Fosamax

This leaflet answers some common questions about FOSAMAX. It is particularly important that you read the sections "When to take it" and "How to take it" before you take this medicine. The leaflet does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking FOSAMAX against the benefits they expect it will have for you.

You may need to read it again.

FOSAMAX is used to treat osteoporosis and Paget's disease of the bone.

It is also used to treat or prevent osteoporosis in people who are receiving corticosteroid medicines, such as prednisone and dexamethasone.

In addition, FOSAMAX is used to prevent osteoporosis in postmenopausal women who have low bone mass.

These conditions are caused by changes in the way bone is normally maintained.

Bone is a living, growing tissue. Throughout life, our bodies are breaking down old bone and rebuilding new bone in a continuous cycle. Until our late 20s, while bones are still developing, we gain bone by building more than we lose. From then until about age 35 the process is usually in balance, so that the amount of bone lost is about equal to the amount that is replaced. This balanced process keeps your skeleton healthy and strong. After about age 35 this balance is disturbed, with bone loss occurring at a slightly faster rate than it can be replaced. In women, after menopause, hormonal changes cause bone loss at an even faster rate. When bone loss is excessive, bones can become thinner and weaker, and therefore are more likely to break.

"Osteo" means bone, and "porosis" means something that has holes in it, like a sponge. Therefore, osteoporosis is a disease which causes bones to become more porous, gradually making them weaker, more brittle and likely to break.

Osteoporosis is common in postmenopausal women. The menopause occurs when the ovaries virtually stop producing the female hormone, oestrogen, or are removed (which may occur, for example, at the time of a hysterectomy). At this time, bone is removed faster than it is formed, so bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

Osteoporosis also occurs in men but is less common than in women.

Osteoporosis can also occur in people receiving corticosteroid medicines. If taken in high doses or for a long period of time, corticosteroid medicines can cause bone to be removed faster than it is formed. This causes loss of bone and therefore, bones become weaker and are more likely to break.

Maintaining bone mass and preventing further bone loss are important to keep your skeleton healthy.

Early on, osteoporosis usually has no symptoms. However, if left untreated it can result in broken bones, also called fractures. 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 ordinarily 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 from curvature of the spine, and loss of mobility.

In Paget's disease of the bone, the process in which old bone is removed and replaced with new bone is abnormally increased. This results in new bone which is weakened and fragile. The bones most commonly affected include the skull, spine, legs, collar bone and pelvis. The weakened bones may lead to pain, difficulty in moving, deformity and fractures.

In osteoporosis, it works by slowing down the process of old bone being removed, which allows the bone-forming cells time to rebuild normal bone. FOSAMAX not only helps prevent the loss of bone but actually helps to rebuild bone and makes bone less likely to fracture. Thus, FOSAMAX prevents or reverses the progression of osteoporosis. FOSAMAX starts working on the bone cells immediately, but measurable effects on bone mass may not be seen for several months or more.

In Paget's disease, FOSAMAX slows down bone resorption, which allows the bone-forming cells time to rebuild normal bone.

FOSAMAX belongs to a group of non-hormonal medicines called bisphosphonates.

You should know that FOSAMAX can irritate or burn the food pipe in some people (also called oesophagus). The chances of this happening should be reduced if you follow the precautions and instructions for taking FOSAMAX.

FOSAMAX has not been studied in pregnant or breast-feeding women.

FOSAMAX has not been studied in children.

Some medicines may affect the way other medicines work.

You can take aspirin while you are being treated with FOSAMAX. However, both aspirin and FOSAMAX may increase the chance of stomach upsets.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking FOSAMAX.

For osteoporosis in postmenopausal women and in men, the usual dose is one 10 mg tablet each day.

For osteoporosis due to corticosteroid medicines in postmenopausal women not using oestrogen, the usual dose is one 10 mg tablet each day.

For osteoporosis due to corticosteroid medicines in men and other women, the usual dose is one 5 mg tablet each day.

For the prevention of osteoporosis, the usual dose is one 5 mg tablet each day.

For Paget's disease of the bone, the usual dose is one 40 mg tablet each day.

They may differ from the information contained in this leaflet.

Do not take any food, medicines or drinks other than plain tap water with your FOSAMAX. It is important to take FOSAMAX with plain water only, not mineral water. Food, other drugs, mineral water and other drinks, including fruit juices, coffee and tea, will reduce the effect of FOSAMAX by interfering with the absorption into the body.

It is important to stay upright (sitting, standing or walking around) for at least 30 minutes after swallowing your tablet.

These actions will help make sure your tablet reaches your stomach quickly and help reduce the potential for irritation to your food pipe (oesophagus).

FOSAMAX is effective only if taken when your stomach is empty. Food, drinks other than plain water, and other medicines will lessen the effect of FOSAMAX by interfering with its absorption into the body.

Mouth ulcers may occur if the tablet is chewed or dissolved in the mouth.

It is important that you take FOSAMAX for as long as your doctor prescribes it. FOSAMAX can only prevent or treat your osteoporosis, by helping prevent further loss of bone and continuing to rebuild bone, if you take it every day. Since it is not known how long you should take FOSAMAX, you should discuss the need to stay on this medication with your doctor periodically to determine if FOSAMAX is still right for you.

In Paget's disease your doctor will tell you how long to take FOSAMAX. The usual length of treatment is up to 6 months.

If you take the forgotten tablet after you have eaten or had a drink, FOSAMAX will not work as well as it should. Therefore, it is better to skip the dose that you missed.

Rarely, patients have experienced fracture in a specific part of the thigh bone.

Your doctor, dietician or pharmacist can tell you what foods you should eat.

Some self help measures suggested below may help your osteoporosis. Talk to your doctor or pharmacist about these measures and for more information.

FOSAMAX helps most people with osteoporosis and Paget's disease of the bone, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Most of these are the more common side effects of FOSAMAX. For the most part, these have been mild.

These side effects are rare, and very rarely, may be serious.

These side effects are rare and may be serious.

These side effects may be due to irritation or ulceration of the food pipe. They may worsen if you continue taking the tablets. Rarely, these side effects may be serious.

These may be serious side effects. You may need urgent medical attention. These side effects are rare.

If you have the swelling described above, you may be having a serious allergic reaction to FOSAMAX.

Rarely, stomach or duodenal ulcers (some severe) have occurred, but it is not known whether these were caused by FOSAMAX.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

FOSAMAX is not addictive.

If you take the tablets out of the blister pack they may not keep well.

Heat and dampness can destroy some medicines.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

FOSAMAX comes in three types of tablets:

A box contains two blister packs with a total of 30 tablets.

Active ingredient:

Inactive ingredients:

FOSAMAX does not contain sucrose, gluten, tartrazine or any other azo dyes.