IBANDRONIC ACID ACTAVIS 50MG FILM-COATED TABLETS
Active substance: SODIUM IBANDRONATE MONOHYDRATE
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Ibandronic Acid 50mg Film-coated tablets
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The full name of this medicine is Ibandronic Acid 50mg Film-coated Tablets but within the leaflet it will be referred to as Ibandronic acid tablets. Take special care with Ibandronic acid tablets if you:
are allergic (hypersensitive) to any other have any swallowing or digestion problems have high or low blood levels of vitamin D or any have kidney problems have a galactose intolerance, the Lapp lactase
bisphosphonates other minerals
deficiency or have problems with glucosegalactose absorption
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Ibandronic acid tablets. If you are having dental treatment or surgery or know that you need some in the future, tell your dentist that you are being treated with Ibandronic acid tablets.
In this leaflet: 1 What Ibandronic acid tablets are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information
1 What Ibandronic acid tablets are and
Children and teenagers
Ibandronic acid tablets should not be used in children and teenagers below age 18 years.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is because Ibandronic acid tablets can affect the way some other medicines work. Also some other medicines can affect the way Ibandronic acid tablets work. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: supplements containing calcium, magnesium, iron or aluminium non-steroidal anti-inflammatory drugs called NSAIDs such as aspirin, ibuprofen or naproxen. This is because NSAIDs and Ibandronic acid tablets can both irritate your stomach and gut a type of antibiotic injection called aminoglycoside such as gentamicin. This is because aminoglycosides and Ibandronic acid tablets can both lower the amount of calcium in your blood. Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic acid tablets.
what they are used for
Ibandronic acid tablets contain the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates. Ibandronic acid tablets are indicated 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. Ibandronic acid tablets work by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.
2 Before you take
When to take your other medicines
It is important that you take Ibandronic acid tablets at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe (oesophagus). This is the tube connecting your mouth with your stomach. Stop taking Ibandronic acid tablets and tell your doctor straight away, if you get severe chest pain, severe pain after swallowing food or drink, feel very sick or are being sick.
Do not take any other medicines or supplements for at least 6 hours before taking Ibandronic acid tablets. Once you have taken Ibandronic acid tablets wait at least 30 minutes before taking any other medicines or supplements.
Taking Ibandronic acid tablets with food and drink
It is important to take Ibandronic acid tablets at the right time and in the right way. See Taking this medicine in Section 3 for the full instructions about when and how to take.
Do not take Ibandronic acid tablets if you:
are allergic (hypersensitive) to ibandronic acid or any of the other ingredients of this medicine that are listed in Section 6 have problems with your food pipe (oesophagus) such as narrowing or difficulty swallowing. cannot stand or sit upright for at least one hour (60 minutes) at a time. have, or ever had low calcium in your blood. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Ibandronic acid tablets.
Pregnancy and breast feeding
Do not take Ibandronic acid tablets if you are pregnant, planning to get pregnant or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
It is not known if Ibandronic acid tablets affect your ability to drive, use machines or tools. Talk to your doctor first if you want to drive, use machine or tools.
Important information about some of the ingredients of Ibandronic acid tablets
Ibandronic acid tablets contain a type of sugar called lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Continued top of next column AAAD3663 Continued over page
3 How to take
Other possible side effects
Always take Ibandronic acid tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor may do regular blood tests while you are taking Ibandronic acid tablets. This is to check that you are being given the right amount of medicine.
Common (affects less than 1 in 10 people) feeling tired stomach pain, indigestion feeling sick or inflamed food pipe (heart burn) low calcium levels in your blood. Uncommon (affects 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 high levels of urea or high levels of parathyroid hormone in your blood. Rare (affects less than 1 in 1000 people) eye pain or inflammation unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone. Very rare (affects less than 1 in 10000 people) a condition involving exposed bone in the mouth called osteonecrosis of the jaw. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Taking this medicine
It is important that you take Ibandronic acid tablets at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe (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 plain water only (about 200 mL). Do not take your tablet with any drink other than plain 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 (oesophagus).
How much to take
The usual dose of Ibandronic acid 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.
5 How to store
If you take more Ibandronic acid tablets 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.
Keep out of the reach and sight of children. Do not use Ibandronic acid tablets after the expiry date which is stated on the blister and carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
If you forget to take Ibandronic acid tablets
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.
6 Further information What Ibandronic acid 50mg tablets contain
The active substance is 56.25mg of ibandronic acid, monosodium salt, monohydrate, equivalent to 50mg of ibandronic acid. The other ingredients are lactose monohydrate, crospovidone (E1202), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), sodium stearyl fumarate (tablet core); polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171) (tablet coating).
If you stop taking Ibandronic acid tablets
Keep taking Ibandronic acid tablets 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 product, ask your doctor or pharmacist.
4 Possible side effects
What Ibandronic acid 50mg tablets look like and contents of the pack
Like all medicines, Ibandronic acid tablets can cause side effects although not everybody gets them. Stop taking Ibandronic acid tablets and see a doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment: rash, itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having an allergic reaction to the medicine pain or sore in your mouth or jaw severe chest pain, severe pain after swallowing food or drink, feeling very sick or being sick. This could be a sign of problems with your food pipe (oesophagus) severe stomach pain, being sick, possibly with blood in it. This could be a sign of a stomach ulcer that is bleeding, or that your stomach lining is inflamed (gastritis). eye pain and inflammation (if prolonged).
Ibandronic acid tablets are white to off-white, oblong tablets inscripted with I9BE on one side and 50 on the other side. They are available in blister packs of 28 Marketing Authorisation Holder Actavis Group PTC ehf. Reykjavikurvegur 76-78, 220 Hafnarfjrur Iceland Manufacturer Synthon Hispania SL Castell 1, Polgono Las Salinas, 08830 Sant Boi de Llobregat Spain This leaflet was last revised in February 2012
Continued top of next column AAAD3663
Actavis, Barnstaple, EX32 8NS, UK
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The full name of this medicine is Ibandronic Acid 50mg Film-coated Tablets but within the leaflet it will be referred to as Ibandronic acid tablets. Take special care with Ibandronic acid tablets if you:
are allergic (hypersensitive) to any other have any swallowing or digestion problems have high or low blood levels of vitamin D or any have kidney problems have a galactose intolerance, the Lapp lactase
bisphosphonates other minerals
deficiency or have problems with glucosegalactose absorption
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Ibandronic acid tablets. If you are having dental treatment or surgery or know that you need some in the future, tell your dentist that you are being treated with Ibandronic acid tablets.
In this leaflet: 1 What Ibandronic acid tablets are and what they are used for 2 Before you take 3 How to take 4 Possible side effects 5 How to store 6 Further information
1 What Ibandronic acid tablets are and
Children and teenagers
Ibandronic acid tablets should not be used in children and teenagers below age 18 years.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is because Ibandronic acid tablets can affect the way some other medicines work. Also some other medicines can affect the way Ibandronic acid tablets work. In particular, tell your doctor or pharmacist if you are taking any of the following medicines: supplements containing calcium, magnesium, iron or aluminium non-steroidal anti-inflammatory drugs called NSAIDs such as aspirin, ibuprofen or naproxen. This is because NSAIDs and Ibandronic acid tablets can both irritate your stomach and gut a type of antibiotic injection called aminoglycoside such as gentamicin. This is because aminoglycosides and Ibandronic acid tablets can both lower the amount of calcium in your blood. Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic acid tablets.
what they are used for
Ibandronic acid tablets contain the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates. Ibandronic acid tablets are indicated 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. Ibandronic acid tablets work by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.
2 Before you take
When to take your other medicines
It is important that you take Ibandronic acid tablets at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe (oesophagus). This is the tube connecting your mouth with your stomach. Stop taking Ibandronic acid tablets and tell your doctor straight away, if you get severe chest pain, severe pain after swallowing food or drink, feel very sick or are being sick.
Do not take any other medicines or supplements for at least 6 hours before taking Ibandronic acid tablets. Once you have taken Ibandronic acid tablets wait at least 30 minutes before taking any other medicines or supplements.
Taking Ibandronic acid tablets with food and drink
It is important to take Ibandronic acid tablets at the right time and in the right way. See Taking this medicine in Section 3 for the full instructions about when and how to take.
Do not take Ibandronic acid tablets if you:
are allergic (hypersensitive) to ibandronic acid or any of the other ingredients of this medicine that are listed in Section 6 have problems with your food pipe (oesophagus) such as narrowing or difficulty swallowing. cannot stand or sit upright for at least one hour (60 minutes) at a time. have, or ever had low calcium in your blood. Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Ibandronic acid tablets.
Pregnancy and breast feeding
Do not take Ibandronic acid tablets if you are pregnant, planning to get pregnant or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
It is not known if Ibandronic acid tablets affect your ability to drive, use machines or tools. Talk to your doctor first if you want to drive, use machine or tools.
Important information about some of the ingredients of Ibandronic acid tablets
Ibandronic acid tablets contain a type of sugar called lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Continued top of next column AAAD3663 Continued over page
3 How to take
Other possible side effects
Always take Ibandronic acid tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor may do regular blood tests while you are taking Ibandronic acid tablets. This is to check that you are being given the right amount of medicine.
Common (affects less than 1 in 10 people) feeling tired stomach pain, indigestion feeling sick or inflamed food pipe (heart burn) low calcium levels in your blood. Uncommon (affects 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 high levels of urea or high levels of parathyroid hormone in your blood. Rare (affects less than 1 in 1000 people) eye pain or inflammation unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone. Very rare (affects less than 1 in 10000 people) a condition involving exposed bone in the mouth called osteonecrosis of the jaw. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Taking this medicine
It is important that you take Ibandronic acid tablets at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe (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 plain water only (about 200 mL). Do not take your tablet with any drink other than plain 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 (oesophagus).
How much to take
The usual dose of Ibandronic acid 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.
5 How to store
If you take more Ibandronic acid tablets 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.
Keep out of the reach and sight of children. Do not use Ibandronic acid tablets after the expiry date which is stated on the blister and carton after EXP. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
If you forget to take Ibandronic acid tablets
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.
6 Further information What Ibandronic acid 50mg tablets contain
The active substance is 56.25mg of ibandronic acid, monosodium salt, monohydrate, equivalent to 50mg of ibandronic acid. The other ingredients are lactose monohydrate, crospovidone (E1202), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), sodium stearyl fumarate (tablet core); polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171) (tablet coating).
If you stop taking Ibandronic acid tablets
Keep taking Ibandronic acid tablets 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 product, ask your doctor or pharmacist.
4 Possible side effects
What Ibandronic acid 50mg tablets look like and contents of the pack
Like all medicines, Ibandronic acid tablets can cause side effects although not everybody gets them. Stop taking Ibandronic acid tablets and see a doctor straight away if you notice any of the following serious side effects you may need urgent medical treatment: rash, itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having an allergic reaction to the medicine pain or sore in your mouth or jaw severe chest pain, severe pain after swallowing food or drink, feeling very sick or being sick. This could be a sign of problems with your food pipe (oesophagus) severe stomach pain, being sick, possibly with blood in it. This could be a sign of a stomach ulcer that is bleeding, or that your stomach lining is inflamed (gastritis). eye pain and inflammation (if prolonged).
Ibandronic acid tablets are white to off-white, oblong tablets inscripted with I9BE on one side and 50 on the other side. They are available in blister packs of 28 Marketing Authorisation Holder Actavis Group PTC ehf. Reykjavikurvegur 76-78, 220 Hafnarfjrur Iceland Manufacturer Synthon Hispania SL Castell 1, Polgono Las Salinas, 08830 Sant Boi de Llobregat Spain This leaflet was last revised in February 2012
Continued top of next column AAAD3663
Actavis, Barnstaple, EX32 8NS, UK
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
