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IBANDRONIC ACID ACTAVIS 3 MG SOLUTION FOR INJECTION

Active substance(s): 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.

Warnings and precautions

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 are under dental treatment or will
undergo dental surgery, tell your dentist that
you are being treated with Ibandronic acid.
When you have cancer, tell your dentist as well
• I f you have heart problems and the doctor
recommended to limit your daily fluid intake.

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

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).

 hat Ibandronic acid is and what it is
W
used for

Children and adolescents

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 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.

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
W
receive Ibandronic acid

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

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

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).

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AAAI8044

!
The following information is intended for medical or healthcare professionals only:

INFORMATION FOR THE HEALTHCARE
PROFESSIONALS
Ibandronic acid 3mg Solution for Injection
Please see the Summary of Product
Characteristics for more information.
Administration of Ibandronic acid 3mg solution
for injection in pre-filled syringe:
Ibandronic acid 3mg solution for injection in prefilled syringe should be injected intravenously over
a period of 15-30 seconds.

Ibandronic acid 3mg solution for injection in prefilled syringe 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
50mg/ml (5 %) glucose solution.

Missed dose:
If a dose is missed, the injection should be
administered as soon as convenient. Thereafter,
The solution is an irritant, therefore strict adherence injections should be scheduled every 3 months
to the intravenous route of administration is
from the date of the last injection.
important. If you inadvertently inject into the
tissues around the vein, patients may experience
Overdose:
local irritation, pain and inflammation at the
No specific information is available on the
injection site.
treatment of overdosage with ibandronic acid.
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AAAI8044

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Ibandronic Acid Pre-filled syringes 1mg/ml (3mg in 3ml) PIL - UK

approved for print/date

item no: AAAI8044

dimensions: 210 x 594

print proof no: 4

pharmacode:

origination date: 22.02.16

min pt size: 12

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

originated by: S.Anson
revision date: 07.03.16

Technical Approval

revised by: S.Anson

date sent: 22.02.16

supplier: Synthon Spain

technically app. date: 07.03.16

Non Printing Colours
1.
2.
3.

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.

5

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.

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.

6

 ontents of the pack and other
C
information

What Ibandronic acid 3mg solution for
injection in pre-filled syringes contains

If a dose of Ibandronic acid is missed

• The active substance is ibandronic acid.
One pre-filled 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.

Possible side effects

What Ibandronic acid 3mg solution for
injection in pre-filled syringes looks like
and contents of the pack

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

How to store Ibandronic acid

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.

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

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AAAI8044

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
AAAI8044

Actavis, Barnstaple, EX32 8NS, UK

Ibandronic Acid Pre-filled syringes 1mg/ml (3mg in 3ml) PIL - UK

approved for print/date

item no: AAAI8044

dimensions: 210 x 594

print proof no: 4

pharmacode:

origination date: 22.02.16

min pt size: 12

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

originated by: S.Anson
revision date: 07.03.16

Technical Approval

revised by: S.Anson

date sent: 22.02.16

supplier: Synthon Spain

technically app. date: 07.03.16

Non Printing Colours
1.
2.
3.

Expand view ⇕

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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