FOSAVANCE 70 mg/2800 IU tablets

What is FOSAVANCE?
FOSAVANCE is a tablet containing the two active substances, alendronic acid and colecalciferol known as vitamin D 3.

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.

FOSAVANCEis 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.

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. Additional vitamin D supplements may be considered on an individual basis.

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.

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.

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.

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 FOSAVANCE contains

The active substances are alendronic acid and colecalciferol (vitamin D 3). Each tablet contains 70 mg alendronic acid as alendronate sodium trihydrate and 70 micrograms (2800 IU) colecalciferol (vitamin D 3).

The other ingredients are microcrystalline cellulose (E460), lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose sodium, sucrose, colloidal silicon dioxide, magnesium stearate (E572), butyl hydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).

What FOSAVANCE looks like and contents of the pack

FOSAVANCE 70 mg/2800 IU tablets are available as capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ?710? on the other.

The tablets are supplied in aluminium blisters in cartons in the following pack sizes

• 2 tablets (1 blister containing 2 tablets)
• 4 tablets (1 blister containing 4 tablets)
• 6 tablets (3 blisters each containing 2 tablets)
• 12 tablets (3 blisters each containing 4 tablets).

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon
Hertfordshire EN11 9BU
United Kingdom

Manufacturer

Merck Sharp & Dohme BV
Waarderweg 39
2031 BN, Haarlem, Netherlands

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiqueBelgiëBelgien Merck Sharp Dohme B.V. Succursale belgeBelgisch bijhuis TélTel 32 0 800 38693 MSDBelgiuminfomerck.com LuxembourgLuxemburg Merck Sharp Dohme B.V. Succursale belge Tél 32 0 800 38693 MSDBelgiuminfomerck.com

. 359 2 819 3737 info-msdbgmerck.com Magyarország MSD Magyarország Kft. Tel. 36 1 888 53 00 hungarymsdmerck.com

eská republika Merck Sharp Dohme IDEA, Inc., org. sl. Tel. 420 233 010 111 msdcrmerck.com Malta Merck Sharp Dohme Cyprus Limited Tel 357 22866700 maltainfomerck.com

Danmark Merck Sharp Dohme Tlf 45 43 28 77 66 dkmailmerck.com Nederland Merck Sharp Dohme BV Tel 31 0 800 99 99 000 31 23 5153153 medicalinfo.nlmerck.com

Deutschland MSD SHARP DOHME GMBH Tel 49 0 89 4561 2612 Infocentermsd.de Norge MSD Norge AS Tlf 47 32 20 73 00 msdnorgemsd.no

Eesti Merck Sharp Dohme OÜ Tel. 372 613 9750 msdeestimerck.com Österreich Merck Sharp Dohme Ges.m.b.H. Tel 43 0 1 26 044 msd-medizinmerck.com

E BIANE . 3 0210 80091 11 Mailboxvianex.gr Polska MSD Polska Sp.z o.o. Tel. 48 22 549 51 00 msdpolskamerck.com

España Merck Sharp Dohme de España, S.A. Tel 34 91 321 06 00 Fosavancemsd.es Portugal Merck Sharp Dohme, Lda Tel 351 214 465 700 informacaodoentemerck.com

France Laboratoires Merck Sharp Dohme Chibret Tél 33 01 47 54 87 00 Contactmsd-france.com România Merck Sharp Dohme Romania S.R.L. Tel 4021 529 29 00 msdromaniamerck.com

Ireland Merck Sharp and Dohme Ireland Human Health Limited Tel 353 01 2998700 medinfoirelandmerck.com Slovenija Merck Sharp Dohme, inovativna zdravila d.o.o. Tel 386 1 5204201 msdsloveniamerck.com

Ísland Icepharma hf. Sími 354 540 8000 ISmailmerck.com Slovenská republika Merck Sharp Dohme IDEA, Inc. Tel. 421 2 58282010 msdskmerck.com

talia MSD Italia S.r.l. Tel 39 06 361911 doccenmerck.com SuomiFinland MSD Finland Oy PuhTel 358 0 9 804650 infomsd.fi

Merck Sharp Dohme Cyprus Limited 80000 673 357 22866700 cyprusinfomerck.com Sverige Merck Sharp Dohme Sweden AB Tel 46 0 77 5700488 medicinskinfomerck.com

Latvija SIA Merck Sharp Dohme Latvija Tel 371 67364 224 msdlvmerck.com United Kingdom Merck Sharp and Dohme Limited Tel 44 0 1992 467272 medicalinformationukmerck.com

Lietuva
UAB ?Merck Sharp & Dohme?
Tel.: +370 5 278 02 47msd_lietuva@merck.com

This leaflet was last approved in