FREQUENCY

82 % MEAN REDUCTION IN VMS

FREQUENCY 3, 4

SEVERITY

43 % MEAN REDUCTION IN VMS

SEVERITY 3, 4

RESPONDERS

86 % OF WOMEN RESPONDED( VMS) 3, 4

OF WOMEN TREATED WITH ESTROGEL ®( 1.5MG ESTRADIOL) SHOWED IMPROVEMENT IN

5

VULVOVAGINAL ATROPHY AFTER 12 WEEKS( vs 71 % for placebo, p < 0. 01; as defined by Meisel’ s score)

PBS Information: EstrogelPro, Estrogel & Prometrium are listed on the PBS. Refer to the PBS for more details.

Minimum Product Information Estrogel( estradiol hemihydrate) gel. Indications: Hormone replacement therapy( HRT) for estrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The lowest effective dose should be used for the shortest duration. Contraindications: Known, past or suspected breast cancer; Known or suspected estrogen-dependent malignant tumours( e. g. endometrial cancer); Undiagnosed genital bleeding; Untreated endometrial hyperplasia; Previous or current venous thromboembolism( e. g. deep venous thrombosis, pulmonary embolism); Known thrombophilic disorders( e. g. protein C, protein S, or antithrombin deficiency); Active or recent arterial thromboembolic disease( e. g. angina, myocardial infarction); Acute liver disease, or a history of liver disease as long liver function tests have failed to return to normal; Known or suspected pregnancy; Lactation; Known hypersensitivity to the active substances or to any of the excipients; Porphyria. Precautions: Appraisal of the risks and benefits should be undertaken at least annually. Refer to full Product information( PI) for conditions which require supervision during treatment with Estrogel. Treatment should be withdrawn if the following occur, jaundice or deterioration in liver function; significant increase in blood pressure; new onset of migraine type headache; pregnancy. Caution: endometrial hyperplasia and carcinoma, breast cancer, ovarian cancer, venous thromboembolism, coronary artery disease( CAD), ischaemic stroke, thyroid function, elderly, ALT elevations, paediatric use( see full PI). Interactions: use of concomitant skin medications, surface active agents or strong skin cleansers and detergents should be avoided at site of application, metabolism of estrogens may be increased by concomitant use of inducers of hepatic enzymes such as anticonvulsants( phenobarbital, phenytoin, carbamezapine) and anti-infectives( rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir) and some herbal preparations( St John’ s wort) reducing the effectiveness of estrogen. Estrogel as a transdermal administration might be less affected than other oral hormones by enzyme inducers. Concomitant use of estrogens with lamotrigine may decrease lamotrigine plasma concentrations. Caution is warranted for co-administration with hepatitis C virus( HCV) combination regimens ombitasvir / paritaprevir / ritonavir with or without dasabuvir and the regimen glecaprevir / pibrentasvir may cause greater than usual ALT elevations. Pregnancy Category B3; not for use in lactation. Adverse Effects: headache, nausea, abdominal pain, breast swelling / pain, breast enlargement, dysmenorrhea, menorrhagia, metrorraghia, leucorrhoea, endometrial hyperplasia, weight gain( increase or decrease), water retention with peripheral edema( see full PI). Dosage and Administration: Estrogel should be used daily on a continuous basis. Estrogel as an estrogen only product is indicated only for women without a uterus. In women with an intact uterus it is recommended to add a progestogen for at least 12 days of each month. Although some women will respond to 1.25 g daily( 1 pump), the usual starting dose is 2.5 g per day( 2 pumps). If after one month of treatment, effective relief of menopausal symptoms is not obtained the dosage may be increased to a maximum of 5 g( 4 pumps)( see full PI). The lowest effective dose should be used for maintenance therapy. The optimal daily maintenance dose needs to be reevaluated regularly( e. g. annually). Estrogel should only be continued for as long as the benefit outweighs the risk. The correct dose of gel should be dispensed and applied to clean, dry, intact areas of skin e. g. on the arms and shoulders, and / or inner thighs. The area of application should be as large as possible. Refer to Full Product Information before prescribing. Minimum Product Information Prometrium( oral, micronised progesterone) Indications: menstrual irregularities; adjunctive use with an estrogen in postmenopausal women with an intact uterus. Contraindications: known allergy / hypersensitivity to progesterone or excipients; severe hepatic dysfunction; undiagnosed vaginal bleeding; known missed abortion / ectopic pregnancy; mammary / genital tract carcinoma; thromboembolic disorders; thrombophlebitis; cerebral haemorrhage; porphyria. Clinically Significant Precautions: not a treatment for premature labour; not a contraceptive; discontinue if unexplained visual loss / changes, proptosis, diplopia, papilloedema, retina vascular lesions or migraine; use caution in conditions affected by fluid retention and history of depression, diabetes, hepatic dysfunction, migraine, photosensitivity and during lactation; increased risk of breast cancer and venous thromboembolism with estrogen concomitant therapy( refer estrogen PI); may cause drowsiness; may affect laboratory test results. Clinically Significant Interactions: caution with P450 enzyme inducers and inhibitors; may increase antidiabetic medication; bioavailability may be reduced by smoking and increased by alcohol abuse. Very Common and Common Adverse Effects: menstrual disturbances; headache. Dosage and Use: take capsules( 100mg / 200mg) orally, OD at bedtime without food. Hormone Replacement Therapy: 200 mg / d for 12d( d15 – d26) of the cycle; or 100mg can be given from d1 – d25. Secondary amenorrhoea: 400mg / d for 10d. Ovulation disorders / anovulation: 200 – 300mg for 10d( d17 – d26, inclusive).

References: 1. Estrogel ®( estradiol hemihydrate) Product Information, updated updated 18 December 2023. 2. Prometrium ®( micronised progesterone) Product Information, updated 1 Feb 2022. 3. Archer DF, et al. Menopause. 2003; 10( 6): 516 – 521. 4. Archer DF et al. Menopause 2012; 19( 6): 622 – 629. 5. Kornafel KL et al. South Med J 1992; 85( 3): 270 – 73. Estrogel ® and Prometrium ® are registered trademarks of Besins Healthcare. Besins Healthcare Australia Pty Ltd ABN 68 164 882 062. Suite 5.02, 12 Help Street, Chatswood NSW 2067. Office phone( 02) 9904 7473. For medical information call 1800 BESINS( 237 467). www. besins-healthcare. com. au EPR-EST-PRM-2392 April 2025

Medicine co-pack containing one pack of Estrogel ®( estradiol hemihydrate) plus one pack of Prometrium ®( micronised progesterone) for women with a uterus

Please review the Product Information before prescribing, accessible at besins-healthcare. com. au / PI or 1800 BESINS( 237 467), or by scanning the QR code:

Jamie Thannoo A WOMAN has died of a brain infection after performing nasal irrigation using water taken directly from her motorhome’ s tap, US investigators report.

The 71-year-old woman developed severe neurological symptoms— including fever, headache, altered mental status and seizures— four days after using a sinus flush squirt bottle.

Despite medical treatment in Texas for a suspected primary amoebic meningoencephalitis infection, the woman died eight days after symptom onset, according to the US Centers for Disease Control and Prevention’ s Morbidity and Mortality Weekly Report. An autopsy confirmed the presence of the amoeba Naegleria fowleri in the woman’ s CSF.

“ The patient had no recreational exposure to fresh water,” the investigators wrote.

“ However, she had reportedly performed nasal irrigation on several occasions using non-boiled water from the recreational vehicle’ s potable water faucet during the four days before illness onset.”

The motorhome’ s potable water tank had been filled with water collected sometime before the patient’ s purchase of the vehicle three months earlier.

A second potential source of contamination was the municipal water system, which was connected to the motorhome’ s water system at the time the patient used it for nasal irrigation.

Investigators examined 12 environmental sample points in and near the motorhome.

No trace of N. fowleri was found, but investigators attributed this to a 23-day delay between the woman flushing her nose and sampling.

They ruled the motorhome water was likely to blame. MMWR Morb Mortal Wkly Rep 2025; 29 May.