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

Active substance(s): IBANDRONIC ACID

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Package leaflet: Information for the user

Ibandronic Acid 3 mg
solution for injection in
pre-filled syringe
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 or
nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
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. What Ibandronic Acid is and what it is used 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 use 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;
- smoking cigarettes, 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 other weight-bearing exercise,
- not smoking and not drinking too much alcohol.

Ibandronic Acid contains sodium
This medicine contains less than 1 mmol sodium
(23 mg) per dose (3 ml), that is, essentially “sodiumfree”.
3. How to receive Ibandronic Acid
The recommended dose of Ibandronic Acid for the
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 healthcare 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 using 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.
If a 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.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects

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).
Warning and precautions
Some patients need to be especially careful when
using Ibandronic Acid.
Talk to your doctor, pharmacist or nurse before
receiveing 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).
- You should take calcium and vitamin-D supplements
while receiving Ibandronic Acid. If you are unable
to do so, inform your doctor.
- If 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.
- 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.
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, breast-feeding and fertility
Ibandronic Acid 3mg for solution for injection in prefilled syringes is for use only by postmenopausal
women and must not be taken by women who could
still have a baby.
Do not use Ibandronic Acid if you are pregnant or
breast-feeding.
Ask your doctor or phrmacist for advice before taking
this medicine.
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

• 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 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 national
reporting system 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.

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

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.

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:

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

Rare (may affect up to 1 in 1,000 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 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).

6. Contents of the pack and other information
What Ibandronic Acid contains
- The active substance is ibandronic acid. One prefilled syringe contains 3 mg of ibandronic acid (as
sodium anhydrous) in 3 ml of solution.
- The other ingredients are: sodium chloride, acetic
acid glacial, sodium acetate trihydrate, sodium
hydroxide for pH adjustment, hydrochloric acid for
pH adjustment and water for injections.
V001
M0xxxxx/xx UK

What Ibandronic Acid looks like and contents of
the pack
Ibandronic Acid is a clear colourless solution. Each
pre-filled syringe contains 3 ml of solution. Ibandronic
Acid is available in packs of 1 pre-filled syringe and 1
injection needle.

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Marketing Authorisation Holder and Manufacturer

Please see the Summary of Product Characteristics for more information.

Marketing Authorisation Holder
Fresenius Kabi Ltd.
Cestrian Court
Eastgate Way, Manor Park
Runcorn, Cheshire
WA7 1NT
United Kingdom
Manufacturer
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
8055 Graz
Austria
This medicinal product is authorised in the Member
States of the EEA under the following names:
Austria
Belgium

Ibandronsäure Fresenius Kabi
3 mg Lösung zur Injektion in
einer Fertigspritze
Ibandroninezuur Fresenius Kabi
3 mg, oplossing voor injectie in
een voorgevulde spuit.
Acide ibandronique Fresenius
Kabi 3 mg, solution injectable en
seringue pré-remplie

Ibandronsäure Fresenius Kabi
3 mg Injektionslösung in einer
Fertigspritze
Czech Republic Ibandronic Acid Fresenius
Kabi 3 mg injekční roztok v
předplněné injekční stříkačce
Denmark
Ibandronsyre Fresenius Kabi
Hungary
Ibandronsav Fresenius Kabi
3 mg oldatos injekció előretöltött
fecskendőben
Iceland
Ibandronsyre Fresenius Kabi
Netherlands
Ibandroninezuur Fresenius Kabi
3 mg, oplossing voor injectie in
een voorgevulde spuit
Poland
Ibandronic acid Fresenius Kabi
Portugal
Ácido Ibandrónico Fresenius
Kabi
Romania
Acid ibandronic Fresenius
Kabi 3 mg soluție injectabilă în
seringă preumplută
Slovakia
Ibandronic Acid Fresenius Kabi
3 mg injekčný roztok naplnený
v injekčnej striekačke
Spain
Ácido Ibandrónico Fresenius
Kabi 3mg Solución inyectable
en jeringa precargada EFG
United Kingdom Ibandronic acid 3mg solution for
injection in pre-filled syringes
This leaflet was last revised in November 2015

The following information is intended for healthcare
professionals only:
INFORMATION FOR THE HEALTHCARE
PROFESSIONALS

Administration of Ibandronic Acid 3mg solution
for injection in pre-filled syringe:
Ibandronic Acid 3mg should be injected intravenously
over a period of 15 - 30 seconds.
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.
Ibandronic Acid 3mg solution for injection in pre-filled
syringes must not be mixed with calcium-containing
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.
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.
Overdose:
No specific information is available on the treatment
of overdosage with Ibandronic Acid.
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 3 mg in pre-filled syringe like other
bisphosphonates administered intravenously may
cause a transient decrease in serum calcium values.
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.
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.

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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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