Ibandronic Acid Genthon 50mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibandronic acid 50 mg film-coated 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 50 mg is and what it is used for
2. Before you take Ibandronic acid 50 mg
3. How to take Ibandronic acid 50 mg
4. Possible side effects
5. How to store Ibandronic acid 50 mg
6. Further information
1. WHAT IBANDRONIC ACID 50 MG IS AND WHAT IT IS USED FOR
Ibandronic acid belongs to the group of medicines known as bisphosphonates. It inhibits increased loss of calcium from the bones (bone resorption), and prevents bone complications and fractures related to the spread of cancer cells into bone.
Ibandronic acid 50 mg is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.
2. BEFORE YOU TAKE IBANDRONIC ACID 50 MG
During treatment your blood may be monitored to ensure that you are receiving the correct dose of Ibandronic acid 50 mg.
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Ibandronic acid 50 mg.
Do not take Ibandronic acid 50 mg:
• if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients of Ibandronic acid 50 mg
• if you have certain problems with your oesophagus
(the tube connecting your mouth with your stomach) such as narrowing or difficulty swallowing
• if you can’t stand or sit upright for at least one hour (60 minutes) at a time
• if you have, or had in the past, low blood calcium. Please consult your doctor.
Ibandronic acid 50 mg should not be used in children.
Take special care with Ibandronic acid 50 mg:
• if you are hypersensitive to other bisphosphonates
• if you have other disturbances of mineral metabolism (such as vitamin D deficiency)
• if you suffer from moderate kidney disease
(creatinine clearance >30 and <50 mL/min ) or severe kidney disease (renal insufficiency i.e. creatinine clearance <30 mL/min)
• if you have any swallowing or digestive problems
• if you are also taking non-steroidal anti-inflammatory drugs (NSAIDs), since both types of medicinal products (NSAIDs and bisphosphonates) may cause irritation to the stomach and intestine
• if you are under dental treatment or will undergo dental surgery. Tell your dentist that you are being treated with Ibandronic acid 50 mg
• if you have been told by your doctor that you have an intolerance to some sugars. Contact your doctor before taking this medicinal product.
Irritation, inflammation or ulceration of the oesophagus (the tube that connects your mouth with your stomach) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of plain water and/or if you lie down within an hour of taking Ibandronic acid 50 mg. If you develop these symptoms, stop taking Ibandronic acid 50 mg and tell your doctor straight away.
Taking other medicines
Other medicines may be affected by Ibandronic acid 50 mg. They, in turn, may affect how well Ibandronic acid 50 mg works.
Ibandronic acid 50 mg can interact with:
• supplements containing calcium, magnesium, iron or aluminium. These may influence the effect of Ibandronic acid 50 mg.
When administered with H2-antagonists or other drugs that increase gastric pH Ibandronic acid 50 mg absorption may be slightly increased but no dose adjustment is needed.
Caution is advised when bisphosphonates are administered with aminoglycosides since both agents can lower serum calcium levels for prolonged periods. Caution should also be paid to the possible existence of simultaneous hypomagnesaemia (reduced magnesium levels).
After taking Ibandronic acid 50 mg, wait at least 30 minutes before taking any other medication of
the day, including indigestion tablets/medicine, calcium supplements and vitamins.
Please tell your doctor or pharmacist if you are taking or have recently taken any of the medicines listed above or any other medicines, including medicines obtained without a prescription.
Taking Ibandronic acid 50 mg with food and drink
Ibandronic acid 50 mg should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day.
Fasting, including avoiding other medication and supplements, should be continued for at least 30 minutes after taking the tablet. Plain water may be taken at any time during the course of Ibandronic acid 50 mg treatment.
Pregnancy and breast-feeding You should not take Ibandronic acid 50 mg if you are pregnant or if you are breast-feeding. If you’re breast feeding, you may need to stop in order to take Ibandronic acid 50 mg.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You can drive and use machines as it’s very unlikely that Ibandronic acid 50 mg will affect your ability to drive and use machines.
Important information about some of the ingredients of Ibandronic acid 50 mg
Ibandronic acid 50 mg tablets contain the milk sugar lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE IBANDRONIC ACID 50 MG
Always take Ibandronic acid 50 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose of Ibandronic acid 50 mg is one tablet per day. If you have severe kidney problems, your doctor may reduce your dose to one tablet per week.
It is important to follow these instructions carefully. They are designed to help your Ibandronic acid 50 mg tablet reach your stomach quickly, so it is less likely to cause irritation.
• Before taking your first food, drink or other medicinal products of the day, take your Ibandronic acid 50 mg tablet with a full glass of plain water
only (about 200 mL). Do not take your tablet with any drink other than plain water
• Do not chew, suck or allow the tablet to dissolve in your mouth.
• After taking your Ibandronic acid 50 mg tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day.
• You should remain in an upright (sitting or standing) position
while taking Ibandronic acid 50 mg tablets and remain upright for 60 minutes after taking your tablet
• It is important to continue taking Ibandronic acid 50 mg for as long as your doctor prescribes the
medicine.
Ibandronic acid 50 mg can help with your condition only if you continue to take the tablets.
If you take more Ibandronic acid 50 mg than you should
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Do not make yourself vomit, and do not lie down
— this could cause Ibandronic acid 50 mg to irritate your oesophagus.
If you forget to take Ibandronic acid 50 mg
Do not take a double dose to make up for a forgotten dose. Return to taking one tablet per day the following day, as usual.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibandronic acid 50 mg can cause side effects, although not everybody gets them.
Irritation of the oesophagus in general is an uncommon side effect but if you experience severe pain in the chest, severe pain after swallowing food or drink, severe nausea or vomiting, contact your doctor immediately.
Common side effects (affects 1 to 10 users in 100)
• Indigestion
• Nausea
• Abdominal pain
• Oesophagitis
• Tiredness
• Low calcium levels in the blood
Uncommon side effects (affects 1 to 10 users in 1,000)
• Strange taste
• Tingling sensation (paraesthesia)
• Dry mouth
• Bleeding gastrointestinal ulcer
• Difficulty swallowing
• Gastritis
• Itching
• Chest pain
• Flu-like symptoms
• Feeling unwell
• Pain
• Low haemoglobin
• High levels of urea
• High levels of parathyroid hormone
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 50 mg 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.
6. FURTHER INFORMATION
What Ibandronic acid 50 mg contains
The active substance is ibandronic acid. Each film-coated tablet contains 56.25 mg of ibandronic sodium 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 50 mg looks like and contents of the pack
Ibandronic acid 50 mg tablets are white to off-white, oblong tablets marked “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., c/ Castello 1 - P.I. Las Salinas, 08830 St. Boi de Llobregat, Barcelona,
Spain
Distributed by:
Consilient Health (UK) Ltd., 500 Chiswick High Road, London, W4 5RG.
This leaflet was last revised in January 2011
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