Duavee
(Estrogens, Conjugated/Bazedoxifene Acetate)

What Duavee is and what it is used for

DUAVIVE is a medicine that contains two active substances called conjugated oestrogens and bazedoxifene. Conjugated oestrogens is a medicine that belongs to a group of medicines called hormone replacement therapy (HRT). Bazedoxifene belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs). DUAVIVE is used in postmenopausal women who still have their uterus (womb) with at least 12 months since their last natural period. DUAVIVE is used for: Relief of symptoms occurring after menopause During the menopause, the amount of the oestrogen produced by a woman’s body drops. This can cause symptoms such as hot face, neck and chest ("hot flushes"). DUAVIVE alleviates these symptoms after menopause. You will only be prescribed this medicine if your symptoms seriously hinder your daily life and your doctor determines that other types of HRT are not appropriate for you

How to take Duavee

Your doctor will aim to prescribe the lowest dose to treat your symptom for as short as necessary. Speak to your doctor if you think this dose is too strong or not strong enough. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. You should continue taking this medicine for as long as your doctor tells you. In order for this medicine to work, it should be taken daily as prescribed.
•The recommended dose is one tablet once daily. Swallow the tablet whole with a glass of water.
•You can take the tablet at any time of the day, with or without food; however, it is advisable to take your tablet at the same time each day as this will help to remind you to take your medicine. If you are having an operation If you are going to have surgery, tell the surgeon you are taking DUAVIVE. You may need to stop taking DUAVIVE about 4 to 6 weeks before the operation, to reduce the risk of a blood clot (see section 2, Blood clots in a vein). Ask your doctor when you can start taking this medicine again. If you take more DUAVIVE than you should Call your doctor or pharmacist. If you take too many tablets you may have nausea (feel sick) or vomit. You may experience breast tenderness, dizziness, abdominal pain, drowsiness/fatigue or experience a short period of vaginal bleeding. If you forget to take DUAVIVE If you forget to take a tablet, take it as soon as you remember. However, if it is almost time to take your next tablet, skip the tablet you missed and only take your next scheduled tablet. Do not take a double dose to make up for a forgotten tablet. If you stop taking DUAVIVE If you decide to stop taking this medicine before finishing the prescribed course of treatment, you should talk to your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking DUAVIVE and see a doctor immediately if you get any of the following serious side effects:

Uncommon (may affect 1 in 100 people):
• If you begin to get migraine-like headaches, or severe headaches

Rare (may affect up to 1 in 1,000 people):
• If you have signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain or difficulty in breathing
• If you have signs of a blood clot in the eye (retinal vein), such as one sided visual disturbance including loss of vision, pain and swelling of the eye especially if sudden
• A severe allergic reaction
•symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
• If you have swelling of the eyes, nose, lips, mouth, tongue or throat, difficulty in breathing, severe dizziness or fainting, skin rash (symptoms of angioedema)
• If you have symptoms of pancreatitis which may include severe upper abdominal pain which may spread to your back, accompanied by abdominal swelling, fever, nausea and vomiting
• Abrupt onset of abdominal pain and passage of bright red blood in the stool, with or without diarrhoea due to sudden blockage of an artery supplying the intestines (ischemic colitis)
• A heart attack
•symptoms will usually include pain, including chest pain spreading to the jaw, neck and upper arm. You may feel sweaty, breathless, fatigued, nauseous and faint in addition to the pain

Very rare (may affect up to 1 in 10,000 people):
• If you have a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• Erythema multiforme: symptoms may include skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister. You may also have ulcers in the mouth, eyes or genitals and have a fever

Not known (frequency cannot be estimated from the available data):
• If you have other ocular events (seeing sparks or flashes of light, narrowing of visual field, and swelling of eye or eye lid)

Other side effects

Very common (may affect more than 1 in 10 people)
• Abdominal pain (stomach ache)

Common (may affect 1 in 10 people):
• Muscle spasms (including leg cramps)
• Constipation
• Diarrhoea
• Nausea
• Thrush (vaginal yeast infection)
• Increases in your triglyceride levels (fatty substances in the blood)

Uncommon (may affect 1 in 100 people):
• Gall bladder disease (e.g. gallstones, inflammation of the gall bladder (cholecystitis))

The following side effects have been observed when either conjugated oestrogens and/or bazedoxifene (the active ingredients in this medicine) has been used alone and may occur also with this medicine:

Very common (may affect more than 1 in 10 people)
• Hot flushes
• Muscle cramps
• Visible swelling of the face, hands, legs, feet or ankles (peripheral oedema)

Common (may affect 1 in 10 people):
• Breast pain, breast tenderness, swollen breasts
• Discharge from the nipples
• Joint pain
• Alopecia (hair loss)
• Changes in weight (increase or decrease)
• Increases in liver enzymes (identified in routine liver function testing)
• Dry mouth
• Drowsiness
• Hives (urticaria)
• Rash
• Itching

Uncommon (may affect up to 1 in 100 people):
• Vaginal inflammation
• Vaginal discharge
• Cervical erosion found on medical examination
• Blood clot in the leg veins
• Blood clot in the lungs
• Blood clot in a vein at the back of the eye (retinal vein) which may lead to loss of vision
• Nausea (feeling sick)
• Headache
• Migraine
• Dizziness
• Changes in mood
• Feeling nervous
• Depression
• Memory loss (dementia)
• Changes in your interest in sex (increased or decreased libido)
• Discolouration of the skin on the face or other parts of the body
• Increase in hair growth
• Difficulty wearing contact lenses

Rare (may affect up to 1 in 1,000 people):
• Pelvic pain
• Changes in breast tissue
• Vomiting
• Feeling irritable
• An effect on the way in which your blood sugar (glucose) levels are controlled including increased glucose levels in the blood
• A worsening of asthma
• A worsening of epilepsy (seizures)
• Growth of benign meningioma, a non-cancerous tumour of the membranes around the brain or spinal cord

Very rare (may affect up to 1 in 10,000 people):
• Painful red bumps on the skin
• A worsening of chorea (an existing neurological disorder characterised by involuntary spasmodic movements of the body)
• Enlargement of hepatic haemangiomas, a benign (non-cancerous) tumour of the liver
• Low levels of blood calcium (hypocalcaemia); frequently there will be no symptoms to suggest that your blood calcium is low, but when hypocalcaemia is severe you may feel tired, generally unwell, depressed and become dehydrated. This may be accompanied by bone pain and abdominal pain. Kidney stones may develop and cause severe pain in the mid-back region (renal colic).
• Worsening of porphyria, a rare blood disorder which is passed down in families (inherited).

Not known (frequency cannot be estimated from the available data):
• Palpitations (awareness of your heart beat)
• Ocular events: dry eye, eye pain, visual acuity reduced, visual impairment, blepharospasm (abnormal, involuntary blinking or spasm of the eyelids) If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Duavee

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last date of that month. Do not store above 25°C. Store in the original package in order to protect from moisture. After opening the blister pouch, use within 60 days. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.