APO-Alendronate Plus Vitamin D

This leaflet answers some common questions about Alendronate Plus D3. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

You can also download the most up to date leaflet from www.apotex.com.au.

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

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

The name of your medicine is APO-Alendronate Plus D3 tablets. It contains the active ingredient alendronate sodium and colecalciferol (vitamin D3).

It is used to:

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.

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.

"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.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor's prescription.

The alendronate in this medicine 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, Alendronate Plus D3 reverses the progression of osteoporosis.

Alendronate Plus D3 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 this medicine belongs to a group of non-hormonal medicines called bisphosphonates.

In addition to alendronate, Alendronate Plus D3 also contains vitamin D3, an essential nutrient required for calcium absorption and healthy bones.

There is no evidence that this medicine is addictive.

This medicine should not be used in children.

You should know that in some people, Alendronate Plus D3 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 this medicine' in this leaflet

Some medicines are likely to interfere with the absorption of Alendronate Plus D3. These include:

Other medicines not listed above may also interact with Alendronate Plus D3. If you are taking any of these you may need a different dose or you may need to take different medicines. Your doctor has more information on medicines to be careful with or avoid while taking Alendronate Plus D3.

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

The usual dose of Alendronate Plus D3 is one tablet once a week.

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

Swallow one tablet whole with a full glass of plain water.

It is important to take Alendronate Plus D3 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 this medicine 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. 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).

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

Alendronate Plus D3 is effective only if taken when your stomach is empty. Food, drinks other than plain water, and other medicines will lessen the effect of Alendronate Plus D3 by interfering with its absorption into the body.

It is important that you continue taking Alendronate Plus D3 for as long as your doctor prescribes.

Alendronate Plus D3 can only treat your osteoporosis, by helping prevent further loss of bone and continuing to rebuild bone, if you take it every week.

Make sure you have enough to last over weekends and holidays.

If you have trouble remembering to take your medicine, ask your doctor for some hints to help you remember.

Tell your doctor that you are taking this medicine if:

Tell any other doctors, dentists and pharmacists who are treating you that you take this medicine.

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.

There have been side effects reported with this medicine that may affect your ability to drive or operate machinery. Individual responses to this medicine may vary (see Possible side effects).

Tell your doctor as soon as possible if you do not feel well while you are taking this medicine or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

These may be serious side effects and you may need medical attention:

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 are very serious side effects and you may need urgent medical attention or hospitalisation:

Other side effects not listed above may occur in some patients.

Symptoms of an allergic reaction may include some or all of the following:

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. 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.

If your doctor tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

70mg/70mcg tablets:

White to off-white biconvex, oval shaped tablet. Engraved "APO" on one side, "A-D28" on the other side.

Blister Pack of 4

70mg/140 mcg tablets:

White to off-white, rectangular, biconvex tablet. Engraved "APO" on one side, "ALE-D56" on the other side.

Blister Pack of 4

* Not all strengths, pack types and/or pack sizes may be available.

Each tablet contains 70 mg alendronate acid (as alendronate sodium) and 70 mcg or 140 mcg colecalciferol (vitamin D3) as the active ingredients.

It also contains the following inactive ingredients:

This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.