FOSAMAX 10MG

Active substance: ALENDRONATE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

6604

FOSAMAX® 10 mg Tablets

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(alendronate sodium)

Technical Info

Read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
• It is particularly important to understand the information in section 3. How to Take Fosamax,
before taking this medicine.

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In this leaflet:
1. What Fosamax is and what it is used for
2. Before you take Fosamax
3. How to take Fosamax
4. Possible side effects
5 How to store Fosamax
6. Further information

1. What Fosamax is and what it is used for
What is Fosamax?
Fosamax contains a medicine called alendronate. This belongs to a group of medicines called
‘bisphosphonates’. Fosamax prevents loss of bone that occurs in women after they have been
through the menopause. It can also prevent loss of bone in men or people taking steroids, such
as prednisolone and methylprednisolone.
It has also been shown to help rebuild bone and reduce the risk of spine and hip fractures
(broken bones) in women (after their menopause) and in men who have thinning of their bones
(osteoporosis).
What is Fosamax used for?
Your doctor has prescribed Fosamax because you either have osteoporosis or you are at risk of
developing this disease.
What is osteoporosis?
Osteoporosis is thinning and weakening of your 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.

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Osteoporosis can also occur in men due to a number of causes including ageing and/or a low
level of the male hormone, testosterone. In all instances, bone is removed faster than it is formed,
so bone loss occurs and bones become weaker.
Corticosteroids can also cause bone loss and osteoporosis in both men and women.
Early on, osteoporosis usually has no symptoms. If left untreated 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 injuries that would not fracture normal bone. Broken bones usually occur at the
hip, spine, or wrist and can lead not only to pain but also considerable problems like stooped
posture (‘dowager’s hump’) and loss of mobility.
How can osteoporosis be treated or prevented?
It is important to remember that if you already have osteoporosis that it can be treated and that
it is never too late to begin. Fosamax not only prevents the loss of bone but actually helps to
rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.
In addition to your treatment with Fosamax, your doctor may recommend that you make some
changes to your lifestyle which may help your condition. These are:
Stopping smoking
S
 moking appears to increase the rate at which you lose bone and
therefore, may increase your risk of broken bones.
Exercise
L
 ike muscles, bones need exercise to stay strong and healthy. Talk to
your doctor before you begin any exercise programme.
Eating a balanced diet
Y
 our doctor can advise you about your diet or whether you should
take any dietary supplements (especially calcium and vitamin D).

2. Before you take Fosamax
Do not take Fosamax if you:
• are allergic (hypersensitive) to alendronate sodium trihydrate, the active ingredient, or any of
the other ingredients (listed in section 6)
• have certain problems with your gullet (oesophagus - the tube that
connects your mouth with your stomach) such as narrowing or
difficulty swallowing
• cannot stand or sit upright for at least 30 minutes
• 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 or pharmacist
first and follow the advice given.
Take special care with Fosamax
It is important to tell your doctor before taking Fosamax if you:
• suffer from kidney problems
• 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)
• have been told you have low blood calcium
• have poor dental health, gum disease, a planned extraction or you don't receive routine
dental care
• have cancer
• are undergoing chemotherapy or radiotherapy
• are taking corticosteroids (such as prednisone or dexamethasone)
• are or have been a smoker (as this may increase the risk of dental problems).

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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.
Taking 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. aspirin or ibuprofen)
might cause digestive problems. Therefore, caution should be used when these medicines are
taken at the same time as Fosamax.
Please tell your doctor about all medicines you are taking or plan to take, including any obtained
without a prescription.
Taking Fosamax with food and drink
It is likely that food and drinks (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.
Children and adolescents
Fosamax is not indicated for use in children or adolescents.
Pregnancy and breast-feeding
Fosamax is only intended for use in postmenopausal women. Do 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 Possible Side Effects.)
Important information about some of the ingredients of Fosamax
Fosamax contains lactose, which is a type of sugar. 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

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Always take Fosamax exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Taking your medicine
It is very important that you follow actions 1 to 5 to help the tablet reach your stomach quickly
and help reduce possible irritation of your oesophagus (the tube that connects your mouth with
your stomach).
1. 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 plain water only (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.

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

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Technical Info

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2. 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.
3. Do not take Fosamax at bedtime or before getting up for the day.
4. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn,
stop taking Fosamax and talk to your doctor immediately.
5. After swallowing your 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
will only work if your stomach is empty.
You must take Fosamax exactly as your doctor has told you. It is important that you continue
taking Fosamax for as long as your doctor prescribes the medicine.
The usual dosage is
• for the treatment of osteoporosis in men and post-menopausal women the usual dose is
10 mg once a day.
• for the treatment and prevention of steroid induced osteoporosis in post-menopausal
women not receiving hormone replacement therapy (HRT) with an oestrogen the usual dose
is 10 mg once a day.
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 forget to take your dose, skip the missed dose.
• Take the next dose as normal.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Fosamax
It is important that you continue taking Fosamax for as long as your doctor prescribes the
medicine for you. Fosamax can treat your osteoporosis only if you continue to take it.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Fosamax can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported.
Very Common (occurring in at least 1 of 10 patients treated)
Common (occurring in 1 or more of 100 and less than 1 of 10 patients treated)
Uncommon (occurring in 1 or more of 1,000 and less than 1 of 100 patients treated)
Rare (occurring in 1 or more of 10,000 and less than 1 of 1,000 patients treated)
Very rare (occurring in less than 1 of 10,000 patients treated)
Very common:
• bone, muscle and/or joint pain which is sometimes severe.
Common:
• 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;
• 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:
• 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:
• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly
causing difficulty breathing or swallowing. Stop taking this medicine and contact your
doctor right away if you experience such symptoms;
• 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;
• severe reactions involving your skin, mucous membranes of your mouth, nose eyes or
genitals. Stop taking this medicine and contact your doctor right away if you experience
such symptoms;
• 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;
• mouth ulcers when the tablets have been chewed or sucked.
Tell your doctor or pharmacist promptly about these or any other unusual symptoms.
It will help if you make a note of what you experienced, when it started and how long it lasted.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store Fosamax
Keep your tablets out of the reach and sight of children.
Do not use Fosamax tablets after the expiry date which is stated on the carton after ‘Expiry date’.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not put the tablets into another container; they might get mixed up. 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.

6. Further information
What Fosamax contains
Active substance
The active substance is alendronate sodium. Fosamax Tablets contain alendronate sodium,
equivalent to 10 mg alendronic acid.
Other ingredients
Microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, carnauba wax and
magnesium stearate.
What Fosamax looks like and contents of the pack
Fosamax Tablets are available as oval, white tablets with ‘936’ on one side and plain on the other,
each containing alendronate sodium, equivalent to 10 mg alendronic acid.
Fosamax Tablets are supplied in blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Merck Sharp & Dohme Limited,
Hoddesdon,
Hertfordshire EN11 9BU
United Kingdom

Profile: BG148x520_260
Profile Revision:
7
Profile Revision Date: 050708
Dimensions (mm):
148 x 520mm

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN, Haarlem
The Netherlands

This leaflet was last revised in June 2014.
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
The National Osteoporosis Society
P.O. Box 10
Radstock
Bath
Avon BA3 3YB.
Telephone (01761) 471771
Fax (01761) 471104
Helpline (01761) 472721.
The National Osteoporosis Society is an independent charity not connected with
Merck Sharp & Dohme Limited.
© Merck Sharp & Dohme Limited 2014. All rights reserved.
PIL.FSM.14.UK.4085.10 mg

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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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