NEW ZEALAND CONSUMER MEDICINE INFORMATION
1
FOSAMAX
®
Once Weekly
alendronate sodium
70 mg tablet
What is in this leaflet
This leaflet answers some common questions about FOSAMAX. It is particularly important
that you read the sections “When to take it” and “How to take it” before you take this
medicine. The leaflet 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
FOSAMAX against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What FOSAMAX Once Weekly is used for
FOSAMAX is used to treat osteoporosis in men and in postmenopausal women.
These conditions are caused by changes in the way bone is normally maintained.
Understanding bone
Bone is a 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. This balanced process keeps your skeleton healthy and strong. 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 and also may occur in men.
Osteoporosis often occurs in women several years after the menopause, which 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). The earlier a woman
reaches the menopause, the greater the risk of osteoporosis. Osteoporosis can also occur
in men due to several causes, including ageing and/or a lower level of male hormone
testosterone. In all instances, bone is removed faster than it is formed, so bone loss
occurs and bones become weaker. Therefore, maintaining bone mass and preventing
further bone loss are important to keep your skeleton healthy.
NEW ZEALAND CONSUMER MEDICINE INFORMATION
2
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.
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.
FOSAMAX belongs to a group of non-hormonal medicines called bisphosphonates.
Before you take FOSAMAX Once Weekly
You should know that FOSAMAX can irritate or burn the food pipe in some people (also
called the oesophagus). 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 (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 is not indicated for use in children.
NEW ZEALAND CONSUMER MEDICINE INFORMATION
3
Before you start to take it
Tell your doctor if:
•
you plan to become pregnant or breast-feed
•
you have any dental problems
•
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.
•
you are or have been a smoker.
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.
Effects on the Ability to Drive and Use Machinery
There have been side effects reported with FOSAMAX that may affect your ability to drive
or operate machinery. Individual responses to FOSAMAX may vary. (See Adverse
Effects.)
How to take FOSAMAX Once Weekly
How much to take
Take FOSAMAX only when prescribed by your doctor.
For osteoporosis in men and in postmenopausal women, the usual dose is one 70 mg
tablet once a week.
Follow all directions given to you by your doctor carefully. They may differ from the
information contained in this leaflet.
NEW ZEALAND CONSUMER MEDICINE INFORMATION
4
If you do not understand the instructions on the box, ask your doctor or pharmacist for
help.
When and how to take it
1. Choose the day of the week that best fits your schedule. Every week take one
FOSAMAX tablet on your chosen day.
2. Take FOSAMAX after getting up for the day and before taking your first food,
beverage, or other medication. Do not take it at bedtime.
3. Swallow FOSAMAX whole with a full glass of plain water only. It is important to take
FOSAMAX with plain water only, not mineral water, not coffee or tea, not juice. 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.
4. 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).
5. 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.
6. 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 take FOSAMAX for as long as your doctor prescribes it. FOSAMAX
can only treat your osteoporosis by helping prevent further loss of bone and continuing to
rebuild bone, if you take it every week.
If you forget to take it
Take just one FOSAMAX tablet on the morning after you remember. Do not take two
tablets on the same day. Return to taking one tablet once a week, as originally scheduled
on your chosen day. Since it is not known how long you should take FOSAMAX, you
should discuss the need to stay on this medication with your doctor periodically to
determine if FOSAMAX is still right for you.
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.
If you have trouble remembering to take your tablets, ask your pharmacist for some hints.
NEW ZEALAND CONSUMER MEDICINE INFORMATION
5
If you take too much (overdose)
Immediately telephone your doctor or National Poisons Centre (telephone 0800 POISON
or 0800 764 766), 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 Once Weekly
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.
Rarely, patients have experienced fracture in a specific part of the thigh bone. Patients have
experienced fractures in other bones as well. If you develop new or unusual pain in the hip,
thigh, or any other bone, contact your doctor.
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.
NEW ZEALAND CONSUMER MEDICINE INFORMATION
6
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, 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
•
bone, muscle and/or joint pain which is rarely severe (most patients experienced relief
after stopping the medicine)
•
transient flu-like symptoms (rarely with fever), typically at the start of treatment
•
hair loss
•
a changed sense of taste
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
•
itching
•
mouth ulcers
•
eye pain
•
ear pain
•
severe skin reactions
•
jaw problems associated with delayed healing and infection (often following tooth
extraction)
•
joint swelling or swelling in hands or legs
•
dizziness
•
unusual tiredness or weakness
•
new or unusual pain in the hip or thigh
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.
NEW ZEALAND CONSUMER MEDICINE INFORMATION
7
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.
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 Once Weekly
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 meters
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 Once Weekly looks like
FOSAMAX Once Weekly comes as a tablet:
•
FOSAMAX 70 mg - a white oval tablet with an outline of a bone image on one side and
31 on the other.
A box of 70 mg tablets contains 4 tablets.
NEW ZEALAND CONSUMER MEDICINE INFORMATION
8
Ingredients
Active ingredient:
FOSAMAX 70 mg - 70 mg alendronate sodium per tablet
Inactive ingredients:
•
microcrystalline cellulose
•
lactose
•
croscarmellose sodium
•
magnesium stearate
FOSAMAX does not contain sucrose, gluten, tartrazine or any other azo dyes.
Supplier
FOSAMAX is supplied in New Zealand by:
Organon (New Zealand) Limited
Level 7, 36 Brandon Street
Wellington 6100
Tel: 0800 111 700
This leaflet was prepared in April 2023.
S-WPPI-OG0217-P-T-012023
