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IBANDRONIC ACID 150 MG FILM-COATED TABLETS

Active substance(s): IBANDRONIC ACID / SODIUM IBANDRONATE MONOHYDRATE / IBANDRONIC ACID / SODIUM IBANDRONATE MONOHYDRATE / IBANDRONIC ACID / SODIUM IBANDRONATE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic Acid 150 mg
Film-coated Tablets
Ibandronic acid

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. This
includes any possible side effects not listed in this
leaflet. See section 4.

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

1. WHAT IBANDRONIC ACID IS AND
WHAT IT IS USED FOR
Ibandronic acid belongs to a group of medicines called
bisphosphonates. It contains the active substance
ibandronic acid.
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.
Ibandronic acid is prescribed to you to treat
postmenopausal 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.
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

 If you are under dental treatment or will undergo dental
surgery, tell your dentist that you are being treated
with Ibandronic acid. When you have cancer, tell your
dentist as well.
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. If you develop these
symptoms, stop taking Ibandronic acid and tell your doctor
straight away (see section 3).
Children and adolescents
Do not give Ibandronic acid to children or adolescents
below 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.
Especially:
 Supplements containing calcium, magnesium, iron
or aluminium, as they could possibly influence the
effects of Ibandronic acid.
 Acetylsalicylic acid 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.
After swallowing your monthly Ibandronic acid tablet, wait
for 1 hour before taking any other medication, including
indigestion tablets, calcium supplements, or vitamins.
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 water
but no other drinks (see section 3 ‘How to take
Ibandronic acid’).
Pregnancy and breast-feeding
Ibandronic acid is for use only by postmenopausal women
and must not be taken by women who could still have a
baby. Do not take Ibandronic acid if you are pregnant or
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’s expected that
Ibandronic acid has no or negligible effect on your ability to
drive and use machines.
Ibandronic acid contains 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 lactase deficiency or have problems
with glucose-galactose absorption), talk to your doctor
before taking this medicine.

3. HOW TO TAKE IBANDRONIC ACID

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.

Always take Ibandronic acid exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE IBANDRONIC ACID

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.
 Take one Ibandronic acid 150 mg tablet once a
month.
 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.
 Take your Ibandronic acid tablet at least 6 hours after
you last had anything to eat or drink except water.
 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)
 Swallow your tablet with a full glass of water (at
least 180 ml).

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 certain problems with your gullet/food pipe
(oesophagus) 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.
Warnings and precautions
Some people need to be especially careful while they’re
taking Ibandronic acid. Talk to your doctor before taking
Ibandronic acid:
 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.

The recommended dose of Ibandronic acid is one
tablet once a month.

Do not take your tablet with water with a high
concentration of calcium, fruit juice or any other drinks. If
there is a 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.
 Swallow your tablet whole, do not chew it, crush it or
let it dissolve in your mouth.
 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

 do not eat anything

 do not drink anything (except 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. After 5 years of
using Ibandronic acid please consult with your doctor
whether you should continue to take Ibandronic acid.
If you take more Ibandronic acid than you should
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 to take Ibandronic acid
 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 you forgot to take your tablet on your chosen
day and your next scheduled dose is only 1 to 7
days away…
Never take two Ibandronic acid tablets within the
same week. 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 you forgot to take your tablet on your chosen
day and 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibandronic acid 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:
Uncommon (may affect up to 1 in 100 people):
 severe pain in the chest, severe pain after swallowing
food or drink, severe nausea, or vomiting, difficulty in
swallowing. You may have a severe inflammation of
your gullet/food pipe, possibly with sores or
constriction of the gullet/food pipe
Rare (may affect up to 1 in 1000 people):
 itching, swelling of your face, lips, tongue and throat,
with difficulty breathing
 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 sore in your mouth or jaw. You may have early
signs of severe jaw problems (necrosis (dead bone
tissue) in the jaw bone)
 serious, potentially life-threatening allergic reaction

Other possible side effects
Common (may affect up to 1 in 10 people):
 headache
 heartburn, discomfort in swallowing, stomach or
tummy pain (may be due to an inflammation of the
stomach), indigestion, nausea, having diarrhoea (loose
bowels)
 muscle cramps, stiffness of your joints and limbs
 flu-like symptoms, including fever, shaking and
shivering, feeling of discomfort, bone pain and aching
muscles and joints. Talk to a nurse or doctor if any
effects become troublesome or last more than a
couple of days
 rash
Uncommon (may affect up to 1 in 100 people):
 dizziness
 flatulence (farting, feeling bloated)
 back pain
 feeling tired and exhausted
 asthma attacks
Rare (may affect up to 1 in 1,000 people):
 Inflammation of the duodenum (first section of the
bowel) causing stomach pain
 hives
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 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 carton after “EXP”. The expiry date refers to
the last day of that month.
There are no special storage instructions.
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
What Ibandronic acid contains
 The active substance is ibandronic acid. One tablet
contains 150 mg of 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:
Activase Pharmaceuticals Limited
11 Boumpoulinas
Nicosia 1060
Cyprus
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7,
Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
This leaflet was last revised in 11/2016.
A0167/O/PIL/A2

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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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