ELLESTE DUET

Posology This product is a continuous sequential HRT. One white tablet to be taken daily for the first 16 days, followed by one pale green tablet for the next 12 days. A new cycle should then begin without any break. Therapy may start at any time in patients with established amenorrhoea or who are experiencing long intervals between spontaneous menses.

In patients who are menstruating, it is advised that therapy starts on the first day of bleeding. Patients changing from another cyclical or continuous sequential preparation should complete the cycle and may then change to Elleste Duet 1mg without a break in therapy.

Patients changing from a continuous combined preparation may start therapy at any time if amenorrhoea is established, or otherwise start on the first day of bleeding.

Elleste Duet tablets are available in two strengths:

Elleste Duet 1 mg (containing 1 mg estradiol and 1 mg norethisterone acetate) and Elleste Duet 2 mg (containing 2 mg estradiol and 1 mg norethisterone acetate). 4) should be used. Elleste Duet 2 mg is additionally indicated for prevention of osteoporosis in postmenopausal women at high risk of future fractures and who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis.

Missed Tablet:

If a tablet is missed it should be taken within 12 hours of when normally taken; otherwise the tablet should be discarded, and the usual tablet should be taken the following day. If a tablet is missed there is an increased likelihood of breakthrough bleeding or spotting.

Elderly There are no special dosage requirements for elderly patients. Paediatric population Not to be used in children. Method of administration For oral use.

The most commonly reported adverse experiences are breast tension and pain, dysmenorrhoea, irregular bleeding, and headache. Within each frequency grouping, adverse drug reactions are presented in the order of decreasing seriousness.

Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (< 1/10,000); not known (cannot be estimated from the available data). System organ class (MedDRA SOC level) Very common ( ≥1/10) Common ( ≥1/100 to <1/10) Uncommon ( ≥1/1,000 to <1/100) Rare ( ≥1/10,000 to <1/1,000) Very rare (<1/10,000) not known** (cannot be estimated from the available data) Immune system disorders Hyper- sensitivity Psychiatric disorders Depression*, nervousness*, affect lability, libido disorder Nervous system disorders Headache*.

Dizziness*, insomnia* Migraine, vertigo Paraesthesia Vascular disorders Hypertension, varicose veins Embolism venous***, thrombo- phlebitis Gastrointestinal disorders Nausea, abdominal distension*, diarrhoea*, dyspepsia*, abdominal pain Vomiting Hepatobiliary disorders Gallbladder disorder, cholelithiasis Jaundice cholestatic Skin and subcutaneous tissue disorders Acne*, rash, pruritus*, dry skin Skin discoloration Hirsutism Alopecia Musculoskeletal and connective tissue disorders Back pain*, pain in extremity* Muscle spasms Myasthenia Reproductive system and breast disorders Breast pain*, breast tenderness, dysmenorrhoea*, menstrual disorder* Breast enlargement*, menorrhagia*, genital discharge *, irregular vaginal bleeding, uterine spasms, vaginal infection, endometrial hyperplasia Breast cancer Uterine leiomyoma, fallopian tube cysts, endocervical polyps General disorders and administration site conditions Pain, asthenia, oedema peripheral*, weight increased* Investigations Transaminases increased (*) Adverse reactions associated with oestrogen and progestogen have been found to be relatively less frequent with the lowest dosage strength.

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. 4 Special warnings and precautions 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, 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 contra-indication 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 Endometrial Hyperplasia and Carcinoma In women with an intact uterus, the risk of endometrial hyperplasia and carcinoma is increased when oestrogens are administered alone for prolonged periods.

g. g. g. 1; Porphyria.