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OPTRUMA 60 mg film coated tablets Raloxifene Hydrochloride,H
2015-03-13 19:50:52 来源: 作者: 【 】 浏览:430次 评论:0

For doctors

 

What is it and how is it used?

OPTRUMA 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. OPTRUMA mimics some of the helpful effects of oestrogen after the menopause.

OPTRUMA is used to treat and prevent osteoporosis in postmenopausal women. OPTRUMA 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 OPTRUMA:

Take special care with OPTRUMA

The following are reasons why this product may not be suitable for you. If any of them apply to you, talk to your doctor before you take the medicine.

It is unlikely that OPTRUMA will cause vaginal bleeding. So any vaginal bleeding while you take OPTRUMA is unexpected. You should have this investigated by your doctor.

OPTRUMA does not treat postmenopausal symptoms, such as hot flushes.

OPTRUMA 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 OPTRUMA.

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
OPTRUMA is for use only by postmenopausal women and must not be taken by women who could still have a baby. Optruma could harm your unborn child.
Do not take OPTRUMA if you are breast-feeding as it might be excreted in mother's milk.

Driving and using machines:
OPTRUMA has no known effects on driving or using machines.

Important information about some ingredients of OPTRUMA:
If you have been told by your doctor that you have an intolerance to lactose, a type of sugar, contact your doctor before taking this medicinal product..

How is it used?

Always take this product 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 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.

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 OPTRUMA. The doctor may also advise you to take calcium and vitamin D supplements.

If you stop taking OPTRUMA:
You should talk to your doctor first.

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

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

If you take more tablets than your doctor prescribed:
Tell your doctor or pharmacist.

What are possible side effects?

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

The most common side effects (affects more than 1 user in 10) are:

Common side effects (affects 1 to 10 users in 100) are:

Uncommon side effects (affects 1 to 10 users in 1000) are:

Very rare side effects (affects less than 1 user in 10,000) are:

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

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 after the expiry date which is stated on the pack.

Store in the original package. Do not freeze.
This medicinal product 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?

Optruma is a medicine containing the active substance raloxifene hydrochloride. It is available as white, oval tablets (60 mg).

What is it used for?

Optruma is used for the treatment and prevention of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause. Optruma 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. Optruma 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 Optruma, 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?

Optruma has been studied in the treatment and in the prevention of osteoporosis in four main studies. Three studies looked at the prevention of osteoporosis in 1,764 women, who took either Optruma or placebo (a dummy treatment) for two years. The studies measured the density of the bones. The fourth study compared the effects of Optruma with those of placebo in the treatment of osteoporosis in 7,705 women over four years. The main measure of effectiveness was how many women had vertebral (spine) fractures during the study.

What benefits has it shown during the studies?

Optruma was more effective than placebo in preventing and treating osteoporosis.
In the prevention of osteoporosis, women receiving Optruma had an increase in bone density in the hip or spine of 1.6% over two years, and those receiving placebo had a decrease of 0.8%. When used to treat osteoporosis, Optruma was more effective than placebo in reducing the number of vertebral fractures. Over four years, in comparison with placebo, Optruma decreased the number of new vertebral fractures by 46% in women who had osteoporosis and by 32% in women who had osteoporosis and an existing fracture. There was no effect of Optruma on hip fractures.

What is the risk associated?

The most common side effects with Optruma (seen in more than 1 patient in 10) are vasodilation (hot flushes) and flu-like symptoms. For the full list of side effects reported with Optruma, see the Package Leaflet.
Optruma should not be used in women who:

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Optruma had shown its effectiveness in preventing and treating osteoporosis, and had no effects on the breast or womb. The Committee decided that Optruma’s benefits are greater than its risks for the treatment and prevention of osteoporosis in postmenopausal women. The Committee recommended that Optruma be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Optruma to Eli Lilly Nederland B.V. on 5 August 1998. The marketing authorisation was renewed on 5 August 2003 and on 5 August 2008.

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Name

 

OPTRUMA 60 mg film coated tablets

 

Composition

 

Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalentto 56 mg raloxifene free base.

Excipient: each tablet contains lactose (149.40 mg)

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Film coated tablet.
Elliptically shaped, white tablets imprinted with the code ’4165’.

 

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