FOSAVANCE 70 mg /70 Mcg Tablets

Зміст інструкції

1. FOSAVANCE 70 mg/2.800 IU tablets, 70 mg/5.600 IU tablets
   1. What is FOSAVANCE and what is it 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

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

alendronic acid/cholecalciferol

Read 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, 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 you take 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 is FOSAVANCE and what is it used for

What is FOSAVANCE?
FOSAVANCE is a tablet that contains two active ingredients, alendronic acid (commonly
called alendronate) and cholecalciferol, known as vitamin D.

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

What is vitaminD?
Vitamin D is an essential nutrient, necessary for calcium absorption and bone health.
The body can only adequately absorb calcium from food if it has enough
vitamin D. Very few foods contain vitamin D. The main source of
vitamin D is in the summer through exposure to sunlight, which produces vitamin D in the
skin. As you age, your skin produces less vitamin D. Too low levels of vitamin D
can cause loss of bone tissue and osteoporosis. A severe deficiency of vitamin D can
cause muscle weakness that can lead to falls and an increased risk of 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 vertebral and
hip fractures in women after menopause.

What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after
menopause. During menopause, the ovaries stop producing female hormones, estrogens, which
help keep a woman's skeleton healthy. As a result, bone tissue is lost and the bone becomes weaker. The risk of osteoporosis is greater the earlier a woman reaches menopause.
In the early stages, osteoporosis usually has no symptoms. However, if left untreated, fractures can occur. Even though fractures are usually painful, fractures of the bones of the spine may not be felt until they result in
a decrease in height. Fractures can occur during daily activities such as lifting
weights, or with minor trauma that would not normally be able to cause fractures in normal bone. Fractures usually occur in the hip, spine, or wrist and
can be not only painful but can lead to significant deformities and disability, such as
for example, curvature of the spine (hunchback) and limitations in movement.

How can osteoporosis be treated?
Along with treatment with FOSAVANCE, your doctor may suggest changing your lifestyle to
improve the condition of the disease, such as:

Stop smokingsmoking appears to increase the rate at which bone tissue is lost and,
therefore, may increase the risk of fractures.

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

Balanced dietyour doctor can provide information on diet or the possible need to
take dietary supplements.

2. What you need to know before taking FOSAVANCE

Do not take FOSAVANCE

• if you are allergic to alendronic acid, cholecalciferol or any of the other ingredients of this medicine (listed in section 6),
• if you have certain problems with your oesophagus (the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing,
• if you are unable to sit or stand 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 and follow the
instructions 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 problems with your digestive system,
• your doctor has told you that you have Barrett's oesophagus (a disease associated with changes in the cells lining the lower part of your oesophagus),
• your doctor has told you that you have a problem with the absorption of minerals in your stomach or intestine (malabsorption syndrome),
• you have poor dental health, have gum disease, are planning to have a tooth extracted or do not have regular dental check-ups,
• you have cancer,
• you are having chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) which are used in the treatment of cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) which are used in the treatment of 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 asked to have a dental check-up before starting treatment with
FOSAVANCE.
It is important to maintain good oral hygiene during treatment with
FOSAVANCE. You should have regular dental check-ups during treatment and should
contact your doctor or dentist if you experience any mouth or dental problems such as
tooth loss, pain or swelling.
Irritation, inflammation or ulceration of the oesophagus (the tube that connects the
mouth to the stomach) may occur, often with symptoms of chest pain, heartburn, difficulty or pain swallowing, especially if patients do not drink a full glass of water
and/or if they lie down during the first 30 minutes after taking FOSAVANCE. These side effects
may worsen if patients continue to take FOSAVANCE after experiencing
these symptoms.

Children and adolescents
FOSAVANCE should not be given to children and adolescents under the age of 18 years.

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 medicines taken by mouth
are likely to interfere with the absorption of FOSAVANCE if taken at the same time.
It is therefore important to follow the instructions given in section 3 and wait at least 30 minutes before
taking any other medicines taken by mouth or supplements.
Some medicines for rheumatism or long-term pain called NSAIDs (e.g. acetylsalicylic acid or ibuprofen) may cause digestive problems. Therefore, caution should be used
when these medicines are taken at the same time as FOSAVANCE.
Some medicines or food additives may prevent the vitamin D contained in
FOSAVANCE from entering the body, including artificial fat substitutes, mineral oils,
weight loss medicines, orlistat, and cholesterol-lowering medicines colestyramine and
colestipol. Medicines for seizures (epilepsy) (such as phenytoin or phenobarbital) may
decrease the effectiveness of vitamin D. Addition of other vitamin D supplements may be considered
on an individual basis.

FOSAVANCE with food and drink
Foods and drinks (including mineral water) are likely to reduce the effectiveness of
FOSAVANCE if taken at the same time. It is therefore important to follow the instructions given in
section 3. You should wait at least 30 minutes before taking any food and drink except
tap water.

Pregnancy and breastfeeding
FOSAVANCE is only indicated for women after menopause. Do not take FOSAVANCE if you are
pregnant or suspect you might be pregnant or if you are breastfeeding.

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

FOSAVANCE contains lactose and sucrose.
If you have been diagnosed with 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, that is to say essentially
“sodium-free”.

3. How to take FOSAVANCE

Take FOSAVANCE following the instructions of your doctor or pharmacist exactly. If you have
any doubts, ask your doctor or pharmacist.

Take one FOSAVANCE tablet once a week.
Follow the instructions below carefully:

• 1) Choose a day of the week that best suits your activities. Take one FOSAVANCE tablet once a week on the chosen day.

It is very important that you follow instructions 2), 3), 4) and 5) to facilitate the quick passage of the
FOSAVANCE tablet into the stomach and help reduce the possibility of irritating the esophagus (the
tube that connects the mouth to the stomach).

• 2) After getting up from bed to start the day, and before taking any food, drink or other medicine, swallow the whole FOSAVANCE tablet with a full glass of tap water (not mineral water) (not less than 200 ml), so that FOSAVANCE is adequately 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 or chew or let the tablet dissolve in your mouth due to the possible
formation of ulcers in the oral cavity.

• 3) Do not lie down – keep your torso upright (while sitting, while standing or while walking) – for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
• 4) FOSAVANCE should not be taken at bedtime or before getting out of bed at the start of the day.
• 5) If difficulty or pain occurs when swallowing, chest pain occurs, or heartburn in the upper stomach appears or worsens, stop taking FOSAVANCE and contact your doctor.
• 6) After swallowing the FOSAVANCE tablet, wait at least 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. FOSAVANCE is only effective 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 the tablet, simply take one FOSAVANCE tablet the
next morning. Do not take two tablets on the same day.Afterwards, start taking the tablet again on the chosen day of the week.

If you stop taking FOSAVANCE
It is important that you take FOSAVANCE for as long as prescribed by your doctor. Since it is
not known how long you need to take FOSAVANCE, you should periodically check with your doctor the
need to continue therapy with this medicine to establish whether the use of FOSAVANCE is
still appropriate for you.
A leaflet with instructions for use is included in the FOSAVANCE box. It contains important
information that reminds you how to take FOSAVANCE correctly.
If you have any doubts about 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.

See your doctor immediatelyif you notice any of the following side effects, which may be serious and require urgent medical treatment:
Common (may affect up to 1 in 10 people):

• burning in the upper stomach; difficulty swallowing; pain when swallowing; ulcers of the esophagus (the tube connecting the mouth to the stomach) which can cause chest pain, burning in the upper stomach, or difficulty or pain when swallowing.

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

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• pain in the mouth, and/or jaw/mandible, swelling or ulcers inside the mouth, numbness or a feeling of heaviness in the jaw/mandible or tooth loss. These could be signs of bone damage in the jaw/mandible (osteonecrosis) generally associated with delayed healing and infection, often after dental extraction. Contact your doctor and dentist if you experience these symptoms,
• rarely, an unusual fracture of the femur 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 could be an early indication of a possible femur fracture,
• bone, muscle and/or joint pain that is severe.

Not known (frequency cannot be estimated from available data)

• unusual fractures in locations other than the femur.

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

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

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

• joint swelling,
• abdominal pain; discomfort in the stomach or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhea, 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 esophagus (the tube connecting the mouth to the stomach) or the stomach,
• black or tarry stools,
• blurred vision; pain or redness of the eyes,
• skin rash; skin redness,
• transient flu-like symptoms, such as muscle aches, general feeling of unwellness and sometimes with fever usually at the beginning of treatment,
• altered taste.

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

• symptoms due to low levels of calcium 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 esophagus (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):

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

Reporting of side effects
If you get 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 through the national reporting system listed 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 which is stated on the box and on the blister after
EXP. The expiry date refers to the last day of that month.
Store in the original blister pack to protect the medicine from moisture and light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What FOSAVANCE contains
The active ingredients are alendronic acid and cholecalciferol (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 cholecalciferol (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 cholecalciferol (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 (corn) and
sodium aluminium silicate (E554).

Description of the appearance of FOSAVANCE and contents of the pack
FOSAVANCE 70 mg/2,800 IU tablets are available as white to off-white tablets,
capsule-shaped, with the outline of a bone image embossed 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 tablets,
modified rectangular in shape, with the outline of a bone image embossed 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
Netherlands

Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
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 medicine, contact the local representative of the Marketing
Authorisation Holder:

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

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

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

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

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

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

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

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

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

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

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

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

Ελλάδα
BIANEΞ Α.Ε.
Τηλ: +30 210 80091 11
[email protected]

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

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

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

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

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

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

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

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

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

Ísland
Vistor hf.
Sími: +354 535 7000

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

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

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

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

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

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

United Kingdom (Northern Ireland)
Organon Pharma (UK) Limited
Tel: +44 (0) 208 159 3593
[email protected]
More detailed information on this medicine is available on the website of the European Medicines
Agency, https://www.ema.europa.eu.