Raloxifene Hydrochloride 60 Mg Film-Coated Tablets
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Raloxifene hydrochloride 60 mg Tablets
(raloxifene hydrochloride)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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.
In this leaflet:
1. What Raloxifene hydrochloride 60 mg Tablets is and what it is used for
2. What you need to know before you take Raloxifene hydrochloride 60 mg Tablets
3. How to take Raloxifene hydrochloride 60 mg Tablets
4. Possible side effects
5. How to store Raloxifene hydrochloride 60 mg Tablets
6. Contents of the pack and other information
1. WHAT RALOXIFENE HYDROCHLORIDE 60 MG TABLETS IS AND WHAT IT IS
USED FOR
Raloxifene belongs to a group of non-hormonal medicines called Selective Estrogen Receptor Modulators (SERMs). When a woman reaches the menopause, the level of the female sex hormone oestrogen goes down. Raloxifene mimics the effects of oestrogen after the menopause.
Raloxifene is used to treat and prevent osteoporosis in postmenopausal women. Raloxifene reduces the risk of fractures in the spine in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been shown.
Osteoporosis is a disease that causes your bones to become thin and fragile. It is especially common in women after the menopause. 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RALOXIFINE HYDROCHLORIDE 60 MG TABLETS
Do not take Raloxifene hydrochloride 60 mg Tablets
• if you are allergic (hypersensitive) to raloxifene or any of the other ingredients of this medicine (listed in section 6).
• if you could still have a baby. Raloxifene may harm your unborn child.
• if you are being treated or have been treated for blood clots in the legs (deep vein thrombosis), in the lungs (pulmonary embolism) or in the eyes (retinal vein thrombosis).if you have liver disease (like cirrhosis, mild hepatic impairment or cholestaticjaundice).
• 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 use in women with this disease.
• if you have severe kidney problems.
Warnings and precautions
• 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 receive oral oestrogen therapy.
• if you suffer from breast cancer, as there is insufficient experience of raloxifene 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 disease
Talk to your doctor or pharmacist before taking Raloxifene hydrochloride 60 mg Tablets.
It is unlikely that raloxifene will cause vaginal bleeding. Therefore any vaginal bleeding while you take raloxifene is unexpected. Contact your doctor for advice.
Raloxifene does not treat postmenopausal symptoms, such as hot flushes.
Raloxifene lowers total cholesterol and LDL ("bad") cholesterol. In general, it does not change the fat levels (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.
Other medicines and Raloxifene hydrochloride 60 mg Tablets
Other medicines may be affected by raloxifene. They, in turn, may affect how well raloxifene works. Raloxifene can interact with:
• digitalis medicines for your heart or anticoagulants (substances used to thin your blood) like warfarin. Your doctor may need to adjust your dose of these medicines.
• cholestyramine (substance mainly used in the treatment of high cholesterol levels), which affects raloxifene by limiting its absorption.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the medicines listed above or any other medicines.
Taking Raloxifene hydrochloride 60 mg Tablets with food and drink
Food and drink do not affect raloxifene.
Pregnancy and breast-feeding
Raloxifene is for use only by postmenopausal women and must not be taken by women who could still have a baby. Raloxifene may harm your unborn child.
Do not take raloxifene if you are breast-feeding as it
might pass into mother's milk.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
Raloxifene has negligible effects on driving or using machinery.
Raloxifene hydrochloride 60 mg Tablets contains lactose
This medicine 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.
3. HOW TO USE RALOXIFINE
HYDROCHLORIDE 60 MG TABLETS
The tablets are for oral use.
The dose is one tablet a day. It does not matter what time of 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.
Do not break or crush the tablet before taking it. A broken or crushed tablet may taste bad and there is a possibility that you will receive an incorrect dose.If you wish you may take a glass of water with it.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how long you should continue to take raloxifene. The doctor may also advise you to take calcium and vitamin D supplements.
If you take more Raloxifene hydrochloride 60 mg Tablets than your should
Tell your doctor or pharmacist. If you take more Raloxifene hydrochloride 60 mg Tablets than you should you could have leg cramps and dizziness.
If you forget to take Raloxifene hydrochloride 60 mg Tablets
If you forget to take your tablet, take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.
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If you stop taking Raloxifene hydrochloride 60 mg Tablets
You should talk to your doctor first, before you stop taking raloxifene.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, raloxifene can cause side effects, although not everybody gets them. The majority of side effects seen with raloxifene has been mild.
Very common (affects more than 1 user in 10)
• Hot flushes (vasodilatation)
• Flu syndrome
• Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset
• Increased blood pressure
Common (affects 1 to 10 users in 100))
• 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 (affects 1 to 10 users in 1,000)
• 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Marketing Authorisation Holder and Manufacturer
Synthon BV Microweg 22 6545 CM Njmegen The Netherlands
Manufacturer
Synthon BV Microweg 22 6545 CM Njmegen The Netherlands
Synthon Hispania S.L.
Castello, 1
Polfgono Las Salinas 08830 Sant Boi de Llobregat Spain
This medicinal product is authorised in the Member States of the EEA under the following names NL Raloxiep 60 mg, filmomhulde tabletten AT Raloxifen Synthon 60 mg Filmtabletten BE Raloxiep 60 mg
DE RaloxNL 60 mg Filmtabletten
EL RaloxNL 60 mg
ES Raloxifeno VIR 60 mg comprimidos recubiertos
con pelfcula EFG
FR Raloxifene Synthon 60 mg, comprime pellicule IE Raloxiep 60 mg film-coated tablets NO Raloxifen Synthon 60 mg SE Ralox 60 mg
UK Raloxifene hydrochloride 60 mg film-coated tablets
This leaflet was last approved: 09/2013.
5. HOW TO STORE RALOXIFENE HYDROCHLORIDE 60 MG TABLETS
Keep out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Raloxifene hydrochloride 60 mg Tablets after the expiry date which is stated on the blister and carton after 'EXP'. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Raloxifene hydrochloride 60 mg Tablets contains
• The active substance is raloxifene hydrochloride. Each tablet contains 60 mg of raloxifene hydrochloride, which is equivalent to 56 mg raloxifene.
• The other ingredients in the tablet core are: lactose monohydrate, cellulose microcrystalline (E460), crospovidone (E1202), povidone K30 (E1201), citric acid, anhydrous (E330), magnesium stearate(E572).
The ingredients in the tablet coating are: hypromellose (E464), Macrogol 4000, lactose monohydrate and titanium dioxide (E171).
What Raloxifene hydrochloride 60 mg Tablets looks like and contents of the pack
Raloxifene hydrochloride 60 mg Tablets is a white oval film-coated tablet, debossed with RX9F on one side and 60 on the other side. Raloxifene hydrochloride 60 mg Tablets is packed in blisters containing 7, 10, 14, 20, 21, 28, 30, 40, 50, 70, 84, 100 or 120 tablets.
Not all pack sizes may be marketed.
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