Package leaflet: Information for the user

Bondenza

150 mg film-coated tablets Ibandronic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

  
  

  What is in this leaflet:

  Planning when to take Bondenza

  with peel-off stickers for your personal calendar

  1. What Bondenza is and what it is used for

  2. What you need to know before you take Bondenza

  3. How to take Bondenza

  4. Possible side effects

  5. How to store Bondenza

  6. Content of the pack and other information

  
  

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  1. What Bondenza is and what it is used for

     
     

     Bondenza belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. Bondenza may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference. Bondenza may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

     
     

     Bondenza is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.

     The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis. Other things that can increase the risk of fractures include:

• not enough calcium and vitamin D in the diet

• smoking, or drinking too much alcohol

• not enough walking or other weight-bearing exercise

• a family history of osteoporosis

  
  

  .A healthy lifestyle will also help you to get the most benefit from your treatment. This includes:

• eating a balanced diet rich in calcium and vitamin D

• walking or any other weight-bearing exercise

• not smoking; and not drinking too much alcohol

  1. What you need to know before you take Bondenza

     
     

     Do not take Bondenza

• If you are allergic to ibandronic acid, or any of the other ingredients of this medicine listed in section 6).

• If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing.

• If you can’t stand or sit upright for at least one hour (60 minutes) at a time.

• If you have, or had in the past low blood calcium. Please consult your doctor.

  
  

  Warnings and precautions

  Some people need to be especially careful while they’re taking Bondenza. Talk to your doctor before taking Bondenza:

• If you have any disturbances of mineral metabolism (such as vitamin D deficiency).

• If your kidneys are not functioning normally.

• If you have any swallowing or digestive problems.

• If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Bondenza.

  
  

  Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Bondenza. If you develop these symptoms, stop taking Bondenza and tell your doctor straight away (see section 3).

  
  

  Children and adolescents

  Do not give Bondenza to children or adolescents below 18 years.

  
  

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  Other medicines and Bondenza

  Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:

  
  

• Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Bondenza.

  
  

• Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine. Bisphosphonates (like Bondenza) may also do so. So be especially careful if you take painkillers or anti-inflammatories while you’re taking Bondenza.

  
  

  After swallowing your monthly Bondenza tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.

  
  

  Bondenza with food and drink:

  Do not take Bondenza with food. Bondenza is less effective if it’s taken with food.

  You can drink water but no other drinks (see 3. How to take Bondenza).

  
  

  Pregnancy and breast feeding

  Do not take Bondenza if you’re pregnant or breast feeding. If you’re breast feeding, you may need to stop in order to take Bondenza.

  Ask your doctor or pharmacist for advice before taking this medicine.

  
  

  Driving and using machines

  You can drive and use machines as it’s expected that Bondenza has no or negligible effect on your ability to drive and use machines.

  Bondenza contains lactose.

  If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose

  absorption), talk to your doctor before taking this medicine.

  
  

  1. How to take Bondenza

     
     

     Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

     The usual dose of Bondenza is one tablet once a month. Taking your monthly tablet

     It’s important to follow these instructions carefully. They are designed to help your Bondenza tablet

     reach your stomach quickly, so it’s less likely to cause irritation.

     
     

• Take one Bondenza 150 mg tablet once a month.

• Choose one day of the month that will be easy to remember. You can choose either the same date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Bondenza tablet. Choose the date that best fits your routine.

• Take your Bondenza tablet at least 6 hours after you last had anything to eat or drink except water.

  
  

• Take your Bondenza tablet

  • after you first get up for the day, and

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  • before you have anything to eat or drink (on an empty stomach)

    
    

• Swallow your tablet with a full glass of water (at least 180 ml).

  
  

  Do not take your tablet with l water with a high concentration of calcium, fruit juice or any other drinks. If there is a concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.

  
  

• Swallow your tablet whole — do not chew it, crush it or let it dissolve in your mouth.

  
  

• For the next hour (60 minutes) after you’ve taken your tablet

  • do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus

    

  • do not eat anything

    

  • do not drink anything (except water if you need it)

  • do not take any other medicines

• After you’ve waited for an hour, you can have your first food and drink of the day. Once you’ve eaten, it’s OK to lie down if you wish, and to take any other medication you need.

  
  

  Do not take your tablet at bedtime or before you get up for the day.

  
  

  Continuing to take Bondenza

  It’s important to keep taking Bondenza every month, as long as your doctor prescribes it for you. Bondenza can treat osteoporosis only as long as you keep taking it.

  
  

  If you take more Bondenza than you should

  If you’ve taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.

  
  

  Do not make yourself vomit, and do not lie down — this could cause Bondenza to irritate your oesophagus.

  
  

  If you forget to take Bondenza

  If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day. Instead, consult your calendar and find out when your next scheduled dose is:

  
  

  If your next scheduled dose is only 1 to 7 days away…

  You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.

  
  

  If your next scheduled dose is more than 7 days away…

  You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.

  
  

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  Never take two Bondenza tablets within the same week.

  
  

  1. Possible side effects

     
     

     Like all medicines, this medicine can cause side effects, although not everybody gets them.

     
     

     Talk to a nurse or a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:

     
     

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

     • flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and aching muscles and joints. Talk to a nurse or doctor if any effects become troublesome or last more than a couple of days

     • rash. You may be having an allergic reaction to the medicine

       
       

       Uncommon (may affect up to 1 in 100 people)

     • severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, difficulty in swallowing. You may have a severe inflammation of your gullet/food pipe, possibly with sores or constriction of the gullet/food pipe

       
       

       Rare (may affect up to 1 in 1000 people):

     • itching, swelling of your face, lips, tongue and throat, with difficulty breathing.

     • persistent eye pain and inflammation

     • new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone

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

     • pain or sore in your mouth or jaw, You may have early signs of severe jaw problems (necrosis (dead bone tissue) in the jaw bone)

     • serious, potentially life-threatening allergic reaction

       
       

       Other possible side effects

       
       

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

     • headache

     • heartburn, discomfort in swallowing, stomach or tummy pain (may be due to an inflammation of the stomach), indigestion, nausea, having diarrhoea (loose bowels)

     • muscle cramps, stiffness of your joints and limbs

       
       

       Uncommon (may affect up to 1 in 100 people)

     • dizziness

     • flatulence (farting, feeling bloated)

     • back pain

     • feeling tired and exhausted

       
       

       Rare (may affect up to 1 in 1000 people):

     • inflammation of the duodenum (first section of the bowel) causing stomach pain

     • hives

     
     

     If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

     
     

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  2. How to store Bondenza

     
     

     Keep this medicine out of the sight and reach of children. There are no special storage instructions.

     Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

     
     

     Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

     
     

  3. Contents of the pack and other information What Bondenza contains

• The active substance is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as sodium monohydrate).

• The other ingredients are:

  
  

  tablet core: lactose monohydrate, povidone, cellulose microcrystalline, crospovidone, stearic acid purified, silica colloidal anhydrous

  
  

  tablet coat: hypromellose, titanium dioxide (E 171), talc, macrogol 6000

  What Bondenza looks like and contents of the pack

  
  

  Bondenza tablets are white to off white, of oblong shape and marked “BNVA” on one side, and “150” on the other side. The tablets are supplied in blisters containing 1 or 3 tablets.

  Not all pack sizes may be marketed.

  Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder

  Roche Registration Limited 6 Falcon Way

  Shire Park

  Welwyn Garden City AL7 1TW

  United Kingdom

  
  

  Manufacturer Roche Pharma AG Emil-Barell-Strasse 1

  D-79639 Grenzach-Wyhlen Germany

  
  

  For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

  
  

  België/Belgique/Belgien

  N.V. Roche S.A.

  Medicinal product no longer authorised

  Tél/Tel: +32 (0) 2 525 82 11

  Luxembourg/Luxemburg

  (Voir/siehe Belgique/Belgien)

  
  

  България

  Рош България ЕООД Тел: +359 2 818 44 44

  Magyarország

  Roche (Magyarország) Kft. Tel: +36 - 23 446 800

  
  

  Česká republika

  Roche s. r. o.

  Tel: +420 - 2 20382111

  Danmark

  Roche a/s

  Tlf: +45 - 36 39 99 99

  Malta

  (See United Kingdom)

  
  

  Nederland

  Roche Nederland B.V. Tel: +31 (0) 348 438050

  
  

  Deutschland

  Roche Pharma AG Tel: +49 (0) 7624 140

  Norge

  Roche Norge AS

  Tlf: +47 - 22 78 90 00

  
  

  Eesti

  Roche Eesti OÜ

  Tel: + 372 - 6 112 401

  Österreich

  Roche Austria GmbH Tel: +43 (0) 1 27739

  
  

  Ελλάδα

  Roche (Hellas) A.E.

  Τηλ: +30 210 61 66 100

  Polska

  Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 88

  
  

  España

  Roche Farma, S.A.

  Tel: +34 – 94 481 83 00

  Portugal

  Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00

  France

  Roche

  Tél: +33 (0) 1 47 61 40 00

  România

  Roche România S.R.L. Tel: +40 21 206 47 01

  
  

  Ireland

  Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700

  Slovenija

  Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00

  
  

  Ísland

  Roche a/s

  c/o Icepharma hf Tel: +354 540 8000

  Slovenská republika Roche Slovensko, s.r.o. Tel: +421 - 2 52638201

  
  

  Italia

  Roche S.p.A.

  Tel: +39 - 039 2471

  Suomi/Finland

  Roche Oy

  Puh/Tel: +358 (0) 10 554 500

  
  

  Kύπρος

  G.A Stamatis & Co.(Cyprus) Ltd

  Τηλ: +357 - 22 76 62 76

  Sverige

  Roche AB

  Tel: +46 (0) 8 726 1200

  
  

  Latvija

  Roche Latvija SIA Tel: +371 -6 7 039831

  United Kingdom

  Roche Products Ltd.

  Tel: +44 (0) 1707 366000

  
  

  Lietuva

  Medicinal product no longer authorised

  UAB “Roche Lietuva” Tel: +370 5 2546799

  
  

  This leaflet was last revised in {date}.

  
  

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  REMINDER STICKERS TEXT

  
  

  

  PLANNING WHEN TO TAKE BONDENZA

  
  

  The dose of Bondenza is one tablet once a month. Choose one day of the month that will be easy to remember:

• either the same date (such as the 1st of each month)

• or the same day (such as the first Sunday of each month). Use the peel-off stickers below to mark the dates on your calendar. Once you’ve taken your tablet, put a tick in the box on the sticker.

PEEL-OFF STICKERS FOR YOUR PERSONAL CALENDAR

Medicinal product no longer authorised

It’s important to keep taking Bondenza every month.