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

Active substance(s): IBANDRONIC ACID MONOSODIUM SALT MONOHYDRATE

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

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If you are having dental treatment or will undergo dental surgery, tell your dentist that
you are being treated with Ibandronic acid.

Package leaflet: Information for the user

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

When you have cancer, tell your dentist as well.
If you have heart problems and the doctor recommended to limit your daily fluid
intake.

ibandronic acid
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).

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.

Children and adolescents
Ibandronic acid must not be used in children or adolescents below 18 years.
What is in this leaflet
Other medicines and Ibandronic acid
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.

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

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.

The recommended dose of Ibandronic acid intravenous injection is 3 mg (1 pre-filled
syringe) once every 3 months.

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.

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).

Tuesday, July 26, 2016 3:10:59 PM

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.
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.
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.

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.

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.

Ibandronic acid must not be mixed with calciumcontaining solutions (such as Ringer-Lactate
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
Ibandronic acid sol for Inj 1mg-ml-248x375-PIL-REV1-EUUK-WithOut SUN-REV2-26-07-16

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

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.

Warnings and precautions
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).

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.

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

4. Possible side effects

6. Contents of the pack and other information

Like all medicines, this medicine can cause side effects, although not everybody gets
them.

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.

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
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.
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)
- serious, potentially life-threatening allergic reaction (see section 2)
- severe adverse skin reactions.

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

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.

Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

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.

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.

Rare (may affect up to 1 in 1000 people)
- hives
Very rare (may affect up to 1 in 10000 people)
- 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.
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.

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

This leaflet was last revised in 02/2016.
5. How to store Ibandronic acid
Keep this medicine out of the sight and reach of children.

044BP1972D

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.

Suppliers LOGO / ID here

The person giving the injection should throw away any unused solution and put the
used syringe and injection needle into an appropriate disposal container.

Tuesday, July 26, 2016 3:11:00 PM

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.

Ibandronic acid sol for Inj 1mg-ml-248x375-PIL-REV1-EUUK-WithOut SUN-REV2-26-07-16

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.

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

044BP1972D

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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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