FOSAVANCE 70 mg/5600 IU TABLETS

Introduction

Package Leaflet: Information for the User

FOSAVANCE 70mg/2,800UI tablets

FOSAVANCE 70mg/5,600UI tablets

alendronic acid/colecalciferol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• It is especially important that you understand the information in section 3 before you take this medicine.

Contents of the pack

1. What FOSAVANCE is and what it is used for
2. What you need to know before you take FOSAVANCE
3. How to take FOSAVANCE
4. Possible side effects
5. Storing FOSAVANCE
6. Contents of the pack and other information

1. What FOSAVANCE is and what it is used for

What is FOSAVANCE?

FOSAVANCE is a tablet that contains two active ingredients, alendronic acid (commonly known as alendronate) and colecalciferol, also known as vitamin D3.

What is alendronate?

Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents bone loss in women after they have entered menopause, and helps to rebuild bone. It reduces the risk of vertebral and hip fractures.

What is vitamin D?

Vitamin D is an essential nutrient necessary for calcium absorption and for maintaining healthy bones. The body can only absorb calcium properly from food if it contains sufficient vitamin D, which occurs in very few foods. The main source of vitamin D is production in the skin through exposure to sunlight. As we age, our skin produces less vitamin D. Vitamin D deficiency can lead to bone loss and osteoporosis, and in severe cases can cause muscle weakness that can result in falls and increase the risk of fractures.

What is FOSAVANCE used for?

Your doctor has prescribed FOSAVANCE to treat your osteoporosis and because you are at risk of having a vitamin D deficiency. It reduces the risk of vertebral and hip fractures in women after menopause.

What is osteoporosis?

Osteoporosis causes wear and tear and fragility of the bones. It is common in women after menopause. During menopause, the ovaries stop producing a type of female hormone, estrogen, which helps to maintain a healthy skeleton. As a result, bone loss occurs and the bones become more fragile. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

Initially, osteoporosis does not present symptoms. However, if left untreated, it can cause bone fractures. Although these are usually painful, vertebral fractures can go unnoticed until they cause loss of height. Weakened bones can break during normal daily activity, such as when getting up or from minor injuries that would not normally break a healthy bone. Bone fractures usually occur in the hip, spine, or wrist, and can cause not only pain but also significant problems such as a hunched posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

In addition to your treatment with FOSAVANCE, your doctor may suggest that you make lifestyle changes to help slow down your disease, such as:

Stopping smokingSmoking seems to increase the rate of bone loss and, therefore, may increase your risk of bone fractures.

ExerciseLike muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.

Eating a balanced dietYour doctor may advise you on your diet or on whether you should take any dietary supplements.

2. What you need to know before you take FOSAVANCE

Do not take FOSAVANCE

• if you are allergic to alendronic acid, colecalciferol, or any of the other ingredients of this medicine (listed in section 6),
• if you have certain problems in your throat (esophagus - the tube that connects your mouth to 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 levels of calcium in your blood.

If you think any of these apply to you, do not take the tablets. Consult your doctor before taking FOSAVANCE and follow their advice.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with FOSAVANCE if:

• you have kidney problems,
• you have, or have recently had, problems swallowing or digestive problems,
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that line the lower part of the esophagus),
• you have been told that you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome),
• you have poor dental hygiene, gum disease, a planned dental extraction, or do not receive regular dental care,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) used in the treatment of diseases such as asthma, rheumatoid arthritis, and severe allergies,
• 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 taking FOSAVANCE. You should have regular dental check-ups during your treatment and should contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or inflammation.

Irritation, inflammation, or ulceration of the throat (esophagus - the tube that connects your mouth to your stomach) can occur, often with symptoms of chest pain, heartburn, difficulty or pain when swallowing, 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 adverse effects can worsen if patients continue taking FOSAVANCE after developing these symptoms.

Girls and adolescents

FOSAVANCE should not be given to girls and adolescents under 18 years of age.

Other medicines and FOSAVANCE

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Calcium supplements, antacids, and some oral medicines may interfere with the absorption of FOSAVANCE if taken at the same time. Therefore, it is important that you follow the instructions given in section 3 and wait at least 30 minutes before taking any other medicine or supplement.

Certain medicines for rheumatism or long-term pain called NSAIDs (such as aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if these medicines are taken at the same time as FOSAVANCE.

Certain medicines or food additives may prevent the absorption of vitamin D from FOSAVANCE, including artificial fat substitutes, mineral oils, weight loss medicine, orlistat, and cholesterol-lowering medicines, cholestyramine, and colestipol. Medicines for epilepsy (seizures) (such as phenytoin or phenobarbital) may decrease the effectiveness of vitamin D. Individually, the need for additional vitamin D supplements may be considered.

Taking FOSAVANCE with food and drinks

Food and drinks (including mineral water) may reduce the effectiveness of FOSAVANCE if taken at the same time. Therefore, it is important that you follow the advice given in section 3. You should wait at least 30 minutes before taking any food or drinks, except water.

Pregnancy and breastfeeding

FOSAVANCE is only intended for use in postmenopausal women. You should not take FOSAVANCE if you are pregnant or think you may be pregnant, or if you are breastfeeding.

Driving and using machines

Adverse effects with FOSAVANCE (such as blurred vision, dizziness, and severe bone, muscle, or joint pain) have been reported that may affect your ability to drive or use machines (see section 4). If you experience any of these adverse effects, you should not drive until you feel better.

FOSAVANCE contains lactose and sucrose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

FOSAVANCE contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take FOSAVANCE

Follow the instructions for administration of FOSAVANCE exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Take one FOSAVANCE tabletonce a week.

Follow these instructions carefully.

1. Choose the day of the week that best suits your routine. Each week, take one FOSAVANCE tablet on the day you have chosen.

It is very important that you follow the instructions 2), 3), 4), and 5) to help the FOSAVANCE tablet reach your stomach quickly and reduce the possible irritation of the throat (esophagus - the tube that connects your mouth to your stomach).

1. After getting up in the morning and before taking any food, drink, or other medicine, swallow the FOSAVANCE tablet whole with a full glass of water (not less than 200 ml), so that FOSAVANCE is absorbed properly.
   • Do not take it with mineral water (with or without gas).
   • Do not take it with coffee or tea.
   • Do not take it with juice or milk.

Do not crush or chew the tablet or allow it to dissolve in your mouth, due to the possibility of ulcers in the mouth.

1. Do not lie down - stay upright (sitting, standing, or walking) - for at least 30 minutes after swallowing the tablet. Do not lie down until after the first meal of the day.

1. Do not take FOSAVANCE at bedtime or before getting up in the morning.

1. If you have difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and inform your doctor.

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

If you take more FOSAVANCE than you should

If you take too many tablets by mistake, drink a full glass of milk and go to your doctor immediately. Do not induce vomiting and do not lie down.

If you forget to take FOSAVANCE

If you forget a dose, take a single tablet the next morning when you remember. Do not take two tablets on the same day.Then take one tablet once a week, on the original day you chose.

If you stop taking FOSAVANCE

It is important that you take FOSAVANCE while your doctor prescribes it for you. Since it is not known how long you should take FOSAVANCE, you should discuss with your doctor periodically the need to continue treatment with this medicine to determine if FOSAVANCE is still suitable for you.

A Patient Information Card is included in the FOSAVANCE pack. It contains important information to remind you how to take FOSAVANCE correctly.

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

4. Possible side effects

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

Consult your doctor immediatelyif you experience any of the following side effects, which may be serious and require urgent medical treatment:

Common (may affect up to 1 in 10 people):

• heartburn; difficulty swallowing; pain when swallowing; ulcers in the throat (esophagus - the tube that connects your mouth to your stomach) that can cause chest pain, heartburn, or difficulty or pain when swallowing.

Rare (may affect up to 1 in 1,000 people):

• allergic reactions such as hives; swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing; severe skin reactions,

• pain in the mouth, and/or jaw, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These can be signs of jawbone damage (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction. Contact your doctor and dentist if you experience these symptoms,
• atypical fractures of the thigh bone (femur) that can occur rarely, especially in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these can be early symptoms of a possible fracture of the femur,
• severe bone, muscle, and/or joint pain.

Frequency not known (cannot be estimated from the available data)

• atypical fracture in places other than the thigh bone (femur).

Other side effects include

Very common (may affect more than 1 in 10 people):

• pain, sometimes severe, in bones, muscles, and/or joints.

Common (may affect up to 1 in 10 people):

• swelling of the joints,
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; feeling of fullness or bloating; diarrhea; flatulence,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or feet.

Uncommon (may affect up to 1 in 100 people):

• nausea; vomiting,
• irritation or inflammation of the throat (esophagus - the tube that connects your mouth to your stomach) or stomach,
• black or tarry stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• transient symptoms, similar to those of the flu, such as muscle pain, general feeling of discomfort, and, sometimes, fever, which usually occur at the start of treatment,
• altered taste.

Rare (may affect up to 1 in 1,000 people):

• symptoms of low calcium levels in the blood, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• narrowing of the throat (esophagus - the tube that connects your mouth to your stomach),
• skin rash that worsens with sunlight,
• mouth ulcers.

Very rare (may affect up to 1 in 10,000 people):

• consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing FOSAVANCE

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Store in the original blister 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 protect the environment.

6. Package Contents and Additional Information

FOSAVANCE Composition

The active ingredients are alendronic acid and colecalciferol (vitamin D3). Each FOSAVANCE 70 mg/2,800 IU tablet contains 70 mg of alendronic acid (as sodium trihydrate salt) and 70 micrograms (2,800 IU) of colecalciferol (vitamin D3). Each FOSAVANCE 70 mg/5,600 IU tablet contains 70 mg of alendronic acid (as sodium trihydrate salt) and 140 micrograms (5,600 IU) of colecalciferol (vitamin D3).

The other ingredients are microcrystalline cellulose (E-460), anhydrous lactose (see section 2), medium-chain triglycerides, gelatin, sodium croscarmellose, sucrose (see section 2), colloidal silicon dioxide, magnesium stearate (E-572), butylhydroxytoluene (E-321), modified cornstarch, and sodium aluminum silicate (E-554).

Product Appearance and Package Contents

FOSAVANCE 70 mg/2,800 IU tablets are white to off-white, modified capsule-shaped, and marked with a bone silhouette on one side and "710" on the other. FOSAVANCE 70 mg/2,800 IU tablets are available in packages containing 2, 4, 6, or 12 tablets.

FOSAVANCE 70 mg/5,600 IU tablets are white to off-white, modified rectangle-shaped, and marked with a bone silhouette on one side and "270" on the other. FOSAVANCE 70 mg/5,600 IU tablets are available in packages containing 2, 4, or 12 tablets.

Only some package sizes may be marketed.

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:<{MM/AAAA}>

Detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.