Actonel 5mg
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3. HOW TO TAKE ACTONEL
PACKAGE LEAFLET: INFORMATION FOR THE USER Actonel® 5mg
(risedronate sodium)
The name of your medicine is Actonel 5mg, but will be referred to as Actonel throughout the remainder of this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What Actonel is and what it is used for
2. Before you take Actonel
3. How to take Actonel
4. Possible side effects
5. How to store Actonel
6. Further information
1. WHAT ACTONEL IS AND WHAT IT IS USED FOR
What Actonel is
Actonel belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to break.
Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone.
Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain.
Osteoporosis is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids.
The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis - related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it.
What Actonel is used for
The treatment of osteoporosis
• in postmenopausal women.
The prevention of osteoporosis
• in women with an increased risk of osteoporosis (including low bone mass, early menopause or a family history of osteoporosis).
• in postmenopausal women who have been on high doses of steroid drugs for a long time. It maintains or increases bone mass.
2. BEFORE YOU TAKE ACTONEL
' ' Do NOT take Actonel
• If you are allergic to risedronate sodium or any of the other ingredients of Actonel (see section 6, “What Actonel contains”).
• If your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level).
• If you may be pregnant, are pregnant or planning to become pregnant.
• If you are breast-feeding.
• If you have severe kidney problems.
Take special care and talk to your doctor BEFORE you start taking Actonel
• If you are unable to stay in an upright position (sitting or standing) for at least 30 minutes.
• If you have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level).
• If you have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach).
For instance you may have had pain or difficulty in swallowing food or you have previously been told that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus).
• If you have been told by your doctor that you have an intolerance to some sugars (such as lactose).
• If you have had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth.
• If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Actonel.
Your doctor will advise you on what to do when taking Actonel if you have any of the above.
Children
Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.
Taking other medicines
Medicines containing one of the following lessen the effect of Actonel if taken at the same time:
• Calcium
• Magnesium
• aluminium (for example some indigestion mixtures)
• iron.
Take these medicines at least 30 minutes after your Actonel tablet. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Actonel with food and drink
It is very important that you do NOT take your Actonel tablet with food or drinks (other than plain water) so that it can work properly. In particular do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, “Taking other medicines”).
Take food and drinks (other than plain water) at least 30 minutes after your Actonel tablet.
Pregnancy and breast-feeding
Do NOT take Actonel if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Actonel”). The potential risk associated with the use of risedronate sodium (active substance in Actonel) in pregnant women is unknown.
Do NOT take Actonel if you are breast-feeding (see section 2, “Do not take Actonel”).
Driving and using machines
Actonel is not known to affect your ability to drive and use machines.
Important information about some of the ingredients of Actonel
Actonel contains a small amount of lactose (see section 2, “Take special care and talk to your doctor before you start taking Actonel”).
Dosage
Always take Actonel exactly as your doctor has told you. You should check with your doctor if you are not sure.
Usual dose:
Take ONE Actonel tablet (5 mg of risedronate sodium) once a day. For your convenience, the days of the week are printed on the blister foil to help you remember to take your medicine.
WHEN to take the Actonel tablet
IT IS BEST to take your Actonel tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day. If in particular instance you are unable to take your Actonel tablet at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:
• EITHER
Between meals: at least 2 hours after your last food, drink (other than plain water) or other medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet.
• OR
In the evening: at least 2 hours after your last food, drink (other than plain water) or other medicine of the day. Actonel should be taken at least 30 minutes before going to bed.
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