Raloxifene Teva film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Raloxifeno Teva 60mg Film-coated Tablets EFG

raloxifene hydrochloride

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Raloxifeno Teva is and what it is used for
2. What you need to know before taking Raloxifeno Teva
3. How to take Raloxifeno Teva
4. Possible side effects
5. How to store Raloxifeno Teva
6. Contents of the pack and other information

1. What Raloxifeno Teva is and what it is used for

Raloxifeno is used for the treatment and prevention of osteoporosis in postmenopausal women. Raloxifeno Teva reduces the risk of vertebral fractures in women with postmenopausal osteoporosis. A reduction in the risk of hip fractures has not been demonstrated.

How Raloxifeno Teva works

Raloxifeno Teva belongs to a group of non-hormonal medicines called selective estrogen receptor modulators (SERMs). When a woman reaches menopause, the level of female sex hormones (estrogens) decreases. Raloxifeno Teva produces some of the beneficial effects of estrogens after menopause.

Osteoporosis is a disease that causes your bones to become thin and fragile; this condition is particularly common in women after menopause. Osteopor游戏副本

2. What you need to know before taking Raloxifeno Teva

Do not take Raloxifeno Teva

• If you are allergic to raloxifene or to any of the other ingredients of this medicine (listed in section 6).
• If you could become pregnant, as Raloxifeno Teva may harm the foetus.
• If you are or have been receiving treatment for blood clotting problems (deep vein thrombosis, pulmonary embolism, or retinal venous thrombosis).
• If you have any liver disease (examples of liver disease include cirrhosis, mild hepatic insufficiency, or cholestatic jaundice).
• If you experience unexplained vaginal bleeding. Your doctor should investigate this.
• If you have active uterine cancer, as there is insufficient experience with the use of Raloxifeno Teva in women with this condition.
• If you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Raloxifeno Teva:

• If you are going to be immobilized for a period of time, such as being confined to a wheelchair, being admitted to hospital, or staying in bed recovering from surgery or an unexpected illness.
• If you are taking oral oestrogen therapy.
• If you have breast cancer, as there is insufficient experience with the use of Raloxifeno Teva in women with this condition.
• If you have had a stroke (e.g., cerebrovascular accident) 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 hepatic disorders. If you have liver problems and your doctor still recommends treatment, you may need to have some blood tests during treatment.

It is unlikely that Raloxifeno Teva will cause vaginal bleeding. For this reason, any vaginal bleeding occurring during treatment with Raloxifeno Teva should be considered unexpected and must be investigated by your doctor.

Raloxifeno Teva does not treat postmenopausal symptoms such as hot flushes.

Raloxifeno Teva decreases total cholesterol and LDL cholesterol ("bad" cholesterol). In general, it does not affect triglycerides or HDL cholesterol ("good" cholesterol). However, if you previously took oestrogens and they caused a marked increase in your triglyceride levels, you should inform your doctor before taking Raloxifeno Teva.

Taking Raloxifeno Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking digitalis medications for the heart or anticoagulants such as warfarin to increase blood fluidity, your doctor may need to adjust the dose of your medication.

Inform your doctor if you are taking colestyramine, a medicine used to reduce fat levels.

Pregnancy and breastfeeding

Raloxifeno Teva should only be used by postmenopausal women and must not be used by women who could still become pregnant. Raloxifeno Teva may harm the foetus.

Do not take Raloxifeno Teva during breastfeeding, as it may be excreted in breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Raloxifeno Teva has no effects, or effects are negligible, on the ability to drive or operate machinery.

3. How to take Raloxifeno Teva

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. It does not matter at what time of day you take the tablet; however, taking it at the same time each day may help you remember. You may take it with or without food.

The tablets are taken orally.

Swallow the tablet whole. If desired, you may take it with a glass of water.

Your doctor will advise you how long you should take Raloxifeno Teva. Your doctor may advise you to take calcium and vitamin D supplements.

If you take more Raloxifeno Teva than you should

Contact your doctor or pharmacist. If you take more Raloxifeno Teva than you should, you may experience leg cramps and dizziness.

If you forget to take Raloxifeno Teva

Take a tablet as soon as you remember and then continue as before.

Do not take a double dose to make up for forgotten doses.

If you stop taking Raloxifeno Teva

Consult your doctor first.

It is important that you continue taking Raloxifeno Teva for as long as your doctor prescribes it. Raloxifeno Teva can treat or prevent your osteoporosis only if you continue taking the tablets.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Most of the adverse effects observed with Raloxifeno Teva have been mild.

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

1. Hot flushes (vasodilation).
2. Influenza-like syndrome.
3. Gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and stomach discomfort.
4. Increased blood pressure

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

1. Headache, including migraines
2. Leg cramps.
3. Swelling of hands, feet, and legs (peripheral edema).
4. Gallstones.
5. Rash
6. Mild breast symptoms such as pain, enlargement, or tenderness

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

1. Increased risk of blood clots in the legs (deep vein thrombosis).
2. Increased risk of blood clots in the lungs (pulmonary embolism).
3. Increased risk of blood clots in the eyes (retinal venous thrombosis).
4. Reddened, painful skin around a vein (superficial venous thrombophlebitis).
5. Blood clots in an artery (e.g., stroke, including increased risk of death from stroke)
6. Decreased number of platelets in the blood

Rarely, blood levels of liver enzymes may increase during treatment with Raloxifeno Teva.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Annex V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Raloxifeno Teva

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 or blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Raloxifeno Teva

• The active substance is raloxifene hydrochloride. Each film-coated tablet contains 60 mg of raloxifene hydrochloride, equivalent to 56 mg of raloxifene.
• The other components are:

Tablet core: Pregelatinized starch (corn), magnesium stearate, povidone (K30), colloidal anhydrous silica, silicated microcrystalline cellulose.

Tablet coating: Polydextrose (E1200), titanium dioxide (E171), hypromellose (E464), and macrogol 4000.

Appearance of the product and contents of the pack

The film-coated tablets are white to almost white, oval-shaped, and marked with the number "60" on one side and "N" on the other.

Raloxifeno Teva 60 mg is available in packs of 14, 28, and 84 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva B.V.

Swensweg 5

2031GA Haarlem

The Netherlands

Manufacturers:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen H-4042

Hungary

TEVA UK Ltd

Brampton Road

Hampden Park

Eastbourne, East Sussex

BN22 9AG United Kingdom

Pharmachemie B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

GALIEN LPS

98 rue Bellocier

89100 Sens

France

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

For any information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Date of the most recent revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/