FOSAMAX(R) Once
Weekly
Alendronate sodium
Consumer Medicine Information
What is in this leaflet cycle. Until our late 20s, while untreated it can result in broken
bones are still developing, we gain bones, also called fractures.
bone by building more than we lose. Although fractures usually cause
This leaflet answers some common
questions about FOSAMAX Once From then until about age 35 the pain, fractures of the bones of the
process is usually in balance, so that spine may go unnoticed until they
Weekly. It is particularly important
that you read the sections "When to the amount of bone lost is about cause height loss. Fractures may
take it" and "How to take it" before equal to the amount that is replaced. occur during normal, everyday
After about age 35 this balance is activity, such as lifting, or from
you take this medicine. This leaflet
does not contain all the available disturbed, with bone loss occurring minor injury that would not
at a slightly faster rate than it can be ordinarily fracture normal bone.
information.
replaced. In women, after Fractures usually occur at the hip,
It does not take the place of talking menopause, hormonal changes cause spine, or wrist and can lead not only
to your doctor or pharmacist. bone loss at an even faster rate. to pain, but also to considerable
All medicines have risks and When bone loss is excessive, bones deformity and disability, such as
benefits. Your doctor has weighed can become thinner and weaker, and stooped posture from curvature of
the risks of you taking FOSAMAX therefore are more likely to break. the spine, and loss of mobility.
Once Weekly against the benefits
they expect it will have for you. Osteoporosis How does FOSAMAX Once
If you have any concerns about Weekly work?
"Osteo" means bone, and "porosis"
taking this medicine, ask your means something that has holes in it, FOSAMAX Once Weekly works by
doctor or pharmacist. like a sponge. Therefore, slowing down the process of old
Keep this leaflet with the medicine. osteoporosis is a disease which bone being removed, which allows
causes bones to become more porous, the bone-forming cells time to
gradually making them weaker, more rebuild normal bone. FOSAMAX
You may need to read it again.
brittle and likely to break. Once Weekly not only helps prevent
Osteoporosis is common in the loss of bone but actually helps to
postmenopausal women. The rebuild bone and makes bone less
menopause occurs when the ovaries likely to fracture. Thus, FOSAMAX
What FOSAMAX Once Once Weekly reverses the
virtually stop producing the female
Weekly is used for hormone, oestrogen, or are removed progression of osteoporosis.
(which may occur, for example, at FOSAMAX Once Weekly starts
FOSAMAX Once Weekly is used to working on the bone cells
the time of a hysterectomy). At this
treat osteoporosis. immediately, but measurable effects
time, bone is removed faster than it is
This condition is caused by changes formed, so bone loss occurs and on bone mass may not be seen for
in the way bone is normally bones become weaker. The earlier a several months or more.
maintained. woman reaches the menopause, the FOSAMAX Once Weekly belongs to
greater the risk of osteoporosis. a group of non-hormonal medicines
Understanding bone Osteoporosis also occurs in men but called bisphosphonates.
Bone is living, growing tissue. is less common than in women.
Throughout life, our bodies are Early on, osteoporosis usually has no
breaking down old bone and symptoms. However, if left
rebuilding new bone in a continuous
FOSAMAX(R) ONCE WEEKLY 1
Before you take FOSAMAX Once Weekly has not being treated with FOSAMAX Once
been studied in children. Weekly. However, both aspirin and
FOSAMAX Once
FOSAMAX Once Weekly may
Weekly
Before you start to take it increase the chance of stomach
upsets.
You should know that in some Tell your doctor if:
people, FOSAMAX Once Weekly Your doctor or pharmacist has more
1. you plan to become pregnant or information on medicines to be
can irritate or burn the food pipe
breast-feed careful with or avoid while taking
(also called oesophagus). The
chances of this happening should be 2. you have any medical FOSAMAX Once Weekly.
conditions, especially the
reduced when you follow the
instructions for 'How to take following:
FOSAMAX Once Weekly' section in * kidney disease
this leaflet. * swallowing or digestive How to take FOSAMAX
problems, such as ulcers Once Weekly
When you must not take it 3. you have any allergies to any
other medicines or any other
Do not take FOSAMAX Once How much to take
substances, such as foods,
Weekly if:
preservatives or dyes. Take FOSAMAX Once Weekly
* you have an allergy to
4. you have dental or jaw-bone only when prescribed by your
FOSAMAX Once Weekly or
problems or are planning to doctor.
any of the ingredients listed at
have a course of dental surgery. The usual dose of FOSAMAX Once
the end of this leaflet
5. you currently smoke or have Weekly is 70 mg tablet once a week.
* you have certain disorders of
been a smoker in the past.
the food pipe (oesophagus) Choose the day of the week that
including those that cause If you have not told your doctor best fits your schedule. Every
difficulty in swallowing about any of the above, tell them week, take one tablet of
* you are unable to stand or sit before you take any FOSAMAX FOSAMAX Once Weekly on your
Once Weekly. chosen day.
upright for at least 30 minutes
* your doctor has told you that Follow all directions given to you
you currently have low blood Taking other medicines by your doctor carefully.
calcium
Tell your doctor if you are taking They may differ from the
* your dentist advises you to any other medicines, including information contained in this leaflet.
consult your doctor first medicines that you buy without a
prescription from your pharmacy, If you do not understand the
Do not take FOSAMAX Once
supermarket or health food shop. instructions on the box, ask your
Weekly if you are pregnant or
breast-feeding. doctor or pharmacist for help.
Some medicines may affect the way
FOSAMAX Once Weekly has not other medicines work.
When and how to take it
been studied in pregnant or
Some medicines are likely to
breast-feeding women. interfere with the absorption of Take FOSAMAX Once Weekly
FOSAMAX Once Weekly if taken after getting up for the day. Do
Do not take FOSAMAX Once
Weekly if: at the same time. These include: not take it at bedtime.
* the packaging is torn or shows * antacids, medicines used to treat Swallow one tablet whole with a
signs of tampering indigestion eg Gaviscon, Mylanta full glass of plain water.
* the expiry date on the pack has Do not take any food, medicines or
passed. * calcium supplements drinks other than plain tap water with
If you take this medicine after the * vitamins your FOSAMAX Once Weekly. It is
expiry date has passed, it may not Therefore, take FOSAMAX Once important to take FOSAMAX Once
work. Weekly at least 30 minutes before Weekly with plain water only, not
taking any of these or other mineral water. Food, other drugs,
If you are not sure whether you
medicines to make sure there is no mineral water and other drinks,
should start taking FOSAMAX
problem with absorption. Check including fruit juices, coffee and tea,
Once Weekly, talk to your doctor.
with your doctor or pharmacist if will reduce the effect of FOSAMAX
Do not give FOSAMAX Once you are not sure whether you are Once Weekly by interfering with the
Weekly to a child. taking any of these medicines.
absorption into the body.
You can take aspirin while you are
FOSAMAX(R) ONCE WEEKLY 2
Stay upright for at least 30 minutes do, talk to your doctor or bone.
after swallowing FOSAMAX Once pharmacist.
Weekly and do not take any food, Make sure you have an adequate
medicines or drinks other than If you have trouble remembering intake of calcium in your diet.
plain tap water during this time. to take your FOSAMAX Once
Your doctor, dietician or pharmacist
Weekly, ask your pharmacist for
Do not lie down immediately after some hints. can tell you what foods you should
swallowing it. eat.
It is important to stay upright If you take too much
(sitting, standing or walking around) (overdose) Things you must not do
for at least 30 minutes after Do not give FOSAMAX Once
swallowing your tablet. Immediately telephone your doctor
or Poisons Information Centre Weekly to anyone else, even if they
It is also very important to stay have the same condition as you.
(telephone 13 11 26), or go to
upright until after you have eaten accident and emergency at your
your first food of the day. nearest hospital, if you think that Things to be careful of
These actions will help make sure you or anyone else may have taken
too much FOSAMAX Once There have been side effects
your dose of FOSAMAX Once reported with FOSAMAX Once
Weekly. Do this even if there are
Weekly reaches your stomach Weekly that may affect your
no signs of discomfort or
quickly and help reduce the potential poisoning. ability to drive or operate
for irritation to your food pipe machinery. Individual responses
(oesophagus). If you take too many tablets at one to FOSAMAX Once Weekly may
time, drink a full glass of milk. Do vary. (See Side Effects).
FOSAMAX Once Weekly is not induce vomiting. Do not lie
effective only if taken when your down.
stomach is empty. Food, drinks Things that would be helpful
other than plain water, and other for your osteoporosis
medicines will lessen the effect of
Some self help measures suggested
FOSAMAX Once Weekly by While you are using below may help your osteoporosis.
interfering with its absorption into FOSAMAX Once Talk to your doctor or pharmacist
the body. Weekly about these measures and for more
Do not chew or suck on a tablet of information.
FOSAMAX Once Weekly.
Things you must do * Exercise - can be helpful in
Mouth ulcers may occur if the tablet building and maintaining strong
is chewed or dissolved in the mouth. If you develop difficulty or pain bones. Regular exercise such as a
upon swallowing, chest pain, or brisk walk is a good idea. Talk to
How long to take it new or worsening heartburn, stop your doctor before you begin any
taking FOSAMAX Once Weekly
exercise program.
It is important that you continue and call your doctor.
taking FOSAMAX Once Weekly for * Diet - eat a balanced diet. You
If you become pregnant while may need to increase the amount
as long as your doctor prescribes. taking FOSAMAX Once Weekly,
FOSAMAX Once Weekly can only of calcium in your diet by eating
stop taking FOSAMAX Once
treat your osteoporosis, by helping calcium-rich foods or taking a
Weekly and tell your doctor.
prevent further loss of bone and calcium supplement. Your
continuing to rebuild bone, if you If you are about to be started on doctor will advise you.
any new medicine, tell your doctor * Smoking - appears to increase the
take it every week.
and pharmacist that you are taking
rate at which you lose bone and,
FOSAMAX Once Weekly.
If you forget to take it therefore, may increase your risk
If you develop a toothache or of fracture. Your doctor may ask
If you miss a tablet, take one tablet require a dental procedure, tell you to stop smoking or at least
on the morning after you your dentist that you are taking cut down.
remember. FOSAMAX Once Weekly.
* Alcohol - your doctor may advise
Do not take two tablets on the If you develop new or unusual you to cut down the amount of
same day. Return to taking one pain in your hip or thigh, tell your alcohol you drink. If you drink
tablet once a week, as originally doctor. excessively on a regular basis,
scheduled on your chosen day. you may increase your risk of
Rarely, patients have experienced
If you are not sure about what to fracture in a specific part of the thigh developing osteoporosis.
FOSAMAX(R) ONCE WEEKLY 3
Side Effects * blurred vision, pain or redness in If you have the swelling described
the eye above, you may be having a serious
* symptoms of low blood calcium allergic reaction to FOSAMAX Once
Tell your doctor or pharmacist as
levels including muscle cramps Weekly.
soon as possible if you do not feel
well while you are taking or spasms or tingling sensation in Rarely, stomach or duodenal ulcers
FOSAMAX Once Weekly. the fingers or around the mouth (some severe) have occurred, but it is
FOSAMAX Once Weekly helps most * new or unusual pain in your hip not known whether these were
people with osteoporosis, but it may or thigh caused by FOSAMAX Once Weekly.
have unwanted side effects in a few These side effects are rare, and very
people. All medicines can have side rarely, may be serious.
Other side effects not listed above
effects. Sometimes they are serious, Tell your dentist and doctor may also occur in some patients.
most of the time they are not. You immediately if you notice any of Tell your doctor if you notice any
may need medical treatment if you the following: other effects.
get some of the side effects. Do not be alarmed by this list of
* Jaw-bone or dental problems
Ask your doctor or pharmacist to (including toothache). Jaw-bone possible side effects. You may not
answer any questions you may problems may include infection, experience any of them.
have. and delayed healing after a tooth FOSAMAX Once Weekly is not
Tell your doctor if you notice any extraction or other work that addictive.
of the following and they worry involves drilling into the
you: jaw-bone.
* stomach pain, gas in the stomach These side effects are rare and may
or bowel, wind be serious. After using FOSAMAX
* an uncomfortable feeling in the If any of the following happen, stop Once Weekly
stomach or belching after eating, taking FOSAMAX Once Weekly
also called dyspepsia, or and tell your doctor immediately:
Storage
heartburn * difficulty or pain upon
* feeling sick (nausea), vomiting swallowing Keep your tablets in the blister
* constipation, diarrhoea * chest pain pack until it is time to take them.
* headache * new or worsening heartburn If you take the tablets out of the
* aching muscles, joints and/or These side effects may be due to blister pack they may not keep well.
bones, which rarely can be irritation or ulceration of the food
severe. Keep FOSAMAX Once Weekly in
pipe. They may worsen if you a cool dry place where the
* flu-like symptoms typically at the continue taking FOSAMAX Once temperature stays below 30
start of treatment, such as aching Weekly. Rarely, these side effects degrees C. Do not freeze the
muscles, generally feeling unwell may be serious. product. Do not store it or any
and rarely fever. other medicine in the bathroom or
If any of the following happen, stop
* swelling of joints near a sink.
taking FOSAMAX Once Weekly
* dizziness or spinning sensation and tell your doctor immediately Do not leave it in the car or on
* unusual tiredness or weakness or go to accident and emergency at window sills.
* swelling of hands, ankles or feet your nearest hospital:
Heat and dampness can destroy some
* hair loss * swelling of the face, lips, mouth, medicines.
* changed sense of taste throat or tongue which may cause
Most of these are the more common difficulty in breathing or Keep it where children cannot
side effects of FOSAMAX Once swallowing reach it.
Weekly. For the most part, these * pinkish, itchy swellings on the A locked cupboard at least
have been mild. skin, also called hives or one-and-a-half metres above the
nettlerash ground is a good place to store
Tell your doctor immediately if
* severe skin reactions medicines.
you notice any of the following:
* black tar-like and/or bloody
* skin rash or redness of the skin, Disposal
stools
sometimes made worse by
These may be serious side effects. If your doctor tells you to stop
sunlight, itchiness
You may need urgent medical taking FOSAMAX Once Weekly,
* mouth ulcers attention. These side effects are rare. or the tablets have passed their
expiry date, ask your pharmacist
FOSAMAX(R) ONCE WEEKLY 4
what to do with any that are left 70 mg Tablets - AUST R 73772
over.
WPC-FSM-022009s
(R)Registered trademark of Merck &
Product description Co., Inc. Whitehouse Station, N.J.,
U.S.A.
What it looks like
FOSAMAX Once Weekly comes as a
white oval tablet, with 31 marked on
one side and an outline of a bone
image on the other.
A box of tablets contains 4 tablets
(trade pack) or 1 tablet (sample
pack).
Ingredients
Active ingredient:
* alendronate sodium equivalent to
70 mg alendronic acid per tablet
Inactive ingredients:
* microcrystalline cellulose
* anhydrous lactose
* croscarmellose sodium
* magnesium stearate
FOSAMAX Once Weekly does not
contain sucrose, gluten, tartrazine or
any other azo dyes.
Supplier
FOSAMAX Once Weekly is
supplied in Australia by:-
Merck Sharp & Dohme (Australia)
Pty Limited
A.C.N. 000 173 508
54-68 Ferndell Street
SOUTH GRANVILLE NSW 2142
This leaflet was prepared in April
2009.
This CMI leaflet was current at the
time of printing. To check if it has
been updated, please view our
website,
www.fosamaxonceweekly.com.au or
ask your pharmacist.
Australian Register Number:
FOSAMAX(R) ONCE WEEKLY 5