Indivina

PRESCRIBING INFORMATION CAN BE FOUND HERE

INDIVINA OVERVIEW:

Indivina is available in 3 different strengths, allowing simple tailoring of therapy to suit individual women. The low starting dose may be suitable for most postmenopausal women.

Hormone Replacement Therapy (HRT) is for oestrogen deficiency symptoms in women with an intact uterus more than 3 years after menopause. 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 experience of treating women older than 65 years is limited.

INDIVIDUAL FLEXIBILITY:

• Offers 3 flexible strength options - 1mg/2.5mg, 1mg/5mg, 2mg/5mg
• Effective reduction of climacteric symptoms¹
• Low incidence of breakthrough bleeding¹
• Low incidence of discontinuations¹

Estradiol is a naturally occurring form of oestrogen (plant origin) and medroxyprogesterone is a synthetic form of progesterone

PRESCRIBE INDIVINA FOR WOMEN:

• On monthly or quarterly sequential HRT ready for continuous combined HRT
• Who may not have had effective relief from their current postmenopausal HRT¹
• Post-menopausal who have not had a natural menstrual bleed in the last three years with an intact uterus to relieve menopausal symptoms

SAFETY PROFILE:

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 idiopathic or current venous thromboembolism
• Known thrombophilic disorders
• Active or recent arterial thromboembolic disease
• Acute liver disease or a history of liver disease
• Hypersensitivity to the active substances or to any of the excipients
• Porphyria

SIDE EFFECTS:

The most frequently reported undesirable effect during Indivina treatment in clinical trials was breast tenderness, which occurred in 10.6% of users.

The common side effects include:

• Increase or decrease of weight
• Depression, nervousness, lethargy
• Headache, dizziness
• Hot flushes
• Nausea, vomiting, stomach cramps, flatulence
• Breasts become tender or painful
• Increase in sweating

See SPC for more information.

June 2023/HRT-2baa(1)

ADVERSE EVENTS SHOULD BE REPORTED. REPORTING FORMS AND INFORMATION CAN BE FOUND AT WWW.MHRA.GOV.UK/YELLOWCARD. ADVERSE EVENTS SHOULD ALSO BE REPORTED TO ORION PHARMA (UK) LTD ON 01635 520300.