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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: PL17780/0528.
Ibandronic Acid 150mg Film-Coated Tablets
Ibandronic acid 150 mg film-coated tablets
1. What ibandronic acid is and what it is used for
2. What you need to know before you take ibandronic acid
3. How to take ibandronic acid
4. Possible side effects
5. How to store ibandronic acid
6. Contents of the pack and other information
The name of your medicine is Ibandronic acid 150mg film-coated Tablets (referred to as ibandronic acid throughout this leaflet).
Ibandronic acid belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.
Ibandronic acid 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. Ibandronic acid may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.
Ibandronic acid 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:
A healthy lifestyle will also help you to get the most benefit from your treatment. This includes
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 ibandronic acid for osteoporosis. 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 you:
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, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.
Some people need to be especially careful while they’re taking ibandronic acid. Talk to your doctor before taking ibandronic acid:
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 ibandronic acid. If you develop these symptoms, stop taking ibandronic acid and tell your doctor straight away (see section 3).
Do not give ibandronic acid to children and adolescents below 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,especially:
After swallowing your monthly ibandronic acid tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Do not take ibandronic acid with food.
Ibandronic acid is less effective if it’s taken with food.
You can drink water but no other drinks.
After you have taken ibandronic acid, please wait for 1 hour before you have your first food and further drinks (see section 3 “How to take ibandronic acid”).
Ibandronic acid is for use only by postmenopausal women and must not be taken by women who could still have a baby.
Do not take ibandronic acid if you are pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before taking this medicine.
You can drive and use machines as it’s expected that ibandronic acid has no or negligible effect on your ability to drive and use machines.
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 this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The usual dose of ibandronic acid is one tablet once a month.
It is important to follow these instructions carefully. They are designed to help your ibandronic acid tablet reach your stomach quickly, so it is less likely to cause irritation.
It is important to keep taking ibandronic acid every month, as long as your doctor prescribes it for you. After 5 years of using ibandronic acid, consult with your doctor whether you should continue to take this medicine.
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 ibandronic acid to irritate your oesophagus.
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 you forgot to take your tablet on your chosen day and your next scheduled dose is only 1 to 7 days away
Never take two ibandronic acid tablets within the same week. 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 you forgot to take your tablet on your chosen day and 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon (may affect up to 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):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to1 in 100 people):
Rare (may affect up to 1 in 1,000 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 Yellow Card Scheme, 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.
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
Ibandronic acid 150mg tablets are white, oblong biconvex film coated tablets.
Pack sizes: 1, 3 or 6 film-coated tablets
Not all pack sizes may be marketed
This leaflet was last revised in October 2022
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