60 mg film-coated tablets
raloxifene hydrochloride
What Raloxifene STADA is and what it is used for
Raloxifene Stada belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs). When a woman reaches menopause (menopause), the levels of the female sex hormone, estrogen, fall. Raloxifene Stada mimics some of the positive effects of estrogen after menopause.
Raloxifene Stada is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Stada reduces the risk of bone fractures in the spine in women who suffer from osteoporosis after menopause. No reduced risk of hip fractures has been shown.
Osteoporosis is a disease that makes your skeleton thin and fragile – this disease is especially common in postmenopausal women. Although no symptoms are noticed at first, osteoporosis increases the risk of bone fractures, especially in the spine, hips, and wrists. Osteoporosis can also cause back pain, reduce body length and give a bent back.
Raloxifene contained in Raloxifene Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Raloxifene STADA
Do not use Raloxifene STADA
- if you are allergic to raloxifene or any of the other ingredients of this medicine (listed in section 6)
- if there is still a possibility that you may become pregnant; Raloxifene Stada can harm your unborn baby
- if you are being treated or have been treated for blood clots (clots in the legs, lungs, or retina of the eye )
- if you have liver disease (eg cirrhosis of the liver, slightly impaired liver function, or jaundice in bile disorders)
- if you get bleeding from the abdomen for no known reason; then you need to be examined by a doctor
- if you have uterine cancer, experience with raloxifene in women with this disease is limited
- if you have severe kidney problems.
Warnings and cautions
Talk to your doctor before taking Raloxifene Stada, if you
- is immobile for some time, for example wheelchair bound, in need of hospitalization or to be bedridden to recover after an operation or after an unexpected illness
- get estrogen tablets (or other estrogen medicines to be taken by mouth)
- have breast cancer, as experience with raloxifene treatment in women with this disease is limited
- have had a brain injury (due to a disease in a blood vessel or clot, such as a brain haemorrhage or stroke ) or if your doctor has told you that you are at high risk of getting one.
Raloxifene Stada is unlikely to cause genital bleeding. Therefore, genital bleeding when taking this medicine is unexpected. You should then have a doctor examine you.
Raloxifene Stada does not help with menopause problems, such as hot flashes.
Raloxifene Stada lowers total cholesterol and LDL – cholesterol (the “bad” cholesterol ). Raloxifene Stada does not usually affect triglycerides or HDL cholesterol (the “good” cholesterol ) . You should still talk to your doctor before taking this medicine if you have previously taken estrogen and received very high triglyceride levels.
Other medicines and Raloxifene STADA
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
If you are taking certain medicines for the heart ( digitalis ) or blood thinners ( anticoagulants , such as warfarin ), your doctor may need to change the dose of these medicines.
Tell your doctor if you are taking cholestyramine, which is most commonly used as a lipid-lowering medicine.
Pregnancy, breastfeeding and fertility
Raloxifene Stada should only be used by women whose menstruation has completely stopped and should not be taken by women who are still able to have children. Raloxifene Stada can harm your unborn baby.
Do not take Raloxifene Stada while breast-feeding, as this medicine may pass into breast milk.
Driving and using machines
Raloxifene Stada does not affect your ability to drive or use machines.
Raloxifene STADA contains lactose and sodium
Raloxifene Stada 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.
Raloxifene Stada contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Raloxifene STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dosage and
The recommended dose is one tablet per day. It does not matter when you take the tablet on the day, but it is easier to remember the medicine if you take the tablet at the same time each day. You can take the tablet with or without food.
Method of administration
The tablets should be swallowed whole, either with or without water.
Usage time
Your doctor will tell you how long to continue taking Raloxifene Stada.
Your doctor may also advise you to take calcium tablets and vitamin D.
If you use more Raloxifene STADA than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. If you take more Raloxifene Stada than you should if you have leg cramps and dizziness.
If you forget to use Raloxifene STADA
Take one tablet as soon as you remember to do so and then continue as usual.
If you stop using Raloxifen STADA
Do not stop taking Raloxifene Stada without talking to your doctor first.
It is important that you continue to take Raloxifen Stada as your doctor advised. Raloxifene Stada can only treat or prevent your osteoporosis if you continue to take the tablets.
If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
Most of the side effects seen with raloxifene treatment have been mild.
Very common side effects ( may affect more than 1 user in 10):
- hot flashes ( vasodilation )
- flu symptoms.
Common side effects ( may affect up to 1 in 10 people):
- leg cramps
- swelling of hands, feet and legs (peripheral edema )
- gallstones .
Uncommon side effects ( may affect up to 1 in 100 people):
- increased risk of blood clots in the legs (deep vein thrombosis )
- increased risk of blood clots in the lungs ( pulmonary embolism )
- increased risk of blood clots in the eyes ( retinal venous thrombosis )
- the skin around a vein becomes red and tender (superficial venous thrombophlebitis )
Very rare side effects ( may affect up to 1 in 10,000 people):
- rash
- symptoms from the stomach or intestines, such as nausea, vomiting, abdominal pain and upset stomach
- high blood pressure
- decreased platelet count
- blood clot in an artery (eg stroke )
- headache (including migraine )
- mild symptoms in the breasts, such as pain, swelling and tenderness.
In rare cases, the levels of liver enzymes in the blood may increase during treatment with Raloxifen Stada.
How to store Raloxifen STADA
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.
Store in the original package. Moisture sensitive. Sensitive to light.
Medicines should not be disposed 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.
Contents of the package and other information
Content declaration
The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, equivalent to 56 mg of raloxifene.
The other ingredients are
Tablet core : sodium starch glycolate, citric acid monohydrate, microcrystalline cellulose, calcium hydrogen phosphate, poloxamer, magnesium stearate.
Tablet cover : hypromellose, lactose monohydrate , titanium dioxide (E171) and macrogol.
What the medicine looks like and contents of the pack
Raloxifene Stada 60 mg film-coated tablets are white and oval. They are packed in blister cards. The packs contain 10, 14, 28, 30, 84, 90, 98, 100 or 126 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Pharmathen SA
6 Dervenakion str.
153 51 Pallini Attiki
Greece
Pharmathen International SA
Industrial Park Sapes
Rodopi Prefecture, Block No 5
Rodopi 69300
Greece
Local representative STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark