VANTAVO

Package leaflet: Information for the user

VANTAVO 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, 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 VANTAVO is and what it is used for
2. What you need to know before taking VANTAVO
3. How to take VANTAVO
4. Possible side effects
5. How to store VANTAVO
6. Contents of the pack and other information

1. What VANTAVO is and what it is used for

What is VANTAVO?
VANTAVO 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 in summer from 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 cause bone tissue loss and osteoporosis. Severe vitamin D deficiency can cause muscle weakness, which may lead to falls and an increased risk of fractures.

What is VANTAVO used for?
Your doctor has prescribed VANTAVO 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 thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing female hormones, the estrogens, which help maintain a woman's healthy skeleton. As a result, bone tissue is lost and bone becomes 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 usually painful, spinal bone fractures may go unnoticed until they result in a decrease in height. Fractures can occur during everyday activities such as lifting weights, or from minor trauma that would not normally cause fractures in normal bone. Fractures typically 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 VANTAVO, your doctor may recommend lifestyle changes to improve the condition, such as:

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

Physical exercise: Like muscles, bones need physical activity to stay strong and healthy. Consult your doctor before starting any exercise programme.

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

2. What you should know before taking VANTAVO

Do not take VANTAVO

• 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 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 VANTAVO if:

• you have kidney problems,
• you have or have recently had difficulty swallowing or gastrointestinal problems,
• 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 planning a tooth extraction, or do not regularly visit your 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 check-up before starting treatment with
VANTAVO.
It is important to maintain good oral hygiene during treatment with VANTAVO.
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 with symptoms such as chest pain, burning 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
within the first 30 minutes after taking VANTAVO. These side effects may worsen if patients continue taking VANTAVO after experiencing these symptoms.

Children and adolescents
VANTAVO must not be given to children and adolescents under 18 years of age.

Other medicines and VANTAVO
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 are likely to interfere with the absorption of VANTAVO 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 used when taking these medicines together with VANTAVO.
Some medicines or food additives may prevent the vitamin D in VANTAVO from being absorbed, including artificial fat substitutes, mineral oils, weight-loss medicines such as orlistat, and cholesterol-lowering medicines such as cholestyramine and colestipol. Medicines for seizures (epilepsy) (such as phenytoin or phenobarbital) may reduce the effectiveness of vitamin D. Additional vitamin D supplements may be considered on an individual basis.

VANTAVO with food and drinks
Food and drinks (including mineral water) may reduce the effectiveness of VANTAVO 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
VANTAVO is intended only for postmenopausal women. Do not take VANTAVO if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

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

VANTAVO contains lactose and sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine.

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

3. How to take VANTAVO

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

1. Choose the day of the week that best fits your routine. Take one tablet of VANTAVO once a week on the chosen day.
   It is very important that you follow instructions 2), 3), 4), and 5) to help the VANTAVO tablet reach the stomach quickly and help reduce the risk of irritating the oesophagus (the tube connecting 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 VANTAVO tablet whole with a full glass of tap water (not mineral water) (at least 200 ml), so that VANTAVO 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, chew, or allow the tablet to dissolve in the mouth, as this may cause mouth ulcers.
3) Do not lie down – remain upright (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
4) VANTAVO must not be taken at bedtime or before getting up from bed in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking VANTAVO and contact your doctor.
6) After swallowing the VANTAVO tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, and vitamins. VANTAVO is effective only when taken on an empty stomach.

If you take more VANTAVO 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 VANTAVO
If you forget to take the tablet, simply take one tablet of VANTAVO 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 VANTAVO
It is important that you continue taking VANTAVO for as long as prescribed by your doctor. Since it is not known how long you should take VANTAVO, you should periodically check with your doctor whether continuing treatment is still appropriate for you.

The VANTAVO package includes a patient instruction card. It contains important information reminding you how to take VANTAVO correctly.
If you have any doubts about how to use 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.
See a doctor immediately if you notice any of the following side effects, which may 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 jaw/mandible pain, 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 a tooth extraction. Contact your doctor and dentist if you experience such symptoms,
• rarely, an unusual femur fracture may occur, particularly in patients on long-term treatment 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 stomach,
• black or dark stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• 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 may be signs of bone damage in the ear.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 VANTAVO

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 pack 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 VANTAVO contains
The active substances are alendronic acid and colecalciferol (vitamin D). Each tablet of
VANTAVO 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 VANTAVO
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).

Description of the appearance of VANTAVO and contents of the pack
VANTAVO 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. VANTAVO 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.

VANTAVO 70 mg/5,600 IU tablets are available as white to off-white, modified rectangular tablets, with the outline of a bone engraved on one side and "270" on the other. VANTAVO 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
Manufacturer
N.V. Organon
Kloosterstraat 6
5349 AB Oss
The Netherlands

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
N.V. Organon
Τηλ: +30-216 6008607

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
Neopharmed Gentili S.p.A.
Tel. +39 02 89 13 21
[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]

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

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520
[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 website of the European Medicines Agency: https://www.ema.europa.eu.