Raloxifene Teva
raloxifene
raloxifene hydrochloride
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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Raloxifene Teva is and what it is used for
What you need to know before you take Raloxifene Teva
How to take Raloxifene Teva
Possible side effects
How to store Raloxifene Teva
Contents of the pack and other information
Raloxifene Teva is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene Teva reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown.
How Raloxifene Teva works
Raloxifene Teva belongs to a group of non-hormonal medicines called selective oestrogen receptor modulators (SERMs). When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down. Raloxifene Teva mimics some of the helpful effects of oestrogen after the menopause.
Osteoporosis is a disease that causes your bones to become thin and fragile - this disease is especially common in women after the menopause. Although it may have no symptoms at first, osteoporosis makes you more likely to break bones, especially in your spine, hips and wrists and may cause back pain, loss of height and a curved back.
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 can get pregnant, Raloxifene Teva could harm your unborn child.
If you are being treated or have been treated for blood clots (deep vein thrombosis, pulmonary embolism or retinal vein thrombosis).
If you have liver disease (examples of liver disease include cirrhosis, mild hepatic impairment or cholestatic jaundice).
If you have any unexplained vaginal bleeding. This must be investigated by your doctor.
If you have active uterine cancer, as there is insufficient experience of Raloxifene Teva use in women with this disease.
If you have severe kidney problems.
Talk to your doctor or pharmacist before taking Raloxifene Teva:
If you are immobilised for some time such as being wheel-chair bound, needing to be admitted to a hospital or having to stay in bed while recovering from an operation or an unexpected illness.
If you are receiving oral oestrogen therapy.
If you are suffering from breast cancer, as there is insufficient experience of Raloxifene Teva use in women with this disease.
If you have had a cerebrovascular accident (e.g. stroke), or if your doctor has told you that you
are at high risk of having one.
If you have liver problems, as there is insufficient experience in people with liver problems. If you do have liver problems and your doctor still recommends treatment, then you may need
some blood tests during treatment.
It is unlikely that Raloxifene Teva will cause vaginal bleeding. So any vaginal bleeding while you take Raloxifene Teva is unexpected. You should have this investigated by your doctor.
Raloxifene Teva does not treat postmenopausal symptoms, such as hot flushes.
Raloxifene Teva lowers total cholesterol and LDL ("bad") cholesterol. In general, it does not change triglycerides or HDL ("good") cholesterol. However, if you have taken oestrogen in the past and had extreme elevations in triglycerides, you should talk to your doctor before taking Raloxifene Teva.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking digitalis medicines for your heart or anticoagulants like warfarin to thin your blood, your doctor may need to adjust your dose of these medicines.
Tell your doctor if you are taking cholestyramine which is mainly used as lipid-lowering medicine.
Raloxifene Teva is for use only by postmenopausal women and must not be taken by women who could still have a baby. Raloxifene Teva could harm your unborn child.
Do not take Raloxifene Teva if you are breast-feeding as it might be excreted in mother's milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicines.
Raloxifene Teva has no or negligible effects on driving or using machines.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet a day. It does not matter at what time of the day you take your tablet but taking the tablet 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. If you wish you may take a glass of water with it.
Your doctor will tell you how long you should continue to take Raloxifene Teva. The doctor may also advise you to take calcium and vitamin D supplements.
Tell your doctor or pharmacist. If you take more Raloxifene Teva than you should you could have leg
cramps and dizziness.
Take a tablet as soon as you remember and then continue as before. Do not take a double dose to make up for a forgotten dose.
You should talk to your doctor first.
It is important that you continue taking Raloxifene Teva for as long as your doctor prescribes the medicine.
Raloxifene Teva can treat or prevent your osteoporosis only if you continue to take the tablets.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The
majority of side effects seen with Raloxifene Teva have been mild.
Very common (may affect more than 1 in 10 people)
Hot flushes (vasodilatation).
Flu syndrome.
Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
Increased blood pressure
Common (may affect up to 1 in 10 people)
Headache including migraine
Leg cramps.
Swelling of hands, feet and legs (peripheral oedema).
Gallstones.
Rash
Mild breast symptoms such as pain, enlargement and tenderness
Uncommon (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 vein thrombosis).
Skin around the vein is red and painful (superficial vein thrombophlebitis).
Blood clot in an artery (for example stroke, including an increased risk of dying from stroke)
Decrease in the number of the platelets in the blood
In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene Teva.
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 outer carton or foil after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package to protect from moisture.
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 to protect the environment.
The active substance is raloxifene hydrochloride. Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene.
The other ingredients are:
Tablet core: pregelatinized starch (maize), magnesium stearate, povidone (K30), colloidal anhydrous silica and microcrystalline cellulose, silicified.
Tablet coating: polydextrose (E1200), titanium dioxide (E171), hypromellose (E464) and
macrogol 4000.
The film-coated tablets are white to off-white, oval shaped and embossed with the number “60” on one side and “N” on the other side.
Raloxifene Teva 60 mg is available in pack sizes of 14, 28 and 84 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Teva B.V.
Swensweg 5 2031GA Haarlem The Netherlands
Manufacturers:
Teva Pharmaceutical Works Private Limited Company Pallagi út 13
Debrecen H-4042
Hungary Pharmachemie B.V.
Swensweg 5
2031 GA Haarlem The Netherlands
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics
Tel: +370 52660203
Тева Фарма ЕАД
Тел: +359 24899585
Teva Pharma Belgium N.V./S.A./AG
Belgique/Belgien
Tél/Tel: +32 38207373
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111
Teva Gyógyszergyár Zrt.
Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +44 2075407117
TEVA GmbH
Tel: +49 73140208
Teva Nederland B.V. Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar A.B.E.E.
Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Teva Pharma, S.L.U. Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550
Pliva Hrvatska d.o.o. Tel: +385 13720000
Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o. Tel: +386 15890390
Teva Pharma Iceland ehf. Sími: +354 5503300
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l. Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666
Teva Pharmaceuticals Ireland Ireland
Tel: +44 2075407117