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ACTONEL(R)*
risedronate sodium
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about ACTONEL.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking ACTONEL against the benefits this medicine is expected to have for you.
What ACTONEL is used for
ACTONEL belongs to a group of medicines called bisphosphonates which are used to treat bone diseases.
ACTONEL works directly on your bones to make them stronger and therefore less likely to break or fracture.
ACTONEL 5mg daily and 35mg Once-a-Week tablets are used to treat:
- osteoporosis (brittle or fragile bones that may fracture easily)
- osteoporosis caused by taking steroids
ACTONEL 30mg tablets are used to treat:
- Paget`s disease of the bone.
Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone.
Osteoporosis (brittle bone disease) is a disease that causes bones to become thinner. Thin bones break (fracture) easily.
Osteoporosis is common in women after the menopause (change of life) and is also more likely to occur in women who have reached the menopause early. However, osteoporosis can also occur in women who have not yet reached menopause, and can also occur in men.
Long term steroid treatment can also lead to osteoporosis in both men and women.
Many patients with osteoporosis have no symptoms and you may not even know that you have osteoporosis. However osteoporosis makes you more likely to break bones when you have a fall or sprain. 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.
In osteoporosis ACTONEL works by slowing down the process of old bone being removed. This allows the bone-forming cells time to rebuild normal bone.
ACTONEL also helps to rebuild bone mass. This creates stronger bone which is less likely to fracture. Therefore ACTONEL can reverse the progression of osteoporosis.
Paget`s disease occurs when the process of bone remodelling happens too quickly and in a disordered way. The new bone that is produced is weaker than normal and the affected bones may become enlarged, deformed, painful and may fracture.
The skull, spine, legs, collar bone and pelvic bone are the most commonly affected.
There is no evidence that ACTONEL is addictive.
This medicine is available only with a doctor`s prescription.
ACTONEL is not recommended for use in people under the age of 18, as there have been no studies of its effects in this age group.
Before you take ACTONEL
When you must not take ACTONEL
Do not take ACTONEL if:
- you have an allergy to ACTONEL or any of the ingredients listed at the end of this leaflet.
- your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level)
- you are unable to stand or sit upright for at least 30 minutes.
Like most medicines, ACTONEL is not recommended for use during pregnancy, unless you and your doctor or pharmacist have discussed the risks and benefits involved.
Like most medicines ACTONEL is not recommended while you are breast-feeding. It is not known whether ACTONEL passes into breast milk.
The safety and effectiveness of ACTONEL in children under 18 years have not been established.
- Do not take ACTONEL after the expiry date printed on the pack.
- If you take this medicine after the expiry date has passed, it may not work as well and may be harmful.
- Do not take ACTONEL if the packaging is torn or shows signs of tampering.
- If you are not sure whether you should start taking ACTONEL, contact your doctor or pharmacist.
Before you start to take it
- Tell your doctor or pharmacist if you have allergies to:
- any other medicines
- any other substances, such as foods, preservatives or dyes
- Tell your doctor or pharmacist if you are pregnant or intend to become pregnant.
- Your doctor or pharmacist will discuss the possible risks and benefits of using ACTONEL during pregnancy.
- Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed.
- Your doctor or pharmacist will discuss the possible risks and benefits of using ACTONEL during breastfeeding.
- Tell your doctor or pharmacist if you have or have had any medical conditions, especially the following:
- you have kidney problems
- you have disturbances of bone and mineral metabolism (for example vitamin D deficiency, parathyroid hormone abnormalities)
- you have had problems in the past with your oesophagus (the tube that takes food from your mouth to your stomach)
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking ACTONEL.
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 ACTONEL may interfere with each other if taken at the same. These include: antacids, such as Algicon, Alu-tab, Amphojel, Eno powder, Gastrogel, Gaviscon, Gelusil, Meracote, Mucaine, Mylanta, Rennie, Simeco, Titralac calcium supplements such as Cal-Sup vitamins.
These antacids may not be available in New Zealand
These products should be taken at a different time of day to your ACTONEL tablet.
Your doctor and pharmacist may have more information on medicines to be careful with while taking ACTONEL.
How to take ACTONEL
How much to take
Your doctor or pharmacist will tell you how many tablets you will need to take each day or each week. This depends on your condition and whether or not you are taking any other medicines.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
For osteoporosis, the usual dose is one 5mg tablet each day or one 35mg tablet once a week.
For Paget`s disease of the bone, the usual dose is one 30 mg tablet each day for 2 months.
How to take it
Swallow ACTONEL with a glass of plain water.
It is important to take ACTONEL 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 ACTONEL.
Take ACTONEL while sitting or standing upright. Do not lie down immediately after swallowing ACTONEL.
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. These actions will help make sure your tablet reaches your stomach quickly and help avoid irritation to your food pipe (oesophagus), which is the tube that connects your mouth with your stomach.
Do not chew or suck on a tablet of ACTONEL.
When to take it
ACTONEL is most effective when your stomach is empty therefore it is best to take ACTONEL in the morning, 30 minutes to 1 hour before your first meal, drink or medication of the day.
For ACTONEL 5mg and 30mg tablets, take it at about the same time each day.
Taking your tablets at the same time each day will have the best effect. It will also help you remember when to take the tablets.
For ACTONEL Once-a-Week 35mg tablets, take it at about the same time each week.
Taking your tablets at the same time each week will have the best effect. It will also help you remember when to take the tablets.
If you forget to take your tablet
For ACTONEL 5mg and 30mg tablets:
If it is almost time for your next tablet skip the tablet you missed and take your next tablet when you are meant to. Do not take a double dose to make up for the tablet that you missed.
This may increase the chance of you getting an unwanted side effect.
For the 5mg and 30mg tablets the days of the week are printed on the blister foil to help you remember to take your medicine.
For ACTONEL Once-a-Week 35mg tablets:
If you have forgotten to take your 35mg Once-a-Week tablet, just take your tablet on the day you remember. Do not take two tablets in one day to make up for the tablet you missed. Return to taking one tablet once a week, as originally scheduled on your chosen day.
Stickers are available in the pack to help you remember to take your medicine.
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.
When you must not take it
Do not use ACTONEL if the tablets do not look quite right.
How long to take it
Your doctor will tell you how long your treatment with ACTONEL should last.
Please talk to your doctor before stopping treatment.
If you take too much (overdose)
If you or somebody else has accidentally taken a large number of tablets, drink a full glass of milk or antacids, and immediately telephone your doctor or pharmacist or the Poisons Information Centre or go to accident and emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are using ACTONEL
Things you must do
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking ACTONEL.
- If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking ACTONEL.
- If you become pregnant while taking ACTONEL tell your doctor or pharmacist.
Things you must not do
- Do not give ACTONEL to anyone else, even if they have the same condition as you.
- Do not take ACTONEL to treat any other complaints unless your doctor or pharmacist tells you to.
- Do not stop taking ACTONEL without checking with your doctor or pharmacist.
Side Effects
- Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ACTONEL.
- 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 or pharmacist if you notice any of the following and they worry you:
- stomach pain
- diarrhoea
- aching muscles, joints or bones
- headache
- nausea
- rash
These side effects are usually mild.
Tell your doctor immediately if your skin, tongue or eyes become inflamed. These side-effects are rare.
Other side effects not listed above may occur in some patients. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
If any of the following happen, stop taking ACTONEL and tell your doctor immediately:
- Difficulty or pain on swallowing
- Chest pain
- New or worsening heartburn
After using ACTONEL
Storage
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they will not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25 degrees C.
Do not store ACTONEL or any other medicine in the bathroom or near a sink.
Do not leave medicines in the car on hot days or on window sills.
Heat and dampness can destroy some medicines.
Keep medicines 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 ACTONEL or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets that are left over.
Product description
What ACTONEL looks like
ACTONEL is available in three types of tablets:
ACTONEL 5mg – oval yellow tablet, with RSN marked on one side and 5mg marked on the other.
ACTONEL 30mg – oval white tablet, with RSN marked on one side and 30mg marked on the other.
ACTONEL Once-a-Week 35mg – oval light orange tablet, with RSN marked on one side and 35mg marked on the other
Ingredients
Active ingredient:
ACTONEL 5 mg tablet:
5 mg risedronate sodium per tablet
ACTONEL 30 mg tablet:
30 mg risedronate sodium per tablet
ACTONEL Once-a-Week 35 mg tablet:
35 mg risedronate sodium per tablet
Inactive ingredients:
microcrystalline cellulose
lactose
crospovidone
magnesium stearate
hypromellose
macrogol 400
macrogol 8000
silicon dioxide
titanium dioxide
hydroxypropylcellulose
iron oxide yellow (5mg and 35mg tablets only)
iron oxide red (35mg tablet only)
ACTONEL does not contain sucrose, gluten, tartrazine or any other azo dyes.
The 5mg tablets are supplied in pack sizes of 7 and 28 tablets.
The 30mg tablets are supplied in pack sizes of 28 tablets.
The 35mg tablets are supplied in pack sizes of 1 and 4 tablets.
Australian Registration Numbers:
5 mg – AUST R 74135
30 mg – AUST R 74136
35 mg – AUST R 82746
Supplier
- ACTONEL is supplied in Australia by:
- Aventis Pharma Pty Ltd
- 27 Sirius Road
- Lane Cove NSW 2066
- Date of leaflet: 9th September 2004
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