Below is a text only representation of the Patient Information Leaflet (ePIL).
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 17277/0400.
Ibandronic acid 1mg, 2mg and 6mg concentrate for solution for infusion
Package leaflet: Information for the patient
Ibandronic acid 1mg concentrate for solution for infusion
Ibandronic acid 2mg concentrate for solution for infusion
Ibandronic acid 6mg concentrate for solution for infusion
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, pharmacist or nurse.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
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
1 What this medicine is and what it is used for
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’).
It helps to prevent your bones from breaking (fractures)
It helps to prevent other bone problems that may need surgery or radiotherapy
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.
2 What you need to know before you receive this medicine
Do not receive this medicine
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 this medicine.
Warnings and precautions
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:
you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
you don’t receive routine dental care or have not had a dental check up for a long time
you are a smoker (as this may increase the risk of dental problems)
you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
you have cancer.
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:
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.
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
This medicine should not be used in children and adolescents below the age of 18 years.
Other medicines and Ibandronic acid
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.
Pregnancy and breast-feeding
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.
Driving and using machines
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”.
3 How to receive this medicine
Receiving this medicine
This medicine 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 Ibandronic acid. 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 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.
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:
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).
severe adverse skin reactions
ear pain, discharge from the ear, and / or an ear infection. These could be signs of bone damage in the ear.
Not known (frequency cannot be estimated from the available data)
asthma attack.
Other possible side effects
Common (may affect up to 1 in 10 people)
rise in body temperature
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.
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
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).
Reporting of side effects
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.
5 How to store 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 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.
6 Content of the pack and other information
What this medicine contains
The active substance is ibandronic acid.
One ampoule with 1ml of a concentrate for solution for infusion contains 1mg ibandronic acid (as sodium monohydrate).
One ampoule with 2ml of a concentrate for solution for infusion contains 2mg ibandronic acid (as sodium monohydrate).
One vial with 6ml of a concentrate for solution for infusion contains 6mg ibandronic acid (as sodium monohydrate).
The other ingredients are sodium chloride, glacial acetic acid, sodium acetate trihydrate and water for injections.
What this medicine looks like and contents of the pack
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).