FOSAVANCE 70 mg/5600 IU tablets

 

What is it and how is it used?

What is FOSAVANCE?
FOSAVANCE is a tablet containing the two active substances, alendronic acid and colecalciferol known as vitamin D .

What is alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents the loss of bone that occurs in women after they have been through the menopause, and helps to rebuild bone. It reduces the risk of spine and hip fractures.

What is vitamin D?
Vitamin D is an essential nutrient, required for calcium absorption and healthy bones. The body can only absorb calcium properly from our food if it has enough vitamin D. Very few foods contain vitamin D. The main source is through exposure to summer sunlight, which makes vitamin D in our skin. As we get older our skin makes less 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 greater risk of fractures.

What is FOSAVANCE used for?
Your doctor has prescribed FOSAVANCE to treat your osteoporosis and because you are at risk of vitamin D insufficiency. FOSAVANCE reduces the risk of spine and hip fractures in women after menopause.

FOSAVANCE is a once weekly treatment.

What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman’s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis.

Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone. Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture (‘dowager’s hump’) and loss of mobility.

How can osteoporosis be treated?
Osteoporosis can be treated and it is never too late to begin treatment. FOSAVANCE not only prevents the loss of bone but actually helps to rebuild bone you may have lost and reduces the risk of bones breaking in the spine and hip.

As well as your treatment with FOSAVANCE, your doctor may suggest you make changes to your lifestyle to help your condition, such as:

Stopping smoking Smoking appears to increase the rate at which you lose bone and, therefore, may increase your risk of broken bones.

Exercise Like muscles, bones need exercise to stay strong and healthy. Consult your doctor before you begin any exercise programme.

Eating a balanced diet Your doctor can advise you about your diet or whether you should take any dietary supplements.

What do you have to consider before using it?

Do not take FOSAVANCE

  • if you are allergic (hypersensitive) to alendronate sodium trihydrate, colecalciferol or any of the other ingredients,
  • if you have certain problems with your gullet (oesophagus - the tube that connects your mouth, with your stomach) such as narrowing or difficulty swallowing,
  • if you cannot stand or sit upright for at least 30 minutes,
  • if your doctor has told you that you have low blood calcium.

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Take special care with FOSAVANCE
It is important to tell your doctor before taking FOSAVANCE if:

  • you suffer from kidney problems,
  • you have any swallowing or digestive problems,
  • your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower oesophagus),
  • you have been told you have low blood calcium,
  • you have poor dental health, gum disease, a planned dental extraction or you don’t receive routine dental care,
  • you have cancer,
  • you are undergoing chemotherapy or radiotherapy,
  • you are taking corticosteroids (such as prednisone or dexamethasone),
  • you are or have been a smoker (as this may increase the risk of dental problems).

You may be advised to have a dental check-up before starting treatment with FOSAVANCE.

It is important to maintain good oral hygiene when being treated with FOSAVANCE. You should have routine dental check-ups throughout your treatment and you should contact your doctor or dentist if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling.

Irritation, inflammation or ulceration of the gullet (oesophagus – the tube that connects your mouth with your stomach) often with symptoms of chest pain, heartburn, or difficulty or pain upon swallowing may occur, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking FOSAVANCE. These side effects may worsen if patients continue to take FOSAVANCE after developing these symptoms.

Use in children
FOSAVANCE should not be given to children less than 18 years of age.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of FOSAVANCE if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAVANCE and wait at least 30 minutes before taking any other oral medicines or supplements.

It is likely that certain medicines or food additives may prevent the vitamin D in FOSAVANCE from getting into your body, including artificial fat substitutes, mineral oils, orlistat and the cholesterol-lowering medicines, cholestyramine and colestipol. Medicines for fits (seizures) may decrease the effectiveness of vitamin D.

Taking FOSAVANCE with food and drink
It is likely that food and beverages (including mineral water) will make FOSAVANCE less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3. HOW TO TAKE FOSAVANCE.

Pregnancy and breast-feeding
FOSAVANCE is only intended for use in postmenopausal women. You should not take FOSAVANCE if you are or think you may be pregnant, or if you are breast-feeding.

Driving and using machines
There have been side effects (for example blurred vision, dizziness and severe bone, muscle or joint pain) reported with FOSAVANCE that may affect your ability to drive or operate machinery. (See POSSIBLE SIDE EFFECTS.) If you experience any of these side effects you should not drive until you feel better.

Important information about some of the ingredients of FOSAVANCE
FOSAVANCE contains lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How is it used?

Always take FOSAVANCE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Take one FOSAVANCE tablet once a week.

Follow these instructions carefully to make sure you will benefit from FOSAVANCE.

1 Choose the day of the week that best fits your schedule. Every week, take one FOSAVANCE tablet on your chosen day.

It is very important to follow instructions 2), 3), 4) and 5) to help the FOSAVANCE tablet reach your stomach quickly and help reduce the chance of irritating your gullet (oesophagus - the tube that connects your mouth with your stomach).

2 After getting up for the day and before taking any food, drink, or other medicine, swallow your FOSAVANCE tablet whole with a full glass of water only not mineral water not less than 200 ml or 7 fl. oz.. Do not take with mineral water still or sparkling. Do not take with coffee or tea. Do not take with juice or milk.

Do not crush or chew the tablet or allow it to dissolve in your mouth.

3 Do not lie down stay fully upright sitting, standing or walking for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.

4 Do not take FOSAVANCE at bedtime or before getting up for the day.

5 If you develop difficulty or pain upon swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.

6 After swallowing your FOSAVANCE tablet, wait at least 30 minutes before taking your first food, drink, or other medicine of the day, including antacids, calcium supplements and vitamins. FOSAVANCE is effective only if taken when your stomach is empty.

If you take more FOSAVANCE than you should
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

If you forget to take FOSAVANCE
If you miss a dose, just take one 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 stop taking FOSAVANCE
It is important that you continue taking FOSAVANCE for as long as your doctor prescribes the medicine. FOSAVANCE can treat your osteoporosis only if you continue to take the tablets.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, FOSAVANCE can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)

Very common:

  • bone, muscle and/or joint pain which is sometimes severe.

Common:

  • heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus - the tube that connects your mouth with your stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing,
  • joint swelling,
  • abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
  • hair loss; itching,
  • headache; dizziness,
  • tiredness; swelling in the hands or legs.

Uncommon:

  • nausea; vomiting,
  • irritation or inflammation of the gullet (oesophagus – the tube that connects your mouth with your stomach) or stomach,
  • black or tar-like stools,
  • blurred vision; pain or redness in the eye,
  • rash; redness of the skin,
  • transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment,
  • taste disturbance.

Rare:

  • allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing,
  • symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
  • stomach or peptic ulcers (sometimes severe or with bleeding),
  • narrowing of the gullet (oesophagus – the tube that connects your mouth with your stomach),
  • rash made worse by sunlight; severe skin reactions,
  • pain in the mouth, and/or jaw, swelling or sores inside the mouth; numbness or a feeling of heaviness in the jaw, or loosening of a tooth. These could be signs of bone damage in the jaw (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms,
  • fracture of the thigh bone in patients on long-term treatment with FOSAVANCE. Thigh pain, weakness or discomfort may be an early indication of a possible fracture of the thigh bone,
  • mouth ulcers when the tablets have been chewed or sucked.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

It will help if you make a note of what you experienced, when it started and how long it lasted.

How should it be stored?

Keep out of the reach and sight of children.

Do not use FOSAVANCE after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.

Store in the original blister in order to protect from moisture and light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is it?

Fosavance is a medicine that contains two active substances: alendronic acid and colecalciferol (vitamin D ). It is available as white tablets (capsule-shaped: 70 mg alendronic acid and 2,800 international units [IU] colecalciferol; rectangular: 70 mg alendronic acid and 5,600 IU colecalciferol).

What is it used for?

Fosavance (containing either 2,800 or 5,600 IU colecalciferol) is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and are at risk of low vitamin D levels. Fosavance 70 mg/5,600 IU is for use in patients who are not taking vitamin D supplements. Fosavance reduces the risk of fractures (broken bones) in the spine and the hip.

The medicine can only be obtained with a prescription.

How is it used?

The recommended dose of Fosavance is one tablet once a week. It is intended for long-term use.

The patient must take the tablet with a full glass of water (but not mineral water), at least 30 minutes before any food, drink or other medicines (including antacids, calcium supplements and vitamins). To avoid irritation of the oesophagus (the tube that leads from the mouth to the stomach), the patient should not lie down until after their first food of the day, which should be at least 30 minutes after taking the tablet. The tablet should be swallowed whole and not crushed, chewed or allowed to dissolve in the mouth.

Patients should also take calcium supplements if they are not getting enough calcium from their diet. For more information, see the package leaflet.

How does it work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more common in women after the menopause, when the levels of the female hormone oestrogen fall, since oestrogen helps to keep bones healthy.

Fosavance contains two active substances alendronic acid and colecalciferol vitamin D3. Alendronic acid is a bisphosphonate that has been used for osteoporosis since the mid-1990s. It slows the action of the osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these cells leads to less bone loss. Vitamin D3 is a nutrient that is found in some foods, but is also made in the skin through exposure to natural sunlight. Vitamin D3, along with other forms of vitamin D, is required for calcium absorption and normal bone formation. Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Fosavance.

How has it been studied?

Because alendronic acid and vitamin D are already used separately in authorised medicines in the European Union (EU), the company presented data obtained in earlier studies and from the published literature from women who had been through the menopause and who were taking alendronic acid and vitamin D as separate tablets.

To support the combination of alendronic acid and vitamin D3 in the same tablet, the company also carried out a study in 717 patients with osteoporosis, including 682 women who had been through the menopause, to show Fosavances ability to increase vitamin D levels. Patients received either Fosavance 70 mg2,800 IU or alendronic acid only once a week. The main measure of effectiveness was the reduction in the number of patients with low vitamin D levels after 15 weeks. This study was extended in 652 patients for a further 24 weeks to compare the effects of continuing with Fosavance 70 mg2,800 IU on its own or adding another 2,800 IU vitamin D3 equivalent to using Fosavance 70 mg5,600 IU.

What benefits has it shown during the studies?

The information presented by the company from earlier studies and the published literature showed that the dose of alendronic acid included in Fosavance was the same as the dose needed to prevent bone loss.

The additional studies showed that including vitamin D in the same tablet with alendronic acid could increase vitamin D levels. After 15 weeks, fewer patients had low vitamin D levels when they took Fosavance 70 mg/2,800 IU (11%) than when they took alendronic acid only (32%). In the extension study, similar numbers of patients taking Fosavance 70 mg/2,800 IU and Fosavance 70 mg/5,600 IU had low vitamin D levels (below 6%), but the patients taking Fosavance 70 mg/5,600 IU had greater increases in vitamin D levels over the 24 weeks of the study.

What is the risk associated?

The most common side effects with Fosavance are headache, abdominal pain (stomach ache), dyspepsia (heartburn), constipation, diarrhoea, flatulence (gas), ulcers in the oesophagus, dysphagia (difficulty swallowing), abdominal distension (swollen tummy), acid regurgitation and musculoskeletal pain (pain in the muscles, bones and joints). For the full list of all side effects reported with Fosavance, see the package leaflet.

Fosavance should not be used in people who may be hypersensitive (allergic) to alendronic acid, vitamin D or any of the other ingredients. It must not be used in patients who have abnormalities of the oesophagus, who have hypocalcaemia (low blood calcium levels), or who cannot stand or sit upright for at least 30 minutes.

Why has it been approved?

The CHMP decided that Fosavance’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Fosavance to Merck Sharp & Dohme Ltd. on 24 August 2005. After five years, the marketing authorisation was renewed for a further five years. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Fosavance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2011.