0.45 mg / 20 mg modified release
conjugated estrogens / bazedoxifene
1. What DUAVIVE is and what it is used for
DUAVIVE is a medicine that contains two active substances called conjugated estrogens and bazedoxifene. Conjugated estrogen s is a drug belonging to the group of medicines called hormonal replacement therapy ( Hormone Replacement Therapy, HRT ). Bazedoxifene belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs).
DUAVIVE is intended for postmenopausal women who have left their wombs and who have not had a natural period in the last 12 months.
DUAVIVE is used to:
Relieve symptoms during and after menopause
When menstruation ceases ( menopause ), a woman’s estrogen drops. It can cause problems such as sweating and hot flashes. DUAVIVE relieves these symptoms after menopause. DUAVIVE should only be used if the symptoms cause problems in daily life and if your doctor considers that other types of hormonal replacement therapy are not suitable for you.
2. What you need to know before using DUAVIVE
Medical background and regular check-ups
The use of DUAVIVE involves risks that must be taken into account when deciding to start treatment or to continue ongoing treatment.
There is no experience with DUAVIVE in the treatment of women whose menstruation has stopped prematurely (when the ovaries have stopped working or the uterus has been removed).
Before starting treatment, your doctor will ask about your own, and your family’s, medical background. Your doctor may perform a general medical and gynecological examination, which also includes an examination of your breasts, if necessary or if you have a specific problem. Tell your doctor if you have any medical problems or illnesses.
Once you have started treatment, you should go for regular medical check-ups, at least once a year. During these tests, you should discuss with your doctor the benefits and risks of continuing treatment with DUAVIVE. It is recommended that:
- perform regular examinations of the breasts and gynecological cell samples according to the doctor’s recommendations
- Regularly examine your breasts yourself to check for changes, such as skin tightness, nipple changes, or lumps that you can see or feel.
Do not take DUAVIVE
- If you are allergic to conjugated estrogens, bazedoxifene, or any of the other ingredients of this medicine (see section 6).
- If you have or have had breast cancer or there is a suspicion that you may have it.
- If you have or have had estrogen-dependent cancer, such as cancer of the lining of the uterus (endometrium), or if there is a suspicion of such cancer.
- If you have recently had unexpected genital bleeding that has not been investigated by a doctor.
- If you have endometrial hyperplasia (severe thickening of the uterine lining) and are not being treated for it.
- If you have or have had a blood clot in a vein (venous thromboembolism ), in your legs (deep vein thrombosis ), in your lungs ( pulmonary embolism ), or your eyes ( retinal venous thrombosis ).
- If you have a coagulation disorder, a condition with an increased risk of blood clots (lack of protein C, protein S, or antithrombin).
- If you have or have had a disease caused by blood clots in the arteries are as heart attack, stroke (stroke), or angina.
- If you have or have had any liver disease and still have abnormal liver values.
- If you are pregnant or may become pregnant or if you are breast-feeding.
- If you have porphyria, a rare inherited blood disorder.
If you have any further questions on the use of this product, ask your doctor before taking this medicine.
If any of the above affects you the first time you use DUAVIVE, stop taking DUAVIVE and contact your doctor immediately.
Warnings and cautions
Talk to your doctor before taking this medicine if you have or have had any of the following problems. They may recur or worsen during treatment with DUAVIVE. Should this occur, have more frequent check-ups with a doctor.
- if you have any disease affecting the lining of the uterus, as well as muscle knots ( fibroids ), endometriosis, or have had endometrial hyperplasia (severe thickening of the uterine lining)
- if you have an increased risk of getting a blood clot (see below “Blood clots in a vein ( thrombosis )”)
- if a close relative has had breast cancer or other estrogen-dependent cancer
- high blood pressure
- liver disease eg liver adenoma (benign tumor )
- diabetes
- gallstone disease
- if you get a migraine or severe headache
- if you have systemic lupus erythematosus ( SLE ) – an autoimmune disease that affects many organs in the body
- epilepsy
- asthma
- otosclerosis (ossification of the middle ear leading to a hearing loss)
- hypertriglyceridemia (elevated blood lipids)
- fluid retention due to heart or kidney disease.
You should contact a doctor immediately and discontinue treatment if any of the following occur:
- any of the things mentioned in the section “Do not take DUAVIVE”
- if skin or whites of the eyes turn yellow (jaundice); it may be a symptom of liver disease
- if your blood pressure rises sharply (symptoms may be headache, fatigue, or dizziness)
- if you are experiencing migraine-like headaches for the first time
- if you become pregnant
- if you get symptoms of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty breathing. For more information, see below “Blood clots in a vein ( thrombosis )”.
DUAVIVE and cancer
Severe thickening of the uterine lining ( endometrial hyperplasia ) and cancer of the uterine lining (endometrial cancer)
This medicine contains conjugated estrogen and bazedoxifen and is intended to treat women who have a uterus.
When taking DUAVIVE, do not take any more estrogen as it may increase the risk of endometrial hyperplasia.
If you have unexplained vaginal bleeding, you must contact a doctor as soon as possible.
Breast cancer
Data show that treatment with estrogen alone as hormone replacement therapy ( HRT ) increases the risk of breast cancer. The extra risk depends on how long you use HRT. The increased risk is seen within 3 years of use. When treatment is stopped, the increased risk decreases over time, but it can persist for 10 years or more if you have used HRT for more than 5 years.
It is not known what effect DUAVIVE has on the risk of breast cancer.
Check your breasts regularly. Contact a doctor as soon as possible if you notice changes such as:
- indentations or pits
- changes of the nipple
- nodules you can see or feel.
Ovarian cancer
Ovarian cancer is rare – much more rare than breast cancer. Long-term use of estrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
The risk of ovarian cancer varies with age. The diagnosis of ovarian cancer will, for example, be made on about 2 women out of 2,000 between the ages of 50 and 54 who do not take HRT for a 5-year period. For women who have taken HRT for 5 years, there will be 3 cases per 2,000 users (ie about 1 extra case). Contact your doctor if you have any questions.
The effect of DUAVIVE on the risk of ovarian cancer is unknown.
DUAVIVE and the heart and circulation
Blood clots in a vein ( thrombosis )
DUAVIVE may increase the risk of blood clots.
Monotherapy (ie treatment with only one drug) with only estrogen and bazedoxifene increases the risk of blood clots in a vein (also called deep vein thrombosis or DVT), especially during the first year of treatment.
Blood clots can be serious. If a blood clot ends up in the lungs, it can cause chest pain, shortness of breath, collapse or even lead to death.
As you are more likely to get a blood clot in a vein with increasing age and if any of the following apply to you, tell your doctor immediately:
- if you have not been able to walk or stand for a long time due to a major operation, injury or illness (see also section 3, “If you need surgery”)
- if you are severely overweight ( BMI over 30 kg / m 2 )
- if you have a coagulation disorder that requires long-term treatment with medicines that prevent blood clots
- if a close relative has had a blood clot in the bone, lung, or another organ
- if you have SLE (systemic lupus erythematosus)
- if you have cancer.
If you have any of these conditions, talk to your doctor before taking this medicine.
Heart disease (heart attack)
There is no evidence that HRT prevents heart attacks. Data in women who had their uterus removed ( hysterectomy ) and who received treatment with estrogen alone did not show an increased risk of coronary heart disease.
Stroke (apoplexy)
The risk of stroke is about 1.5 times higher for those who take HRT compared to those who do not. The risk of stroke is age-dependent, therefore the number of cases of stroke increases due to the use of HRT with increasing age.
For women in their 50s who do not take HRT, an average of 8 out of 1,000 people is expected to have a stroke over a 5-year period.
For women in their 50s who have taken HRT for more than 5 years, 11 out of 1,000 users are expected to have a stroke (ie 3 extra cases).
It is not known what effect DUAVIVE has on the risk of stroke.
Other things that can increase the risk of stroke are:
- high age
- high blood pressure
- smoking
- high alcohol consumption
- irregular heartbeats.
If you are going to have surgery
If you are going to have surgery, tell your surgeon that you are taking DUAVIVE. You may need to take a break from taking DUAVIVE for 4 to 6 weeks before surgery to avoid the risk of blood clots (see Blood clots in a vein). Ask your doctor when it is appropriate to start taking this medicine again.
If you are not sure, talk to your doctor before taking this medicine.
Other conditions
If you have any of the following conditions, your doctor should tell you:
- kidney problems
- high levels of fat in the blood ( triglycerides ) in the past
- liver problem
- asthma
- seizures ( epilepsy )
- migraine
- the systemic lupus erythematosus ( SLE – a rare disease of the immune system that affects several organs of the body)
- accumulation of fluid
The use of estrogen does not prevent memory loss. The risk of memory loss may be slightly higher in women who start using estrogen after the age of 65. Consult your doctor.
Children and young people
This medicine is not intended for use in children and adolescents under 18 years of age.
Other medicines and DUAVIVE
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may interfere with the effect of DUAVIVE. It can lead to irregular bleeding. This applies to the following medicines:
- antiepileptic drugs (eg phenobarbital, phenytoin and carbamazepine)
- drugs against tuberculosis (eg rifampicin, rifabutin)
- drugs against HIV – infection (for example, nevirapine, efavirenz, ritonavir, nelfinavir)
- an herbal medicine containing St. John’s wort (Hypericum perforatum).
Pregnancy, breastfeeding, and fertility
DUAVIVE is intended for women whose menstruation has stopped. Do not take this medicine if you are pregnant or think you may be pregnant. Do not take this medicine if you are breast-feeding.
Driving and using machines
DUAVIVE has less effect on the ability to drive and use machines.
If you feel drowsy after taking this medicine, do not drive or use machines.
The substance bazedoxifene in this medicine may cause vision problems, such as blurred vision. If this happens, do not drive or use machines until your doctor tells you it is safe to do so.
DUAVIVE contains lactose, sucrose, liquid maltitol, glucose and sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains 0.0088 mg sorbitol in each tablet.
3. How to use DUAVIVE
Your doctor will strive to give you the lowest dose, which will give you relief of symptoms, and to use DUAVIVE for the shortest possible time. Talk to your doctor if you do not get any relief from the symptoms, or feel that the dose is too high.
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet once a day.
Swallow the tablet whole with a glass of water.
You can take the tablet at any time of the day, with or without food. It is still recommended that you take the tablet at the same time each day as it will help you remember it.
You should continue to take this medicine for as long as your doctor tells you to. For this medicine to work, it must be taken daily as prescribed.
If you use more DUAVIVE than you should
Talk to a doctor or pharmacist.
If you take too many tablets, you may experience nausea or vomiting. You may experience breast tenderness, dizziness, abdominal pain, drowsiness/fatigue, or a short period of vaginal bleeding.
If you forget to use DUAVIVE
If you forget to take a tablet, take it as soon as you remember. If it is almost time for the next tablet, skip the tablet you forgot and take the next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you stop using DUAVIVE
If you have decided to stop taking this medicine before the prescribed treatment period has expired, talk to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. 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 up to 1 in 100 people
- If you start having migraine-like headaches or severe headaches.
Rare: may affect up to 1 in 1,000 users
- Signs of a blood clot, such as painful swelling and redness of the legs, sudden chest pain, or difficulty breathing.
- Signs of a blood clot in the eye ( retinal vein), e.g. unilateral visual disturbance including vision loss, pain, or swelling of the eye, especially if it occurs suddenly.
- A severe allergic reaction – symptoms may include sudden wheezing and chest pain or pressure over the chest, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse.
- Swelling of eyes, nose, lips, mouth, tongue or throat, difficulty breathing, severe dizziness or fainting, skin rash (symptoms of angioedema ).
- Symptoms of pancreatitis ( pancreatitis ) can include severe pain in the upper abdomen that can spread to the back, followed by swelling of the abdomen, fever, nausea, and vomiting.
- Sudden abdominal pain and the presence of bright red blood in the stool, with or without diarrhea, due to a sudden blockage of an artery that supplies the intestines (ischemic colitis ).
- A heart attack – symptoms usually include pain, including chest pain that spreads to the jaw, neck, and upper arm. In addition to the pain, you may feel sweaty, short of breath, tired, nauseous, and dull.
Very rare: may affect up to 1 in 10,000 people
- A large increase in blood pressure (symptoms may include headache, fatigue, dizziness)
- Erythema multiforme: symptoms may include rash with pink-red spots, especially on the palms or soles of the feet, which may form blisters. You may also get sores in your mouth, eye,s or genitals and fever.
No known frequency: occurs in an unknown number of users
- Other reactions that affect the eye and/or vision (see sparks or flashes of light, have narrowing fields of vision and swelling of the eye or eyelids).
Additional side effects are
Very common: may affect more than 1 user in 10
- Abdominal pain (stomach pain)
Common: may affect up to 1 in 10 users
- Muscle spasms (including leg cramps)
- Constipation
- Diarrhea
- Nausea
- Candida (fungal infection of the abdomen)
- Increased levels of triglycerides (fats in the blood)
Uncommon: may affect up to 1 in 100 people
- Gallbladder disease (eg gallstones or inflammation of the gallbladder (cholecystitis))
The following side effects have been observed when either conjugated estrogens and/or bazedoxifene (the active ingredient in this medicine) have been used on their own and may also occur with this medicine:
Very common: may affect more than 1 user in 10
- Pastures
- Muscle cramps
- Visible swelling of the face, hands, legs, feet, or ankles (peripheral edema )
Common: may affect up to 1 in 10 users
- Chest pain, breast tenderness, swollen breasts
- Excretion from the nipples
- Joint pain
- Alopecia (hair loss)
- Weight change (increase or decrease)
- Elevated liver enzymes (identified in routine liver function tests)
- Dry mouth
- Drowsiness
- Hives ( urticaria )
- Rash
- Itching
Uncommon: may affect up to 1 in 100 people
- Inflammation of the vagina
- Relocations
- Ulcers on the cervix (cervical erosion) that are detected during a medical examination
- A blood clot in veins in the leg
- Blood clots in the lungs
- A blood clot in a vein in the back of the eye ( retinal vein) can lead to vision loss
- Nausea
- Headache
- Migraine
- Dizziness
- Mood swings
- Nervousness
- Depression
- Memory loss (dementia)
- Changes in interest in sex (increased or decreased libido )
- Discoloration of the skin on the face or other parts of the body
- Increased hair growth
- Difficulty wearing contact lenses
Rare: may affect up to 1 in 1,000 users
- Pelvic pain
- Changes in breast tissue
- Vomiting
- Feeling irritated
- Effects on the way blood sugar levels ( glucose ) are controlled including increased blood glucose levels
- Deterioration of asthma
- Exacerbation of epilepsy (seizures)
- Growth of benign meningioma, a benign tumor 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
- Worsening of chorea (an existing neurological disease characterized by involuntary spastic movements in the body)
- Enlargement of hemangioma, a benign (benign) tumor, in the liver
- Low levels of blood calcium (hypocalcemia); often there are no signs that the blood calcium level is low but in severe hypocalcemia, you may feel tired, generally unwell, depressed, and dehydrated. This can be accompanied by skeletal pain and abdominal pain. Kidney stones can develop and cause severe pain in the middle part of the back ( renal colic )
- Exacerbation of porphyria, a rare inherited blood disorder
No known frequency: occurs in an unknown number of users
- Palpitations (awareness of your heartbeat)
- Dry eyes, eye pain, decreased visual acuity, impaired vision, blepharospasm(abnormal unintentional blinking or twitching of the eyelids).
5. How to store DUAVIVE
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 expiration date is the last day of the specified month.
Do not store above 25 ° C.
Store in the original package. Moisture sensitive.
To be used within 60 days after opening the blister bag.
Do not dispose of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substances are conjugated estrogens and bazedoxifene. Each tablet contains 0.45 mg of conjugated estrogen and bazedoxifene acetate equivalent to 20 mg of bazedoxifene.
The other ingredients are lactose monohydrate, sucrose, sucrose monopalmitate, polydextrose (E1200, contains glucose and sorbitol) and liquid maltitol (see section 2), microcrystalline cellulose, powdered cellulose, hydroxypropyl cellulose, hydroxyethylcellulose, magnesium stearate, ascorbic acid, Hypromellose (E464), povidone (E1201 ), poloxamer 188, calcium phosphate, titanium dioxide (E171), macrogol (400), red iron oxide (E172), black iron oxide (E172) and propylene glycol (E1520).
What the medicine looks like and the contents of the pack
The DUAVIVE tablet 0.45 mg / 20 mg with the modified release is a pink, oval tablet marked with “0.45 / 20” on one side.
The modified-release tablets are supplied in PVC / Aclar / PVC blister packs containing 28 tablets.
Marketing Authorization Holder and Manufacturer
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Brussels, Belgium.
Manufacturer
Pfizer Ireland Pharmaceuticals, Little Connell, Newbridge, County Kildare, Ireland.
Contact the representative of the marketing authorization holder to find out more about this medicine:
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