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Raloxifene Teva 60 mg film-coated tablets Raloxifene Hydroch
2015-03-13 19:51:24 来源: 作者: 【 】 浏览:368次 评论:0

For doctors

 

What is it and how is it used?

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.

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.

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.

What do you have to consider before using it?

Do not take Raloxifene Teva

Take special care with Raloxifene Teva
The following are reasons why this medicine may not be suitable for you. If any of them apply to you, talk to your doctor before you take this medicine:

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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

Pregnancy and breast-feeding
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.

Ask your doctor or pharmacist for advice before taking any medicines.

Driving and using machines
Raloxifene Teva has no known effects on driving or using machines.

How is it used?

Always take Raloxifene Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The 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.

If you take more Raloxifene Teva than you should
Tell your doctor or pharmacist.

If you forget to take Raloxifene Teva
Take a tablet as soon as you remember and then continue as before.

If you stop taking Raloxifene Teva
You should talk to your doctor first.

If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.

What are possible side effects?

Like all medicines, Raloxifene Teva can cause side effects, although not everybody gets them. The majority of side effects seen with Raloxifene Teva have been mild.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10), common (affects 1 to 10 users in 100), uncommon (affects 1 to 10 users in 1,000), rare (affects 1 to 10 users in 10,000), very rare (affects less than 1 user in 10,000) and not known (frequency cannot be estimated from the available data).

Very common (affects more than 1 user in 10)

Common (affects 1 to 10 users in 100)

Uncommon (affects 1 to 10 users in 1,000)

Rare (affects 1 to 10 users in 10,000)

Very rare (affects less than 1 user in 10,000)

In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene Teva.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Raloxifene Teva after the expiry date which is stated on the outer carton or foil. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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.

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For doctors

What is it?

Raloxifene Teva is a medicine that contains the active substance raloxifene hydrochloride. It is available as white, oval tablets (60 mg).

Raloxifene Teva is a ‘generic medicine’. This means that Raloxifene Teva is similar to a ‘reference medicine’ already authorised in the European Union (EU) called Evista. For more information on generic medicines, see the question-and-answer document here.

What is it used for?

Raloxifene Teva is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. Raloxifene Teva has been shown to significantly reduce vertebral fractures (breaks in the spine), but not hip fractures.

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose for adults and the elderly is one tablet taken once a day, with or without food. Patients may also receive calcium and vitamin D supplements if they do not get enough from their diet. Raloxifene Teva is intended for long-term use.

How does it work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break (fracture). Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall: oestrogen slows down bone breakdown and makes the bones less likely to fracture.

The active substance in Raloxifene Teva, raloxifene, is a selective oestrogen receptor modulator (SERM). Raloxifene acts as an ‘agonist’ of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body. Raloxifene has the same effect as oestrogen in the bone, but it does not have an effect in the breast or the womb.

How has it been studied?

Studies in patients have been limited to tests to determine that it is bioequivalent to the reference Evista. Two medicines are bioequivalent when they produce the same levels of the active substance in the body.

What benefits has it shown during the studies?

Because Raloxifene Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.

What is the risk associated?

Because Raloxifene Teva is a generic medicine, its benefit and risk are taken as being the same as the reference medicine.

Why has it been approved?

The CHMP concluded that, in accordance with EU requirements, Raloxifene Teva has been shown to have comparable quality and to be bioequivalent to Evista. Therefore, the CHMP’s view was that, as for Evista, the benefit outweighs the identified risk. The Committee recommended that Raloxifene Teva be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Raloxifene Teva to Teva Pharma B.V. on 29 April 2010. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Raloxifene Teva, read the Package Leaflet (also part of the EPAR).

This summary was last updated in 03-2010.

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Name

 

Raloxifene Teva 60 mg film-coated tablets

 

Composition

 

Each film-coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Film-coated tablet.

White to off-white, film coated, oval shaped tablets, debossed with the number “60” on one side and “N” on the other side of the tablet.

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

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