FOSAMAX®
Alendronate sodium
5mg, 10mg & 40mg Tablets
What FOSAMAX is used
for
FOSAMAX is used to treat or prevent
osteoporosis in postmenopausal women and treat Paget's disease
of the bone.
FOSAMAX is also used to treat or prevent
osteoporosis in people who are receiving corticosteroid
medicines, such as prednisone and dexamethasone.
These conditions are caused by changes
in the way bone is normally maintained.
Understanding
bone
Bone is living, growing tissue. Throughout life, our bodies
are breaking down old bone and rebuilding new bone in a
continuous cycle. Until our late 20s, while bones are still
developing, we gain bone by building more than we lose. From
then until about age 35 the process is usually in balance, so
that the amount of bone lost is about equal to the amount that
is replaced. After about age 35 this balance is disturbed,
with bone loss occurring at a slightly faster rate than it can
be replaced. In women, after menopause, hormonal changes cause
bone loss at an even faster rate. When bone loss is excessive,
bones can become thinner and weaker, and therefore are more
likely to break.
Osteoporosis
"Osteo" means bone, and "porosis" means
something that has holes in it, like a sponge. Therefore,
osteoporosis is a disease which causes bones to become more
porous, gradually making them weaker, more brittle and likely
to break.
Osteoporosis is common in postmenopausal
women. The menopause occurs when the ovaries virtually stop
producing the female hormone, oestrogen, or are removed (which
may occur, for example, at the time of a hysterectomy). At
this time, bone is removed faster than it is formed, so bone
loss occurs and bones become weaker. The earlier a woman
reaches the menopause, the greater the risk of
osteoporosis.
Osteoporosis can also occur in people
receiving corticosteroid medicines. If taken in high doses for
a long period of time, corticosteroid medicines can cause bone
to be removed faster than it is formed. This causes loss of
bone and therefore, bones become weaker and are more likely to
break.
Early on, osteoporosis usually has no
symptoms. However, if left untreated it can result in broken
bones, also called fractures. Although fractures usually cause
pain, fractures of the bones of the spine may go unnoticed
until they cause height loss. Fractures may occur during
normal, everyday activity, such as lifting, or from minor
injury that would not ordinarily fracture normal bone.
Fractures usually occur at the hip, spine, or wrist and can
lead not only to pain, but also to considerable deformity and
disability, such as stooped posture from curvature of the
spine, and loss of mobility.
Paget's disease of the
bone
In Paget's disease of the bone, the process in which old
bone is removed and replaced with new bone is abnormally
increased. This results in new bone which is weakened and
fragile. The bones most commonly affected include the skull,
spine, legs, collar bone and pelvis. The weakened bones may
lead to pain, difficulty in moving, deformity and
fractures.
How does FOSAMAX
work?
In osteoporosis it works by slowing down
the process of old bone being removed, which allows the
bone-forming cells time to rebuild normal bone. FOSAMAX not
only helps prevent the loss of bone but actually helps to
rebuild bone and makes bone less likely to fracture. Thus,
FOSAMAX reverses the progression of osteoporosis. FOSAMAX
starts working on the bone cells immediately, but measurable
effects on bone mass may not be seen for several months or
more.
In Paget's disease, FOSAMAX slows down
bone resorption, which allows the bone-forming cells time to
rebuild normal bone.
FOSAMAX belongs to a group of
non-hormonal medicines called bisphosphonates.
Before you take
FOSAMAX
You should know that FOSAMAX can irritate or burn the food
pipe in some people. The chances of this happening should be
reduced if you follow the precautions and instructions for
taking FOSAMAX.
When you must not take
it
Do not take FOSAMAX if:
- you have an allergy to FOSAMAX or any
of the ingredients listed at the end of this leaflet
- you have certain disorders of the
food pipe (also called oesophagus) including those that
cause difficulty in swallowing
- you are unable to stand or sit
upright for at least 30 minutes
- your doctor has told you that you
currently have low blood calcium.
Do not take FOSAMAX if you are pregnant
or breast-feeding.
FOSAMAX has not been studied in pregnant
or breast-feeding women.
Do not take FOSAMAX if:
- the packaging is torn or shows signs
of tampering
- the expiry date on the pack has
passed
If you take this medicine after the
expiry date has passed, it may not work.
If you are not
sure whether you should start taking FOSAMAX, talk to your
doctor.
Do not give FOSAMAX to a child. FOSAMAX
has not been studied in children.
Before you start to take
it
Tell your doctor if:
- you plan to become pregnant or
breast-feed
- you have any medical conditions,
especially the following:
- kidney disease
-
swallowing or digestive problems, such as ulcers
- you have any allergies to any other
medicines or any other substances, such as foods,
preservatives or dyes.
If you have not told your doctor about
any of the above, tell them before you take any
FOSAMAX.
Taking other
medicines
Tell your doctor if you are taking any
other medicines, including medicines that you buy without a
prescription from your pharmacy, supermarket or health food
shop. Some medicines may affect the way other medicines
work.
Some medicines are likely to interfere
with the absorption of FOSAMAX if taken at the same time.
These include:
- antacids, such as Aludrox*, Aludrox
Plus*, Amphojel*, Andrews Effervescent*, Eno* powder,
Gavisgon*, Mylanta*, Quickeze*, Roter*, Titralac*,
Titralac-Sil*, Tums*, Ural*
- calcium supplements
- vitamins.
Therefore, take FOSAMAX at least 30
minutes before taking any of these or other medicines to make
sure there is no problem with absorption. Check with your
doctor or pharmacist if you are not sure whether you are
taking an antacid.
You can take aspirin while you are being
treated with FOSAMAX. However, both aspirin and FOSAMAX may
increase the chance of stomach upsets.
Your doctor or pharmacist has more
information on medicines to be careful with or avoid while
taking FOSAMAX.
How to take FOSAMAX
How much to take
Take FOSAMAX only when prescribed by
your doctor.
For osteoporosis in postmenopausal
women, the usual dose is one 10 mg tablet each day.
For the prevention of osteoporosis in
postmenopausal women, the usual dose is one 5mg tablet each
day.
For osteoporosis due to corticosteroid
medicines in postmenopausal women not using oestrogen, the
usual dose is one 10mg tablet each day.
For osteoporosis due to corticosteroid
medicines in men and other women, the usual dose is one 5mg
tablet each day.
For Paget's disease of the bone, the
usual dose is one 40 mg tablet each day.
Follow all directions given to you by
your doctor carefully.
They may differ from the information
contained in this leaflet.
If you do not understand the
instructions on the box, ask your doctor or pharmacist for
help.
When and how to take
it
Take FOSAMAX after getting up for the
day. Do not take it at bedtime.
It is important to stay
upright for at least 30 minutes after swallowing your
tablet.
Swallow FOSAMAX whole with a full glass
of plain water only.
It is important to take FOSAMAX with
plain water only, not mineral water. Mineral water and other
drinks, including fruit juices, coffee and tea, will reduce
the effect of FOSAMAX by interfering with the absorption into
the body.
Stay upright for at least 30 minutes
after swallowing FOSAMAX. 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. These actions will help make sure your
tablet reaches your stomach quickly and help reduce the
potential for irritation to your food pipe
(oesophagus).
Wait at least 30 minutes before taking
any food, other drinks or medicines.
FOSAMAX is effective
only if taken when your stomach is empty. Food, drinks other
than plain water, and other medicines will lessen the effect
of FOSAMAX by interfering with its absorption into the
body.
Do not chew or suck on a tablet of
FOSAMAX.
Mouth ulcers may occur if the tablet is chewed or
dissolved in the mouth.
How long to take it
It is important that you continue taking
FOSAMAX for as long as your doctor prescribes. FOSAMAX can
only treat your osteoporosis, or help prevent you from
developing osteoporosis by helping prevent further loss of
bone and continuing to rebuild bone, if you take it every
day.
In Paget's disease your doctor will tell
you how long to take FOSAMAX. The usual length of treatment is
6 months.
If you forget to take
it
Skip the dose you missed and take your
next dose the following morning.
If you take the forgotten
tablet after you have eaten or had a drink, FOSAMAX will not
work as well as it should. Therefore, it is better to skip the
dose that you missed.
If you are not sure whether to skip the
dose, talk to your doctor or pharmacist.
Do not take a double dose to make up for
the dose that you missed.
If you have trouble remembering to take
your tablets, ask your pharmacist for some hints.
If you take too much
(overdose)
Immediately telephone your doctor or
Poisons Information Centre (telephone 03 4747000), or go to
accident and emergency at your nearest hospital, if you think
that you or anyone else may have taken too much FOSAMAX. Do
this even if there are no signs of discomfort or
poisoning.
If you take too many tablets at one
time, drink a full glass of milk. Do not induce vomiting. Do
not lie down.
While you are using
FOSAMAX
Things you must do
If you develop difficulty or pain upon
swallowing, chest pain, or new or worsening heartburn, stop
taking FOSAMAX and call your doctor.
If you become pregnant while taking
FOSAMAX, stop taking the tablets and tell your
doctor.
If you are about to be started on any
new medicine tell your doctor and pharmacist that you are
taking FOSAMAX.
Make sure you have an adequate intake of
calcium in your diet.
Your doctor, dietician or pharmacist
can tell you what foods you should eat.
Things you must not
do
Do not give FOSAMAX to anyone else, even if they have the
same condition as you.
Things that would be helpful for
your osteoporosis
Some self help measures suggested below
may help your osteoporosis. Talk to your doctor or pharmacist
about these measures and for more information.
- Exercise - can be helpful in building
and maintaining strong bones. Regular exercise such as a
brisk walk is a good idea. Talk to your doctor before you
begin any exercise program.
- Diet - eat a balanced diet. You may
need to increase the amount of calcium in your diet by
eating calcium-rich foods or taking a calcium supplement.
Your doctor will advise you.
- Smoking - appears to increase the
rate at which you lose bone and, therefore, may increase
your risk of fracture. Your doctor may ask you to stop
smoking or at least cut down.
- Alcohol - your doctor may advise you
to cut down the amount of alcohol you drink. If you drink
excessively on a regular basis you may increase your risk of
developing osteoporosis.
Adverse Effects
Tell your doctor or pharmacist as soon
as possible if you do not feel well while you are taking
FOSAMAX.
FOSAMAX helps most people with
osteoporosis and Paget's disease of the bone, but it may have
unwanted adverse effects in a few people. All medicines can
have adverse effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get
some of the adverse effects.
Ask your doctor or pharmacist to answer
any questions you may have.
Tell your doctor if you notice any of
the following and they worry you:
- stomach pain, gas in the stomach or
bowel, wind
- an uncomfortable feeling in the
stomach or belching after eating, also called dyspepsia, or
heartburn
- feeling sick (nausea), vomiting
- constipation, diarrhoea
- headache
- aching muscles, joints or bones
These are the more common adverse
effects of FOSAMAX. For the most part these have been
mild.
Tell your doctor immediately if you
notice any of the following:
- skin rash or redness of the skin
sometimes made worse by sunlight
- mouth ulcers
- eye pain
These adverse effects are rare and very
rarely may be serious.
If any of the following happen, stop
taking FOSAMAX and tell your doctor immediately:
- difficulty or pain upon swallowing
- chest pain
- new or worsening heartburn
These adverse effects may be due to
irritation or ulceration of the food pipe. They may worsen if
you continue taking the tablets. Rarely, these adverse effects
may be serious.
If any of the following happen, stop
taking FOSAMAX and tell your doctor immediately or go to
accident and emergency at your nearest hospital:
- swelling of the face, lips, mouth,
throat or tongue which may cause difficulty in breathing or
swallowing
- pinkish, itchy swellings on the skin,
also called hives or nettlerash
- black tar-like and or bloody stools
These may be serious adverse effects.
You may need urgent medical attention. These adverse effects
are rare.
If you have the swelling described
above, you may be having a serious allergic reaction to
FOSAMAX.
Rarely, stomach or duodenal ulcers (some
severe) have occurred, but it is not known whether these were
caused by FOSAMAX.
Other adverse effects not listed above
may also occur in some patients. Tell your doctor if you
notice any other effects.
Do not be alarmed by this list of
possible adverse effects. You may not experience any of
them.
FOSAMAX is not addictive.
After using FOSAMAX
Storage
Keep your tablets in the blister pack
until it is time to take them.
If you take the tablets out
of the blister pack they may not keep well.
Keep FOSAMAX in a cool dry place where the temperature
stays below 30°
C. Do not store it or
any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window
sills.
Heat and dampness can destroy some
medicines.
Keep it 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 tells you to stop taking the tablets or the
tablets have passed their expiry date, ask your pharmacist
what to do with any that are left over.
Product description
What FOSAMAX looks
like
FOSAMAX comes in three types of tablets:
- FOSAMAX 5mg- white round tablet, with
MSD925 marked on one side and an outline of a bone image on
the other.
- FOSAMAX 10 mg - white round tablet,
with MSD 936 marked on one side and FOSAMAX marked on the
other.
- FOSAMAX 40 mg - white triangular
shaped tablet, with MSD 212 marked on one side and FOSAMAX
marked on the other.
A box contains two blister packs with a
total of 30 tablets.
Ingredients
Active
ingredient:
FOSAMAX 5mg- 5mg alendronate sodium per tablet
FOSAMAX
10 mg - 10 mg alendronate sodium per tablet
FOSAMAX 40 mg -
40 mg alendronate sodium per tablet
Inactive
ingredients:
microcrystalline cellulose
anhydrous
lactose
croscarmellose sodium
magnesium
stearate
FOSAMAX does not contain sucrose,
gluten, tartrazine or any other azo
dyes.
