Fablyn
lasofoxifene
lasofoxifene
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What FABLYN is and what it is used for
Before you take FABLYN
How to FABLYN
Medicinal product no longer authorised
Possible side effects
How to store FABLYN
Further information
FABLYN is used to treat osteoporosis in women after the menopause (postmenopausal osteoporosis) who are likely to break bones, especially in the spine, hips and wrists. It belongs to a group of medicines called Selective Estrogen Receptor Modulators (SERM).
In women with postmenopausal osteoporosis, FABLYN reduces the risk of both fractures of the spine (vertebral fractures) and non-spine fractures (non-vertebral fractures), but not hip fractures.
if you are allergic (hypersensitive) to lasofoxifene or any of the other ingredients of FABLYN.
if you currently have or previously had blood clots, for example in your veins, lungs or eyes (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
if you have any vaginal bleeding. This must be investigated by your doctor before starting treatment.
if you could still become pregnant.
if you are pregnant or breast-feeding.
if you are taking FABLYN, you should walk around or exercise your legs and feet at regular intervals when traveling long distances. This is because sitting for a long time in the same position may prevent good blood circulation and may increase your risk of blood clots.
It is unlikely that FABLYN will cause vaginal bleeding. So any vaginal bleeding while you take FABLYN is unexpected. You should have this investigated by your doctor.
The following are reasons why this medicine may not be suitable for you. You should talk to your doctor before starting to take FABLYN:
if you have or have had breast cancer.
if you experience any unexplained breast abnormality.
if you have severe liver disease.
if you have severe kidney disease.
Medicinal product no longer authorised
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you are taking estrogen replacement therapy (ERT)
or hormone replacement therapy (HRT), FABLYN may not be suitable for you.
FABLYN can be taken with or without food and drink.
FABLYN is only for women after the menopause and must not be taken by women who can still become pregnant.
Do not take FABLYN if you are pregnant or breast-feeding as it might be excreted in mother’s milk.
No studies on the effects on the ability to drive and use machines have been performed. FABLYN has no known influence on the ability to drive and use machines.
FABLYN contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take FABLYN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one tablet each day.
Swallow the tablet whole. You may take it with or without food.
If you wish, you may take it with water or another beverage of choice.
Your doctor may also advise you to take Calcium and Vitamin D supplements while you are treated with FABLYN if your daily intakes are not considered sufficient.
If you take more tablets than you should, tell your doctor or pharmacist.
Do not take a double dose to make up for a forgotten tablet. Take your next tablet and continue as before.
You should talk to your doctor before stopping FABLYN.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Medicinal product no longer authorised
Like all medicines, FABLYN can cause side effects, although not everybody gets them. Most of the side effects that occurred during studies were mild.
These side effects may occur with certain frequencies, which are defined as follows:
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data
Muscle cramps
Hot flush
Constipation
Pressure in the lower abdomen
Vaginal discharge
Excessive sweating
Urinary tract infection, burning on urination, urgent need to urinate, urinary incontinence
Abdominal pain or pressure, pain in the back, neck, joints or chest
Tiredness, abnormal or excessive bleeding commonly from the nose
Diabetes (typical symptoms are excessive thirst, frequent urination)
Burning sensation, dizziness, numbness, memory impairment, impaired or partial loss of movement of a limb, headache, restless legs syndrome (an irresistible urge to move legs to stop an uncomfortable or odd sensations)
Abnormal or irregular beating of the heart, increased heart rate
Swelling of hands, arms, feet or legs, limb pain
Cough, difficulty breathing, stuffy nose, runny nose
Dry mouth, flatulence (excessive amount of air or gases in the stomach or the intestine), stomach ache
Dry eye, hair loss, skin rash, night sweats, itching, feeling hot, weight gain
Breast stiffening, breast pain, vaginal bleeding, genital itching
Infection in the ear, eye, respiratory tract or skin, diarrhea, blood in stools
Change in appetite
Abnormal dreams, mood swings
Dizziness, altered sense of taste, seizures, migraine, weakness of arms or legs, sciatica (pain felt in the lower back, buttock, and/or various parts of the leg and foot; typically on one side of the body)
Impaired vision, pain in eyes, itchy eyes, swollen eyelids, redness of the eyes, ear pain
Lip lesions, change of bowel habits, difficulty swallowing, mouth ulcer, heart burn, mouth pain, anal pain
Jaundice (yellowing of the skin and eyes), changes in blood tests of liver function
Medicinal product no longer authorised
Dry skin, unusual hair texture, nail disorder, skin rash, skin darkening, altered shape of fingers, skin lesion
Painful urination, blood in urine
Breast discharge, breast lump, vaginal pain, varicose vein
Decreased pulse in feet, bruising
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use FABLYN after the expiry date which is stated on the blister or bottle label and on the carton after “EXP:”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The active substance is lasofoxifene. Each film-coated tablet contains lasofoxifene tartrate, equivalent to 500 micrograms of lasofoxifene.
The other ingredients are lactose anhydrous; microcrystalline cellulose; croscarmellose sodium; silica, colloidal anhydrous; magnesium stearate; sunset yellow FCF aluminium lake (E110); hypromellose; lactose monohydrate; titanium dioxide (E171) and triacetin.
FABLYN tablets are triangular, peach coloured, film-coated tablets marked with “Pfizer” on one side and “OPR 05” on the other.
The tablets are provided in blister packs containing 7, 28 or 30 tablets, and in bottle packs containing 90 tablets. Not all pack sizes may be marketed.
The Marketing Authorisation Holder is Dr. Friedrich Eberth Arzneimittel GmbH, Am Bahnhof 2, 92289 Ursensollen, Germany.
The Manufacturer is Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, 89257 Illertissen, Germany.
Medicinal product no longer authorised