Fosamax®

(alendronate sodium)

Please read all of this leaflet carefully before you start to take your tablets, even if you have just had a repeat prescription. Some of the information in your previous leaflet may have changed.

IT IS PARTICULARLY IMPORTANT TO READ THE SECTION ‘HOW SHOULD YOU TAKE FOSAMAX?’ BEFORE TAKING THIS MEDICINE.

Keep this leaflet You may want to read it again.

What is in your tablets?

Active ingredient

The active ingredient in Fosamax Tablets is alendronate sodium. Fosamax is available as round white tablets each containing alendronate sodium, equivalent to 10 mg alendronic acid.

Other ingredients

Microcrystalline cellulose EP, anhydrous lactose USNF, croscarmellose sodium USNF, and magnesium stearate E P.

Fosamax Tablets are supplied in blister packs of 28 tablets.

How do your tablets work?

Fosamax belongs to a group of non-hormonal medicines called aminobisphosphonates. Fosamax stops the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone.

Who makes your tablets?

Your tablets are made by Merck Sharp & Dohme (Italia)SpA, Via Emilia 21, 27100 Pavia, ltaly, for Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon Hertfordshire, UK, who hold the Product Licence in the UK and the Product Authorisation in Ireland.

Why do you need to take Fosamax?

Your doctor has prescribed Fosamax because you have a disease called osteoporosis.

Osteoporosis is a thinning and weakening of the bones that is common in post-menopausal women. Following the menopause, the ovaries stop producing the female hormone, oestrogen. At this time, 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 fractures (broken bones). Although fractures usually cause pain, fractures of the bones of the spine may go unnoticed until they cause height loss. Fractures may occur during normal, everyday activity, such as lifting, or from minor injury that would not be sufficient to fracture normal bone. Fractures usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable deformity and disability (such as stooped posture, or 'dowager's hump', and loss of mobility).

How can osteoporosis be treated?

It is important to remember that osteoporosis can be treated and that it is never too late to begin. Your doctor has prescribed Fosamax to treat your osteoporosis. Fosamax not only prevents the loss of bone but actually helps to rebuild bone.

In addition to your treatment with Fosamax, your doctor may recommend that you make some changes to your lifestyle which should 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 fracture.

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.

Are there patients who should not take these tablets?

Yes. Do not take these tablets if:

  • you have certain disorders of the oesophagus (the tube that connects your mouth with your stomach).
  • you are unable to stand or sit upright for at least 30 minutes.
  • you are allergic to any of the ingredients.
  • your doctor has told you that you have low blood calcium.
  • you are or think you may be pregnant.
  • you are breast-feeding.

Fosamax should not be given to children.

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow his advice .

What else should you know before taking Fosamax?

It is important to tell your doctor before taking Fosamax if:

  • you suffer from kidney problems.
  • you have any allergies.
  • you have any swallowing or digestive problems.

Can you take Fosamax with other medicines?

Fosamax can interact with food, drinks and other medication which you take by mouth, and it is important that you follow the advice given under the heading 'How should you take Fosamax?'

You should always tell your doctor about all drugs you are taking or plan to take, including any obtained without a prescription.

How should you take Fosamax?

It is very important that you do the following to help make sure you will benefit from Fosamax:

  1. After getting up for the day, swallow your Fosamax Tablet with a full glass of plain water only (not less than 200 ml or 7 fl oz).
  • not mineral water.
  • not coffee or tea
  • not juice.
  1. After swallowing your Fosamax Tablet do not lie down - stay fully upright (sitting or standing) for at least 30 minutes and until after your first food of the day. Do not chew or suck on a tablet of Fosamax.
  2. Do not take Fosamax at bedtime or before getting up for the day.

By following actions 1, 2 and 3 you will help the Fosamax Tablet reach your stomach quickly and help avoid irritation of your oesophagus (the tube that connects your mouth with your stomach).

  1. After swallowing your Fosamax Tablet, wait at least 30 minutes before taking your first food beverage, or other medication of the day including antacids, calcium supplements and vitamins. Fosamax is effective only if taken when your stomach is empty.
  2. If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking Fosamax and contact your doctor.
  3. Take one Fosamax Tablet once a day, every day.
  4. It is important that you continue taking Fosamax for as long as your doctor prescribes the medicine. Fosamax can treat your osteoporosis only if you continue to take the tablets.

What if you forget to take a tablet or take too many?

Try to take Fosamax once daily as prescribed. However, if you miss a dose, do not take an extra tablet to make up, just carry on with the next dose as normal.

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.

What unwanted effects could Fosamax have?

Most patients do not have side effects from taking Fosamax; however, as with any medicine, Fosamax

Do not put the tablets into another container; they might get mixed up. Do not remove the tablets from