FOSAMAX^® Once Weekly

70mg Tablets

alendronate sodium

What is in this leaflet

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.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What FOSAMAX Once Weekly is used for

FOSAMAX is used to treat osteoporosis in men and in postmenopausal women.

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

Understanding bone

Bone is 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. 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.

Osteoporosis

"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 and also may occur in men. Osteoporosis often occurs in women several years after the menopause, which 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). The earlier a woman reaches the menopause, the greater the risk of osteoporosis. Osteoporosis can also occur in men due to several causes, including ageing and/or a lower level of male hormone testosterone. In all instances, bone is removed faster than it is formed, so bone loss occurs and bones become weaker. Therefore, 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.

How does FOSAMAX work?

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 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.

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

Before you take FOSAMAX Once Weekly

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

When you must not take it

Do not take FOSAMAX if:

• you have an allergy to FOSAMAX or any of the ingredients listed at the end of this leaflet
• you have certain disorders of the food pipe (also called oesophagus) including those that cause difficulty in swallowing
• you are unable to stand or sit upright for at least 30 minutes
• your doctor has told you that you currently have low blood calcium.

Do not take FOSAMAX if you are pregnant or breast-feeding. FOSAMAX has not been studied in pregnant or breast-feeding women.

• the packaging is torn or shows signs of tampering
• the expiry date on the pack has passed.
  If you take this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start taking FOSAMAX, talk to your doctor.

Do not give FOSAMAX to a child. FOSAMAX has not been studied in children.

Before you start to take it

Tell your doctor if:

• you plan to become pregnant or breast-feed
• you have any medical conditions, especially the following:
• kidney disease
• swallowing or digestive problems, such as ulcers.
• you have any allergies to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about any of the above, tell them before you take any FOSAMAX.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may affect the way other medicines work.

Some medicines are likely to interfere with the absorption of FOSAMAX if taken at the same time. These include:

• antacids, such as Aludrox™, Aludrox Plus™, Amphojel™, Andrews Effervescent™, Eno™ powder, Gavisgon™, Mylanta™, Quickeze™, Roter™, Titralac™, Titralac-Sil™, Tums™, Ural™
• calcium supplements
• vitamins.

Therefore, take FOSAMAX at least 30 minutes before taking any of these or other medicines to make sure there is no problem with absorption. Check with your doctor or pharmacist if you are not sure whether you are taking an antacid.

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.

How to take FOSAMAX Once Weekly

How much to take

Take FOSAMAX only when prescribed by your doctor.

For osteoporosis in men and in postmenopausal women, the usual dose is one 70mg tablet once a week.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

When and how to take it

1. Choose the day of the week that best fits your schedule. Every week take one FOSAMAX tablet on your chosen day.
2. Take FOSAMAX after getting up for the day and before taking your first food, beverage, or other medication. Do not take it at bedtime.
3. Swallow FOSAMAX whole with a full glass of plain water only. It is important to take FOSAMAX with plain water only, not mineral water. 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.
4. Do not chew or suck on a tablet of FOSAMAX. Mouth ulcers may occur if the tablet is chewed or dissolved in the mouth.
5. Stay upright for at least 30 minutes after swallowing FOSAMAX. Do not lie down immediately after swallowing it. It is important to stay upright, for example, sitting, standing or walking around, for at least 30 minutes after swallowing your tablet. It is also very important to stay upright until after you have eaten your first food of the day. These actions will help make sure your tablet reaches your stomach quickly and help reduce the potential for irritation to your food pipe (oesophagus).
6. Wait at least 30 minutes before taking any food, other drinks or medicines. 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.

How long to take it

It is important that you continue taking FOSAMAX for as long as your doctor prescribes. FOSAMAX can only treat your osteoporosis by helping prevent further loss of bone and continuing to rebuild bone, if you take it every week.

If you forget to take it

Take just one FOSAMAX tablet on the morning after you remember. Do not take two tablets on the same day. Return to taking one tablet once a week, as originally scheduled on your chosen day.

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.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

If you have trouble remembering to take your tablets, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or go to accident and emergency at your nearest hospital, if you think that you or anyone else may have taken too much FOSAMAX. Do this even if there are no signs of discomfort or poisoning.

If you take too many tablets at one time, drink a full glass of milk. Do not induce vomiting. Do not lie down.

While you are using FOSAMAX Once Weekly

Things you must do

If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAMAX and call your doctor.

If you become pregnant while taking FOSAMAX, stop taking the tablets and tell your doctor.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are taking FOSAMAX.

Make sure you have an adequate intake of calcium in your diet. Your doctor, dietician or pharmacist can tell you what foods you should eat.

Things you must not do

Do not give FOSAMAX to anyone else, even if they have the same condition as you.

Things that would be helpful for your osteoporosis

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

• Exercise - can be helpful in building and maintaining strong bones. Regular exercise such as a brisk walk is a good idea. Talk to your doctor before you begin any exercise program.
• Diet - eat a balanced diet. You may need to increase the amount of calcium in your diet by eating calcium-rich foods or taking a calcium supplement. Your doctor will advise you.
• Smoking - appears to increase the rate at which you lose bone and, therefore, may increase your risk of fracture. Your doctor may ask you to stop smoking or at least cut down.
• Alcohol - your doctor may advise you to cut down the amount of alcohol you drink. If you drink excessively on a regular basis you may increase your risk of developing osteoporosis.

Adverse Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking FOSAMAX.

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

Ask your doctor or pharmacist to answer any questions you may have.

• stomach pain, gas in the stomach or bowel, wind
• an uncomfortable feeling in the stomach or belching after eating, also called dyspepsia, or heartburn
• feeling sick (nausea), vomiting
• constipation, diarrhoea
• headache
• aching muscles, joints or bones.

These are the more common adverse effects of FOSAMAX. For the most part these have been mild.

• skin rash or redness of the skin sometimes made worse by sunlight
• mouth ulcers
• eye pain.

These adverse effects are rare and very rarely may be serious.

• difficulty or pain upon swallowing
• chest pain
• new or worsening heartburn.

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

If any of the following happen, stop taking FOSAMAX and tell your doctor immediately or go to accident and emergency at your nearest hospital:

• swelling of the face, lips, mouth, throat or tongue which may cause difficulty in breathing or swallowing
• pinkish, itchy swellings on the skin, also called hives or nettlerash
• black-tar-like and or bloody stools.

These may be serious adverse effects. You may need urgent medical attention. These adverse 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.

Other adverse effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

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

FOSAMAX is not addictive.

After using FOSAMAX Once Weekly

Storage

Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.

Keep FOSAMAX in a cool dry place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom or near a sink.

Do not leave it in the car or on window sills. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking the tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.

Product description

What FOSAMAX Once Weekly looks like

FOSAMAX Once Weekly comes as a tablet:

• FOSAMAX 70mg - a white oval tablet with an outline of a bone image on one side and 31 on the other.

A box of 70mg tablets contains 4 tablets.

Ingredients

Active ingredient:

FOSAMAX 70mg - 70mg alendronate sodium per tablet

Inactive ingredients:

microcrystalline cellulose
anhydrous lactose
croscarmellose sodium
magnesium stearate.

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