Adrovance

Package leaflet: Information for the user

ADROVANCE 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 others, even if their symptoms are the same as yours, as it could 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 ADROVANCE is and what it is used for
2. What you need to know before taking ADROVANCE
3. How to take ADROVANCE
4. Possible side effects
5. How to store ADROVANCE
6. Contents of the pack and other information

1. What ADROVANCE is and what it is used for

What is ADROVANCE?
ADROVANCE is a tablet containing two active substances, alendronic acid (commonly
called alendronate) and colecalciferol, 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 occurs in 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, which may result in falls and an increased risk of fractures.
What is ADROVANCE used for?
Your doctor has prescribed ADROVANCE 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 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 the early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are typically painful, spinal 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 healthy bone. Fractures typically occur in the hip, spine, or wrist and can be not only painful but may also lead to significant deformities and disabilities, such as curvature of the back (dowager's hump) and limitations in movement.
How can osteoporosis be treated?
Along with treatment with ADROVANCE, 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 on diet or the possible need for dietary supplements.

2. What you should know before taking ADROVANCE

Do not take ADROVANCE

• 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 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 their
advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking ADROVANCE 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 have regular dental check-ups,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking anti-angiogenesis agents (such as bevacizumab or thalidomide) used in cancer treatment,
• 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
ADROVANCE.
It is important to maintain good oral hygiene during treatment with
ADROVANCE. You should have regular dental check-ups throughout 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 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 ADROVANCE. These side effects may worsen if patients continue taking ADROVANCE after experiencing such symptoms.
Children and adolescents
ADROVANCE must not be administered to children and adolescents under 18 years of age.
Other medicines and ADROVANCE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Calcium supplements, antacids, and certain oral medications may interfere with the absorption of ADROVANCE 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 medication 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 ADROVANCE.
Certain medicines or food additives may reduce the absorption of vitamin D contained in ADROVANCE, including artificial fat substitutes, mineral oils, weight-loss medicines, orlistat, and cholesterol-lowering medicines such as cholestyramine and colestipol. Antiepileptic drugs (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.
ADROVANCE with food and drink
Food and beverages (including mineral water) may reduce the effectiveness of ADROVANCE 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
ADROVANCE is indicated only for postmenopausal women. Do not take ADROVANCE if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.
Driving and using machines
With ADROVANCE, side effects have been reported (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) which may affect the ability to drive or operate machinery (see section 4). If you experience any of these side effects, you must not drive until you feel well again.
ADROVANCE contains lactose and sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
ADROVANCE contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take ADROVANCE

Take ADROVANCE exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Take one tablet of ADROVANCE once a week.
Follow carefully the instructions below:

1. Choose the day of the week that best fits your routine. Take one tablet of ADROVANCE once a week on the chosen day.
   It is very important that you follow steps 2), 3), 4), and 5) to help the ADROVANCE tablet reach the stomach quickly and 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 ADROVANCE tablet whole with a full glass of tap water (not mineral water) (at least 200 ml), to ensure adequate absorption of ADROVANCE.

• 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) ADROVANCE must not be taken at bedtime or before getting out of bed in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking ADROVANCE and contact your doctor.
6) After swallowing the ADROVANCE tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, and vitamins. ADROVANCE is effective only when taken on an empty stomach.

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

The ADROVANCE package includes a patient instruction card. It contains important information reminding you how to take ADROVANCE 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.
Contact your 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 sensation 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 dental extraction. Contact your doctor and dentist if you experience such symptoms,
• rarely, an unusual femoral 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 femoral 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, flatulence,
• 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,
• rash; skin redness,
• flu-like symptoms, transient, 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 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 oesophagus (the tube connecting the mouth to the stomach),
• 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 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 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 ADROVANCE

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 you no longer use. This will help protect the environment.

6. Package contents and other information

What ADROVANCE contains
The active substances are alendronic acid and colecalciferol (vitamin D). Each tablet of
ADROVANCE 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 ADROVANCE
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 components 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 ADROVANCE and contents of the pack
ADROVANCE 70 mg/2,800 IU tablets are white to off-white, modified capsule-shaped tablets, with the outline of a bone engraved on one side and "710" on the other. ADROVANCE 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
ADROVANCE 70 mg/5,600 IU tablets are white to off-white, modified rectangular-shaped tablets, with the outline of a bone engraved on one side and "270" on the other. ADROVANCE 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
Marketing Authorisation Holder Merck Sharp & Dohme B.V.
N.V. Organon Waarderweg 39
Kloosterstraat 6 2031 BN Haarlem
5349 AB Oss, The Netherlands
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 Lietuva
Organon Belgium Organon Pharma B.V. Lithuania
Tél/Tel: 0080066550123 (+32 2 2418100) atstovybė
[email protected] Tel.: +370 52041693
[email protected]

България Luxembourg/Luxemburg
Органон (И.А.) Б.В. - клон България Organon Belgium
Тел.: +359 2 806 3030 Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected] [email protected]

Česká republika Magyarország
Organon Czech Republic s.r.o. Organon Hungary Kft.
Tel: +420 233 010 300 Tel.: +36 1 766 1963
[email protected] [email protected]

Danmark Malta
Organon Denmark ApS Organon Pharma B.V., Cyprus branch
Tlf: +45 4484 6800 Tel: +356 2277 8116
[email protected] [email protected]

Deutschland Nederland
Organon Healthcare GmbH N.V. Organon
Tel: 0800 3384 726 (+49 (0) 89 2040022 10) Tel.: 00800 66550123 (+32 2 2418100)
[email protected] [email protected]

Eesti Norge
Organon Pharma B.V. Estonian RO Organon Norway AS
Tel: +372 66 61 300 Tlf: +47 24 14 56 60
[email protected] [email protected]

Eλλάδα Österreich
N.V. Organon Organon Healthcare GmbH
Τηλ: +30-216 6008607 Tel: +49 (0) 89 2040022 10
[email protected]

España Polska
Organon Salud, S.L. Organon Polska Sp. z o.o.
Tel: +34 91 591 12 79 Tel.: +48 22 105 50 01
[email protected] [email protected]

France Portugal
Organon France Organon Portugal, Sociedade Unipessoal Lda.
Tél: +33 (0) 1 57 77 32 00 Tel: +351 218705500
[email protected]

Hrvatska România
Organon Pharma d.o.o. Organon Biosciences S.R.L.
Tel: +385 1 638 4530 Tel: +40 21 527 29 90
[email protected] [email protected]

Ireland Slovenija
Organon Pharma (Ireland) Limited Organon Pharma B.V., Oss, podružnica Ljubljana
Tel: +353 15828260 Tel: +386 1 300 10 80
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Organon Slovakia s.r.o.
Sími: +354 535 7000 Tel: +421 2 44 88 98 88
[email protected]

Italia Suomi/Finland
Addenda Pharma S.r.l. Organon Finland Oy
Tel: +39-06-9139 3303 Puh/Tel: +358 (0) 29 170 3520
[email protected] [email protected]

Κύπρος Sverige
Organon Pharma B.V., Cyprus branch Organon Sweden AB
Tel: +357 22866730 Tel: +46 8 502 597 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Ārvalsts komersanta “Organon Pharma B.V.” pārstāvniecība Organon Pharma (UK) Limited
Tel: +371 66968876 Tel: +44 (0) 208 159 3593
[email protected] [email protected]

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