Contains the active ingredient risedronate sodium (as hemipentahydrate)
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about . It does not contain all the information that is known about . It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.
What this medicine is used for
The name of your medicine is Terry White Chemists Risedronate. It contains the active ingredient, risedronate sodium.
This medicine is used to:
Treat osteoporosis (brittle or fragile bones that may fracture easily)
Treat osteoporosis caused by taking steroids
It is also used to preserve bone mineral density in patients on long term steroid therapy
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
How it works
Understanding bone
Bone is a living tissue consisting of calcium and other minerals.
Throughout life, old bone is constantly broken down and replaced with new bone. After the age of 35, bone loss may occur faster than your body can replace it. If you lose too much bone then they become weaker and are more likely to break.
Osteoporosis
Osteoporosis (brittle bone disease) is a disease that causes bones to become weaker. Weak bones break (fracture) easily.
Many patients with osteoporosis have no symptoms and may not even know that they have osteoporosis. However osteoporosis makes you more likely to break bones when you have a fall or bump. The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis can also cause back pain, height loss and a curved back.
Osteoporosis is common in women after the menopause and is also more likely to occur in women who have reached the menopause early. Osteoporosis can also occur in women who have not yet reached menopause, and in men.
Long term steroid treatment can also lead to osteoporosis in both men and women.
Risedronate works by slowing down the process of old bone being removed. This allows the bone-forming cells time to rebuild normal bone.
Risedronate also helps to rebuild bone mass. This creates stronger bone which is less likely to fracture.
Therefore risedronate can help reverse the progression of osteoporosis.
There is no evidence that this medicine is addictive.
Use in children
Do not give risedronate to children or adolescents under 18 years of age. There is not enough information to recommend the use of this medicine in children.
Before you use this medicine
When you must not use it
Do not use this medicine if:
You have had an allergic reaction to risedronate sodium or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting or hayfever-like symptoms.
If you think you are having an allergic reaction, do not take any more of this medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
Do not take this medicine if you are unable to stand or sit upright for at least 30 minutes.
Do not take this medicine if you have a condition called hypocalcaemia (a low level of calcium in the blood).
Do not take this medicine if you are pregnant. Risedronate may affect your developing baby if you take it during pregnancy.
Do not take this medicine if you are breast-feeding. It is not known if risedronate passes into human breast milk.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.
If you are not sure whether you should start taking this medicine, talk to your doctor or pharmacist.
Before you start to take it
Before you start taking this medicine, tell your doctor if:
1. You have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
2. You have or have had any medical conditions, especially the following:
disturbances of bone and mineral metabolism (for example vitamin D deficiency, parathyroid hormone abnormalities)
problems with the tube that takes food from your mouth to your stomach (oesophagus) such as ulcers
3. You are currently pregnant or you plan to become pregnant.
4. You are currently breastfeeding or you plan to breastfeed.
5. You are planning to have surgery or an anaesthetic.
6. You are currently receiving or are planning to receive dental treatment. Check with your doctor or dentist to see if a dental check-up is required before starting risedronate.
If you have not told your doctor about any of the above, tell them before you use this medicine.
This is especially important if you are receiving medicines or therapy used to treat cancer or taking corticosteroids, such as prednisone or cortisone.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and risedronate may interfere with each other. These include:
Antacids, medicines used to treat indigestion e.g. Gaviscon, Mylanta
Other products containing calcium
Iron supplements
These medicines may be affected by risedronate or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking risedronate.
How to take this medicine
Follow carefully all directions given to you by your doctor or pharmacist.
Their instructions may be different to the information in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
Your doctor or pharmacist will tell you how many tablets you will need to take. This depends on your condition and whether or not you are taking any other medicines.
For osteoporosis, the usual dose is one 35mg tablet weekly.
Do not stop taking your medicine or change your dosage without first checking with your doctor.
How to take it
Take your risedronate tablet while sitting or standing upright. Do not lie down immediately after swallowing it.
It is important to stay upright, for example, sitting, standing or walking around, for at least 30 minutes after swallowing your tablet. It is also very important to stay upright until after you have eaten your first food of the day. This will help make sure the tablet reaches your stomach quickly and helps avoid irritation to your oesophagus.
Swallow your risedronate tablet whole with a glass of plain water. Do not chew or suck the tablet.
It is important to take risedronate with plain water only (120 mL), not mineral water. Mineral water and other drinks, including fruit juices, coffee and tea, will reduce the effect of risedronate.
When to take it
Risedronate is most effective when your stomach is empty.
Take risedronate in the morning, 30 minutes to 1 hour before your first meal, drink or medication of the day.
Take your risedronate 35mg tablet on the same day each week. This tablet should be taken each week. Choose a day of the week that suits you the best.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.
If you forget to take it
If you have forgotten to take your 35mg tablet, just take your tablet on the day you remember.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of you experiencing side effects.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
In adults, symptoms of an overdose may include leg cramps and dizziness.
In children, symptoms of an overdose may include coordination problems, dizziness, vomiting, rash, diarrhoea, repetitive shaking, and flushing.
While you are taking this medicine
Things you must do
If you become pregnant while you are using this medicine, tell your doctor.
Tell any other doctors, dentists and pharmacists who are treating you that you are using this medicine.
If you are about to be started on any new medicine, tell your doctor or pharmacist that you are using this medicine.
If you require a dental procedure, tell your dentist that you are taking risedronate. Invasive dental procedures should be avoided where possible.
This type of medicine may cause jaw-bone problems in some people. Jaw-bone problems may include infection, and delayed healing after teeth are pulled out or other work that involves drilling into the jaw.
If you develop a toothache, jaw pain, painful exposed bone or swelling, especially following dental work, tell your doctor or dentist immediately.
Speak to your doctor and dentist about good oral hygiene and regular dental check-ups while you are using risedronate.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
Go to your doctor regularly for a check-up.
Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.
If you are going to have surgery, inform your doctor and tell the surgeon or anaesthetist that you are using this medicine.
Things you must not do
Do not:
Lie down for 30 minutes after taking risedronate.
Have any food or drink, except for plain water for 30 minutes after taking risedronate.
Give this medicine to anyone else, even if their symptoms seem similar to yours
Take your medicine to treat any other condition unless your doctor or pharmacist tells you to
Stop taking your medicine, or change the dosage, without first checking with your doctor.
Things to be careful of
Be careful while driving or operating machinery until you know how risedronate affects you.
Possible side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using this medicine.
Your doctor will decide whether any change in your treatment is needed.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following:
stomach pain
diarrhoea
aching muscles, joints or bones
headache
nausea
runny nose
sore throat
dizziness
These side effects are usually mild
Tell your doctor as soon as possible if you notice any of the following:
skin rash or redness of the skin, sometimes made worse by sunlight, itchiness
blurred vision, pain or redness in the eyes
problems with your jaw or
teeth, associated with delayed healing and/or infection often following a tooth extraction or invasive dental work
These side-effects are rare.
If any of the following happen, stop taking your medicine and either tell your doctor immediately
difficulty or pain on swallowing
chest pain
new or worsening heartburn
These side effects may be due to irritation or ulceration of the food pipe. They may worsen if you continue taking the tablets.
These side effects are rare.
Tell your doctor immediately or go to the Accident and Emergency Department at your nearest hospital if you notice any of the following:
swelling of the face, lips, mouth, throat or tongue
severe skin reactions
These may be serious side effects.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
Storage and disposal
Storage
Keep your tablets in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
Disposal
If your doctor or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.
Product description
What Terry White Chemists Risedronate looks like
Terry White Chemists Risedronate is an orange, round, biconvex coated tablets, engraved "APO" on one side, "RIS" over "35" on the other side
Ingredients
Each tablet contains 35 mg of the active ingredient risedronate sodium
It also contains the following inactive ingredients:
anhydrous lactose
crospovidone
magnesium stearate
colloidal anhydrous silica
hypromellose
hydroxypropyl cellulose
macrogol 8000
titanium dioxide
iron oxide red
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
Terry White Chemists Risedronate tablets are available in:
Blister packs of 1, 4, 8, 12 and 16 tablets
Not all strengths, pack types and/or pack sizes may be available
Australian Registration Numbers
Terry White Chemists Risedronate 35 mg blister pack: AUST R 160640
Sponsor
Apotex Pty Ltd
66 Waterloo Road
North Ryde, NSW 2113
Australia
Distributor
Symbion Pharmacy Services Pty Ltd
48-58 Overseas Drive
Noble Park North, VIC 3174
Australia
Terry White Chemists is a registered trademark of Symbion Pharmacy Services Pty Ltd.
This leaflet was prepared in June 2011.
