Skip to Content

IBANDRONIC ACID ACTAVIS 150 MG FILM COATED TABLETS

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

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

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 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.
• 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.

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
of the pack and other information
6 Contents

1 What Ibandronic acid tablets are and what they

are used for

Ibandronic acid tablets belong to a group of medicines

called bisphosphonates. They 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 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.

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.
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 What you need to know before you take

Ibandronic acid tablets

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.

Warnings and precautions

A side effect called osteonecrosis of the jaw (ONJ) (bone
damage in the jaw) has been reported very rarely in the post
marketing setting in patients receiving Ibandronic acid 150 mg
for osteoporosis. ONJ can also occur after stopping treatment.

Continued top of next column
AAAJ1389

It is important to try and prevent ONJ developing as it is a painful
condition that can be difficult to treat. In order to reduce the risk of
developing osteonecrosis of the jaw, there are some precautions you
should take.
Before receiving treatment, tell your doctor/nurse (health care
professional) if:
• you have any problems with your mouth or teeth such as poor
dental health, gum disease, or a planned tooth extraction
• you don’t receive routine dental care or have not had a dental
check up for a long time
• you are a smoker (as this may increase the risk of dental problems)
• you have previously been treated with a bisphosphonate (used to
treat or prevent bone disorders)
• you are taking medicines called corticosteroids (such as
prednisolone or dexamethasone)
• you have cancer
Your doctor may ask you to undergo a dental examination before
starting treatment with Ibandronic acid 150 mg.
While being treated, you should maintain good oral hygiene
(including regular teeth brushing) and receive routine dental
check-ups. If you wear dentures you should make sure these
fit properly. If you are under dental treatment or will undergo
dental surgery (e.g. tooth extractions), inform your doctor about
your dental treatment and tell your dentist that you are being
treated with Ibandronic acid 150 mg.

Contact your doctor and dentist immediately if you experience any
problems with your mouth or teeth such as loose teeth, pain or
swelling, or non-healing of sores or discharge, as these could be signs
of osteonecrosis of the jaw.
Some people need to be especially careful while they’re taking
Ibandronic acid tablets. 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.
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
Do not give Ibandronic acid 150 mg to children or adolescents below
18 years.
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 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 tablets.
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
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
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 are pregnant or breast feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
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.
Continued over page

Ibandronic acid tablets contains 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 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.
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 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.

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
• 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, discomfort in swallowing, stomach or tummy pain
(may be due to an inflammation of the stomach), indigestion,
nausea, having diarrhoea (loose bowels) rash
• 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
Uncommon (may affect up to 1 in 100 people)back pain
• back pain
• feeling tired and exhausted
• dizziness
• flatulence (farting, feeling bloated)
• asthma attacks

• 
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)
• 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 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.
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.
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 Ibandronic acid tablets
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 date 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, 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:

5 How to store Ibandronic acid tablets

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 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 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 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).
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.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78,
220 Hafnarfjörður
Iceland
Manufacturer
Synthon Hispania SL
Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat
Spain
This leaflet was last revised in July 2016

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.
Continued top of next column
AAAJ1389

Actavis, Barnstaple, EX32 8NS, UK

Expand Transcript

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.

Hide