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BONEFURBIT 150MG FILM-COATED TABLETS

Active substance(s): SODIUM IBANDRONATE MONOHYDRATE

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ANVERSO
PACKAGE LEAFLET: INFORMATION FOR THE USER
BONEFURBIT 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. 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.
What is in this leaflet:
1. What Bonefurbit is and what it is used for
2. What you need to know before you take
Bonefurbit
3. How to take Bonefurbit
4. Possible side effects
5. How to store Bonefurbit
6. Contents of the pack and other information

1. What Bonefurbit is and what it is used for
Bonefurbit belongs to a group of medicines called
bisphosphonates. It contains the active substance
ibandronic acid.
Bonefurbit 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. Bonefurbit may help
lower the chances of breaking bones (fractures).
This reduction in fractures was shown for the spine
but not for the hip.
Bonefurbit 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.
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
Bonefurbit

Do not take Bonefurbit
• If you are allergic to ibandronic acid, or to 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’re taking Bonefurbit. Talk to your doctor before
taking Bonefurbit:
• 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 Bonefurbit.

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 Bonefurbit. If you develop
these symptoms, stop taking Bonefurbit and tell
your doctor straight away (see section 3).
Children and adolescents
Do not give Bonefurbit to children or adolescents
below 18 years.
Other medicines and Bonefurbit
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines, including medicines obtained without
prescription. Especially:
• Supplements containing calcium, magnesium,
iron or aluminium, as they could possibly
influence the effects of Bonefurbit.
• Acetylsalicylic acid and other non-steroidal
anti-inflammatory medicines (NSAIDs)
(including ibuprofen, diclofenac sodium and
naproxen) may irritate the stomach and intestine.
Bisphosphonates (like ) Bonefurbit may also
do so. So be especially careful if you take
painkillers or anti-inflammatories while you’re
taking Bonefurbit.
After swallowing your monthly Bonefurbit
tablet, wait for 1 hour before taking any other
medication, including indigestion tablets, calcium
supplements, or vitamins.
Taking Bonefurbit with food and drink:
Do not take Bonefurbit with food. Bonefurbit is
less effective if it’s taken with food.
You can drink water but no other drinks (see
section 3. How to take Bonefurbit).
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Driving and using machines
You can drive and use machines as it’s expected that
Bonefurbit has no or negligible effect on your ability
to drive and use machines.
Bonefurbit contains lactose.
If you have been told by your doctor that you cannot
tolerate or digest 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 Bonefurbit
Always take this medicine exactly as your
doctor has told you. Check with you’re doctor or
pharmacist if you are not sure.
The recommended dose of Bonefurbit is one tablet
once a month.
Taking your monthly tablet
It’s important to follow these instructions carefully.
They are designed to help your Bonefurbit tablet
reach your stomach quickly, so it’s less likely to
cause irritation.
• Take one Bonefurbit 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 Bonefurbit tablet. Choose the date that
best fits your routine.
• Take your Bonefurbit tablet at least 6 hours
after you last had anything to eat or drink
except plain water.
• Take your Bonefurbit tablet
- after you first get up for the day, and

REVERSO
-b
 efore you have anything to eat or drink
(on an empty stomach)
• Swallow your tablet with a full glass of water
(at least 180 ml). 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
-d
 o 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
-d
 o not drink anything (except
plain water if you need it)

pipe, possibly with sores or constriction of the
gullet/food pipe
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
Other possible side effects
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)
- do not take any other medicines
• muscle cramps, stiffness of your joints and limbs
• After you’ve waited for an hour, you can have
your first food and drink of the day. Once you’ve Uncommon (may affect up to 1 in 100 people)
• dizziness
eaten, it’s OK to lie down if you wish, and to
• flatulence (farting, feeling bloated)
take any other medication you need.
Do not take your tablet at bedtime or before you get • back pain
• feeling tired and exhausted
up for the day.
Rare (may affect up to 1 in 1000 people):
Continuing to take Bonefurbit
• Inflammation of the duodenum (first section of
It’s important to keep taking Bonefurbit every
the bowel) causing stomach pain
month, as long as your doctor prescribes it for you.
• hives
Bonefurbit can treat osteoporosis only as long as
you keep taking it.
If you get any of the side effects talk to your doctor
or pharmacist. This includes any possible side
If you take more Bonefurbit than you should
If you’ve taken more than one tablet by mistake,
effects not listed in this leaflet.
drink a full glass of milk and talk to your doctor
5. How to store Bonefurbit
straight away.
Do not make yourself vomit, and do not lie
Keep this medicine out of the sight and reach of
down – this could cause Bonefurbit to irritate your
children.
oesophagus.
Do not use after the expiry date which is stated on
If you forget to take Bonefurbit
the carton after “EXP”. The expiry date refers to the
If you forget to take your tablet on the morning of
last day of that month.
your chosen day, do not take a tablet later in the
There are no special storage instructions.
day. Instead, consult your calendar and find out
Do not throw away any medicines via wastewater or
when your next scheduled dose is:
household waste. Ask your pharmacist how to throw
If your next scheduled dose is only 1 to 7 days
away medicines you no longer use. These measures
away…
will help to protect the environment.
You should wait until the next scheduled dose is
due and take it as normal; then, continue taking
6. Contents of the pack and other
one tablet once a month on the scheduled days
information
you’ve marked on your calendar.
What Bonefurbit contains
If your next scheduled dose is more than 7 days
• The active substance is ibandronic acid. One
away…
tablet contains 150 mg of ibandronic acid (as
You should take one tablet the next morning after
ibandronate sodium hydrate).
the day you remember; then, continue taking one
• The other ingredients are:
tablet once a month on the scheduled days you’ve
tablet core: lactose monohydrate, cellulose
marked on your calendar.
microcrystalline, croscarmellose sodium,
Never take two Bonefurbit tablets within the
magnesium stearate, silica colloidal anhydrous
same week.
tablet coat: hydroxypropylcellulose, titanium
dioxide (E171), macrogol 6000
4. Possible side effects
What Bonefurbit looks like and contents of the
Like all medicines, this medicine can cause side
pack
effects, although not everybody gets them.
Bonefurbit 150 mg Film-coated tablets are white
Talk to a nurse or a doctor straight away if you
film-coated tablets of oblong shape and scored “LC”
notice any of the following serious side effects on one side.
you may need urgent medical treatment:
Bonefurbit 150 mg Film-coated tablets is available
These side effects may occur with certain
in pack sizes of 1 and 3 film-coated tablets. The
frequencies, which are defined as follows:
tablets are supplied in blisters containing 1 or 3
Common (may affect up to 1 in 10 people):
tablets.
• flu-like symptoms, including fever, shaking and Not all pack sizes may be marketed.
shivering, feeling of discomfort, bone pain and
Marketing Authorisation Holder:
aching muscles and joints. Talk to a nurse or
Glenmark Pharmaceuticals Europe Limited
doctor if any effects become troublesome or last Laxmi House, 2B Draycott Avenue,
more than a couple of days
Kenton, Middlesex, HA3 0BU, United Kingdom
• rash. You may be having an allergic reaction to
Manufacturer:
the medicine
Laboratorios LICONSA, S.A.
Uncommon (may affect up to 1 in 100 people)
Avda. Miralcampo, Nº 7, Polígono Industrial
• severe pain in the chest, severe pain after
Miralcampo, 19200 Azuqueca de Henares
swallowing food or drink, severe nausea, or
(Guadalajara), SPAIN
vomiting, difficulty in swallowing. You may
This leaflet was last revised in: October 2014
have a severe inflammation of your gullet/food


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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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