Fosavance

Patient Information Leaflet: Information for the User

FOSAVANCE 70 mg/2.800 IU tablets, 70 mg/5.600 IU tablets

alendronic acid/colecalciferol
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• It is very important to understand the information contained in section 3 before taking this medicine.

Contents of this leaflet

1. What FOSAVANCE is and what it is used for
2. What you need to know before taking FOSAVANCE
3. How to take FOSAVANCE
4. Possible side effects
5. How to store 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 containing two active substances: alendronic acid (commonly known as alendronate) and colecalciferol, also known as vitamin D.

What is alendronate?
Alendronate belongs to a group of non-hormonal medicines called bisphosphonates. Alendronate prevents bone tissue loss that occurs in women after menopause and promotes bone rebuilding. Alendronate reduces the risk of vertebral and hip fractures.

What is vitamin D?
Vitamin D is an essential nutrient required for calcium absorption and bone health. The body can adequately absorb calcium from food only if sufficient vitamin D is present. Very few foods contain vitamin D. The main source of vitamin D comes during summer through exposure to sunlight, which triggers vitamin D production in the skin. With aging, the skin produces less vitamin D. Too low levels of vitamin D can lead to bone tissue loss and osteoporosis. Severe vitamin D deficiency can cause muscle weakness, increasing the risk of falls and fractures.

What is FOSAVANCE used for?
Your doctor has prescribed FOSAVANCE for the treatment of osteoporosis and to reduce the risk of vitamin D deficiency. This medicine reduces the risk of spinal and hip fractures in postmenopausal women.

What is osteoporosis?
Osteoporosis is a condition characterized by thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing female hormones, estrogens, which help maintain a woman's skeletal health. As a result, bone tissue is lost and bones become weaker. The risk of osteoporosis is greater the earlier a woman reaches menopause.

In its early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are typically painful, vertebral fractures may go unnoticed until they result in a decrease in height. Fractures can occur during everyday activities such as lifting heavy objects, or following minor trauma that would not normally cause fractures in healthy bone. Fractures commonly occur in the hip, spine, or wrist and can be not only painful but may also lead to significant deformities and disability, such as curvature of the back (kyphosis) and limitations in movement.

How can osteoporosis be treated?
Along with treatment with FOSAVANCE, your doctor may recommend lifestyle changes to improve the condition, such as:

Stopping smoking: smoking appears to increase the rate at which bone tissue is lost and therefore may increase the risk of fractures.

Physical exercise: just as muscles need exercise to stay strong, so do bones. Consult your doctor before starting any exercise program.

Balanced diet: your doctor can provide information about diet or the possible need for dietary supplements.

2. What you should know before taking 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 with your oesophagus (the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing,
• if you are unable to 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 you fall into any of these categories, do not take the tablets. Consult your doctor and follow the advice given.

Warnings and precautions

Talk to your doctor or pharmacist before taking FOSAVANCE if:

• you have kidney problems,
• you have or have recently had difficulty swallowing or gastrointestinal disorders,
• your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus),
• your doctor has told you that you have a problem with mineral absorption in the stomach or intestine (malabsorption syndrome),
• you have poor dental health, gum disease, are scheduled for a tooth extraction, or do not regularly visit the dentist,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions 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 examination before starting treatment with FOSAVANCE.
It is important to maintain good oral hygiene during treatment with FOSAVANCE. You should have regular dental check-ups throughout your treatment and contact your doctor or dentist if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by symptoms such as chest pain, burning sensation in the upper stomach, difficulty or pain when swallowing—especially if patients do not drink a full glass of tap water and/or lie down during the first 30 minutes after taking FOSAVANCE. These side effects may worsen if patients continue taking FOSAVANCE after experiencing such symptoms.

Children and adolescents
FOSAVANCE must not be administered to children and adolescents under 18 years of age.

Other medicines and FOSAVANCE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Some medicines used for rheumatism or long-term pain, called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be exercised when taking these medicines together with FOSAVANCE.

Certain medicines or food additives may prevent the vitamin D in FOSAVANCE from being absorbed into the body, including artificial fat substitutes, mineral oils, weight-loss medicines (such as orlistat), and cholesterol-lowering medicines such as cholestyramine and colestipol. Antiepileptic medicines (for seizures or epilepsy), such as phenytoin or phenobarbital, may reduce the effectiveness of vitamin D. Additional vitamin D supplementation may be considered on an individual basis.

FOSAVANCE with food and drink
Food and drinks (including mineral water) may reduce the effectiveness of FOSAVANCE if taken at the same time. Therefore, it is important to follow the instructions in section 3. You must wait at least 30 minutes before consuming any food or drink other than tap water.

Pregnancy and breastfeeding
FOSAVANCE is intended only for postmenopausal women. Do not take FOSAVANCE if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and using machines
Undesirable effects have been reported with FOSAVANCE (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery (see section 4). If you experience any of these side effects, do not drive until you feel well again.

FOSAVANCE contains lactose and sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

FOSAVANCE contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take FOSAVANCE

Take FOSAVANCE exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one tablet of FOSAVANCE once a week.
Follow carefully the instructions below:

1. Choose the day of the week that best fits your routine. Take one tablet of FOSAVANCE once a week on the chosen day.
   It is very important that you follow instructions 2), 3), 4), and 5) to help the FOSAVANCE tablet pass quickly into the stomach and help reduce the risk of irritating the oesophagus (the tube connecting the mouth to the stomach).
2. After getting up for the day, and before taking any food, drink, or other medicines, swallow the FOSAVANCE tablet whole with a full glass of tap water (not mineral water) (at least 200 ml), so that FOSAVANCE is properly absorbed.

• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with juices or milk.

Do not crush, chew, or allow the tablet to dissolve in the mouth, as this may cause mouth ulcers.
3) Do not lie down – remain in an upright position (sitting, standing, or walking) for at least 30 minutes after taking the tablet. Do not lie down until you have eaten something.
4) FOSAVANCE must not be taken at bedtime or before getting up in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking FOSAVANCE and contact your doctor.
6) After swallowing the FOSAVANCE tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids, calcium supplements, and vitamins. FOSAVANCE is effective only when taken on an empty stomach.

If you take more FOSAVANCE than you should
If you accidentally take too many tablets, drink a full glass of milk and contact your doctor immediately. Do not induce vomiting and do not lie down.

If you forget to take FOSAVANCE
If you forget to take your tablet, simply take one tablet of FOSAVANCE the following morning. Do not take two tablets on the same day. Afterwards, resume taking the tablet on your chosen day of the week.

If you stop taking FOSAVANCE
It is important to continue taking FOSAVANCE for as long as prescribed by your doctor. Since it is not known how long you should continue treatment, you should periodically review with your doctor whether continuing therapy with this medicine is still appropriate for you.

A patient instruction card is included in the FOSAVANCE package. It contains important information reminding you how to take FOSAVANCE correctly.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Go to the doctor immediately if you notice any of the following side effects, which can be serious and for which you may need urgent medical treatment:
Common (may affect up to 1 in 10 people):

• burning sensation in the upper stomach; difficulty swallowing; pain when swallowing; oesophageal ulcers (the tube connecting the mouth to the stomach) which may cause chest pain, burning in the upper stomach, 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, possibly causing difficulty breathing or swallowing; severe skin reactions,
• mouth pain, and/or pain in the jaw/mandible, swelling or ulcers inside the mouth, numbness or a sensation of heaviness in the jaw/mandible or tooth loss. These may be signs of bone damage in the jaw/mandible (osteonecrosis), usually associated with delayed healing and infection, often following tooth extraction. Contact your doctor and dentist if you experience such symptoms,
• rarely, an unusual femur fracture may occur, particularly in patients treated for a long time for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this may be an early sign of a possible femur fracture,
• severe bone, muscle and/or joint pain.

Not known (frequency cannot be estimated from the available data):

• unusual fractures occurring at sites other than the femur.

Other side effects include
Very common (may affect more than 1 in 10 people):

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

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

• joint swelling,
• abdominal pain; stomach discomfort or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhoea; intestinal gas,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

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

• nausea; vomiting,
• irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) or of the stomach,
• black or dark stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• transient flu-like symptoms such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment,
• altered taste.

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

• symptoms due to low calcium levels in the blood including muscle cramps or spasms and/or tingling in the fingers or around the mouth,
• peptic or stomach ulcers (sometimes severe or with bleeding),
• narrowing of the oesophagus (the tube connecting the mouth to the stomach),
• skin rash worsened by exposure to sunlight,
• mouth ulcers.

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

• consult your doctor if you experience ear pain, ear discharge and/or ear infection. These events could be signs of bone damage in the ear.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FOSAVANCE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store in the original blister to protect the medicine from moisture and light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What FOSAVANCE contains
The active substances are alendronic acid and colecalciferol (vitamin D). Each tablet of
FOSAVANCE 70 mg/2,800 IU contains 70 mg of alendronic acid (as sodium trihydrate) and
70 micrograms (2,800 IU) of colecalciferol (vitamin D). Each tablet of FOSAVANCE
70 mg/5,600 IU contains 70 mg of alendronic acid (as sodium trihydrate) and 140 micrograms
(5,600 IU) of colecalciferol (vitamin D).
The other ingredients are microcrystalline cellulose (E460), anhydrous lactose (see section 2),
medium-chain triglycerides, gelatin, sodium croscarmellose, sucrose (see section 2), colloidal silicon dioxide, magnesium stearate (E572), butylated hydroxytoluene (E321), modified starch (maize), and sodium aluminium silicate (E554).

What FOSAVANCE looks like and contents of the pack
FOSAVANCE 70 mg/2,800 IU tablets are available as white to off-white, modified capsule-shaped tablets, with the outline of a bone engraved on one side and “710” on the other. FOSAVANCE 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
FOSAVANCE 70 mg/5,600 IU tablets are available as white to off-white, modified rectangular-shaped tablets, with the outline of a bone engraved on one side and “270” on the other. FOSAVANCE 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands

Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

Vianex S.A.
15 Km Marathonos Avenue
Pallini 153 51, Greece

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

България
Органон (И.А.) Б.В. - клон България
Тел.: +359 2 806 3030
[email protected]

Česká republika
Organon Czech Republic s.r.o.
Tel: +420 233 010 300
[email protected]

Danmark
Organon Denmark ApS
Tlf: +45 4484 6800
[email protected]

Deutschland
Organon Healthcare GmbH
Tel: 0800 3384 726 (+49 (0) 89 2040022 10)
[email protected]

Eesti
Organon Pharma B.V. Estonian RO
Tel: +372 66 61 300
[email protected]

Ελλάδα
BIANEΞ Α.Ε.
Τηλ: +30 210 8009111
[email protected]

España
Organon Salud, S.L.
Tel: +34 91 591 12 79
[email protected]

France
Organon France
Tél: +33 (0) 1 57 77 32 00

Hrvatska
Organon Pharma d.o.o.
Tel: +385 1 638 4530
[email protected]

Ireland
Organon Pharma (Ireland) Limited
Tel: +353 15828260
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000

Italia
Organon Italia S.r.l.
Tel: +39 06 90259059
[email protected]

Κύπρος
Organon Pharma B.V., Cyprus branch
Τηλ: +357 22866730
[email protected]

Latvija
Ārvalsts komersanta “Organon Pharma B.V.” pārstāvniecība
Tel: +371 66968876
[email protected]

Lietuva
Organon Pharma B.V. Lithuania atstovybė
Tel.: +370 52041693
[email protected]

Luxembourg/Luxemburg
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Magyarország
Organon Hungary Kft.
Tel.: +36 1 766 1963
[email protected]

Malta
Organon Pharma B.V., Cyprus branch
Tel: +356 2277 8116
[email protected]

Nederland
N.V. Organon
Tel.: 00800 66550123 (+32 2 2418100)
[email protected]

Norge
Organon Norway AS
Tlf: +47 24 14 56 60
[email protected]

Österreich
Organon Healthcare GmbH
Tel: +49 (0) 89 2040022 10
[email protected]

Polska
Organon Polska Sp. z o.o.
Tel.: +48 22 105 50 01
[email protected]

Portugal
Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500
[email protected]

România
Organon Biosciences S.R.L.
Tel: +40 21 527 29 90
[email protected]

Slovenija
Organon Pharma B.V., Oss, podružnica Ljubljana
Tel: +386 1 300 10 80
[email protected]

Slovenská republika
Organon Slovakia s.r.o.
Tel: +421 2 44 88 98 88
[email protected]

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520
[email protected]

Sverige
Organon Sweden AB
Tel: +46 8 502 597 00
[email protected]

United Kingdom (Northern Ireland)
Organon Pharma (UK) Limited
Tel: +44 (0) 208 159 3593
[email protected]

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