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IBANDRONIC ACID STRIDES 3 MG SOLUTION FOR INJECTION

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Package leaflet: Information for the user

Ibandronic Acid 3 mg
solution for injection
Ibandronic acid

Read all of this leaflet carefully before you start
taking 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, nurse
or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Ibandronic acid is and what it is used for
2. What you need to know before you take Ibandronic
acid
3. How to take 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 ibandronic acid. It does not
contain hormones.
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 will not 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 a solution for intravenous injection,
which is administered by a health care professional. Do
not inject Ibandronic acid yourself.
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

Dimension: 300 x 200 mm

women after menopause. At menopause, a woman’s
ovaries stop producing the female hormone, oestrogen,
which helps to keep her skeleton healthy.
The earlier a woman reaches 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.

−− you have or have ever had kidney problems, kidney
failure or have needed dialysis, or   you have any
other disease that may affect your kidneys

−− smoking cigarettes, or drinking too much alcohol.

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

−− not enough walking or other weight-bearing exercise.
−− a family history of osteoporosis.
Many people with osteoporosis have no symptoms.
If you have no symptoms you may not know if you
have the condition. However, osteoporosis makes you
more likely to break bones if you fall or hurt yourself.
A broken bone after the age of 50 may be a sign of
osteoporosis. Osteoporosis can also cause back pain,
height loss and a curved back.
Ibandronic acid prevents loss of bone from
osteoporosis, thus helping to rebuild lost bone.
Therefore, Ibandronic acid makes bones less likely to
break.
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.
2. What you need to know before you take
Ibandronic acid
Do not take Ibandronic acid
−− if you have, or had in the past , low blood calcium. Please consult your doctor
−− if you are allergic (hypersensitive) 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 taking this medicine if:

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−− 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, you should inform your doctor.

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
You should not be given Ibandronic acid if you are
pregnant, or if there is a possibility you may become
pregnant. If you are breast-feeding, you will need to
stop breast-feeding in order to receive Ibandronic acid.
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby ask your doctor
or pharmacist for advice before taking this medicine.
Driving and using machines
You can drive and use machines as it is very unlikely
that Ibandronic acid will affect your ability to drive and
use machines.
Ibandronic acid contains less than 1 mmol sodium
(23 mg) per dose (3ml). Therefore, this medicine is
essentially “sodium-free”.
3. How to take Ibandronic acid
The recommended dose of Ibandronic acid for
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.
Continuing to take Ibandronic acid
To get the most benefit from the treatment it is

This information is intended for
medical or healthcare professionals
only.
INFORMATION FOR THE
HEALTHCARE PROFESSIONALS
Please see the Summary of
Product Characteristics for more
information.
Administration of Ibandronic Acid 3
mg solution for injection:
Ibandronic Acid 3 mg solution
for injection 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.
In the absence of compatibility studies,
this medicinal product must not be
mixed with other 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

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 solution for
injection 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.

Dimension: 300 x 200 mm

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.
You should also take calcium and vitamin-D
supplements, as recommended by your doctor.
If you take more Ibandronic acid than you should
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 you forget to take Ibandronic acid
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, or pharmacist or nurse.
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:
• rash, itching, swelling of your face, lips, tongue and
throat, with difficulty breathing. You may be having
an allergic reaction to the medicine.
• severe pain in the chest, severe pain after swallowing
food or drink, severe nausea, or vomiting.
• flu-like symptoms (if any effects become
troublesome or last more than a couple of days).
• pain or sore in your mouth or jaw
• eye pain and inflammation (if prolonged)
Other possible side effects
Common (may affect up to 1 in 10 people)
• headache
• heartburn, stomach pain (such as “gastroenteritis” or
“gastritis”), indigestion, nausea,

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having diarrhoea or constipation
• rash
• pain or stiffness in your muscles, joints, or back
• flu-like symptoms (including fever, shaking and
shivering, feeling of discomfort, fatigue,
bone pain and aching muscles and joints)
• fatigue
Uncommon (may affect up to 1 in 100 people)
• bone pain
• feeling weak
• dizziness
• flatulence (too much gas or air in the stomach or
intestine)
• inflammation of a vein and pain or injury at the
injection site
Rare (may affect up to 1 in 1,000 people):
• hypersensitivity reaction; swelling of the face, lips
and mouth (see allergy)
• itching
• eye pain or inflammation
• unusual fracture of the thigh bone particularly in
patients on long-term treatment for osteoporosis
may occur rarely. Contact your doctor if you
experience pain, weakness or discomfort in your
thigh, hip or groin as this may be an early indication
of a possible fracture of the thigh bone.
Very rare (may affect up to 1 in 10,000 people)
• a condition involving exposed bone in the mouth
called “osteonecrosis of the jaw”.
If you get any side effects talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet.
Also you can help to make sure that medicines remain
as safe as possible by reporting any unwanted side
effects via the internet at www.mhra.gov.uk/yellowcard.
Alternatively you can call Freephone 0808 100 3352
(available from 10 a.m. to 2 p.m. Mondays to Fridays)
or fill in a paper form available from your local
pharmacy.

5. How to store Ibandronic acid
Keep this medicine out of the sight and reach of
children.
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.
This medicinal product does not require any special
storage condition.
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 prefilled syringe contains 3 mg of ibandronic acid in
3 ml of solution (as 3.375 mg of ibandronic acid,
monosodium salt, monohydrate).
−− The other ingredients are sodium chloride, glacial
acetic acid, sodium acetate trihydrate and water for
injections.
What Ibandronic acid looks like and contents of the
pack
Ibandronic acid is a clear colourless solution in a prefilled syringe. Each pre-filled syringe contains 3 ml
of solution. Ibandronic acid is available in packs of 1
pre-filled syringe and 1 injection needle or 4 pre-filled
syringes and 4 injection needles.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Strides Arcolab International Ltd.
Unit 4, Metro Centre, Tolpits Lane,
Watford, Hertfordshire WD 189SS
United Kingdom
Manufacturer
Agila Specialties Polska Sp. Z.o.o
10, Daniszewska Str., 03-230 Warsaw
Poland
This leaflet was last revised in 03/2013

101xxxx

on the treatment of overdosage with
Ibandronic acid.
Based on knowledge of this
class of compounds, intravenous
overdosage may result in

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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