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IBANDRONIC ACID MYLAN 150 MG FILM-COATED TABLETS

Active substance(s): 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
or pharmacist. 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.

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 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 antiinflammatories 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 is taken with food. You can
drink water but no other drinks
After you have taken Ibandronic Acid, please wait for
1 hour before you have your first food and further
drinks (see 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.

The earlier a woman reaches the menopause, the
greater her risk of fractures in osteoporosis.

Driving and using machines

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 contains Lactose

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.

You can drive and use machines as it is expected that
Ibandronic Acid has no or negligible effect on your
ability to drive and use machines.
This medicine contains lactose monohydrate. If your
doctor has told you that you have an intolerance to
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

2. What you need to know before you take
Ibandronic Acid

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

Do not take Ibandronic Acid:

The usual dose of Ibandronic Acid is one tablet
once a month.

• 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
are taking Ibandronic Acid. Talk to your doctor or
pharmacist 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.
• 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.

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 Ibandronic Acid 150 mg 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 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).

50061924

Description Ibandronic Acid 150 mg 3,1
Component Type Leaflet
Affiliate Item Code 969633
Superceded Affiliate Item Code 760124
TrackWise PR No. 969633
MA No. N/A
Packing Site/Printer N/A
Supplier Code 50061924

Pharma Code 4951
SAP No. N/A
Vendor Job No. 289352
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Date: 23 Aug 2016
No. of colours
Colours

1

Time: 09:12
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 360 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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

• severe skin reactions including itchy red skin rash
with raised patches and severe blistering or peeling
of the skin
• serious, potentially life-threatening allergic reaction

• 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 have
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

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

• After you have waited for an hour, you can have
your first food and drink of the day. Once you have
eaten it is OK to lie down if you wish, and to take
any other medication you need.
Do not take your medicine at bedtime or before you
get up for the day.

Continuing to take Ibandronic Acid

Other possible side effects

Uncommon (may affect up to 1 in 100 people):
• dizziness
• flatulence (farting, feeling bloated)
• back pain
• feeling tired and exhausted
• asthma attacks

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.

Rare (may affect up to 1 in 1,000 people):
• inflammation of the duodenum (first section of the
bowel) causing stomach pain
• hives

If you take more Ibandronic Acid than you should

If you get any side effects, talk to your doctor or
pharmacist. 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.

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 forget 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 forget 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, 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:
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 1,000 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)
• 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

Description Ibandronic Acid 150 mg 3,1
Component Type Leaflet
Affiliate Item Code 969633
Superceded Affiliate Item Code 760124
TrackWise PR No. 969633
MA No. N/A
Packing Site/Printer N/A
Supplier Code 50061924

Pharma Code 4951
SAP No. N/A
Vendor Job No. 289352
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market United Kingdom
Keyline/Drawing No. N/A
Barcode Info N/A

Reporting of side effects

5. How to store Ibandronic Acid
Keep this medicine out of the sight and reach
of children.
This medicinal product does not require any special
storage conditions.
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.
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 150 mg (as
sodium monohydrate).
The other ingredients are:
• tablet core: lactose monohydrate, povidone,
microcrystalline cellulose, crospovidone, colloidal
anhydrous silica, and magnesium stearate.
• tablet coat: hydroxypropylcellulose, macrogol and
titanium dioxide (E171).
• The imprinting ink contains shellac glaze, iron
oxide black and propylene glycol.

What Ibandronic Acid looks like and contents of
the pack

Your medicine comes as a white film-coated,
capsule-shaped, biconvex tablet, with “G” over “I-150”
imprinted in black ink on one side and plain on other.
Ibandronic Acid is available in blister packs of 1, 3,
6 and 12 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire EN6 1TL, UK

Manufacturer

Generics (UK) Limited, Station Close, Potters Bar, Herts
EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., H-2900, Komárom, Mylan utca 1,
Hungary.
This leaflet was last revised in August 2016
969633
50061924

Date: 23 Aug 2016
No. of colours
Colours

1

Time: 09:12
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 360 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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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