patient information leaflet fosamax

PATIENT INFORMATION LEAFLET

FOSAMAX® 10 mg Tablets

FOSAMAX® 5 mg Tablets

(Alendronate sodium)

Read all of this leaflet carefully before you start taking this medicine, even if this is a repeat prescription.

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

What is ‘Fosamax’?

‘Fosamax’ belongs to a group of non-hormonal medicines called bisphosphonates. ‘Fosamax’ prevents the loss of bone that occurs in men, post-menopausal women and patients receiving glucocorticoids such as prednisolone and methylprednisolone. ‘Fosamax’ also has been shown to help rebuild bone and makes bone less likely to fracture in post-menopausal women and men with 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.

Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. The menopause occurs when the ovaries stop producing the female hormone, oestrogen or they are removed. Oestrogen helps to keep a woman’s skeleton healthy. Following the menopause, 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 sexes.

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/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.

Your doctor has prescribed these tablets to treat your osteoporosis or to prevent you from developing this disease. ‘Fosamax’ not only prevents the loss of bone but actually helps to rebuild bone you may have lost and make bone less likely to fracture.

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 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.

2. BEFORE YOU TAKE ‘FOSAMAX’

Do not take ‘Fosamax’

(1) if you have certain disorders of the oesophagus (sometimes called the gullet and is the tube that connects your mouth with your stomach)
(2) if you are unable to stand or sit upright for at least 30 minutes
(3) if you are allergic to any of the ingredients
(4) if your doctor has told you that you have low blood calcium
(5) if you are or think you may be pregnant
(6) if you are breast-feeding.

‘Fosamax’ tablets 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.

Take special care with ‘Fosamax’

It is important to tell your doctor before taking ‘Fosamax’

if you suffer from kidney problems
if you have any allergies
if you have any swallowing or digestive problems
if you have low blood calcium
if you have gum disease
if you have a planned dental extraction

A dental examination should be considered before you start treatment with ‘FOSAMAX’ if you have any of the conditions below.

you have cancer
you are undergoing chemotherapy or radiotherapy
you are taking steroids
you don’t receive routine dental care
you have gum disease

Appropriate preventative dental care, as recommended by the dentist, should be followed during treatment.

Taking other medicines

This medicine can interact with other medication which you take by mouth, and it is important that you follow the advice given in section 3. HOW TO TAKE ‘FOSAMAX’

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

Taking ‘Fosamax’ with food and drink

This medicine can interact with food and drink, and it is important that you follow the advice given in section 3. HOW TO TAKE ‘FOSAMAX’?

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. You should not take ‘Fosamax’ if you are or think you may be pregnant, or if you are breast-feeding.

Driving and using machines

‘Fosamax’ should not affect your ability to drive or use machines.

Important information about some of the ingredients of ‘Fosamax’

‘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 medicinal product.

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.

You should do the following to help make sure you will benefit from ‘Fosamax’. It is very important that you follow actions 1, 2, 3 and 4 to help the tablet reach your stomach quickly and help reduce potential for irritation of your oesophagus (the tube that connects your mouth with your stomach).

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

2. 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 allow the tablet to dissolve in your mouth.

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 contact your doctor.

5. After swallowing your 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.

6. 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. How much ‘Fosamax’ you need to take will depend on why you are taking it and what other drugs you are taking.

Treatment of male osteoporosis or post-menopausal osteoporosis: the usual dosage is one ‘Fosamax’ 10 mg Tablet once a day.

Treatment and prevention of glucocorticoid induced osteoporosis:

For post-menopausal women not receiving hormone replacement therapy (HRT) with an oestrogen, the usual dosage is one ‘Fosamax’ 10 mg Tablet once a day.

For post-menopausal women who are receiving HRT with an oestrogen, pre-menopausal women and also men, the usual dosage is one ‘Fosamax’ 5 mg Tablet once a day.

Prevention of post-menopausal osteoporosis: the usual dosage is one ‘Fosamax’ 5 mg Tablet 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 miss a dose, do not take an extra tablet to make up, just carry on with the next dose as normal.

If you stop taking ‘Fosamax’

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.

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.

Most patients do not have side effects from taking these tablets; however, as with any medicine, they may have unintended or undesirable effects. Side effects usually have been mild, but some patients may experience digestive disturbances which may be severe. These include irritation, ulceration or perforation of the oesophagus (the tube that connects your mouth with your stomach) which can cause chest pain, heartburn, difficulty or pain upon swallowing and/or scarring leading to narrowing of the oesophagus. These reactions may occur especially if patients do not drink a full glass of water with their tablet and/or if they lie down less than 30 minutes after taking it or before their first food of the day. Oesophageal reactions may worsen if patients continue to take ‘Fosamax’ after developing symptoms suggesting irritation of the oesophagus.

Other gastro-intestinal side-effects include abdominal pain, dyspepsia, constipation, diarrhoea, difficulty in swallowing, flatulence, full or bloated feeling in the stomach, nausea, vomiting and black and/or bloody stools.

Rarely a patient’s blood calcium may fall. These changes are usually small and cause no symptoms, but can sometimes lead to muscle spasms, painful cramps or tingling in the fingers or around the mouth.

Some patients may experience bone, muscle or joint pain, which is rarely severe. Most patients experienced relief after stopping the drug. Patients who develop severe bone, joint and/or muscle pain should contact their physician. Transient flu-like symptoms (rarely with fever), typically at the start of treatment, have occurred. Some patients may experience headache or rarely a rash (occasionally made worse by sunlight), itching, eye pain, diminished or hazy vision and/or see black floating spots. Isolated cases of severe skin reactions have occurred. Allergic reactions such as hives or rarely, swelling of the face, lips, tongue and/or throat possibly causing difficulty in breathing or swallowing, may occur. Rarely stomach or other peptic ulcers have occurred, of which some were severe and some bled. It is not known whether these were caused by treatment with ‘Fosamax’. Mouth ulcers have occurred when the tablets have been chewed or sucked.

Rarely, patients have had jaw problems associated with delayed healing and infection, often following tooth extraction (see section 3. HOW TO TAKE ‘FOSAMAX’).

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 ingredient is alendronate sodium.

‘Fosamax’ Tablets are available in two strengths:

5 mg Tablets: Each 5 mg tablet contains alendronate sodium, equivalent to 5 mg alendronic acid.
10 mg Tablets: Each 10 mg tablet contains alendronate sodium, equivalent to 10 mg alendronic acid.

Other ingredients

Microcrystalline cellulose, anhydrous lactose, croscarmellose sodium and magnesium stearate.

‘Fosamax’ 10 mg Tablets also contain carnauba wax.

‘What ‘FOSAMAX’ looks like and contents of the pack

‘Fosamax’ 5 mg Tablets are available as round, white tablets with an outline of a bone image on one side, and ‘MSD 925’ on the other

‘Fosamax’10 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’ 5 and 10 mg Tablets are supplied in blister packs of 28 tablets.

Medicine: fosamax