- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
Special circumstances requiring additional contraception:Management of missed pills: If the user forgets a pill she should take it as soon as she remembers and carry on with the next pill at the same time. If the pill was more than 3 hours overdue (> 27 hours since the last pill was taken) she will not be protected from pregnancy. She should continue normal pill taking but must also use barrier contraceptive methods for the next 7 days. If intercourse took place in the preceding 7 days, the possibility of a pregnancy should be considered. The more tablets are missed, the higher the risk of a pregnancy.Gastro-intestinal upsets: If vomiting occurs within 2 hours of taking a tablet, another pill should be taken as soon as possible. If a replacement pill is not taken within 3 hours of the scheduled time, additional, barrier contraceptive methods should be used for 7 days. In cases of persistent vomiting and/or very severe diarrhoea, additional barrier contraceptive methods should be used during the illness and for 7 days after recovery.
Medical ExaminationAssessment of women prior to starting oral contraceptives (and at regular intervals thereafter) should include a personal and family medical history of each woman. Physical examination should be guided by this and by the contraindications (section 4.3) and warnings (section 4.4) 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.
WarningsWomen 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. Six weeks before an elective major operation (e.g. abdominal, orthopaedic) any surgery to the legs, medical treatment for varicose veins or prolonged immobilisation e.g. after accidents or surgery. Do not restart until 2 weeks after full ambulation. In case of emergency surgery, thrombotic prophylaxis is usually indicated e.g. subcutaneous heparin.5. Onset of jaundice, hepatitis, itching of the whole body.6. Clear exacerbation of conditions known to be capable of deteriorating during oral contraception or pregnancy (e.g. recurrence of cholestatic jaundice and/or pruritus which occurred first during pregnancy or previous use of sex steroids).7. Pregnancy is a reason for stopping immediately because it has been suggested by some investigations that oral contraceptives taken in early pregnancy may slightly increase the risk of foetal malformations. Other investigations have failed to support these findings. The possibility therefore cannot be excluded, but it is certain that if a risk exists at all it is very small.
Circulatory DisordersIn the few epidemiological studies conducted, which are limited in the number of subjects, there is little evidence for an association between progestogen only pills and an increased risk of myocardial infarction and cerebral thromboembolism. The risk of cardiovascular and cerebral events is rather related to increasing age, hypertension, and smoking. In women with hypertension the risk of stroke may be slightly enhanced by progestogen-only pills.There may be a slightly, but not statistically significant increased risk of venous thromboembolism (deep venous thrombosis, pulmonary embolism) associated with the use of progestogen-only pills. Generally recognized risk factors for venous thromboembolism (VTE) include a positive personal or family history (VTE in a sibling or a parent at a relatively early age), age, obesity and prolonged immobilization, major surgery or major trauma.
Tumours• Breast CancerA meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk of having breast cancer diagnosed in women who are currently using oral contraceptives (OC). The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The additional breast cancers diagnosed in current users of OCs or in women who have used OCs in the last 10 years are more likely to be localised to the breast than those in women who never used OCs.Breast cancer is rare among women under 40 years of age whether or not they take OCs. Whilst the background risk increases with age, the excess number of breast cancer diagnoses in current and recent progestogen-only pill (POP) users is small in relation to the overall risk of breast cancer, possibly of similar magnitude to that associated with combined OCs. However, for POPs, the evidence is based on much smaller populations of users and so is less conclusive than that for combined OCs. Available studies do not provide evidence for causation.The most important risk factor for breast cancer in POP users is the age women discontinue the POP; the older the age at stopping, the more breast cancers are diagnosed. Duration of use is less important and the excess risk gradually disappears during the course of the 10 years after stopping POP use, such that by 10 years there appears to be no excess.The evidence suggests that compared with never-users, among 10,000 women who use POPs for up to 5 years but stop by age 20, there would be much less than 1 extra case of breast cancer diagnosed up to 10 years afterwards. For those stopping by age 30 after 5 years use of the POP, there would be an estimated 2-3 extra cases (additional to the 44 cases of breast cancer per 10,000 women in this age group never exposed to oral contraceptives). For those stopping by age 40 after 5 years use, there would be an estimated 10 extra cases diagnosed up to 10 years afterwards (additional to the 160 cases of breast cancer per 10,000 never-exposed women in this age group).It is important to inform patients that users of all contraceptive pills appear to have a small increase in the risk of being diagnosed with breast cancer, compared with non-users of oral contraceptives, but that this has to be weighed against the known benefits.• Liver CancerIn rare cases benign, and in even rarer cases, malignant liver tumours leading in isolated cases to life-threatening intra-abdominal haemorrhage have been observed after the use of hormonal substances such as the one contained in Norgeston. If severe upper abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a liver tumour should be included in the differential diagnostic considerations.
Other conditions• DiabetesDiabetes mellitus or tendency towards diabetes mellitus requires careful medical supervision.• Ectopic PregnancyIf there is a history of ectopic pregnancy or one Fallopian tube is missing, the use of Norgeston should be decided on only after carefully weighing the benefits against the risks.If obscure lower abdominal complaints occur together with an irregular cycle pattern (above all amenorrhoea followed by persistent irregular bleeding), an extrauterine pregnancy must be considered.• Persistent ovarian folliclesPersistent ovarian follicles (often referred to as functional ovarian cysts) may occur during the use of Norgeston. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia. In most cases, the enlarged follicles disappear spontaneously during two to three months of observation.• ChloasmaChloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Norgeston.• Lactose and Sucrose intoleranceEach tablet of this medicinal product contains 33.12 mg lactose and 19.66 mg sucrose per tablet. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, fructose intolerance or glucose-galactose malabsorption or sucrase-isomaltase should not take this medicine.• Bleeding patternsMenstrual changes: A usual feature of all progestogen-only oral contraceptives is that they can produce an initial irregularity of the bleeding pattern, but such irregularity tends to decrease with time. Some women may experience amenorrhoea.For these reasons the possibility of such changes in menstrual rhythm should, as a precaution, be pointed out to the patient before the start of tablet-taking.Amenorrhoea / Missed menstruation: If no menstrual bleeding has occurred within 6 weeks after the last menstrual bleeding, pregnancy must be excluded before tablet-taking is continued. If pregnancy has been excluded and the amenorrhoea lasts longer than 3 months or recurs repeatedly, Norgeston should be withheld until normal menstrual bleeding has been restored.Procedure in the event of irregular bleeding: Irregular bleeding is not a medical reason for stopping tablet-taking, as long as organic causes for such bleeding and pregnancy can be ruled out provided it is ensured that the patient is fully compliant.It is extremely inadvisable to attempt to influence cycle disturbances by the additional administration of an oestrogen. This would only serve to reverse the changes brought about by Norgeston in the cervical mucus, thereby seriously reducing the contraceptive effect.
Effect on blood chemistry:The use of oral contraceptives may influence the results of certain laboratory tests including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of carrier proteins and lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Laboratory staff should therefore be informed about oral contraceptive use when laboratory tests are requested.
Immune system disordersAllergic reaction
Metabolism and nutrition disordersIncreased or decreased weight
Psychiatric disordersDepressed mood
Nervous system disordersMigraine, Headache, Dizziness
Gastrointestinal disordersVomiting, Nausea
Reproductive system and breast disordersChanges in vaginal bleeding pattern (including irregular bleeding, amenorrhoea)Decreased or increased libidoThe following serious adverse events have been reported in women using OCs, which are discussed in section 4.4 'Special warnings and precautions for use':• Venous thromboembolic disorders• Arterial thromboembolic disorders• Strokes (e.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).
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