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.