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The product code(s) for this leaflet is: PL35533/0161 .
Ibandronic acid 150mg film-coated tablets
Ibandronic acid 150mg 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
This medicine 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 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.
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 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 or other healthcare 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, or non-healing sores or discharge, as these could be signs of osteonecrosis of the jaw.
Some people need to be especially careful while they are taking this medicine. 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 this medicine. 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 or 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 medicine, including indigestion tablets, calcium supplements, or vitamins.
Do not take Ibandronic acid with food. This medicine is less effective if it’s taken with food. You can drink water but no other drinks.
After you have taken this medicine, 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 this medicine 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 medicine.
This medicine contains less than 1mmol sodium (23mg) per film-coated tablet, that is to say essentially ‘sodium free’.
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’s important to follow these instructions carefully. They are designed to help your Ibandronic acid tablet reach your stomach quickly, so it’s less likely to cause irritation.
Do not take your tablet with 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.
It’s important to keep taking this medicine every month, as long as your doctor prescribes it for you. After 5 years of using Ibandronic acid, please 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’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 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.
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1000 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 to 1 in 100 people):
Rare (may affect up to 1 in 1000 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 at 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.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 film-coated tablets are white, round biconvex tablets.
Ibandronic acid 150mg film-coated tablets are supplied in a cardboard box containing the appropriate number of PA/Aluminium/PVC- Aluminium foil blisters (alu-alu blister) containing 1 or 3 tablets.
Not all pack sizes may be marketed.
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This leaflet was last revised in 03/2021
1010123-P15.2