Risedronate Sodium 35mg Film-Coated Tablets
Out of date information, search another1. What Actonel Once a Week is and what it is used for
PACKAGE LEAFLET: INFORMATION FOR THE USER ACTONEL Once a Week 35mg Tablets/
Risedronate Sodium 35mg Film-Coated Tablets
(risedronate sodium)
This product is known as either of the above but will be referred to as Actonel Once a Week throughout this leaflet.
Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Actonel Once a Week is and what it is used for
2. What you need to know before you take Actonel Once a Week
3. How to take Actonel Once a Week
4. Possible side effects
5. How to store Actonel Once a Week
6. Contents of the pack and other information
• 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 Once a Week.
Your doctor will advise you on what to do when taking Actonel Once
a Week if you have any of the above.
Children and adolescents
Risedronate sodium is not recommended for use in children below
age 18 due to insufficient data on safety and efficacy.
Other medicines and Actonel Once a Week
Medicines containing one of the following lessen the effect of Actonel Once a Week 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 Once a Week tablet.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
What Actonel Once a Week is
Actonel Once a Week 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 can also occur in men due to a number of causes including ageing and/or a low level of the male hormone, testosterone.
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 Once a Week is used for
Treatment of osteoporosis in postmenopausal women, even if osteoporosis is severe. It reduces the risk of spinal and hip fractures. T reatment of osteoporosis in men at high risk of fractures.
Taking Actonel Once a Week with food and drink
It is very important that you do NOT take your Actonel Once a Week 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, “Other medicines and Actonel Once a Week”).
Take food and drinks (other than plain water) at least 30 minutes after your Actonel Once a Week tablet.
Pregnancy and breast-feeding
Do NOT take Actonel Once a Week if you may be pregnant, are pregnant or planning to become pregnant (see section 2, “Do not take Actonel Once a Week”). The potential risk associated with the use of risedronate sodium (active substance in Actonel Once a Week) in pregnant women is unknown.
Do NOT take Actonel Once a Week if you are breast-feeding (see section 2, “Do not take Actonel Once a Week”).
Actonel Once a Week should only be used to treat postmenopausal women and men.
Driving and using machines
Actonel Once a Week is not known to affect your ability to drive and use machines.
Actonel Once a Week contains a small amount of lactose (see section 2, “Warnings and precautions”).
3. How to take Actonel Once a Week
Do not take Actonel Once a Week
• If you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6)
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Actonel Once a
Week:
• 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 or have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have or 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).
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Recommended dose:
Take ONE Actonel Once a Week tablet (35 mg of risedronate sodium) once a week.
Choose one day of the week that best fits your schedule. Every week, take the Actonel Once a Week tablet on your chosen day.
For your convenience, so that you take your tablet on the right day every week, there is a feature included with the Actonel Once a Week pack:
There are boxes/spaces on the back of the blister card. Please mark the day of the week you have chosen to take your Actonel Once a Week tablet. Also, write in the dates you will take the tablet.
WHEN to take the Actonel Once a Week tablet
Take your Actonel Once a Week tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day.