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FOSAMAX ONCE WEEKLY 70 MG TABLETS

Active substance(s): ALENDRONATE SODIUM TRIHYDRATE / ALENDRONIC ACID

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Package leaflet: Information for the patient
FOSAMAX® Once Weekly 70 mg Tablets
(alendronic acid)
Read all of this leaflet carefully before you start taking
this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
It is particularly important to understand the
information in section 3. How to take Fosamax,
before taking this medicine.
Your medicine is available using the above name but will
be referred to as Fosamax throughout the remainder of this
leaflet.
What is in this leaflet:
1.
What Fosamax is and what it is used for
2.
What you need to know before you take Fosamax
3.
How to take Fosamax
4.
Possible side effects
5.
How to store Fosamax,
6.
Contents of the pack and other information

1. What Fosamax is and what it is used for
What is Fosamax?
Fosamax is a tablet containing the active substance
alendronic acid (commonly called alendronate) and
belongs to a group of non-hormonal medicines called
bisphosphonates. Fosamax prevents the loss of bone that
occurs in women after they have been through the
menopause, and helps to rebuild bone. It reduces the risk
of spine and hip fractures.
What is Fosamax used for?
Your doctor has prescribed Fosamax to treat your
osteoporosis. Fosamax reduces the risk of spine and hip
fractures.
Fosamax is a once weekly treatment.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It
is common in women after the menopause. At the
menopause, the ovaries stop producing the female
hormone, oestrogen, which helps to keep a woman’s
skeleton healthy. As a result, bone loss occurs and bones
become weaker. The earlier a woman reaches the
menopause, the greater the risk of osteoporosis.
Early on, osteoporosis usually has no symptoms. If left
untreated, however, it can result in broken bones. Although
these usually hurt, breaks in the bones of the spine may go
unnoticed until they cause height loss. Broken bones can
happen during normal, everyday activity, such as lifting, or
from minor injury that would not generally break normal
bone. Broken bones usually occur at the hip, spine, or wrist
and can lead not only to pain but also to considerable
problems like stooped posture (‘dowager’s hump’) and loss
of mobility.

How can osteoporosis be treated?
As well as your treatment with Fosamax, your doctor may
suggest you make changes to your lifestyle to help your
condition, such as:
Stopping smoking

Smoking appears to increase the
rate at which you lose bone and,
therefore, may increase your risk
of broken bones.

Exercise

Like muscles, bones need
exercise to stay strong and
healthy. Consult your doctor
before you begin any exercise
programme.

Eating a balanced diet

Your doctor can advise you about
your diet or whether you should
take any dietary supplements
(especially calcium and
Vitamin D).

It is important to maintain good oral hygiene when being
treated with Fosamax. You should have routine dental
check-ups throughout your treatment and you should
contact your doctor or dentist if you experience any
problems with your mouth or teeth such as loose teeth,
pain or swelling.
Irritation, inflammation or ulceration of the gullet
(oesophagus – the tube that connects your mouth with your
stomach) often with symptoms of chest pain, heartburn, or
difficulty or pain upon swallowing may occur, especially if
patients do not drink a full glass of water and/or if they lie
down less than 30 minutes after taking Fosamax. These
side effects may worsen if patients continue to take
Fosamax after developing these symptoms.
Children and adolescents
Fosamax should not be given to children and adolescents
less than 18 years of age.
Other medicines and Fosamax
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

2. What you need to know before you take Fosamax
Do not take Fosamax

if you are allergic to alendronic acid or any of the
other ingredients of this medicine (listed in section 6)

if you have certain problems with your gullet
(oesophagus - the tube that connects your mouth
with your stomach) such as narrowing or difficulty
swallowing

if you cannot stand or sit upright for at least 30
minutes

if your doctor has told you that you have low blood
calcium
If you think any of these apply to you, do not take the
tablets. Talk to your doctor first and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Fosamax.
It is important to tell your doctor before taking Fosamax if:

you suffer from kidney problems,

you have any swallowing or digestive problems,

your doctor has told you that you have Barrett’s
oesophagus (a condition associated with changes in
the cells that line the lower oesophagus),

you have been told you have low blood calcium,

you have poor dental health, gum disease, a planned
dental extraction or you don’t receive routine dental
care,

you have cancer,

you are undergoing chemotherapy or radiotherapy,

you are taking angiogenesis inhibitors (such as
bevacizumab, or thalidomide),

you are taking corticosteroids (such as prednisone or
dexamethasone),

you are or have been a smoker (as this may
increase the risk of dental problems).
You may be advised to have a dental check-up before
starting treatment with Fosamax.

It is likely that calcium supplements, antacids, and some
oral medicines will interfere with the absorption of Fosamax
if taken at the same time. Therefore, it is important that you
follow the advice given in section 3 How to take Fosamax.
Certain medicines for rheumatism or long-term pain called
NSAIDs (e.g. acetylsalicylic acid or ibuprofen) might cause
digestive problems. Therefore, caution should be used
when these medicines are taken at the same time as
Fosamax.

3. How to take Fosamax
Always take Fosamax exactly as your doctor or pharmacist
has told you. Check with your doctor or pharmacist if you
are not sure.
Take one Fosamax tablet once a week.
Follow these instructions carefully to make sure you will
benefit from Fosamax.
1)

It is very important to follow instructions 2), 3), 4) and 5) to
help the Fosamax tablet reach your stomach quickly and
help reduce the chance of irritating your gullet
(oesophagus - the tube that connects your mouth with your
stomach).
2)
After getting up for the day and before taking any
food, drink, or other medicine, swallow your
Fosamax tablet whole with a full glass of water only
(not mineral water) (not less than 200 ml).
• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juice or milk.
Do not crush or chew the tablet or allow it to dissolve in
your mouth.
3)

4)
Fosamax with food and drink
It is likely that food and beverages (including mineral water)
will make Fosamax less effective if taken at the same time.
Therefore, it is important that you follow the advice given in
section 3 How to take Fosamax.
Pregnancy and breast-feeding
Fosamax is only intended for use in postmenopausal
women. You should not take Fosamax if you are or think
you may be pregnant, or if you are breast-feeding.
Driving and using machines
There have been side effects (including blurred vision,
dizziness and severe bone, muscle or joint pain) reported
with Fosamax that may affect your ability to drive or
operate machinery. Individual responses to Fosamax may
vary. (See section 4.)
Fosamax contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicine.

Choose the day of the week that best fits your
schedule. Every week, take one Fosamax tablet on
your chosen day.

5)

6)

Do not lie down — stay fully upright (sitting, standing
or walking) — for at least 30 minutes after
swallowing the tablet. Do not lie down until after your
first food of the day.
Do not take Fosamax at bedtime or before getting up
for the day.
If you develop difficulty or pain upon swallowing,
chest pain, or new or worsening heartburn, stop
taking Fosamax and contact your doctor.
After swallowing your Fosamax tablet, wait at least
30 minutes before taking your first food, drink, or
other medicine of the day, including antacids,
calcium supplements and vitamins. Fosamax is
effective only if taken when your stomach is empty.

If you take more Fosamax than you should
If you take too many tablets by mistake, drink a full glass of
milk and contact your doctor immediately. Do not make
yourself vomit, and do not lie down.
If you forget to take Fosamax
If you miss a dose, just take one 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.
If you stop taking Fosamax
It is important that you take Fosamax for as long as your
doctor prescribes the medicine.
Since it is not known how long you should take Fosamax,
you should discuss the need to stay on this medicine with
your doctor periodically to determine if Fosamax is still right
for you.
An Instruction Card is included in the carton for Fosamax. It
contains important information reminding you how to take
Fosamax properly.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
See your doctor immediately if you notice any of the
following side effects, which may be serious, and for which
you may need urgent medical treatment:
Common (may affect up to 1 in 10 people):

heartburn; difficulty swallowing; pain upon
swallowing; ulceration of the gullet (oesophagus –
the tube that connects your mouth with your
stomach) which can cause chest pain, heartburn or
difficulty or pain upon swallowing.
Rare (may affect up to 1 in 1,000 people):

allergic reactions such as hives; swelling of the face,
lips, tongue and/or throat, possibly causing difficulty
breathing or swallowing; severe skin reactions,

pain in the mouth, and/or jaw, swelling or sores
inside the mouth, numbness or a feeling of
heaviness in the jaw, or loosening of a tooth. These
could be signs of bone damage in the jaw
(osteonecrosis) generally associated with delayed
healing and infection, often following tooth extraction.
Contact your doctor and dentist if you experience
such symptoms,

unusual fracture of the thigh bone particularly in
patients on long-term treatment for osteoporosis may
occur rarely. Contact your doctor if you experience
pain, weakness or discomfort in your thigh, hip or
groin as this may be an early indication of a possible
fracture of the thigh bone.

bone, muscle and/or joint pain which is severe.
Other side effects include
Very common (may affect more than 1 in 10 people):

bone, muscle and/or joint pain which is sometimes
severe.
Common (may affect up to 1 in 10 people):

joint swelling,

abdominal pain; uncomfortable feeling in the
stomach or belching after eating; constipation; full or
bloated feeling in the stomach; diarrhoea; flatulence,

hair loss; itching,

headache; dizziness,

tiredness; swelling in the hands or legs.
Uncommon (may affect up to 1 in 100 people):

nausea; vomiting,

irritation or inflammation of the gullet (oesophagus –
the tube that connects your mouth with your
stomach) or stomach,

black or tar-like stools,

blurred vision; pain or redness in the eye,

rash; redness of the skin,

transient flu-like symptoms, such as aching muscles,
generally feeling unwell and sometimes with fever
usually at the start of treatment,

taste disturbance.

Rare (may affect up to 1 in 1000 people):

symptoms of low blood calcium levels including
muscle cramps or spasms and/or tingling sensation
in the fingers or around the mouth,

stomach or peptic ulcers (sometimes severe or with
bleeding),

narrowing of the gullet (oesophagus – the tube that
connects your mouth with your stomach),

rash made worse by sunlight,

mouth ulcers when the tablets have been chewed or
sucked.
Very rare (may affect up to 1 in 10,000 people):

talk to your doctor if you have ear pain, discharge
from the ear, and/or an ear infection. These could be
signs of bone damage in the ear.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow card Scheme at: www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple
App Store.

By reporting side effects, you can help provide more
information on the safety of this medicine.
5. How to store Fosamax
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and the blister after EXP. The expiry
date refers to the last day of that month.
This medicine does not require any special storage
conditions.

This medicine is manufactured by: Merck Sharp & Dohme BV
Waarderweg 39 - 2031 BN Haarlem, The Netherlands. Procured
from within the EU. Product Licence Holder: Quadrant
Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock,
Bolton, BL6 4SA. Repackaged by Maxearn Ltd, Bolton, BL6 4SA.
Fosamax Once Weekly 70 mg Tablets

PL 20774/1568

POM
Fosamax is a registered trademark of Merck Sharp & Dohme
Corp.
nd

Date of preparation 2

February 2018

Blind or partially sighted?
Is this leaflet hard to see or read?
Contact Quadrant
Pharmaceuticals Ltd,
Tel: 01204 473081
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT
FOSAMAX?
This leaflet gives you the most important patient
information about Fosamax. If you have any questions after
you have read it, ask your doctor or pharmacist, who will
give you further information.
For more information about osteoporosis, contact (in UK)
The National Osteoporosis Society, Camerton, Bath BA2
0PJ. Telephone (01761) 471771 / 0845 130 3076; Helpline
0845 4500230; Email: info@nos.org.uk or (in RoI) The Irish
Osteoporosis Society, 114 Pembroke Road, Garden Level,
Ballsbridge, Dublin 4. Telephone (01) 6375050 / 1890 252
751; Email: info@irishosteoporosis.ie.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Fosamax contains
The active substance is alendronic acid. Each tablet
contains 70 mg alendronic acid (as sodium trihydrate).
The other ingredients are microcrystalline cellulose (E460),
lactose anhydrous, croscarmellose sodium and magnesium
stearate (E572). (See section 2 “Fosamax contains
lactose”)
What Fosamax looks like and contents of the pack
Fosamax tablets are available as oval, white tablets
marked with an outline of a bone image on one side and
‘31’ on the other.
The tablets are supplied in aluminium blister in the carton in
the following pack size: 4 tablets.

PP1/1568/V2

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