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.

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

what they are used for

Take special care with Ibandronic acid tablets
if you:
• are allergic (hypersensitive) 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
• have a galactose intolerance, the Lapp lactase

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.

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.

It helps to prevent your bones from breaking
(fractures).
It also helps to prevent other bone problems that may
need surgery or radiotherapy.

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.

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.

Taking medicines that reduce stomach acid such as
cimetidine and ranitidine, may slightly increase the
effects of Ibandronic acid tablets.

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”).

2 Before you take

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 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.

When to take your other medicines

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.

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.
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3 How to take

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.

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.

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.

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.

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

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).

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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

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.

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).

What Ibandronic acid 50mg tablets look 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 28
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78,
220 Hafnarfjörður
Iceland
Manufacturer
Synthon Hispania SL
Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat
Spain
This leaflet was last revised in February 2012

Actavis, Barnstaple, EX32 8NS, UK

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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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