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IBANDRONIC ACID 50 MG FILM COATED TABLETS

Active substance(s): SODIUM IBANDRONATE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

IBANDRONIC ACID 50MG FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are
the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
See section 4.

1 WHAT IBANDRONIC ACID IS AND WHAT IT IS USED FOR
The name of your medicine is Ibandronic Acid 50mg
film-coated tablets (referred to as Ibandronic acid throughout
this leaflet). Ibandronic acid belongs to a group of medicines
called bisphosphonates.
Ibandronic acid 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.
Ibandronic acid works by reducing the amount of calcium that
is lost from your bones. This helps to stop your bones from
getting weaker.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
IBANDRONIC ACID
Do not take Ibandronic acid:
- if you are allergic to Ibandronic acid or any of the other
ingredients of this medicine (listed in section 6).
- if you have problems with your food pipe/gullet
(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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ibandronic acid
if you:
- are allergic to any other bisphosphonates.
- have any swallowing or digestion problems.
- have high or low blood levels of Vitamin D or any other
minerals.
- have kidney problems.
- 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 for cancer.
Irritation, inflammation or ulceration of the food pipe/gullet
(oesophagus) 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
water and/or if you lie down within an hour of taking Ibandronic acid.
If you develop these symptoms, stop taking Ibandronic acid and
tell your doctor straight away (see section 3 and 4).

Ibandronic acid with food, drink and alcohol
Do not take Ibandronic acid with food or any other drinks except
water as Ibandronic acid is less effective if it is taken with food
or drink (see section 3).
Take Ibandronic acid at least 6 hours after you had last had
anything to eat, drink or any other medicines or supplements
(e.g. products containing calcium (milk), aluminium,
magnesium and iron) except water.
After taking, wait at least 30 minutes. Then you can have your
first food and drink, and take any medicines or supplements
(see section 3).
Pregnancy, breast feeding and fertility
Do not take Ibandronic acid if you are pregnant, planning to get
pregnant or if you are breast-feeding. Ask your doctor or pharmacist
for advice before taking this medicine.
Driving and using machines
You can drive and use machines as it is expected that Ibandronic acid
has no or negligible effect on your ability to drive and use machines.
Talk to your doctor first if you want to drive, use machines or tools.
Ibandronic acid tablets contain 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
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
Ibandronic acid. 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 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
200ml). 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.

Children and adolescents
Ibandronic acid should not be used in children and adolescents
below the age of 18 years.
Other medicines and Ibandronic acid
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. This is because
Ibandronic acid can affect the way some other medicines work.
Also some other medicines can affect the way Ibandronic acid
works.
In particular, tell your doctor or pharmacist if you are taking any
of the following medicines:
• supplements containing calcium, magnesium, iron or
aluminium.
• acetylsalicylic acid and non-steroidal anti-inflammatory
medicines called “NSAIDs” such as ibuprofen or
naproxen. This is because NSAIDs and Ibandronic acid
can both irritate your stomach and gut
• a type of antibiotic injection called “aminoglycoside”
such as gentamicin. This is because aminoglycosides
and Ibandronic acid 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.

-

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).

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.
If you take more Ibandronic acid 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.
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What is in this leaflet:
1. What Ibandronic acid is and what it is used for
2. What you need to know before you take Ibandronic acid
3. How to take Ibandronic acid
4. Possible side effects
5. How to store Ibandronic acid
6. Contents of the pack and other information.

If you forget to take Ibandronic acid
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
Keep taking Ibandronic acid 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, 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.

What Ibandronic Acid 50mg Film-Coated Tablets looks like
and contents of the pack
Ibandronic acid tablets are white to off-white, oblong tablets
debossed with “I9BE” on one side and “50” on the other side.
They are available in blister packs of 1, 28, 30, 84, 90 and
100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer:
Synthon Hispania S.L.
Castello 1, Poligono las Salinas,
08830 Sant boi de Llobregat
Spain
This leaflet was last revised in April 2015

Common (may affect up to 1 in 10 people):
• Feeling sick, heartburn and discomfort in swallowing
(inflammation of your food pipe/gullet).
Uncommon (may affect up to 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 soreness in your mouth or jaw. You may have early
signs of severe jaw problems (necrosis (dead bone tissue)
in the jaw bone).
• Itching, swelling of the face, lips, tongue and throat with
difficulty breathing. You may be having a serious, potentially
life threatening allergic reaction.
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):
• Stomach pain, indigestion.
• Low calcium levels in your blood.
• Weakness.
Uncommon (may affect up to 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.
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 via the Yellow Card
Scheme: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information
on the safety of this medicine.
5 HOW TO STORE IBANDRONIC ACID
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.
This medicine does not require any special storage conditions.
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.
6 CONTENTS OF THE PACK AND OTHER INFORMATION

The other ingredients are:
Tablet core: lactose monohydrate, crospovidone (E1202),
microcrystalline cellulose (E460), colloidal anhydrous silica (E551),
sodium stearyl fumarate.
Tablet coating: polyvinyl alcohol, macrogol/PEG 3350, talc (E553b)
and titanium dioxide (E171).

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What Ibandronic Acid 50mg Film-Coated Tablets contains
The active substance is 56.25mg of Ibandronic acid,
monosodium salt, monohydrate, equivalent to 50mg of
Ibandronic acid.

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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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