTON

First treatment cycle:

One tablet daily, starting on the first day of the menstrual cycle, at a time of day chosen by the patient. All subsequent tablets must then be taken at this time. The contraceptive effect is likely to be reduced if a tablet is delayed by more than three hours.

Additional contraceptive precautions are not necessary when initiating treatment.

Subsequent cycles:

The tablets are taken daily and pack follows pack without interruption, and without regard to bleeding. Changing from a combined oral contraceptive (COC), vaginal ring, or transdermal patch: If the woman has correctly and consistently used the previous COC, the first tablet of Norgeston should be taken on the first day after the last active tablet of the COC pack (In the case of every day (ED) tablet use, the inactive ones should be omitted).

If a vaginal ring or transdermal patch has been used correctly and consistently before the switch, the woman should start using Norgeston on the day of removal of the last vaginal ring or transdermal patch of a cycle pack and thereby omit the hormone-free interval of this product.

Additional contraceptive precautions are not required.

Changing from another POP:

The switch can be made at any time without interruption of contraceptive protection.

Changing from a progestogen-only parenteral method (implant, injection):

The switch should be made before or when the next injection or implant is due.

Post-partum use:

Norgeston can be initiated up to 21 days post-partum (no additional contraceptive is required). If started after 21 days additional barrier contraceptive methods should be used for 7 days. However, if intercourse has already occurred, pregnancy should be excluded before the actual start of Norgeston use or the woman has to wait for her first menstrual period.

6 Post-abortion or miscarriage use After a first trimester abortion, Norgeston may be started at the time of the abortion or miscarriage. Additional contraceptive precautions will not then be required. If started after this time barrier contraceptive methods should be used for 7 days.

Summary of the safety profile:

The most commonly reported adverse reactions with progestogen-only pills including Norgeston are uterine/vaginal bleeding including spotting, menorrhagia and/or metrorrhagia and amenorrhea. They occur in ≥ 10 % of users. The undesirable effects are mapped to the respective System Organ Class (SOC), based on MedDRA v.

1. g. transient ischemic attack, ischemic stroke, haemorrhagic stroke) • Benign and malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage • Diabetes mellitus or tendency towards diabetes mellitus require careful medical supervision.

• A history of ectopic pregnancy or a missing Fallopian tube require careful weighing of the benefits of Norgeston against the risks. The frequency 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.

For progesterone-only pills (POPs) the evidence for causation is less conclusive than that for combined oral contraceptives (COCs). 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

Exclude the likelihood of pregnancy before starting treatment. Warnings The benefits of using Norgeston should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start using it.

In the event of aggravation, exacerbation or first appearance of any of these conditions or risk factors, the woman should contact her physician. The physician should then decide on whether Norgeston should be discontinued. Women should be advised that oral contraceptives do not protect against HIV infections (AIDS) and other sexually transmitted diseases.

Reasons for stopping Norgeston immediately. When stopping oral contraception non-hormonal contraception should be used to ensure contraceptive protection is maintained. 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. First signs of thrombophlebitis or thromboembolic symptoms (for example, unusual pains in or swelling of the legs, stabbing pains on breathing or coughing for no apparent reason), feeling of pain and tightness in the chest.

4. g. g. after accidents or surgery. Do not restart until 2 weeks after full ambulation. g. subcutaneous heparin. 5. Onset of jaundice, hepatitis, itching of the whole body. 6. g. recurrence of cholestatic jaundice and/or pruritus which occurred first during pregnancy or previous use of sex steroids).

3. Patients with renal impairment Norgeston has not been specifically studied in renally impaired patients. 3 Contraindications Norgeston should not be used in the presence of any of the conditions listed below. Should any of the conditions appear during the use of Norgeston, the use of the preparation must be discontinued immediately.

• Known or suspected pregnancy. • Presence or history of severe hepatic disease as long as liver function values have not returned to normal. g. stroke, myocardial infarction). • Presence or history of liver tumours (benign or malignant).

g. current or history of breast cancer). • Undiagnosed abnormal vaginal bleeding. • Severe diabetes with vascular changes. • Hypersensitivity to the active substance or to any of the excipients.