2. What should I know before I take FONAT?
Do not take if you have ever had an allergic reaction to FONAT or any of the ingredients
listed at the end of the CMI. Do not take FONAT if you have the following medical
conditions: certain disorders of the food pipe, conditions that cause swallowing difficulty,
unable to stand or sit upright for at least 30 minutes, low blood calcium.
Talk to your doctor if you have other medical conditions, take other medicines, have
dental or jaw bone problems or planning dental surgery, pregnant or breastfeeding
or plan to become pregnant or breastfeed. See Section
2. What should I know before I take FONAT? in the full CMI.
3. What if I am taking other medicines?
4. How do I take FONAT?
Swallow whole one tablet with a full glass of plain water, once per week. Do not
chew or suck on the tablet.
Take in the morning after getting up, do not take at bedtime. Stay upright (sitting
or standing) for at least 30 minutes after swallowing. Do not eat, drink (other than
plain water), or take other medications during this time.
5. What should I know while taking FONAT?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking FONAT.
Stop taking FONAT and call your doctor if you develop pain or difficulty swallowing,
chest pain, or new or worsening heartburn, or if you become pregnant.
Tell your doctor immediately if you develop new or unusual hip, thigh, bone, muscle
or join pain, or if you break a bone.
|
|
Things you should not do
|
Do not give FONAT to anyone else, even if they have the same condition as you.
Do not stop taking your medicine, or change the dosage, without first checking with
your doctor.
|
|
Driving or using machines
|
Be careful driving or operating machinery until you know how FONAT affects you.
|
|
Drinking alcohol
|
Tell your doctor if you drink alcohol: your doctor may suggest drinking less.
|
|
Looking after your medicine
|
Keep FONAT in a cool, dry place, away from light and moisture where the temperature
stays below 25°C. Keep the tablets in the blister pack until it's time to take them.
|
6. Are there any side effects?
Less serious side effects: stomach pain, gas; heartburn; nausea, vomiting; constipation, diarrhoea; headache;
unusual tiredness; muscle, joint, bone aches (rarely may be severe); flu-like symptoms;
joint swelling; dizziness or spinning sensation; swelling of hands, ankles or feet;
hair loss; changes in sense of taste.
Serious side effects: skin rash or itchiness; mouth ulcers; blurred vision, eye pain or redness; jaw or
dental problems; new or unusual pain in hips or thigh, tingling sensation in the fingers
or around the mouth, difficulty or pain upon swallowing, chest pain; new or worsening
heartburn; swelling of the face, lips, mouth, throat or tongue causing difficulty
in breathing; pinkish, itchy swellings on the skin, severe skin reactions; black tar-like
and/or bloody stools. For more information, including what to do if you have any side
effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
alendronate sodium
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking FONAT. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking FONAT.
Where to find information in this leaflet:
1. Why am I taking FONAT?
FONAT contains the active ingredient alendronate sodium. FONAT belongs to a group of nonhormonal medicines called bisphosphonates.
FONAT is used to treat osteoporosis. This condition is caused by changes in the way bone is normally maintained.
FONAT works by slowing down the process of old bone being removed, which allows the
bone-forming cells time to rebuild normal bone. FONAT not only helps prevent the loss
of bone but actually helps to rebuild bone and makes bone less likely to fracture.
Thus, FONAT prevents or reverses the progression of osteoporosis.
FONAT starts working on the bone cells immediately, but measurable effects on bone
mass may not be seen for several months or more.
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. 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. 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 also occurs in men but is less common than in women.
Osteoporosis can also occur in people receiving corticosteroid medicines. If taken
in high doses or 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.
Maintaining bone mass and preventing further bone loss are important to keep your
skeleton healthy.
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.
Ask your doctor if you have any questions about why FONAT has been prescribed for
you.
Your doctor may have prescribed FONAT for another reason.
FONAT is not addictive.
2. What should I know before I take FONAT?
Warnings
Do not take FONAT if:
you are allergic to alendronate sodium, or any of the ingredients listed at the end
of this leaflet.
Always check the ingredients to make sure you can take this medicine.
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
your dentist advises you to consult your doctor first
the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking FONAT, talk to your doctor.
Check with your doctor if you:
have any other medical conditions especially the following:
kidney disease
swallowing or digestive problems, such as ulcers
take any medicines for any other condition
have have any allergies to any other medicines, foods, preservatives or dyes
have dental or jaw-bone problems or are planning to have a course of dental surgery
currently smoke or have been a smoker in the past.
If you have not told your doctor about any of the above, tell him/ her before you
start taking FONAT.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Irritation of the food pipe (oesophagus)
You should know that in some people, FONAT can irritate or burn the food pipe (also
called oesophagus). The chances of this happening should be reduced when you follow
the instructions in section
4. How do I take FONAT?.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take FONAT if you are pregnant or breastfeeding.
FONAT has not been studied in pregnant or breastfeeding women.
Talk to your doctor if you are pregnant or breastfeeding or plan to become pregnant
or breastfeed.
Children
Do not give FONAT to a child.
FONAT has not been studied in children.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with FONAT and affect how it works. These include:
antacids, medicines used to treat indigestion
calcium supplements
vitamins
You may need different amounts of your medicines, or you may need to take different
medicines.
Therefore, take FONAT at least 30 minutes before taking any of these or other medicines
to make sure there is no problem with absorption.
You can take aspirin while you are being treated with FONAT. However, both aspirin
and FONAT may increase the chance of stomach upsets.
Your doctor or pharmacist has more information on medicines to be careful with or
avoid while taking FONAT.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FONAT.
4. How do I take FONAT?
How much to take
Take FONAT only when prescribed by your doctor.
The usual dose of FONAT is one 70 mg tablet once a week.
When to take FONAT
Choose the day of the week that best fits your schedule. Every week, take one table
of FONAT on your chosen day.
How to take FONAT
Take FONAT after getting up for the day. Do not take it at bedtime.
Swallow one tablet whole with a full glass of plain water only.
Do not take any food, medicines or drinks other than plain water with your FONAT.
It is important to take FONAT with plain water only, not mineral water.
Food, other drugs, mineral water and other drinks, including fruit juices, coffee
and tea, will reduce the effect of FONAT by interfering with the absorption into the
body.
Stay upright for at least 30 minutes after swallowing FONAT and do not take any food,
medicines or drinks other than plain water during this time.
Do not lie down immediately after swallowing it.
It is important to stay upright (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 burn or irritation to your food pipe (oesophagus).
FONAT is effective only if taken when your stomach is empty. Food, drinks other than
plain water, and other medicines will lessen the effect of FONAT by interfering with
its absorption into the body.
Do not chew or suck on a tablet of FONAT.
Mouth ulcers may occur if the tablet is chewed or dissolved in the mouth.
How long to take FONAT
It is important that you continue taking FONAT for as long as your doctor prescribes.
FONAT 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 FONAT
Skip the tablet you missed and take one tablet the following morning after you remember.
If you take the missed FONAT tablet after you have eaten or had a drink, it may not
work as well as it should.
Therefore, it is better to skip the missed tablet and continue with your regular schedule
on your chosen day.
If you are not sure about what to do, talk to your doctor or pharmacist.
Do not take two tablets on the same day to make up for the dose that you missed.
If you have trouble remembering to take your FONAT, ask your pharmacist for some hints.
If you take too much FONAT
If you take too many tablets at one time, drink a full glass of milk. Do not induce
vomiting. Do not lie down.
If you think that you or anyone else has taken too much FONAT, urgent medical attention
maybe needed.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while taking FONAT?
Things you should do
Tell your doctor and pharmacist that you are taking FONAT, if you are about to be
started on any new medicine.
Tell your dentist that you are taking FONAT, if you develop a toothache or require
a dental procedure.
Tell your doctor, if you develop new or unusual pain in your leg.
Rarely, patients have experienced fracture in a specific part of the thigh bone.
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.
Visit your doctor regularly so they can check on your progress.
Call your doctor straight away if you:
develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn
and stop taking FONAT
become pregnant while taking FONAT and stop taking the tablets.
Remind any doctor, dentist or pharmacist you visit that you are taking FONAT.
Things you should not do
Do not give FONAT 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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how FONAT
affects you.
There have been side effects reported with alendronate that may affect your ability
to drive or operate machinery. Individual responses to alendronate may vary. (See
6. Are there any side effects?)
Drinking alcohol
Tell your doctor if you drink alcohol.
If you drink excessively on a regular basis, you may increase your risk of developing
osteoporosis. Your doctor may advise you to cut down the amount of alcohol you drink.
Looking after your medicine
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 FONAT below 25°C.
Do not freeze the product.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
A locked cupboard at least one-and a- half metres above the ground is a good place
to store medicines.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take this medicine after the expiry date.
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Do not be alarmed by this list of possible side effects. You may not experience any
of them.
Less serious side effects
Serious side effects
Very serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What FONAT contains
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Active ingredient
(main ingredient)
|
alendronate sodium 70 mg
|
|
Other ingredients
(inactive ingredients)
|
lactose monohydrate
microcrystalline cellulose
povidone
croscarmellose sodium
magnesium stearate
|
|
Potential allergens
|
sulfites
sugars as lactose.
|
Do not take this medicine if you are allergic to any of these ingredients.
What FONAT looks like
FONAT is a white bi-convex tablet, debossed "AD70" on one side and "G" on the reverse
(AUST R 134702).
FONAT is available in a blister pack containing 4 tablets
Who distributes FONAT
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in December 2025.
FONAT® is a Viatris company trade mark
FONAT_cmi/Dec25/00