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IBANDRONIC ACID LICONSA 150 MG FILM-COATED TABLETS

Active substance(s): SODIUM IBANDRONATE MONOHYDRATE

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2. BEFORE YOU TAKE IBANDRONIC ACID
Do not take Ibandronic acid
- If you are allergic (hypersensitive) to
ibandronic acid, or to any of the other
ingredients of Ibandronic acid.
- 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.
Do not give Ibandronic acid to children
or adolescents.

Driving and using machines
You can drive and use machines as it’s very
unlikely that Ibandronic acid will affect your
ability to drive and use machines.
Important information about some of
the ingredients of Ibandronic acid.
Ibandronic acid contains an ingredient
called 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 Ibandronic acid exactly as your
doctor has told you. If you’re not sure about
anything, ask your doctor or pharmacist.
The usual dose of Ibandronic acid is one
tablet once a month.
Taking your monthly tablet
It’s important to follow these instructions
carefully. They are designed to help your
Ibandronic acid tablet reach your stomach
quickly, so it’s less likely to cause irritation.

Please read the back of this leaflet.

Very rare side effects are ear pain, discharge
from the ear, and/or an ear infection. These
could be signs of bone damage in the ear.
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
Keep out of the reach and sight of children.

- do not drink anything (except plain
water if you need it)
- do not take any other medicines
- After you’ve waited for an hour, you can
have your first food and drink of the day.
Once you’ve eaten, it’s OK to lie down if
you wish, and to take any other
medication you need.
Do not take your tablet at bedtime or
before you get up for the day.
Continuing to take Ibandronic acid
It’s important to keep taking Ibandronic
acid every month, as long as your doctor
prescribes it for you.
Ibandronic acid can treat osteoporosis only
as long as you keep taking it.
If you take too much Ibandronic acid
If you’ve taken more than one tablet by
mistake, drink a full glass of milk and talk
to your doctor straight away.
Do not make yourself vomit, and do not
lie down - this could cause Ibandronic acid
to irritate your oesophagus.
If you forget a dose
If you forget to take your tablet on the
morning of your chosen day, do not take a
tablet later in the day. Instead, consult
your calendar and find out when your next
scheduled dose is:
If your next scheduled dose is only 1 to
7 days away…
You should wait until the next scheduled
dose is due and take it as normal; then,
continue taking one tablet once a month
on the scheduled days you’ve marked on
your calendar.
If your next scheduled dose is more than
7 days away…
You should take one tablet the next
morning after the day you remember; then,
continue taking one tablet once a month
on the scheduled days you’ve marked on
your calendar.
Never take two Ibandronic acid tablets
within the same week.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibandronic acid can
cause side effects, although not everybody
gets them. These side effects may occur
with certain frequencies, which are defined
as follows:
- very common: affects more than 1 user
in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000

Do not use after the expiry date which is
stated on the carton after “EXP”. There are
no special storage instructions.
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 contains
- The active substance is ibandronic acid.
One tablet contains 150 mg ibandronic
acid (as ibandronate sodium hydrate).
- The other ingredients are:
tablet core: lactose monohydrate,
cellulose microcrystalline, croscarmellose
sodium, magnesium stearate, silica
colloidal anhydrous
tablet coat: hydroxypropylcellulose,
titanium dioxide (E171), macrogol 6000
What Ibandronic acid looks like and
contents of the pack
Ibandronic acid 150 mg film-coated tablets
are white film-coated tablets of oblong
shape and scored “LC” on one side.
Ibandronic acid 150 mg film-coated tablets
is available in pack sizes of 1 and 3
film-coated tablets. The tablets are supplied
in blisters containing 1 or 3 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Laboratorios LICONSA S.A.
Gran Via Carlos 98,
7th Floor 08028, Barcelona
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7,
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara),
SPAIN
Distributor:
Creo Pharma Ltd
Felsted Business Centre, Felsted,
Essex CM6 3LY, UK.
This leaflet was last approved in:
December 2015

CRE-IBA-PIL-095_05
15/12/2015

Typefaces
Myriad Pro 10/11 pt
Artwork prepared by David Heaton +44 (0)1462 431277 dc.heaton@ntlworld.com

A healthy lifestyle will also help you to get
the most benefit from your treatment. This
includes eating a balanced diet rich in
calcium and vitamin D; walking or any
other weight-bearing exercise; not
smoking; and not drinking too much
alcohol.

Pregnancy and breast feeding
Ask your doctor or pharmacist for advice
before taking any medicine.
There are no adequate data from the use of
Ibandronic acid in pregnant women.
Studies in animals have shown that
Ibandronic acid could be toxic to
reproduction. Ibandronic acid should
therefore not be used during pregnancy.
It is not known if the medicine is excreted
in human milk. Studies in animals have
shown low levels of the active substance in
milk. Ibandronic acid should therefore not
be used during breast feeding.

Rare side effects are swelling and itching of
the face, lips and mouth.

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Ibandronic acid prevents loss of bone from
osteoporosis, and helps to rebuild bone.
Therefore Ibandronic acid makes bone less
likely to break.

Taking Ibandronic acid with food and
drink:
Do not take Ibandronic acid with food.
Ibandronic acid is less effective if it’s taken
with food.
You can drink plain water but no other
drinks (see 3. HOW TO TAKE IBANDRONIC
ACID).

- do not eat anything

Uncommon side effects are dizziness, back
pain and flatulence.

Job No. CRE-IBA-PIL-095

Many people with osteoporosis have no
symptoms. If you have no symptoms you
may not know if you have the condition.
However, osteoporosis makes you more
likely to break bones if you fall or hurt
yourself. A broken bone after the age of 50
may be a sign of osteoporosis. Osteoporosis
can also cause back pain, height loss and a
curved back.

After swallowing your monthly Ibandronic
acid tablet, wait for 1 hour before taking
any other medication, including
indigestion tablets, calcium supplements,
or vitamins.

- For the next hour (60 minutes) after
you’ve taken your tablet
- do not lie down; if you do not stay
upright (standing or sitting), some of
the medicine could leak back into your
oesophagus

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The earlier a woman reaches the
menopause, the greater her risk of fractures
in osteoporosis. Other things that can
increase the risk of fractures include:
- not enough calcium and vitamin D in the
diet
- smoking, or drinking too much alcohol
- not enough walking or other
weight-bearing exercise
- a family history of osteoporosis

- Aspirin and other non-steroidal
anti-inflammatory medicines (NSAIDs)
(including ibuprofen, diclofenac sodium
and naproxen) may irritate the stomach
and intestine. Bisphosphonates (like
Ibandronic acid) may also do so. So be
especially careful if you take painkillers
or anti-inflammatories while you’re
taking Ibandronic acid.

- Swallow your tablet whole - do not
chew it, crush it or let it dissolve in your
mouth.

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Ibandronic acid is prescribed to you to
treat osteoporosis because you have an
increased risk of fractures. Osteoporosis
is a thinning and weakening of the bones,
which is common in women after the
menopause. At the menopause, a woman’s
ovaries stop producing the female
hormone, oestrogen, which helps to keep
her skeleton healthy.

Taking other medicines
Please tell your doctor or pharmacist if you
are taking, or have recently taken any other
medicines, including medicines obtained
without prescription. Especially:
- Supplements containing calcium,
magnesium, iron or aluminium, as they
could possibly influence the effects of
Ibandronic acid.

- Swallow your tablet with a full glass of
plain water (at least 180 ml). Do not take
your tablet with mineral water, fruit juice
or any other drinks.

Important
Please ensure that the texts and layout are to
your satisfaction as David Heaton cannot accept
liability for any errors overlooked.
All Bar Codes and Braille text must be verified
by the client/manufacturer/printer.
David Heaton is unable to do this and cannot
accept liability for any errors.
Colours may not reproduce accurately on this
proof. You should refer to Pantone Reference
Guides for accurate colour match.

Ibandronic acid belongs to a group of
medicines called bisphosphonates. It
contains ibandronic acid. It does not
contain hormones. Ibandronic acid may
reverse bone loss by stopping more loss of
bone and increasing bone mass in most
women who take it, even though they
won’t be able to see or feel a difference.
Ibandronic acid may help lower the
chances of breaking bones (fractures). This
reduction in fractures was shown for the
spine but not for the hip.

- Take your Ibandronic acid tablet
- after you first get up for the day, and
- before you have anything to eat or
drink (on an empty stomach)

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

Irritation, inflammation or ulceration of the
oesophagus (the tube connecting 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. If
you develop these symptoms, stop taking
Ibandronic acid and tell your doctor
straight away.

- Take your Ibandronic acid tablet at least
6 hours after you last had anything to
eat or drink except plain water.

Date
25/11/2013
26/11/2013
08/01/2014
14/12/2015
15/12/2015

In this leaflet:
1. What Ibandronic acid is and what it is
used for
2. Before you take Ibandronic acid
3. How to take Ibandronic acid
4. Possible side effects
5. How to store Ibandronic acid
6. Further information

Take special care with Ibandronic acid.
Some people need to be especially careful
while they’re taking Ibandronic acid. Check
with your doctor:
- If you have any disturbances of mineral
metabolism (such as vitamin D
deficiency).
- If your kidneys are not functioning
normally.
- If you have any swallowing or digestive
problems.
- If you are under dental treatment or will
undergo dental surgery, tell your dentist
that you are being treated with
Ibandronic acid.

Common side effects are heartburn,
indigestion, diarrhoea, stomach ache, and
nausea.
Ibandronic acid can also irritate the
oesophagus, although you can usually
avoid this by taking your dose as
described in this leaflet. If you develop
symptoms such as severe pain in the
chest, severe pain after swallowing food
or drink, severe nausea, or vomiting, tell
your doctor straightaway.
Other common side effects include rash,
cramps in the muscles, pain in the muscles
and joints, and headache.
It also includes flu-like symptoms (aches
and pains, feeling of discomfort, fatigue)
which are usually mild, are short-lasting
and disappear soon after you have taken
the first dose. So you should be able to
carry on taking Ibandronic acid. Talk to your
doctor if any effects become troublesome
or last a long time.

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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.

- Choose one day of the month that will
be easy to remember. You can choose
either the same date (such as the 1st of
each month) or the same day (such as
the first Sunday of each month) to take
your Ibandronic acid tablet. Choose the
date that best fits your routine.

Date
25/11/2013
Client Creo Pharma
Country UK

Ibandronic acid

- very rare: affects less than 1 user in
10,000
- not known: frequency cannot be
estimated from the available data.

Ibadrronic acid
150 mg
140 x 540 mm

IBANDRONIC ACID 150 mg film-coated tablets

- Take one Ibandronic acid 150 mg
tablet once a month.

Product Title
Strength
PIL Format
Initial Code

PACKAGE LEAFLET: INFORMATION FOR THE USER

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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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