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IBANDRONIC ACID GENTHON 50MG FILM-COATED TABLETS

Active substance(s): SODIUM IBANDRONATE MONOHYDRATE

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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

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.

1. WHAT IBANDRONIC ACID 50 MG IS AND
WHAT IT IS USED FOR

Ibandronic acid 50 mg can interact with:
• supplements containing calcium, magnesium,
iron or aluminium. These may influence the effect
of Ibandronic acid 50 mg.

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,

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.

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

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/ Castelló 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

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.

P0106

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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