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IBANDRONIC ACID SUN 3 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Active substance(s): IBANDRONIC ACID MONOSODIUM SALT MONOHYDRATE / IBANDRONIC ACID MONOSODIUM SALT MONOHYDRATE

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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 patients need to be especially careful when using Ibandronic acid. Talk to your doctor, pharmacist or nurse before
receiving Ibandronic acid:
- if you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you have any other disease
that may affect your kidneys
- if you have any disturbance of mineral metabolism (such as vitamin D deficiency).

Package leaflet: Information for the user

Ibandronic acid 3 mg solution for injection in pre-filled syringe
ibandronic acid

You should take calcium and vitamin D supplements while receiving Ibandronic acid. If you are unable to do so, you
should inform your doctor.

Read all of this leaflet carefully before you start using 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 nurse.
- 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.

If you have heart problems and the doctor recommended to limit your daily fluid intake.
Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with intravenous ibandronic
acid. If you experience one of the following symptoms, such as shortness of breath/difficulty breathing, tight feeling in
throat, swelling of tongue, dizziness, feeling of loss of consciousness, redness or swelling of face, body rash, nausea and
vomiting, you should immediately alert your doctor or nurse (see section 4).
Children and adolescents
Ibandronic acid must not be used in children or adolescents below 18 years.

What is in this leaflet
1. What Ibandronic acid is and what it is used for
2. What you need to know before you receive Ibandronic acid
3. How to receive Ibandronic acid
4. Possible side effects
5. How to store Ibandronic acid
6. Contents of the pack and other information

Other medicines and Ibandronic acid
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.
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.

1. What Ibandronic acid is and what it is used for
If you are pregnant or breast-feeding, think you may be pregnant ask your doctor or pharmacist for advice before taking
this medicine.

Ibandronic acid belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic
acid.
Ibandronic acid may reverse bone loss. It works by halting bone loss 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 therefore help reduce the chance of
breaking bones (fractures). This reduction has been shown for the spine but not for the hip.
The doctor has given you Ibandronic acid to treat postmenopausal osteoporosis. 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 the skeleton healthy. This means there is an increased
risk of bone fractures after the menopause. The earlier a woman reaches the menopause, the greater her risk of fractures
because of osteoporosis.
Other things that can increase the risk of osteoporosis and therefore fractures include:
- not enough calcium and vitamin D in the diet
- smoking cigarettes, or drinking too much alcohol
- not enough walking or other weight-bearing exercise
- a family history of osteoporosis.

Driving and using machines
You can drive and use machines as it's expected that Ibandronic acid has no or negligible effect on your ability to drive
and use machines.
Ibandronic acid contains sodium
Ibandronic acid contains less than 1 mmol sodium (23 mg) per its single maximum dose (3 mg/3 ml), i.e. it is essentially
“sodium-free”.

3. How to receive Ibandronic acid
The recommended dose of Ibandronic acid intravenous injection is 3 mg (1 pre-filled syringe) once every 3 months.
The injection should be given into the vein by a physician or qualified/trained health care worker. Do not administer the
injection to yourself.
The solution for injection must be administered into a vein only, and not anywhere else in the body.

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 doing other weight-bearing exercise
- not smoking and not drinking too much alcohol.

Continuing to receive Ibandronic acid
To get the most benefit from the treatment it is important to continue receiving the injections every 3 months for as long
as your doctor advises. Ibandronic acid can treat osteoporosis only while you are having the treatment, even though you
will not be able to see or feel a difference.
After 5 years of receiving Ibandronic acid, please consult with your doctor whether you should continue to receive
Ibandronic acid.

2. What you need to know before you receive Ibandronic acid
Do not receive Ibandronic acid
- if you have, or had in the past, low blood calcium. Please consult your doctor.
- if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).

You should also take calcium and vitamin D supplements, as recommended by your doctor.
If too much Ibandronic acid is given
You may develop low levels of calcium, phosphorus or magnesium in the blood. Your doctor may take steps to correct
such changes and may give you an injection containing these minerals.

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 SUN for osteoporosis. ONJ can also occur after stopping
treatment.

If a dose of Ibandronic acid is missed
You should arrange an appointment to get the next injection as soon as possible. After that, go back to getting the
injections every 3 months from the date of the most recent injection.

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.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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.

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

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Any unused solution for injection, syringe
and injection needle should be disposed
of in accordance with local requirements.

Patients with concomitant diseases, or who
use medicinal products which have a
potential for undesirable effects on the
kidney, should be reviewed regularly in line
with good medical practice during
treatment.

Hypocalcaemia and other disturbances of
bone and mineral metabolism should be
assessed and effectively treated before
starting Ibandronic acid injection therapy.
Adequate intake of calcium and vitamin D is
important in all patients. All patients must
receive supplemental calcium and vitamin D.

General advice:
Ibandronic acid like other bisphosphonates
administered intravenously, may cause a
transient decrease in serum calcium values.

Based on knowledge of this class of
compounds, intravenous overdosage may
result in hypocalcaemia, hypophosphataemia,
and hypomagnesaemia, which can cause
paraesthesia. In severe cases intravenous
infusion of appropriate doses of calcium
gluconate, potassium or sodium phosphate,
and magnesium sulfate, may be needed.

Overdose:
No specific information is available on the
treatment of overdosage with Ibandronic
acid.

Missed dose:
If a dose is missed, the injection should be
administered as soon as convenient.
Thereafter, injections should be scheduled
every 3 months from the date of the last
injection.

Ibandronic acid must not be mixed with
calcium-containing solutions (such as RingerLactate solution, calcium heparin) or other
intravenously administered medicinal
products. Where Ibandronic acid is
administered via an existing intravenous
infusion line, the intravenous infusate should
be restricted to either isotonic saline or
50 mg/ml (5%) glucose solution.

The solution is irritant, therefore strict
adherence to the intravenous route of
administration is important. If you
inadvertently inject into the tissues around
the vein, patients may experience local
irritation, pain and inflammation at the
injection site.

Administration of Ibandronic acid:
Ibandronic acid should be injected
intravenously over a period of 15 - 30 seconds.

Please see the Summary of Product
Characteristics for more information.

INFORMATION FOR THE HEALTHCARE
PROFESSIONALS

The following information is intended for
healthcare professionals only:

ibandronic acid

Ibandronic acid 3 mg
solution for injection in
pre-filled syringe

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 SUN.

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 (if prolonged)
- 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.

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Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronic acid SUN.

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do not print here

Very rare (may affect up to 1 in 10000 people)
- pain or soreness 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
- serious, potentially life-threatening allergic reaction (see section 2)
- severe adverse skin reactions.
Other possible side effects
Common (may affect up to 1 in 10 people)
- headache
- stomach pain (such as gastritis) or tummy pain, indigestion, nausea, having diarrhoea (loose bowels) or constipation
- pain in your muscles, joints, or back
- feeling tired or exhausted
- 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.
Uncommon (may affect up to 1 in 100 people)
- inflammation of a vein
- pain or injury at the injection site
- bone pain
- feeling weak
- asthma attacks.
Rare (may affect up to 1 in 1000 people)
- hives
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.
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 and on the syringe after “EXP”. The expiry
date refers to the last day of that month.
The person giving the injection should throw away any unused solution and put the used syringe and injection needle
into an appropriate disposal container.

6. Contents of the pack and other information
What Ibandronic acid contains
- The active substance is ibandronic acid. One pre-filled syringe contains 3 mg of ibandronic acid in 3 ml of solution (as
3.375 mg of ibandronic acid, monosodium salt, monohydrate). The concentration of ibandronic acid in the solution for
injection is 1 mg per ml.
- The other ingredients are sodium chloride, water for injection, sodium acetate trihydrate and glacial acetic acid for pH
adjustment.
What Ibandronic acid looks like and contents of the pack
Ibandronic acid is a clear, colourless solution for injection. Each prefilled syringe contains 3 ml of solution.
Ibandronic acid is available in packs of 1, 2, 4 or 5 pre-filled syringes with injection needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

This leaflet was last revised in 11/2016.

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This medicinal product is authorised in the Member States of the EEA under the following names:
Denmark:
Ibandronsyre SUN 3 mg injektionsvæske, opløsning i en fyldt injektionssprøjte
Germany:
Ibandronsäure SUN 3 mg Injektionslösung in einer Fertigspritze
Finland:
Ibandronihappo SUN 3 mg injektioneste, liuos esitäytetyssä ruiskussa
France:
Acide ibandronique SUN 3 mg solution injectable en seringue pré-remplie
The Netherlands: Ibandroninezuur SUN 3 mg oplossing voor injectie in voorgevulde spuit
Norway:
Ibandronsyre SUN 3 mg injeksjonsvæske, oppløsning, i ferdigfylt sprøyte
Spain:
Ácido ibandrónico SUN 3 mg solución inyectable en una jeringa precargada EFG
Sweden:
Ibandronsyra SUN 3 mg injektionsvätska, lösning, i en förfylld spruta
United Kingdom: Ibandronic acid SUN 3 mg solution for injection in pre-filled syringe.

Suppliers LOGO / ID here

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

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First Fold here

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Patient reminder card
Osteonecrosis of the jaw
during treatment with
Ibandronic acid SUN 3 mg

Sun Pharmaceutical Industries
Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Tel +31 (0)235685501
Fax +31 (0)235685505
www.sunpharma.com

044BP1972F

Front side

Ibandronic acid sol for Inj-PRCard-A4-297x210mm-29-11-16
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Folding Crease Line

Patient reminder card
regarding
osteonecrosis of the jaw

This reminder card contains important
safety information that you need to be
aware of before and during treatment
with Ibandronic acid SUN 3 mg.
Your doctor has recommended that you
receive Ibandronic acid SUN 3 mg, which is
used to treat post-menopausal women with
osteoporosis. These diseases involve thinning
and weakening of the bones so they may break
more easily.
A side effect called osteonecrosis of the jaw
(ONJ) (bone damage in the jaw) has been
reported very rarely in patients receiving
Ibandronic acid SUN 3 mg for osteoporosis.
ONJ can also occur after stopping treatment.

Folding Crease Line

Before starting treatment:

Tell your doctor/nurse (health care
professional) if you have any problems with
your mouth or teeth.
Your doctor may ask you to undergo a dental
examination if you:
- were previously treated with another
medication being a bisphosphonate
- are taking medicines called corticosteroids
(such as prednisolone or dexamethasone)
- are a smoker
- have cancer
- have not had a dental check up for a long
time
- have problems with your mouth or teeth.

While being treated:

- You should maintain good oral hygiene,
brush your teeth regularly 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 and tell your
dentist that you are being treated with
Ibandronic acid SUN 3 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.
Please read the package leaflet that comes
with your medicine for further information.

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 ONJ, there are some precautions
you should take:

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.
044BP1972F

Back side

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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.

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