Bondronat
(Ibandronate Sodium)

What Bondronat is and what it is used for

Bondronat contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates. Bondronat 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 also helps to prevent other bone problems that may need surgery or radiotherapy Bondronat works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker

How to take Bondronat

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Take your tablet at least 6 hours after you 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 Bondronat. This is to check that you are being given the right amount of medicine. Taking this medicine It is important that you take Bondronat 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:
• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements
• Take your tablet with a full glass of water only (about 200 mL). Do not take your tablet with any drink other than water
• Swallow the tablet whole. Do not chew, suck or crush the tablet. Do not let the tablet dissolve in your mouth
• After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink, and take any medicines or supplements
• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes). Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus) 4 How much to take The usual dose of Bondronat 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 more Bondronat than you should 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. If you forget to take Bondronat 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. If you stop taking Bondronat Keep taking Bondronat 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.

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:

Common (may affect up to 1 in 10 people):
• feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe)

Uncommon (may affect less than 1 in 100 people):
• severe stomach pain. This could be a sign of an ulcer of the first section of the bowel (duodenum) that is bleeding, or that your stomach is inflamed (gastritis)

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)
• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.
• itching, swelling of your face, lips, tongue and throat with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction
• severe adverse skin reactions

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):
• tummy pain, indigestion
• low calcium levels in your blood
• weakness

Uncommon (may affect less than 1 in 100 people):
• chest pain
• itching or tingling skin (paraesthesia)
• flu-like symptoms, feeling generally unwell or in pain
• dry mouth, strange taste in your mouth or difficulty swallowing
• anaemia (bloodlessness)
• high levels of urea or high levels of parathyroid hormone in your blood

Reporting of side effects 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. Ireland HPRA Pharmacovigilance Earlsfort Terrace IRL
•Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 Website: www.hpra.ie e-mail: [email protected] Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

How to Store Bondronat

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 blister and carton after EXP. The expiry date refers to the last day of that month
• Store in the original package in order to protect from moisture
• 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