NOVOFEM

Novofem is a continuous sequential HRT product for oral use. The oestrogen is dosed continuously. The progestagen is added for 12 days of every 28 day cycle, in a sequential manner. One tablet is taken daily in the following order: oestrogen therapy (red film-coated tablet) over 16 days, followed by 12 days of oestrogen/progestagen therapy (white film-coated tablet).

After intake of the last white tablet, treatment is continued with the first red tablet of a new pack on the next day. A menstruation-like bleeding usually occurs at the beginning of a new treatment cycle. In women who are not taking HRT or women in transition from a continuous combined HRT product, treatment with Novofem may be started on any convenient day.

In women in transition from another sequential HRT regimen, treatment should begin the day following completion of the preceding regimen. 4) should be used. A switch to a higher dose combination product could be indicated if the response after 3 months is insufficient for symptom relief.

If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours have passed, the tablet should be discarded. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting.

Clinical experience The most frequently reported adverse events during treatment in clinical trials conducted with an HRT product similar to Novofem were breast tenderness and headache (reported in ≥ 10% of patients). The adverse events listed below may occur during oestrogen-progestagen treatment.

The frequencies are derived from clinical trials conducted with an HRT product similar to Novofem and from a Post-marketing Surveillance study on Novofem. System organ class Very common ≥ 1/10 Common ≥ 1/100; < 1/10 Uncommon ≥ 1/1 000; < 1/100 Rare ≥ 1/10 000; < 1/1 000 Infections and infestations Vaginal candidiasis Immune system disorders Allergic reaction Psychiatric disorders Nervousness Headache Dizziness Migraine Vertigo Insomnia Libido disorder NOS (not otherwise specified) Nervous system disorders Depression Vascular disorders Increased blood pressure.

Aggravated hypertension Peripheral embolism and thrombosis Dyspepsia Vomiting Diarrhoea Abdominal pain Bloating Flatulence Gastrointestinal disorders Nausea Gall bladder disease Hepatobiliary disorders Gallstones Rash Alopecia AcneSkin and subcutaneous tissue disorders Pruritus Musculoskeletal and connective tissue disorders Muscle cramps Breast tenderness Vaginal haemorrhage Uterine fibroid Reproductive system and breast disorders Uterine fibroids aggravated.

General disorders and administration site conditions Oedema Investigations Weight increased Post-marketing experience In addition to the above mentioned adverse drug reactions, those presented below have been spontaneously reported, and are by an overall judgement considered possibly related to Novofem treatment.

g. anaphylactic reaction/shock) – Psychiatric disorders: Anxiety – Nervous system disorders: Stroke – Eye disorders: Visual disturbances – Cardiac disorders: Myocardial infarction – Vascular disorders: Hypertension aggravated – Hepatobiliary disorders: Cholelithiasis aggravated, cholelithiasis recurrence – Skin and subcutaneous tissue disorders: Seborrhoea, angioneurotic oedema, hirsutism – Reproductive system and breast disorders: Endometrial hyperplasia, vulvovaginal pruritus – Investigations: Weight decreased.

For the treatment of postmenopausal symptoms, HRT should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be undertaken at least annually and HRT should only be continued as long as the benefit outweighs the risk.

Evidence regarding the risks associated with HRT in the treatment of premature menopause is limited. Due to the low level of absolute risk in younger women, however, the balance of benefits and risks for these women may be more favourable than in older women.

Medical examination/follow-up Before initiating or reinstituting HRT, a complete personal and family medical history should be taken. Physical (including pelvic and breast) examination should be guided by this and by the contraindications and warnings for use.

During treatment, periodic check-ups are recommended of a frequency and nature adapted to the individual woman. Women should be advised what changes in their breasts should be reported to their doctor or nurse (see ‘Breast cancer’ below).

g. mammography, should be carried out in accordance with currently accepted screening practices and modified to the clinical needs of the individual. Conditions which need supervision If any of the following conditions are present, have occurred previously and/or have been aggravated during pregnancy or previous hormone treatment, the patient should be closely supervised.

g. g. liver adenoma) – Diabetes mellitus with or without vascular involvement – Cholelithiasis – Migraine or (severe) headache – Systemic lupus erythematosus – A history of endometrial hyperplasia (see below) – Epilepsy – Asthma – Otosclerosis.

Reasons for immediate withdrawal of therapy Therapy should be discontinued in case a contraindication is discovered and in the following situations: – Jaundice or deterioration in liver function – Significant increase in blood pressure – New onset of migraine-type headache – Pregnancy.

g. g. g. angina, myocardial infarction) – Acute liver disease or a history of liver disease as long as liver function tests have failed to return to normal – Known hypersensitivity to the active substances or to any of the excipients – Porphyria.