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Ibandronic acid 50mg film-coated tablets
Ibandronic acid 50 mg film-coated tablets
1. What this medicine is and what it is used for.
2. What you need to know before you take this medicine.
3. How to take 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.
Ibandronic acid is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases’).
Ibandronic acid works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking ibandronic acid.
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 or pharmacist before taking this medicine:
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 this medicine. If you develop these symptoms, stop taking this medicine and tell your doctor straight away (see sections 3 and 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 taking any of the following medicines:
Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of ibandronic acid.
Do not take this medicine with food or any other drinks except plain water as ibandronic acid is less effective if it is taken with food or drink (see section 3).
Take this medicine at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water. After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink and take any medicines or supplements (see section 3).
Do not take 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.
If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water. Water with a high concentration of calcium should not be used. If there is 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.
Your doctor may do regular blood tests while you are taking this medicine. This is to check that you are being given the right amount of medicine.
It is important that you take this medicine at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).
You can help stop this happening by doing the following:
The usual dose of this medicine is one tablet each day. If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day. If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.
If you take too many tablets talk to a doctor or go to hospital straight away. Drink a full glass of milk before you go. Do not make yourself sick. Do not lie down.
Do not take a double dose to make up for a forgotten dose.
If you are taking a tablet each day, skip the missed dose completely. Then carry on as usual the next day. If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.
Keep taking this medicine for as long as your doctor tells you. This is because the medicine will only work if it is taken all the time.
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.
Common (may affect up to 1 in 10 people):
Uncommon (may affect less than 1 in 100 people):
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 or pharmacist. 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.
The other ingredients are:
The film-coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC - Aluminium foil blister. They are available in packs of 3, 6, 9, 28 and 84 tablets.
Not all pack sizes may be marketed
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Manufacturer
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This leaflet was last revised in 02/2022
1010568 - P1.3