Ibandronic acid 1mg concentrate for solution for infusion

• 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.

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

• 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.

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).

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”.

• 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.

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.

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.

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
• difficulty swallowing
• mouth ulcers, swollen lips (‘cheilitis’), oral thrush
• itching or tingling skin around your mouth
• 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).

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.

• 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.

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).

Marketing Authorisation Holder

Manufacturer