Package leaflet: Information for the user

Raloxifene Sandoz 60 mg coated tablets

Generic medicine
Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet as 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, even if their symptoms seem identical to yours, as it may be harmful.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Raloxifene Sandoz is and what it is used for
What you need to know before taking Raloxifene Sandoz
How to take Raloxifene Sandoz
Possible side effects
How to store Raloxifene Sandoz
Contents of the pack and other information

1. What Raloxifene Sandoz is and what it is used for

Raloxifene Sandoz contains the active substance raloxifene hydrochloride.
Raloxifene Sandoz is used to treat and prevent osteoporosis in postmenopausal women.
Raloxifene Sandoz reduces the risk of vertebral fractures in women with postmenopausal osteoporosis.
A reduction in the risk of hip fracture has not been demonstrated.

How Raloxifene Sandoz works
Raloxifene Sandoz belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs). When a woman reaches menopause, the levels of estrogens, the female sex hormones, decrease. Raloxifene Sandoz mimics some of the beneficial effects of estrogens after menopause.

Osteoporosis is a disease that makes your bones thin and fragile – this condition is particularly common in women after menopause. Although it may initially have no symptoms, osteoporosis makes you more prone to bone fractures, especially in the spine, hips, and wrists, and could cause back pain, loss of height, and a curved spine.

2. Before taking Raloxifene Sandoz

Do not take Raloxifene Sandoz:
If you are currently being treated or have been treated for blood clots in the
legs (deep vein thrombosis), lungs (pulmonary embolism), or eyes
(retinal venous thrombosis).
If you are allergic (hypersensitive) to raloxifene or to any of the other ingredients of this
medicine.
If there is still a possibility that you could become pregnant, as Raloxifene Sandoz could harm the unborn child.
If you have liver disease (examples of liver diseases include cirrhosis, mild liver failure, or cholestatic jaundice).
If you have severe kidney problems.
If you have unexplained vaginal bleeding. This condition must be evaluated by your
doctor.
If you have active uterine cancer, as there is insufficient experience with the use of Raloxifene
Sandoz in women affected by this disease.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Raloxifene Sandoz.
If you have been immobile for some time, for example if confined to a wheelchair, if you require hospitalization, or if you need to stay in bed recovering from an accident or unexpected illness, as these conditions may increase the risk of thrombosis (deep vein thrombosis, pulmonary embolism, or retinal venous thrombosis).
If you have had a cerebrovascular event (e.g. stroke) or if your doctor has told you that you are at high risk of having one.
If you have liver disease.
If you have breast cancer, as there is insufficient experience with the use of Raloxifene
Sandoz in women affected by this disease.
If you are taking oral estrogen therapy.

Vaginal bleeding is unlikely to be caused by Raloxifene Sandoz. Therefore, any vaginal bleeding during treatment with Raloxifene Sandoz is not expected and should be evaluated by your doctor.

Raloxifene Sandoz does not treat post-menopausal symptoms such as hot flushes.
Raloxifene Sandoz lowers total cholesterol and LDL cholesterol ("bad" cholesterol). In general, it does not change triglyceride or HDL cholesterol ("good" cholesterol) levels. However, if you have previously taken estrogens and experienced a marked increase in triglycerides, you should consult your doctor before taking Raloxifene Sandoz.

Raloxifene Sandoz contains lactose
If your doctor has diagnosed you with lactose intolerance, a type of sugar intolerance, please contact your doctor before taking this medicine.

Other medicines and Raloxifene Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
If you are taking digitalis drugs for the heart or anticoagulants such as warfarin to thin the blood, your doctor may need to adjust the dose of these medicines.
Tell your doctor if you are taking colestyramine, which is mainly used as a lipid-lowering drug, as Raloxifene Sandoz may not work optimally.

Pregnancy, breastfeeding and fertility
Raloxifene Sandoz is intended only for post-menopausal women and must not be taken by women who could still become pregnant. Raloxifene Sandoz could harm the unborn child.
Do not take Raloxifene Sandoz if you are breastfeeding, as it may pass into breast milk.

Driving and using machines
Raloxifene Sandoz has no effect or negligible effects on the ability to drive and use machines.

3. How to take Raloxifene Sandoz

Always take Raloxifene Sandoz exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily. It does not matter at what time of day you take it, but taking it at the same time each day will help you remember to take it. You may take it with or without food.
The tablets are for oral use.
Swallow the tablet whole. You may drink water with it. Do not break or crush the tablet before taking it. A broken or crushed tablet may have an unpleasant taste and there is a risk that you may receive an incorrect dose.
Your doctor will tell you how long you should continue taking Raloxifene Sandoz. Your doctor may also recommend that you take calcium and vitamin D supplements.
If you take more Raloxifene Sandoz than you should
Contact your doctor or pharmacist. If you take more Raloxifene Sandoz than prescribed, you may experience leg cramps and dizziness.
If you forget to take Raloxifene Sandoz
Take a tablet as soon as you remember, then continue as usual. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Raloxifene Sandoz
Talk to your doctor before stopping treatment.
It is important that you continue taking Raloxifene Sandoz for the full duration prescribed by your doctor.
Raloxifene Sandoz can treat or prevent osteoporosis only if you continue taking the tablets as directed.

4. Possible side effects

Like all medicines, Raloxifene Sandoz may cause side effects, although not everybody gets them. Most of the side effects observed with raloxifene have been mild.

Very common side effects (may affect more than 1 in 10 people) are:

Hot flushes (vasodilatation)
Flu-like syndrome
Gastrointestinal symptoms such as feeling unwell (nausea), vomiting, abdominal pain and indigestion (dyspepsia)
Increased blood pressure

Common side effects (may affect up to 1 in 10 people) are:

Headache, including migraine
Leg cramps
Swelling of the hands, feet and legs (peripheral oedema)
Gallstones
Rash
Mild breast symptoms such as pain, enlargement and tenderness

Uncommon side effects (may affect up to 1 in 100 people) are:

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)
Redness and pain around the vein (superficial venous thrombophlebitis)
Formation of a blood clot in an artery (e.g. stroke, including increased risk of death from stroke)
Reduction in platelets in the blood, increasing the risk of bleeding or bruising

In rare cases (may affect up to 1 in 1,000 people), blood levels of liver enzymes may increase during treatment with Raloxifene Sandoz.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Raloxifene Sandoz

Keep this medicine out of the sight and reach of children.
Do not use Raloxifene Sandoz after the expiry date stated on the pack.
Keep the blister in the outer carton to protect it from light and moisture. Do not freeze.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Raloxifene Sandoz contains

The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, equivalent to 56 mg of raloxifene.
The other components of Raloxifene Sandoz tablets are:
Tablet core: sodium starch glycolate, citric acid monohydrate, microcrystalline cellulose, dicalcium phosphate, poloxamer 407, magnesium stearate.
Tablet coating: hypromellose, lactose monohydrate, titanium dioxide (E171), and macrogol/PEG 4000.

Description of the appearance of Raloxifene Sandoz and contents of the pack
Raloxifene Sandoz are white, elliptical, film-coated tablets. The tablets are packed in blisters.
Cartons contain blister packs of 14, 28, 30, 84, or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
Pharmathen S.A., Dervenakion Str. 6, Pallini 15351 Attikis, Greece
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300, Greece

This patient information leaflet was last revised on