Bondenza (previously Ibandronic Acid Roche) - patient leaflet, side effects, dosage

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

What Bondenza is and what it is used for

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

2. What you need to know before you take BondenzaDo 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 being treated with Bondenza.

Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) o

severe pain in the chest, severe pain after swallowing food and/or drink may occur, especially if you do not drink a full glass of water and/or i taking Bondenza. If you develop these symptoms, stop taking Bond away (see section 3).

Children and adolescents

Do not give Bondenza to children or

Other medicines and Bondenza

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

agnesium, iron or aluminium , as they could possibly

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.

3. 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.

D…

– 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 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 h

  – do not li

  could lea

  
  

r (60 minutes) after you’ve taken your tablet

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

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 tablet once a month on the scheduled days you’ve ma

Never take two Bondenza tablets within the same week.

4. 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:

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.

5. How to store Bondenzahildren.

Keep this medicine out of the sight and reac

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.

6. Contents of the pack and other informationWhat 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 re Authorisation Holder:

België/Belgiqu­e/Belgien

N.V. Roche S.A.

Tél/Tel: +32 (0) 2 525 82 11

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

EÀÀàôa

Roche (Hellas) A.E.

Tql: +30 210 61 66 100

Polska

Roche Polska Sp.z o.o.

Tel: +48 – 22 345 18 88

Portugal

Roche Farmacêutica Química, Lda

Tel: +351 – 21 425 70 00

| 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).