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FOSAMAX ONCE WEEKLY 70 MG TABLETS

Active substance(s): ALENDRONIC ACID

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Patient Information Leaflet

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.
• The name of this medicine is FOSAMAX Once Weekly 70 mg Tablets
but will be referred to as Fosamax throughout the remainder of this
leaflet.
• 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.
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:

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.
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.
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.
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.

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

Follow these instructions carefully to make sure you will benefit from
Fosamax.

Exercise

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

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).

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).

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 or 7 fl. oz.).
• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juice or milk.

Stopping smoking

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 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.

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

Do not crush or chew the tablet or allow it to dissolve in your mouth.
3) 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.
4) Do not take Fosamax at bedtime or before getting up for the day.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or
worsening heartburn, stop taking Fosamax and contact your doctor.
6) 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.
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 longterm 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.
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
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 Fosamax after the expiry date which is stated on the carton
and blister after EXP. The expiry date refers to the last day of that
month.
• This medicinal product does not require any special storage
conditions. Do not remove the tablets from the blister pack until you
are ready to take the medicine.
• If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Fosamax contains
Each tablet contains: The equivalent of 70mg alendronic acid as
91.37mg of alendronate sodium trihydrate.
The other ingredients are: microcrystalline cellulose, lactose anhydrous,
croscarmellose sodium and magnesium stearate.
What Fosamax looks like and contents of the pack
Fosamax are oval white tablets, marked with an outline of a bone image
on one side and ‘31’ on the other.
Fosamax Once Weekly 70 mg Tablets are available in a calendar blister
pack of 4 tablets.

Product Licence Holder
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Manufactured by:
Merck Sharp & Dohme B.V., Waarderweg, 39,
2031 Haarlem, Netherlands
Repackaged by MPT Pharma Ltd.

POM

Leaflet dated 26th November 2015
Leaflet coded xxxxxxxxx
PL: 33532/0420
Fosamax® is a registered trademark of Merck Sharp & Dohme Corp.
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; Fax (01761) 471104; Helpline 0845 4500230
or (in RoI) The Irish Osteoporosis Society, 114 Pembroke Road,
Garden Level, Ballsbridge, Dublin 4, Telephone (01) 6375050.
The National Osteoporosis Society and the Irish Osteoporosis Society
are independent charities not connected with Merck Sharp & Dohme
Limited and MPT Pharma Ltd.

Patient Information Leaflet

Alendronic Acid Once Weekly 70 mg Tablets
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.
• The name of this medicine is Alendronic Acid Once Weekly 70 mg
Tablets but will be referred to as Alendronic Acid throughout the
remainder of this leaflet.
• 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 Alendronic Acid, before taking this medicine.
What is in this leaflet:
1) What Alendronic Acid is and what it is used for
2) What you need to know before you take Alendronic Acid
3) How to take Alendronic Acid
4) Possible side effects
5) How to store Alendronic Acid
6) Contents of the pack and other information
1) WHAT ALENDRONIC ACID IS AND WHAT IT IS USED FOR
What is Alendronic Acid?
Alendronic Acid is a tablet containing the active substance alendronic
acid (commonly called alendronate) and belongs to a group of nonhormonal medicines called bisphosphonates. Alendronic Acid 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 Alendronic Acid used for?
Your doctor has prescribed Alendronic Acid to treat your osteoporosis.
Alendronic Acid reduces the risk of spine and hip fractures.
Alendronic Acid 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 Alendronic Acid, 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).

2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ALENDRONIC ACID
Do not take Alendronic Acid
• 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 Alendronic Acid.

It is important to maintain good oral hygiene when being treated with
Alendronic Acid. 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 Alendronic Acid. These side
effects may worsen if patients continue to take Alendronic Acid after
developing these symptoms.
Children and adolescents
Alendronic Acid should not be given to children and adolescents less
than 18 years of age.
Other medicines and Alendronic Acid
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
It is likely that calcium supplements, antacids, and some oral medicines
will interfere with the absorption of Alendronic Acid if taken at the same
time. Therefore, it is important that you follow the advice given in section
3) How to take Alendronic Acid.
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 Alendronic Acid.
Alendronic Acid with food and drink
It is likely that food and beverages (including mineral water) will make
Alendronic Acid less effective if taken at the same time. Therefore, it is
important that you follow the advice given in section 3) How to take
Alendronic Acid.
Pregnancy and breast-feeding
Alendronic Acid is only intended for use in postmenopausal women. You
should not take Alendronic Acid 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 Alendronic Acid that may
affect your ability to drive or operate machinery. Individual responses to
Alendronic Acid may vary. (See section 4.)
Alendronic Acid 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.
3) HOW TO TAKE ALENDRONIC ACID
Always take Alendronic Acid exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
Take one Alendronic Acid tablet once a week.
Follow these instructions carefully to make sure you will benefit from
Alendronic Acid.
1) Choose the day of the week that best fits your schedule. Every week,
take one Alendronic Acid tablet on your chosen day.
It is very important to follow instructions 2), 3), 4) and 5) to help the
Alendronic Acid 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 Alendronic Acid tablet whole with a full glass of
water only (not mineral water) (not less than 200 ml or 7 fl. oz.).
• 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) 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.
4) Do not take Alendronic Acid at bedtime or before getting up for the
day.
5) If you develop difficulty or pain upon swallowing, chest pain, or new or
worsening heartburn, stop taking Alendronic Acid and contact your
doctor.
6) After swallowing your Alendronic Acid tablet, wait at least 30 minutes
before taking your first food, drink, or other medicine of the day,
including antacids, calcium supplements and vitamins. Alendronic Acid
is effective only if taken when your stomach is empty.

It is important to tell your doctor before taking Alendronic Acid 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 corticosteroids (such as prednisone or
dexamethasone),
• you are or have been a smoker (as this may increase the risk of dental
problems).

If you take more Alendronic Acid 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.

You may be advised to have a dental check-up before starting treatment
with Alendronic Acid.

If you have any further questions on the use of this medicine, ask your
doctor or pharmacist

If you forget to take Alendronic Acid
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 Alendronic Acid
It is important that you take Alendronic Acid for as long as your doctor
prescribes the medicine. Since it is not known how long you should take
Alendronic Acid, you should discuss the need to stay on this medicine
with your doctor periodically to determine if Alendronic Acid is still right
for you.

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 longterm 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.
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
By reporting side effects, you can help provide more information on the
safety of this medicine.
5) HOW TO STORE ALENDRONIC ACID
• Keep out of the sight and reach of children.
• Do not use Alendronic Acid after the expiry date which is stated on the
carton and blister after EXP. The expiry date refers to the last day of
that month.
• This medicinal product does not require any special storage
conditions. Do not remove the tablets from the blister pack until you
are ready to take the medicine.
• If your tablets become discoloured or show any sign of deterioration,
return them to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Alendronic Acid contains
Each tablet contains: The equivalent of 70mg alendronic acid as
91.37mg of alendronate sodium trihydrate.
The other ingredients are: microcrystalline cellulose, lactose anhydrous,
croscarmellose sodium and magnesium stearate.
What Alendronic Acid looks like and contents of the pack
Alendronic Acid are oval white tablets, marked with an outline of a bone
image on one side and ‘31’ on the other.
Alendronic Acid Once Weekly 70 mg Tablets are available in a calendar
blister pack of 4 tablets.

Product Licence Holder
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Manufactured by:
Merck Sharp & Dohme B.V., Waarderweg, 39,
2031 Haarlem, Netherlands
Repackaged by MPT Pharma Ltd.

POM

Leaflet dated 26th November 2015
Leaflet coded xxxxxxxxx
PL: 33532/0420
HOW CAN YOU OBTAIN MORE INFORMATION ABOUT
ALENDRONIC ACID?
This leaflet gives you the most important patient information about
Alendronic Acid. 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; Fax (01761) 471104; Helpline 0845 4500230
or (in RoI) The Irish Osteoporosis Society, 114 Pembroke Road,
Garden Level, Ballsbridge, Dublin 4, Telephone (01) 6375050.
The National Osteoporosis Society and the Irish Osteoporosis Society
are independent charities not connected with Merck Sharp & Dohme
Limited and MPT Pharma Ltd.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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