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The product codes for this leaflet are: EU/1/96/012/011 , EU/1/96/012/012, EU/1/96/012/013

 

Bondronat 6mg/6ml concentrate for solution for infusion

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Roche Products Limited


Hexagon Place6 Falcon WayShire ParkWelwyn Garden CityHertfordshireAL7 1TW
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Medical Information e-mail:medinfo.uk@roche.com
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Package leaflet: Information for the patient

Bondronat 6 mg concentrate for solution for infusion

ibandronic acid

Read all of this leaflet carefully before you start using 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.
  • 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:

1. What Bondronat is and what it is used for
2. What you need to know before you receive Bondronat
3. How to receive Bondronat
4. Possible side effects
5. How to store Bondronat
6. Content of the pack and other information

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1. What Bondronat is and what it is used for

Bondronat contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.

Bondronat is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone “metastases”).

  • It helps to prevent your bones from breaking (fractures).
  • It helps to prevent other bone problems that may need surgery or radiotherapy.

Bondronat can also be prescribed if you have a raised calcium level in your blood due to a tumour.

Bondronat works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.

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2. What you need to know before you receive Bondronat

Do not receive Bondronat:

  • if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in Section 6
  • if you have, or have ever had low levels of calcium in your blood.

Do not receive this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before having Bondronat.

Warnings and precautions

  • if you are allergic to any other bisphosphonates
  • if you have high or low levels of vitamin D, calcium or any other minerals
  • if you have kidney problems
  • If you have heart problems and the doctor recommended to limit your daily fluid intake

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before receiving Bondronat.

If you are having dental treatment or surgery or know that you need some in the future, tell your dentist that you are being treated with Bondronat.

Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic acid.

If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately alert your doctor or nurse (see section 4).

Children and adolescents

Bondronat should not be used in children and adolescents below age 18 years.

Other medicines and Bondronat

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Bondronat can affect the way some other medicines work. Also, some other medicines can affect the way Bondronat works.

In particular, tell your doctor or pharmacist if you are receiving a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because aminoglycosides and Bondronat can both lower the amount of calcium in your blood.

Pregnancy and breast-feeding

Do not receive Bondronat if you are pregnant, planning to get pregnant or if you are breast-feeding.

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 Bondronat has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use machines or tools.

Bondronat contains less than 1 mmol sodium (23 mg) per vial, i.e. ‘essentially sodium free’.

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3. How to receive Bondronat

Receiving this medicine

  • Bondronat is normally given by a doctor or other medical staff who have experience with the treatment of cancer.
  • It is given as an infusion into your vein

Your doctor may do regular blood tests while you are receiving Bondronat. This is to check that you are being given the right amount of this medicine.

How much to receive

Your doctor will work out how much Bondronat you will be given depending on your illness.

If you have breast cancer that has spread to your bones, than the recommended dose is 1 vial (6 mg) every 3-4 weeks, as an infusion to your vein over at least 15 minutes.

If you have a raised calcium level in your blood due to a tumour than the recommended dose is a single administration of 2 mg or 4 mg depending on the severity of your illness. The medicine should be administered as an infusion to your vein over two hours. A repeated dose may be considered in case of insufficient response or if your illness reappears.

Your doctor may adjust your dose and duration of intravenous infusion if you have kidney problems.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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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:

Common (may affect up to 1 in 10 people)

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

Rare (may affect up to 1 in 1,000 people)

  • 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.
  • itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction (see section 2).

Other possible side effects

Common (may affect up to 1 in 10 people)

  • rise in body temperature
  • stomach and tummy pain, indigestion, being sick, vomiting or having diarrhoea (loose bowels)
  • low calcium or phosphate levels in your blood
  • changes in blood test results such as Gamma GT or creatinine
  • a heart rhythm problem called “bundle branch block”
  • pain in your bone or muscles
  • headache, feeling dizzy or feeling weak
  • feeling thirsty, sore throat, changes in taste
  • swollen legs or feet
  • aching joints, arthritis, or other joint problems
  • problems with your parathyroid gland
  • bruising
  • infections
  • a problem with your eyes called ‘cataracts
  • skin problems
  • tooth problems

Uncommon (may affect less than 1 in 100 people)

  • shaking or shivering
  • your body temperature getting too low (hypothermia)
  • a condition affecting the blood vessels in your brain called “cerebrovascular disorder” (stroke or brain bleeding)
  • heart and circulatory problems (including palpitations, heart attack, hypertension (high blood pressure) and varicose veins)
  • changes in your blood cells (anaemia)
  • a high level of alkaline phosphatase in your blood
  • fluid build up and swelling (“lymphoedema”)
  • fluid in your lungs
  • stomach problems such as “gastroenteritis” or “gastritis”
  • gallstones
  • being unable to pass water (urine), cystitis (bladder inflammation)
  • migraine
  • pain in your nerves, damaged nerve root
  • deafness
  • increased sensitivity of sound, taste or touch or changes in smell
  • difficulty swallowing
  • mouth ulcers, swollen lips (“cheilitis”), oral thrush
  • itching or tingling skin around your mouth
  • pelvic pain, discharge, itching or pain in the vagina
  • a skin growth called a “benign skin neoplasm”
  • memory loss
  • sleep problems, feeling anxious, emotional instability, or mood swings
  • skin rash
  • hair loss
  • injury or pain at the injection site
  • weight loss
  • kidney cyst (fluid-filled sac in the kidney)

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

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5. How to store Bondronat

  • Keep this medicine out of the sight and reach of children.
  • Do not use this medicine after the expiry date which is stated on the folding box and on the label after EXP. The expiry date refers to the last day of that month.
  • After dilution the infusion solution is stable for 24 hours at 2-8 °C (in a refrigerator).
  • Do not use this medicine if you notice that the solution is not clear or contains particles.
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6. Content of the pack and other information

What Bondronat contains

  • The active substance is ibandronic acid. One vial with 6 ml of a concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate).
  • The other ingredients are sodium chloride, acetic acid, sodium acetate and water for injections.

What Bondronat looks like and contents of the pack

Bondronat is a colourless, clear solution. Bondronat is supplied as packs containing 1, 5 and 10 vials (6 ml type I glass vial with a bromobutyl rubber stopper). 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.

United Kingdom
Roche Products Ltd.
Tel:+44 (0) 1707 366000
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This leaflet was last revised in November 2013

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

Bondronat-uk-ie-mt-PIL-clean-1311-6mg-inj


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