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 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. Do
not pass it on to others. It may harm them, even
if their symptoms 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.
• 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.

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

what they are used for

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”).
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 tablets work 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

Do not take Ibandronic acid tablets if you:

• re allergic to ibandronic acid or any of the other
a
ingredients of this medicine that are listed in
section 6
• ave problems with your food pipe/gullet
h
(oesophagus) such as narrowing or difficulty
swallowing
• annot stand or sit upright for at least one hour
c
(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.

Warnings and precautions





Talk to your doctor or pharmacist before taking
Ibandronic acid tablets 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

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AAAH0618

• have a galactose intolerance, the Lapp lactase
deficiency or have problems with glucose
galactose absorption
• 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 gullet/
food pipe (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 50 mg. If you develop these
symptoms, stop taking Ibandronic acid 50 mg and tell
your doctor straight away (see sections 3 and 4).

Children and adolescents

Ibandronic acid tablets 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 tablets
can affect the way some other medicines work.
Also some other medicines can affect the way
Ibandronic acid tablets work.

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 antiinflammatory drugs called “NSAIDs” such as 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.
Taking medicines that reduce stomach acid such as
cimetidine and ranitidine, may slightly increase the
effects of Ibandronic acid tablets.

Ibandronic acid tablets with food and drink

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),
aluminum, magnesium and iron) except water. After
taking your tablet, wait at least 30 minutes. Then you
can have your food and drink and take any medicines
or supplements (see section 3).

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

You can drive and use machines as it`s expected that
Ibandronic acid 50 mg has no or negligible effect on
your ability to drive and use machines. Talk to your
doctor first if you want to drive, use machinery or
tools.

Ibandronic acid tablets contain lactose

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 (e.g. if you have
a galactose intolerance, the Lapp lactose deficiency
or have problems with glucose-galactose absorption),
talk to your doctor before taking this medicine.
Continued over page

3 How to take

Always take this medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
Take your tablet at least 6 hours after you had 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 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/gullet (oesophagus).







You can help stop this happening by doing the
following:
• ake your tablet as soon as you get up for the day
T
before having your first food, drink, any medicine
or supplements.
• ake your tablet with a full glass of plain water only
T
(about 200 mL). Do not take your tablet with any
drink other than plain water.
• wallow the tablet whole. Do not chew, suck
S
or crush the tablet. Do not let the tablet dissolve in
your mouth.
• fter taking your tablet, wait at least 30 minutes.
A
Then you can have your first food and drink, and
take any medicines or supplements.
• tay upright (sitting or standing) while taking
S
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 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, 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:
Common (may affect up to 1 in 10 people):
• eeling sick, heartburn and discomfort in swallowing
f
(inflammation of your gullet/food pipe)

Uncommom (may affect less than 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)

Very rare (may affect up to 1 in 10,000 people)
• ain or sore in your mouth or jaw. You may have
p
early signs of severe jaw problems (necrosis (dead
bone tissue) in the jaw bone)
• tching, swelling of your face, lips, tongue and throat,
i
with difficulty breathing. You may be having a
serious, potentially life threatening allergic reaction

Other possible side effects
Common (may affect up to 1 in 10 people)
• feeling tired
• stomach pain, indigestion
• low calcium levels in your blood.
Uncommon (may affect less than 1 in 100 people)
• chest pain
• itching or tingling skin (paraesthesia)
• u-like symptoms, feeling generally unwell or in pain

• ry mouth, strange taste in your mouth or difficulty
d
swallowing
• anaemia (bloodlessness)
• igh levels of urea or high levels of parathyroid
h
hormone in your blood.










Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
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

Keep out of the sight and reach 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.
Do not throw away 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

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 July 2014

Rare (may affect up to 1 in 1,000 people)
• persistent eye pain and inflammation
• ew pain, weakness or discomfort in your thigh,
n
hip or groin. You may have early signs of a possible
unusual fracture of the thigh bone

Continued top of next column
AAAH0618

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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