Bondenza 150 mg film-coated tablets

Bondenza belongs to a group of medicines called bisphosphonates. It contains ibandronic acid. It does not contain hormones.
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

Many people with osteoporosis have no symptoms. If you have no symptoms you may not know if you have the condition. However, osteoporosis makes you more likely to break bones if you fall or hurt yourself. A broken bone after the age of 50 may be a sign of osteoporosis. Osteoporosis can also cause back pain, height loss and a curved back.

Bondenza prevents loss of bone from osteoporosis, and helps to rebuild bone. Therefore Bondenza makes bone less likely to break.

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.

Do not take Bondenza

• If you are allergic (hypersensitive) to ibandronic acid, or to any of the other ingredients ofBondenza.
• If you have certain problems with your oesophagus (the tube connecting your mouth with your stomach) 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.

Children and teenagers
Do not give Bondenza to children or teenagers.

Take special care with Bondenza

Some people need to be especially careful while they?re taking Bondenza. Check with your doctor:

• 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 oesophagus (the tube connecting your mouth with your stomach) 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 plain 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without prescription. Especially:

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

Taking Bondenza with food and drink:
Do not take Bondenza with food. Bondenza is less effective if it?s taken with food. You can drink plain 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 any medicines.

Driving and using machines

You can drive and use machines as it?s very unlikely that Bondenza will affect your ability to drive and use machines.

Important information about some of the ingredients of Bondenza

Bondenza contains an ingredient called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take Bondenza exactly as your doctor has told you. If you?re not sure about anything, ask your doctor or pharmacist.
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 1 st 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 plain water.
• Take your Bondenza tablet
• after you first get up for the day, and
• before you have anything to eat or drink (on an empty stomach)
• Swallow your tablet with a full glass of plain water (at least 180 ml). Do not take your tablet with mineral water, fruit juice or any other drinks.
• 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 plain 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 too much Bondenza

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 a dose

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.

Never take two Bondenza tablets within the same week.

Like all medicines, Bondenza 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:

• rash, itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having an allergic reaction to the medicine.
• severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting.
• flu-like symptoms (if any effects become troublesome or last more than a couple of days).
• pain or sore in your mouth or jaw
• eye pain and inflammation (if prolonged)

Other possible side effects

Common (affects less than 1 in 10 people)

• headache
• heartburn, stomach pain (such as ?gastroenteritis? or ?gastritis?), indigestion, nausea, having diarrhoea or constipation
• rash
• pain or stiffness in your muscles, joints, or back
• flu-like symptoms (including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints)
• fatigue

Uncommon (affects less than 1 in 100 people)

• bone pain
• feeling weak
• dizziness
• flatulence

Rare (affects less than 1 in 1000 people):

• hypersensitivity reaction; swelling of the face, lips and mouth (see allergy)
• itching
• eye pain or inflammation

Very rare (affects less than 1 in 10000 people)

• a condition involving exposed bone in the mouth called ?osteonecrosis of the jaw?.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

There are no special storage instructions.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What Bondenza contains

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

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW

United Kingdom

Manufacturer:

Roche Pharma AGEmil-Barell-Strasse 1D-79639 Grenzach-WyhlenGermany

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

LuxembourgLuxemburg Voirsiehe BelgiqueBelgien BelgiëBelgiqueBelgien N.V. Roche S.A. TélTel 32 0 2 525 82 11

359 2 818 44 44 Magyarország Roche Magyarország Kft. Tel 36 - 23 446 800

Malta See United Kingdom eská republika Roche s. r. o. Tel 420 - 2 20382111 Danmark Roche as Tlf 45 - 36 39 99 99 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

Roche Hellas A.E. 30 210 61 66 100 Polska Roche Polska Sp.z o.o. Tel 48 - 22 345 18 88

España Faes 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 46 40 50 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 druba d.o.o. Tel 386 - 1 360 26 00

Slovenská republika Roche Slovensko, s.r.o. Tel 421 - 2 52638201 Ísland Roche as co Icepharma hf Tel 354 540 8000

Italia Roche S.p.A. Tel 39 - 039 2471 SuomiFinland Roche Oy PuhTel 358 0 10 554 500

K G.A Stamatis Co.Cyprus Ltd 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

UAB ?Roche Lietuva?
Tel: +370 5 2546799

This leaflet was last approved in {date}

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 1 st 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

Monthly tablet Monthly tablet Monthly tablet

Bondenza Bondenza Bondenza

It?s important to keep taking Bondenza every month.