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ALENDRONIC ACID ONCE WEEKLY 70MG TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSAMAX® ONCE WEEKLY 70 MG TABLETS
ALENDRONIC ACID ONCE WEEKLY 70MG TABLETS
(Alendronic acid as alendronate sodium trihydrate)
This product will be referred to as Fosamax throughout this leaflet.
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.
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.

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 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.

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) 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.

Other medicines and FOSAMAX
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

FOSAMAX is a once weekly treatment.

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.

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

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.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

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).
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.

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.
Follow these instructions carefully to make sure you will benefit from
FOSAMAX.
1) Choose the day of the week that best fits your schedule. Every week,
take one FOSAMAX tablet on your chosen day.
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).

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 (see details below). By reporting side effects,
you can help provide more information on the safety of this medicine.
United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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.

What is FOSAMAX used for?
Your doctor has prescribed FOSAMAX to treat your osteoporosis.
FOSAMAX reduces the risk of spine and hip fractures.

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.

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.

An Instruction Card is included in the carton for FOSAMAX. It contains
important information reminding you how to take FOSAMAX properly.

4.

Possible side effects

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.

5.


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6.

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. 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.
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.
Contents of the pack and other information

What Fosamax contains
 The active ingredient is alendronate sodium trihydrate. Each tablet
contains 91.37mg alendronate sodium trihydrate equivalent to 70mg
alendronic acid.
 Fosamax also contains microcrystalline cellulose, anhydrous
lactose, croscarmellose sodium and magnesium stearate.
What Fosamax looks like and contents of the pack
Fosamax is available as oval, white tablets marked with the outline of a
bone image on one side and ‘31’ on the other.
Fosamax is supplied in blister packs of 4 tablets.
Manufacturer
This product is manufactured by: Merck Sharp & Dohme (Italia) S.p.A.
Via Emilia 21, 27100 Pavia, Italy. It is procured from within the EU.
Product Licence holder: G. Pharma Ltd, Salford M50 2PU.
POM

PL NO: 16369/1343

Leaflet Revision: 8th July 2016
‘Fosamax’ is a registered trademark of Merck & Co. Inc.
The National Osteoporosis Society and the Irish Osteoporosis Society are
independent charities not connected with Merck Sharp & Dohme Limited.
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.

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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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