SANDRENA

Posology Sandrena is a gel for transdermal use. Sandrena can be used for continuous or cyclical treatment. 0 g gel) daily but the selection of the initial dose can be based on the severity of the patient’s symptoms. 5 mg estradiol per day.

4) should be used. In patients with an intact uterus, it is recommended to combine Sandrena with an adequate dose of progestagen, for adequate duration for at least 12–14 consecutive days per month/28 day cycle or to oppose oestrogen-stimulated hyperplasia of the endometrium.

Unless there is a previous diagnosis of endometriosis, it is not recommended to add a progestagen in hysterectomised women. In women who are not using hormone replacement therapy (HRT), or women transferring from continuous combined HRT product, treatment with Sandrena may be started on any convenient day.

In women transferring from a continuous sequential HRT regimen, treatment should begin the day following completion of the prior regimen. If the patient has forgotten to apply one dose, the forgotten dose is to be applied as soon as possible if the dose is not more than 12 hours late.

If the dose is more than 12 hours late, the dose should be forgotten and continue as normal. Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting. There is no relevant indication for use of Sandrena in children.

5 g of Sandrena gel once daily for most patients. Method of administration Apply on dry and clean skin. The Sandrena dose is applied once daily on the skin of the lower trunk or the right or left thigh, on alternate days. The application surface should be 1–2 times the size of a hand.

Sandrena should not be applied on the breasts, on the face or irritated skin. After application the gel should be allowed to dry for a few minutes and the application site should not be washed within 1 hour. Contact of the gel with eyes should be avoided.

The pump pack will require priming before using a new pump pack for the first time. The first two doses dispensed should be discarded. Re-prime the bottle if unused for 2 days/over the weekend by discarding the first dose. g. child or spouse) or pet accidentally touches the application site, that area of their skin should be washed with soap and water right away.

g. child, spouse, pets), which may cause adverse effects to them. In case of any signs of symptoms of adverse effects, physician or veterinarian should be contacted. 4).

During the first few months of treatment, breakthrough bleeding, spotting and breast tenderness or enlargement can occur. These are usually temporary and normally disappear after continued treatment. g. in 3 phase III clinical studies (n = 611 women at risk) and were included in the table when considered at least possibly related to treatment with 50 mcg/day estradiol or 100 mcg/day estradiol, respectively, following transdermal application.

The table below lists adverse drug reactions recorded in clinical studies as well as adverse drug reactions reported post-marketing. The experience of adverse drug reactions is overall expected in 76 % of the patients. Adverse drug reactions appearing in > 10 % of patients in clinical trials were application site reactions and breast pain.

Undesirable effects according to organ system class associated with transdermal estradiol treatment are presented in the table below. e. deep leg or pelvic venous thrombosis and pulmonary embolism) 2 Cerebral ischaemic events Respiratory, thoracic and mediastinal disorders Dyspnoea1, rhinitis1 Gastrointestinal system disorders Nausea, vomiting, stomach cramps, flatulence, abdominal pain Constipation, dyspepsia1, diarrhoea1, rectal disorder1 Bloating (abdominal distension) Hepatobiliary disorders Alterations in liver function and biliary flow Cholestatic jaundice Skin and subcutaneous disorders Rash, pruritus Acne, alopecia, dry skin, nail disorder1, skin nodule1, hirsutism1, erythema nodosum, urticaria Contact dermatitis, eczema Musculoskeletal and connective tissue disorders Joint disorders, muscle cramps Renal and urinary disorders Increased urinary frequency/urgenc y, urinary incontinence1, cystitis1, urine discoloration1, haematuria1 Reproductive system and breast disorders Unscheduled vaginal bleeding or spotting, vaginal discharge, disorder of vulva/vagina, menstrual disorder, breast pain/tension Breast enlargement, breast tenderness, endometrial hyperplasia, uterine disorder1 Dysmenorrhea, pre-menstrual like syndrome Organ system class Common ADRs, (≥ 1/100, < 1/10) Uncommon ADRs, (≥ 1/1 000, < 1/100) Rare ADRs, (≥ 1/10 000, < 1/1 000) Adverse events reported post marketing with frequency not known (cannot be estimated from the available data) General disorders and administration site conditions Skin irritation, application site pain, increased sweating, edema Fatigue, abnormal laboratory test1, asthenia1, fever1, flu syndrome1, malaise1 1 have been reported in single cases in clinical trials.

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 hormone replacement therapy (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, 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 - Angioedema (hereditary or acquired).

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