FOSAMAX 10MG

Active substance: ALENDRONATE SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

FOSAMAX® 10 mg Tablets
(alendronate sodium)

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.
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

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).
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.
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.

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3. How to take Fosamax
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.
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.

For Position Only

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.
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
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. Talk to 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).

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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
Fosamax10 mg 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
Manufacturer
Merck Sharp & Dohme Limited,
Merck Sharp & Dohme (Italia) SpA,
Hoddesdon,
Via Emilia 21,
Hertfordshire EN11 9BU
27100 Pavia,
United Kingdom
Italy
This leaflet was last revised in October 2012
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 2012. All rights reserved.
PIL.FSM.12.UK.3666 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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