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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.    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 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.

o’ —

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    ■

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.