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Alendronic Acid Once Weekly 70mg Tablets

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1. What Fosamax is and what it is used for


PACKAGE LEAFLET: INFORMATION FOR THE USER FOSAMAX® ONCE WEEKLY 70 MG TABLETS ALENDRONIC ACID ONCE WEEKLY 70MG TABLETS

(Alendronic acid as alendronate sodium trihydrate)

This product will be referred to as Fosamax throughout this 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.

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

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 Fosamax to treat your osteoporosis. Fosamax 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.

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).

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,

•    you are undergoing chemotherapy or radiotherapy,

•    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.

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2. What you need to know before you take Fosamax


3. How to 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.

Always take Fosamax exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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