This leaflet answers some of the common questions about alendronate/colecalciferol. It is particularly important that you read the sections "When to take it" and "How to take it" before you take this medicine.

It does not contain all the information that is known about alendronate and colecalciferol.

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

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

You may need to read it again.

The name of your medicine is FonatPlus. It contains the active ingredients alendronate sodium and colecalciferol.

It is used to treat osteoporosis and to provide additional vitamin D.

Osteoporosis is caused by changes in the way bone is normally maintained. Vitamin D (colecalciferol) 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.

Alendronate 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 reverses the progression of osteoporosis.

Alendornate starts working on the bone cells immediately, but measurable effects on bone mass may not be seen for several months or more.

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

In addition to alendronate, your medicine also contains vitamin D, an essential nutrient required for calcium absorption and healthy bones.

Your doctor will have explained why you are being treated with this medicine.

They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Alendronate/colecalciferol is not addictive.

Do not give alendronate/colecalciferol to a child as its effects in children have not been established.

You should know that in some people, alendronate/colecalciferol 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.

Alendronate/colecalciferol has not been studied in pregnant or breast-feeding women.

It may have no effect at all, or worse, an entirely unexpected effect if you take it after the expiry date.

Some medicines may affect the way other medicines work.

You can take aspirin while you are being treated with this medicine.

However, both aspirin and alendronate/colecalciferol may increase the chance of stomach upsets.

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

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

The usual dose is one tablet once a week.

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

It is important to take this medicine 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.

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

Do not stop taking it unless your doctor tells you to - even if you feel better.

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

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

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

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.

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

Alendronate/colecalciferol 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. 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.

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

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

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

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

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.

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 or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.

FonatPlus 70 mg/70 mcg are white to off-white, modified capsule shaped uncoated tablet, debossed with 'ADC' on one side and '28' on the other side.

FonatPlus 70 mg/140 mcg are white to off-white, modified capsule shaped uncoated tablet, debossed with 'ADC' on one side and '56' on the other side.

FonatPlus are available in blister packs of 1 and 4 tablets.

Not all strengths and pack types may be available.

Each FonatPlus tablet contains 70 mg of alendronate sodium and 70 mcg or 140 mcg of colecalciferol as the active ingredients.

It also contains the following inactive ingredients:

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