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IBANDRONIC ACID ACTAVIS 3 MG SOLUTION FOR INJECTION

Active substance(s): IBANDRONIC ACID / IBANDRONIC ACID / IBANDRONIC ACID

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Package leaflet: Information for the patient

Ibandronic acid 3mg Solution for Injection
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,
pharmacist or nurse.
•  If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
•  The full name of this medicine is Ibandronic acid
3mg Solution for Injection but within the leaflet it
will be referred to as Ibandronic acid.

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
1

 hat Ibandronic acid is and what it is used
W
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. 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
• s moking cigarettes, or drinking too much alcohol
•n
 ot 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
•e
 ating a balanced diet rich in calcium and vitamin D
• walking or other weight-bearing exercise
•n
 ot smoking and not drinking too much alcohol.

2

 hat you need to know before you receive
W
Ibandronic acid
Do not receive Ibandronic acid if you:

•h
 ave, or had in the past, low blood calcium.
Please consult your doctor
• a re allergic to Ibandronic acid or any of the other
ingredients of this medicine (listed in section 6).

Warnings and precautions

• y ou don’t receive routine dental care or have not had
a dental check up for a long time
• y ou are a smoker (as this may increase the risk of
dental problems)
• y ou have previously been treated with a
bisphosphonate (used to treat or prevent bone
disorders)
• y ou are taking medicines called corticosteroids (such
as prednisolone or dexamethasone)
• y ou have cancer
Your doctor may ask you to undergo a dental
examination before starting treatment with
ibandronic acid.
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.
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 before
receiving Ibandronic acid:
• I f 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
• I f you have any disturbance of mineral metabolism
(such as vitamin D deficiency)
•Y
 ou should take calcium and vitamin-D supplements
while receiving Ibandronic acid. If you are unable to
do so, you should inform your doctor
• I f 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.

Other medicines and Ibandronic acid

Tell your doctor, nurse or pharmacist if you are taking,
or have recently taken, any other medicines.

Pregnancy, breast-feeding and fertility

Ibandronic acid is for use 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.

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 for osteoporosis. ONJ can
also occur after stopping treatment.

Driving and using machines

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.

This medicinal product contains less than 1mmol
sodium (23mg) per dose (3ml), i.e. essentially “sodiumfree”.

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

Before receiving treatment, tell your doctor/nurse
(health care professional) if:
• y ou have any problems with your mouth or teeth
such as poor dental health, gum disease, or a
planned tooth extraction
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The following information is intended for medical or healthcare professionals only:

INFORMATION FOR THE HEALTHCARE
PROFESSIONALS
Ibandronic acid 3mg Solution for Injection

Ibandronic acid 3mg solution for injection in pre-filled
syringe must not be mixed with calcium-containing
solutions (such as Ringer-Lactate solution, calcium
heparin) or other intravenously administered medicinal
Please see the Summary of Product Characteristics for products. Where ibandronic acid is administered via
more information.
an existing intravenous infusion line, the intravenous
infusate should be restricted to either isotonic saline or
Administration of Ibandronic acid 3mg solution for
50mg/ml (5 %) glucose solution.
injection in pre-filled syringe:
Ibandronic acid 3mg solution for injection in pre-filled
Missed dose:
syringe should be injected intravenously over a period of If a dose is missed, the injection should be administered
15-30 seconds.
as soon as convenient. Thereafter, injections should
be scheduled every 3 months from the date of the last
The solution is an irritant, therefore strict adherence to
injection.
the intravenous route of administration is important.
If you inadvertently inject into the tissues around the
Overdose:
vein, patients may experience local irritation, pain and
No specific information is available on the treatment of
inflammation at the injection site.
overdosage with ibandronic acid.
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Continued over page

Ibandronic acid 1mg/ml (3mg in 3ml) Solution for injection PIL UK

approved for print/date

item no: AAAJ1344

dimensions: 250 x 680

print proof no: 03

pharmacode:

origination date: 29-06-2016

min pt size: 7pt

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: MH
revision date: 23-08-2016

Technical Approval

revised by: MD

date sent: 29-06-2016

supplier: Synthon Spain

technically app. date: 22-08-2016

Non Printing Colours
1.
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

3

How to receive Ibandronic acid

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

By reporting side effects you can help provide more
information on the safety of this medicine.
5

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 prescribes it for
you. Ibandronic acid can treat osteoporosis only for
as long as you keep receiving 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 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.

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.
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:
Rare (may affect up to 1 in 1000 people)
• itching, swelling of your face, lips, tongue and throat,
with difficulty breathing.
•p
 ersistent eye pain and inflammation (if prolonged)
•n
 ew 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 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 reactions
(see section 2).
• 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.

6

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.

Contents of the pack and other information

What Ibandronic acid 3mg solution for injection
in pre-filled syringes contains
• The active substance is ibandronic acid. One prefilled syringe contains 3mg of ibandronic acid in
3ml of solution (as 3.375mg of ibandronic acid,
monosodium salt, monohydrate).
• The other ingredients are sodium chloride, sodium
hydroxide (E524) (for pH adjustment), acetic acid,
glacial (E260), sodium acetate trihydrate and water
for injections.

What Ibandronic acid 3mg solution for injection
in pre-filled syringes looks like and contents of
the pack
Ibandronic acid 3mg solution for injection in pre-filled
syringes is a clear colourless solution. Each pre-filled
syringe contains 3ml of solution.
Packs sizes are
1 pre-filled syringe and 1 injection needle.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturers
Synthon BV
Microweg 22
6545CM Nijmegen
The Netherlands
Synthon Hispania SL
Castelló 1, Polígono Las Salinas
08830 Sant Boi de Llobregat
Spain
This leaflet was last revised in July 2016

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 diarrhea (loose bowels)
or constipation
• pain or stiffness in your muscles, joints, or back
• feeling tired and 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

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Actavis, Barnstaple, EX32 8NS, UK

!
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.
General advice:
Ibandronic acid 3mg solution for injection in pre-filled
syringe like other bisphosphonates administered
intravenously, may cause a transient decrease in serum
calcium values.

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.

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.
Continued top of next column
AAAJ1344

Actavis, Barnstaple, EX32 8NS, UK

Ibandronic acid 1mg/ml (3mg in 3ml) Solution for injection PIL UK

approved for print/date

item no: AAAJ1344

dimensions: 250 x 680

print proof no: 03

pharmacode:

origination date: 29-06-2016

min pt size: 7pt

colours/plates:
1. Black
2.
3.
4.
5.
6.

originated by: MH
revision date: 23-08-2016

Technical Approval

revised by: MD

date sent: 29-06-2016

supplier: Synthon Spain

technically app. date: 22-08-2016

Non Printing Colours
1.
2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make
changes to the above artwork. No changes are permitted by any 3rd party
other than added notes and mark ups for required changes.

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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