The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 17277/0402.
Ibandronic acid 1mg, 2mg and 6mg concentrate for solution for infusion
Ibandronic acid 1mg concentrate for solution for infusion
Ibandronic acid 2mg concentrate for solution for infusion
Ibandronic acid 6mg concentrate for solution for infusion
1. What this medicine is and what it is used for
2. What you need to know before you receive this medicine
3. How to receive this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
This medicine contains the active substance ibandronic acid.
This belongs to a group of medicines called bisphosphonates.
This medicine is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases’).
This medicine can also be prescribed if you have a raised calcium level in your blood due to a tumour.
This medicine works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.
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 this medicine.
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ibandronate for cancer-related conditions. ONJ can also occur after stopping treatment.
It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Before receiving treatment, tell your doctor/nurse (health care professional) if:
Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.
While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with ibandronic acid.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Talk to your doctor, pharmacist or nurse before receiving ibandronic acid:
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).
This medicine should not be used in children and adolescents below the age of 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because ibandronic acid can affect the way some other medicines work. Also, some other medicines can affect the way ibandronic acid 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 ibandronic acid can both lower the amount of calcium in your blood.
Do not receive this medicine 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.
You can drive and use machines as it’s expected that this medicine 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.
This medicine contains less than 1mmol sodium (23mg) per dose, that is to say essentially “sodium-free”.
Your doctor may do regular blood tests while you are receiving Ibandronic acid. This is to check that you are being given the right amount of this medicine.
Your doctor will work out how much Ibandronic acid you will be given depending on your illness.
If you have breast cancer that has spread to your bones, then the recommended dose is 6mg every 3-4 weeks, as an infusion in your vein over at least 15 minutes.
If you have a raised calcium level in your blood due to a tumour then the recommended dose is a single administration of 2mg or 4mg, depending on the severity of your illness. The medicine should be administered as an infusion in 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.
Like all medicines, this medicine can cause side effects although not everybody gets them.
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
Common (may affect up to 1 in 10 people)
Uncommon (may affect less than 1 in 100 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
This medicine is a colourless, clear solution.
Ibandronic acid 1mg concentrate for solution for infusion is supplied in a pack containing 1 ampoule (2ml type I glass ampoule).
Ibandronic acid 2mg concentrate for solution for infusion is supplied in a pack containing 1 ampoule (4ml type I glass ampoule).
Ibandronic acid 6mg concentrate for solution for infusion is supplied in packs containing 1, 5 and 10 vials (9ml type I glass vial with a bromobutyl rubber stopper).
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This leaflet was last revised in 02/2022
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