Ibandronic Acid Genthon 50mg Film-Coated Tablets
Package leaflet: Information for the patient Ibandronic acid Genthon 150 mg Tablets
ibandronic acid
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.
In this leaflet:
1. What Ibandronic acid Genthon 50 mg is and what it is used for.
2. Before you take Ibandronic acid Genthon 50 mg.
3. How to take Ibandronic acid Genthon 50 mg
4. Possible side effects.
5. How to store Ibandronic acid Genthon 50 mg
6. Further information.
1. WHAT IBANDRONIC ACID GENTHON 50 MG IS AND WHAT IT IS USED FOR
Ibandronic acid Genthon 50 mg contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.
Ibandronic acid Genthon 50 mg is 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 Genthon 50 mg works 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 IBANDRONIC ACID GENTHON 50 MG
It is important that you take Ibandronic acid Genthon 50 mg 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 Genthon 50 mg 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 Ibandronic acid Genthon 50 mg:
• if you are allergic (hypersensitive) to ibandronic acid or any of the other
ingredients of this medicine that are listed in Section 6.
• if you have problems with your food pipe (oesophagus) such as narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least one hour (60 minutes) at a time
• if you 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 Genthon 50 mg
Take special care with Ibandronic acid Genthon 50 mg :
• if you are allergic (hypersensitive) to any other bisphosphonates
• if you have any swallowing or digestion problems.
• if you have high or low blood levels of vitamin D or any other minerals
• if you have kidney problems
• if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Ibandronic acid Genthon 50 mg
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 Genthon 50 mg.
Children and teenagers
Ibandronic acid Genthon 50 mg 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 Genthon 50 mg can affect the way some other medicines work. Also some other medicines can affect the way Ibandronic acid Genthon 50 mg works.
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 Genthon 50 mg can both irritate your stomach and gut
• a type of antibiotic injection called “aminoglycoside” such as gentamicin.
This is because aminoglycosides and Ibandronic acid Genthon 50 mg 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 Genthon 50 mg.
When to take your other medicines
Do not take any other medicines or supplements for at least 6 hours before taking Ibandronic acid Genthon 50 mg. Once you have taken Ibandronic acid Genthon 50 mg, wait at least 30 minutes before taking any other medicines or supplements.
Taking Ibandronic acid Genthon 50 mg with food and drink
It is important to take Ibandronic acid Genthon 50 mg 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.
Pregnancy and breast feeding
Do not take Ibandronic acid Genthon 50 mg 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 Genthon 50 mg affects 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 Genthon 50 mg
Ibandronic acid Genthon 50 mg 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.
3. HOW TO TAKE IBANDRONIC ACID GENTHON 50 MG
Always take Ibandronic acid Genthon 50 mg 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 Genthon 50 mg. This is to check that you are being given the right amount of medicine.
Taking this medicine
It is important that you take Ibandronic acid Genthon 50 mg 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 Genthon 50 mg 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 Ibandronic acid Genthon 50 mg 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 Ibandronic acid Genthon 50 mg
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 Ibandronic acid Genthon 50 mg
Keep taking Ibandronic acid Genthon 50 mg 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibandronic acid Genthon 50 mg can cause side effects although not everybody gets them.
Stop taking Ibandronic acid Genthon 50 mg 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).
Other possible side effects
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.
5. HOW TO STORE <IBANDRONIC ACID 50 MG>
Keep out of the reach and sight of children.
Do not use Ibandronic acid Genthon 50 mg 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.
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.
6. FURTHER INFORMATION
What Ibandronic acid Genthon 50 mg Ibandronic acid Genthon 50 mg contains
The active substance is 56.25 mg of ibandronic acid, monosodium salt, monohydrate, equivalent to 50 mg 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).
What Ibandronic acid Genthon 50 mg looks like and contents of the pack
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 1, 7, 10, 14, 20, 21, 28, 30, 42, 50, 56, 60, 84, 90, 100, 126, 168 and 210 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Genthon BV Microweg 22,
6545 CM Nijmegen The Netherlands
Manufacturers:
• Synthon BV, Microweg 22, 6545 CM, Nijmegen, the Netherlands
• Synthon Hispania S.L., castello 1, Poligono Las Salinas, 08830 Sant Boi de Llobregat, Spain
This medicinal product is authorized in the Member States of the EEA under the following names:
Finland
Germany
Greece
The Netherlands Spain
United Kingdom
Clastec 50 mg
Ibandronsaure Genthon 50 mg Filmtabletten Ibandronic acid Genthon 50 mg Ibandroninezuur Genthon 50 mg, filmohulde tabletten Acido Ibandronico Genthon 50 mg comprimidos recubiertos con pelicula EFG
Ibandronic acid Genthon 50 mg Tablets
This leaflet was last approved in 03/2012.
Detailed information on this medicine is available on the European Medicines Agency web site:http://www.ema.europa.eu/