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FOSAMAX 10MG

Active substance: ALENDRONATE SODIUM

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XXXXXXX/XX-X

6604

Package leaflet: Information for the patient

FOSAMAX® 10 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.
• 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.
2.
3.
4.
5
6.

What Fosamax is and what it is used for
What you need to know before you take Fosamax
How to take Fosamax
Possible side effects
How to store Fosamax
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 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.
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?
As well as 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).

2. What you need to know before you take Fosamax
Do not take Fosamax if you:
• are allergic to alendronic acid, the active ingredient, or any of the other ingredients of this
medicine (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

For Position Only

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.
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
• 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.
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. acetylsalicyclic acid
(aspirin) 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 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.
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 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 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.

For Position Only

For Position Only

Corticosteroids can also cause bone loss and osteoporosis in both men and women.

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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.
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 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 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;
• 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 this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after
‘EXP’. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Fosamax contains
The active substance is alendronic acid. Each tablet contains 10 mg alendronic acid (as sodium
trihydrate).
The other ingredients are microcrystalline cellulose, anhydrous lactose, croscarmellose sodium,
carnauba wax and magnesium stearate. (See section 2 “Fosamax contains lactose”)
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.
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

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

This leaflet was last revised in January 2015.
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
National Osteoporosis Society
Camerton
Bath
BA2 0PJ
Telephone: (01761) 471771
Email: info@nos.org.uk
Helpline: 0845 450 0230
The National Osteoporosis Society is an independent charity not connected with
Merck Sharp & Dohme Limited.
© Merck Sharp & Dohme Limited 2015. All rights reserved.
PIL.FSM.15.UK.4102.IB-QRD

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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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