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IBANDRONIC ACID ACTAVIS 150 MG FILM COATED TABLETS

Active substance(s): SODIUM IBANDRONATE MONOHYDRATE

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Package leaflet: Information for the patient

Ibandronic Acid 150mg
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
signs of illness 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
150mg Film-coated Tablets but within the leaflet it
will be referred to as Ibandronic acid tablets.

• 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.

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
Ibandronic acid tablets
3 How to take Ibandronic acid tablets
4 Possible side effects
5 How to store Ibandronic acid tablets
6 Contents of the pack and other information

Do not give Ibandronic acid 150 mg to children or
adolescents below 18 years.

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 plain water and/or if you
lie down within an hour of taking Ibandronic acid tablets. If
you develop these symptoms, stop taking Ibandronic acid
tablets and tell your doctor straight away (see section 3).

Children and adolescents

Other medicines and Ibandronic acid tablets
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 effect of
ibandronic acid.
Acetylsalicylic acid and other non-steroidal antiinflammatory 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
tablets.

1 What Ibandronic acid tablets are and what

they are used for

Ibandronic acid tablets belong to a group of medicines
called bisphosphonates. They contain 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.

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

Taking Ibandronic acid tablets with food and
drink

Ibandronic acid tablets are 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.

Do not take Ibandronic acid with food. Ibandronic acid
tablets are less effective if it’s taken with food.
You can drink plain water but no other drinks. After you
have taken Ibandronic acid, please wait for 1 hour before
you can have your first food and further drinks (see 3. How
to take Ibandronic acid tablets)

Pregnancy and breast feeding

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.

Ibandronic acid tablets are 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’re pregnant or breast
feeding.
Ask your doctor or pharmacist for advice before taking any
medicines.

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 weightbearing exercise; not smoking; and not drinking too much
alcohol.

Driving and using machines

You can drive and use machines as it’s expected that
Ibandronic acid tablets have no or negligible effect on your
ability to drive and use machines.

2 What you need to know before you take

Ibandronic acid tablets contains lactose

Ibandronic acid tablets

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 tablets if you:

• are allergic to ibandronic acid or to any of the other
ingredients of this medicine listed in section 6.
• have certain problems with your gullet/food pipe
(oesophagus) such as narrowing or difficulty swallowing.
• can’t stand or sit upright for at least one hour (60
minutes) at a time.
• have, or had in the past, low blood calcium. Please
consult your doctor.

3 How to take Ibandronic acid tablets

Always take this medicine exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not
sure.
The recommended dose is one tablet once a month.

Warnings and precautions

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.

Some people need to be especially careful while they’re
taking Ibandronic acid tablets. Talk to your doctor before
taking Ibandronic acid;
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Ibandronic Acid 150mg 1 & 3 Tablets PIL - UK
item no: AAAJ0229

dimensions: 160 x 330

print proof no: 2

pharmacode:

origination date: 17.05.16

min pt size: 8.5

1. Black
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originated by: S.Anson
approved for print/date

colours/plates:

revision date: 25.05.16

Technical Approval

revised by: S.Anson

date sent: 17.05.16

supplier: Synthon ES

technically app. date: 25.05.16

Non Printing Colours
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• Take one Ibandronic acid 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 180ml). 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.

Rare (may affect up to 1 in 1000 people)
• rash, 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
• severe adverse skin reactions
• 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.

Other possible side effects

Common (may affect up to1 in 10 people)
headache
• heartburn, stomach pain (such as “gastroenteritis” or
“gastritis”), indigestion, nausea, having diarrhoea or
constipation
• 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)
• fatigue



• do not eat anything.

Uncommon (may affect up to 1 in 100 people)back pain
• feeling weak
• dizziness
• flatulence
• asthma attacks



• 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.

Rare (may affect up to 1 in 1000 people)
• itching (hives)
• inflammation of the duodenum (first section of the
bowel) causing stomach pain

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.

Do not take your tablet at bedtime or before you get up for
the day.
Continuing to take Ibandronic acid tablets
It’s important to keep taking Ibandronic acid tablets
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.

5 How to store Ibandronic acid tablets

Keep this medicine 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.

If you take more Ibandronic acid tablets 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
If you forgot 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:

6 Contents of the pack and other information
What Ibandronic acid tablets contain
The active substance is 150mg 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).

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.

What Ibandronic acid 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 “150” on the
other side.
They are available in blister packs of 1 and 3

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.

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78,
220 Hafnarfjörður
Iceland

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:

Manufacturer
Synthon Hispania SL
Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat
Spain

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.

This leaflet was last revised in May 2016

Continued top of next column
AAAJ0229

Actavis, Barnstaple, EX32 8NS, UK

Ibandronic Acid 150mg 1 & 3 Tablets PIL - UK
item no: AAAJ0229

dimensions: 160 x 330

print proof no: 2

pharmacode:

origination date: 17.05.16

min pt size: 8.5

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 25.05.16

Technical Approval

revised by: S.Anson

date sent: 17.05.16

supplier: Synthon ES

technically app. date: 25.05.16

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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