IBANDRONIC ACID AVANSOR 150 MG FILM COATED TABLETS

Active substance: 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.
• 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.
In this leaflet:
1.
2.
3.
4.
5.
6.

1

What Ibandronic acid 150 mg is and what it is used for.
Before you take Ibandronic acid 150 mg.
How to take Ibandronic acid 150 mg.
Possible side effects.
How to store Ibandronic acid 150 mg.
Further information.

What Ibandronic acid 150 mg is and what it is used for
Ibandronic acid belongs to a group of medicines called bisphosphonates.
Ibandronic acid tablets do 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.

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.

2

Before you take Ibandronic acid 150 mg
Do not take Ibandronic acid 150 mg:
- if you are allergic (hypersensitive) to ibandronic acid or any of the
other ingredients of Ibandronic acid 150 mg.
- 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.
Ibandronic acid should not be used in children or adolescents.
Take special care with Ibandronic acid 150 mg:
- if you have any disturbances of mineral metabolism (such as vitamin
D deficiency)
- if you suffer from severe kidney disease (renal insufficiency i.e.
creatinine clearance <30 mL/min)
- 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 have been told by your doctor that you have an intolerance to
some sugars. Contact your doctor before taking this medicinal product.

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.
Taking other medicines
Other medicines may be affected by ibandronic acid. They, in turn, may
affect how well ibandronic acid works.
Ibandronic acid can interact with:
- supplements containing calcium, magnesium, iron or aluminium.
These may influence the effect of ibandronic acid.
- aspirin and other non-steroidal anti-inflammatory medicines
(NSAIDs) ( including ibuprofen, diclofenac sodium and naproxen).
These 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 taking ibandronic acid, wait at least 1 hour before taking any other
medication of the day, including indigestion tablets/medicine, calcium
supplements and vitamins.
Please tell your doctor or pharmacist if you are taking or have recently
taken any of the medicines listed above or any other medicines, including
medicines obtained without a prescription.
Taking Ibandronic acid 150 mg with food and drink
Ibandronic acid should be taken after an overnight fast (at least 6 hours)
and before the first food or drink of the day. Fasting, including avoiding
other medication and supplements, should be continued for at least 1 hour
after taking the tablet. Plain water may be taken at any time during the
course of ibandronic acid treatment.

Pregnancy and breast feeding
Do not take ibandronic acid if you’re pregnant or breast feeding. If you’re
breast feeding, you may need to stop in order to take ibandronic acid.
Ask your doctor or pharmacist for advice before taking any 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 machines.
Important information about some of the ingredients of Ibandronic acid
150 mg
Ibandronic acid tablets contain the milk sugar 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 150 mg
Always take ibandronic acid exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
The usual dose of ibandronic acid is one tablet once a month.
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 plain 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 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 150 mg
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 150 mg 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 150 mg
If you forgot to take your tablet, do not take a tablet on the day you
remember. 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.
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 can cause side effects although not
everybody gets them.
Common side effects (affects 1 to 10 users in 100)
Heartburn • Indigestion • Diarrhea • Stomach ache • Nausea rash • Cramps in
the muscles • Pain in the muscles and joints • Headache.
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, stop taking ibandronic acid
and tell your doctor straightaway.
Flu-like symptoms can occur (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.
Uncommon side effects (affects 1 to 10 users in 1,000)
Dizziness • Back pain • Flatulence
Rare side effects (affects 1 to 10 users in 10,000)
Swelling and itching of the face, lips and mouth

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 150 mg
Keep out of the reach and sight of children.
Do not use ibandronic acid 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 150 mg contains
The active substance is 150 mg 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 150 mg looks like and contents of the pack
Ibandronic acid tablets are white to off-white, oblong tablets inscripted with
“I9BE” on one side and “150” on the other side.
They are available in blister packs of

1 or 3 tablets. (NL/H/1826)

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

AVANSOR PHARMA OY, TEKNIIKANTIE 14, ESPOO, 02150, FINLAND
Manufacturers:
<[To be completed nationally]>
This medicinal product is authorised in the Member States of the EEA
under the following names:
<{Name of the Member State}> <{Name of the medicinal product}>
This leaflet was last approved in 11/2010

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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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