This leaflet answers some common questions about FOSAMAX PLUS D-Cal. It is particularly important that you read the sections "When to take it" and "How to take it" before you take this medicine. This 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 PLUS D-Cal against the benefits they expect it will have for you.

You may need to read it again.

FOSAMAX PLUS D-Cal is a combination medicine consisting of 4 once weekly tablets of FOSAMAX PLUS 70mg/140 micrograms (5600 IU) together with 48 tablets of BoneCal®

FOSAMAX PLUS D-Cal is used to treat osteoporosis and to provide additional vitamin D and additional calcium.

Osteoporosis is caused by changes in the way bone is normally maintained. Vitamin D is an essential nutrient required for calcium absorption and healthy bones. Calcium is an essential mineral, necessary to maintain the bone structure in the body.

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.

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.

Vitamin D is an essential nutrient, required for calcium absorption and healthy bones. The main source is through exposure to summer sunlight, which makes vitamin D in our skin. Clothing or sun block can prevent enough sunlight from getting through. In addition, as people age, their skin becomes less able to make vitamin D. Very few foods are natural sources of vitamin D.

Too little vitamin D leads to inadequate calcium absorption and low phosphate-minerals that make bones strong. Even if you are eating a diet rich in calcium or taking a calcium supplement, your body cannot absorb calcium properly unless you have enough vitamin D. Too little vitamin D may lead to bone loss and osteoporosis. Severe vitamin D deficiency may cause muscle weakness which can lead to falls and a higher risk of fracture.

Calcium is vital for healthy teeth and bones and also plays a crucial role in other systems of the body, such as the health and functioning of nerves and muscle tissue. People at different life stages need different amounts of calcium - young children, teenagers and older men and women all have greater than average requirements. Many ralian adults do not achieve the recommended amount of calcium in their diets and can benefit from calcium supplements.

Not having enough calcium in your diet may lead to disorders like osteoporosis. Making sure you have enough calcium in your diet is an important way to slow bone loss and keep bones strong. If not enough calcium from food and supplements can be absorbed to keep blood calcium normal, the body will remove calcium from the bones. If your dietary intake of calcium is constantly low, your body will eventually remove so much calcium from the skeleton that your bones will become weak and brittle and more likely to break.

The alendronate in FOSAMAX PLUS 70mg/140 micrograms (5600 IU) works by slowing down the process of old bone being removed, which allows the bone-forming cells time to rebuild normal bone. Alendronate not only helps prevent the loss of bone but actually helps to rebuild bone and make bone less likely to fracture. Thus, FOSAMAX PLUS 70mg/140 micrograms (5600 IU) reverses the progression of osteoporosis.

FOSAMAX PLUS 70mg/140 micrograms (5600 IU) starts working on the bone cells immediately, but measurable effects on bone mass may not be seen for several months or more.

The alendronate in FOSAMAX PLUS 70mg/140 micrograms (5600 IU) belongs to a group of non-hormonal medicines called bisphosphonates.

In addition to alendronate, FOSAMAX PLUS 70mg/140 micrograms (5600 IU) also contains vitamin D, an essential nutrient required for calcium absorption and healthy bones.

BoneCal contains calcium, an essential mineral necessary to help maintain the bone structure in the body.

You should know that in some people, FOSAMAX PLUS 70mg/140 micrograms (5600 IU) can irritate or burn the food pipe (also called oesophagus). The chances of this happening should be reduced when you follow the instructions for 'How to take FOSAMAX PLUS D-Cal' in this leaflet.

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

FOSAMAX PLUS D-Cal 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 PLUS D-Cal. However, both aspirin and FOSAMAX PLUS 70mg/140 micrograms (5600 IU) 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 PLUS D-Cal.

The usual dose of FOSAMAX PLUS 70mg/140 micrograms (5600 IU) is one tablet once a week.

They may differ from the information contained in this leaflet.

Swallow one tablet whole with a full glass of plain water [not mineral water, not coffee or tea, not juice].

It is important to take FOSAMAX PLUS 70mg/140 micrograms (5600 IU) with plain water only, not mineral water. Food, other drugs and mineral water and other drinks, including fruit juices, coffee and tea, will reduce the effect of FOSAMAX PLUS 70mg/140 micrograms (5600 IU) 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 PLUS 70mg/140 micrograms (5600 IU) 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 PLUS 70mg/140 micrograms (5600 IU) 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 PLUS D-Cal for as long as your doctor prescribes it. FOSAMAX PLUS D-Cal can only treat your osteoporosis, by helping prevent further loss of bone and continuing to rebuild bone, if you take it as directed. Since it is not known how long you should take FOSAMAX PLUS D-Cal, you should discuss the need to stay on this medication with your doctor periodically to determine if FOSAMAX PLUS D-Cal is still right for you.

 

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 PLUS D-Cal helps most people with osteoporosis, 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 PLUS D-Cal. 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 PLUS D-Cal.

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

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

FOSAMAX PLUS D-Cal is not addictive.

If you take the tablets out of the original containers 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 PLUS D-Cal is a combination pack consisting of a box of 4 once weekly tablets of FOSAMAX PLUS 70mg/140 micrograms (5600 IU) together with a bottle of 48 tablets of BoneCal.

FOSAMAX PLUS 70mg/140 micrograms (5600 IU): comes as a white to off-white, modified rectangle-shaped tablet with "270" on one side and a bone image on the other.

BoneCal comes as a pale green, capsule shaped tablet.

Inactive ingredients:

FOSAMAX PLUS 70mg/140 micrograms (5600 IU) does not contain gluten, tartrazine or any other azo dyes.

BoneCal contains 1250 mg calcium carbonate equivalent to 500mg elemental calcium per tablet.

Inactive ingredients:

BoneCal does not contain gluten or preservatives.