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Ibandronic Acid 150 mg
Film-coated Tablets
Ibandronic acid

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
- This medicine has been prescribed for you only.
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. 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

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

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.
 If you had problems with your oesophagus in the past.
For example, when you had pain or difficulties during
swallowing of food or if you were informed in the past
that you had a Barrett's oesophagus (a disease with
changes to the cells lining the lower part of the
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
Other medicines and Ibandronic acid
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.
 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.
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 plain water but no other drinks (see
section 3 ‘How to take Ibandronic acid’).
Pregnancy, breast feeding and fertility
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.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
for advice before taking this medicine.
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

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.

Ibandronic acid contains lactose
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.



Do not take Ibandronic acid
 If you are allergic (hypersensitive) to ibandronic acid,
or to any of the other ingredients of this medicine
(listed in section 6).
 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.
Children and adolescents
Do not give Ibandronic acid to children or adolescents.

Always take Ibandronic acid exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
The recommended 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.
 Take one Ibandronic acid 150 mg tablet once a
 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 plain
 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 plain water
(at least 180 ml). Do not take your tablet with mineral
water, fruit juice or any other drinks.
 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 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 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 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
If your next scheduled dose is more than 7 days
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
Never take two Ibandronic acid tablets within the same

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:
 rash, itching, swelling of your face, lips, tongue and
throat, with difficulty breathing. You may be having an
allergic reaction to the medicine.
 severe pain in the chest, severe pain after swallowing
food or drink, severe nausea, or vomiting.
 flu-like symptoms (if any effects become troublesome
or last more than a couple of days).
 pain or sore in your mouth or jaw
 eye pain and inflammation (if prolonged)
 new pain, weakness or discomfort in your thigh, hip or
groin. This may be early signs of a possible unusual
fracture of the thigh bone
 serious, potentially life-threatening allergic reaction

Other possible side effects
Common (may affect up to 1 in 10 people)
 headache
 heartburn, stomach pain (such as “gastroenteritis” or
“gastritis”), indigestion, nausea, having diarrhoea or
 rash
 pain or stiffness in your muscles, joints, or back
 flu-like symptoms (including fever, shaking and
shivering, feeling of discomfort, fatigue, bone pain and
aching muscles and joints)
Uncommon (may affect up to 1 in 100 people)
 back pain
 feeling weak
 dizziness
 flatulence
Rare (may affect up to 1 in 1,000 people):
 hypersensitivity reaction; swelling of the face, lips and
mouth (see allergy), hives
 itching
 inflammation of the duodenum causing stomach pain
 eye pain or inflammation
Very rare (may affect up to 1 in 10,000 people)
 a condition involving exposed bone in the mouth called
“osteonecrosis of the jaw”
 Talk to your doctor if you have ear pain, discharge
from the ear, and/or an ear infection. These could be
signs of bone damage in the ear
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
By reporting side effects you can help provide more
information on the safety of this medicine.

Keep this medicine out of the sight and reach of
Do not use 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

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
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 Vía Carlos III, 98,
7th Floor, 08028 Barcelona, Spain
Laboratorios LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), Spain
This leaflet was last revised in 11/2015.

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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.