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ALENDRONATE SODIUM ONCE WEEKLY 70MG TABLETS

Active substance(s): ALENDRONATE SODIUM TRIHYDRATE

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Ref: 0897/150216/1/F

Fosamax® Once Weekly 70mg Tablets / Alendronate Sodium Once Weekly
70mg Tablets / Alendros Once weekly 70mg Tablets
(alendronate sodium)
Patient Information 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.
Your medicine is called Fosamax Once weekly 70mg / Alendronate Sodium
Once Weekly 70mg Tablets / Alendros Once Weekly 70mg Tablets but will
be referred to as Fosamax throughout 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

Contnets 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 Fosmax to treat your osteoporosis. Fosmax
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.

* 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.
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 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.
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,

How to take Fosamax

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).
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.

Ref: 0897/150216/1/B

®

Fosamax Once Weekly 70mg Tablets / Alendronate Sodium Once Weekly
70mg Tablets / Alendros Once weekly 70mg Tablets
(alendronate sodium)
Patient Information Leaflet (continued)
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

5

How to store Fosamax

* KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.

* Do not take your tablets out of the blister strip until it is time to take your

dose.
Remember this medicine is for you. Only a doctor can prescribe it. Never
give your medicine to other people. It may harm them, even if their
symptoms are the same as yours. This leaflet does not tell you everything
about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist (chemist). He/she will have
additional information about this medicine and will be able to advise you.
* Do not use this medicine after the expiry date shown on the carton label or
blister strip.
* If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist (chemist) for safe disposal. Only keep this
medicine, if your doctor tells you to. If your tablets become discoloured or
show any other signs of deterioration, consult your pharmacist (chemist)
who will tell you what to do.

*

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.
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

6

Contents of the pack and other information

What this medicine contains:
Each tablet contains Alendronate sodium 91.37mg equivalent to Alendronic
acid 70mg as the active ingredient.
Your medicine also contains the following inactive ingredients:
Microcrystalline cellulose, anhydrous lactose, croscarmellose sodium and
magnesium stearate.
What this medicine looks like and contents of the pack
They are white, oval tablets and have an outline of a bone image on one
side and '31' on the other side. Available in blister packs of 4 tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Merck Sharp & Dohme (Italia) S.p.A. Via
Emilia 21, 27100 Pavia, Italy and are procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK), Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/0897

Fosamax Once Weekly 70mg Tablets

Fosamax is a registered trademark of Merck & Co. Inc.
Revision date: 15/02/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

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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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