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IBANDRONIC ACID 3MG/3ML SOLUTION FOR INJECTION

Active substance(s): IBANDRONIC ACID

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TEVA UK Ref:

2
PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic Acid 3mg/3ml 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 or pharmacist.
• If you get any side effects, talk to your doctor 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 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

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Version:

231-30-11778-D LEA IBANDRONIC ACID 3mg/ml SOL TEVAH
What Ibandronic Acid is and what it is used for

Ibandronic acid belongs to a group of medicines called bisphosphonates.
Ibandronic Acid 3mg/3ml Solution for Injection contains the active substance
ibandronic acid. Ibandronic Acid 3mg/3ml Solution for Injection 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 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 3mg/3ml Solution for Injection in pre-filled syringes is a
solution for intravenous injection by a health care professional. Do not inject
ibandronic acid yourself.

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11 March 2016

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 (hypersensitive) to ibandronic acid or any of the other
ingredients in ibandronic acid injection
Warnings and precautions
Talk to your doctor of pharmacist before using Ibandronic Acid.
Some patients need to be especially careful when using Ibandronic Acid. Tell
your doctor:
• 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, you should 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.
Other medicines and Ibandronic Acid
Tell your doctor, nurse or pharmacist if you are taking, or have recently
taken, any other medicines. Mention to your doctor, nurse or pharmacist
anything you are taking which you bought over the counter, without a
prescription.
Pregnancy and breast-feeding
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.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
You can drive and use machines as it’s very unlikely that ibandronic acid will
affect your ability to drive and use machines.

Ibandronic acid is prescribed to you to treat postmenopausal osteoporosis
because you have an increased risk of fractures. Osteoporosis is a thinning
Ibandronic Acid 3mg/3ml Solution for Injection contains sodium
and weakening of the bones, which is common in women after the
menopause. At the menopause, a woman’s ovaries stop producing the female This medicinal product contains less than 1 mmol sodium (23 mg) per dose
(3 ml), i.e. essentially “sodium-free”.
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

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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
health care worker. Do not administer the injection to yourself.

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.

The solution for injection must be administered into a vein only, and not
anywhere else in the body.

This information is intended for medical healthcare professionals only.

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.

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
Ibandronic acid prevents loss of bone from osteoporosis, thus helping to
osteoporosis only for as long as you keep receiving the treatment, even
rebuild lost bone. Therefore, Ibandronic acid makes bones less likely to break. though you will not be able to see or feel a difference.
You should also take calcium and vitamin-D supplements, as recommended
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, by your doctor.
walking or other weight-bearing exercise, not smoking and not drinking too
much alcohol.

INFORMATION FOR THE HEALTHCARE PROFESSIONALS

Please see the Summary of Product Characteristics for more information. Missed dose:
Administration of Ibandronic Acid 3mg/3ml Solution for Injection in
pre-filled syringe:

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.

Ibandronic Acid 3mg/3ml Solution for Injection in pre-filled syringe
should be injected intravenously over a period of 15 - 30 seconds.

Overdose:

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/3ml 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

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.

TEVA UK Ref:

231-30-11778-D LEA IBANDRONIC ACID 3mg/ml SOL TEVAH
Version:

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11 March 2016

If you receive more Ibandronic Acid than you should
6 Contents of the pack and other information
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 What Ibandronic Acid 3mg/3ml Solution for Injection in pre-filled syringes
contains
an injection containing these minerals.
The active substance is ibandronic acid. One pre-filled syringe contains 3 mg
If you miss a dose of Ibandronic Acid You should arrange an appointment to of ibandronic acid in 3 ml of solution (as 3.375 mg of ibandronic acid,
get the next injection as soon as possible. After that, go back to getting the
monosodium salt, monohydrate).
injections every 3 months from the date of the most recent injection.
The other ingredients are sodium chloride, sodium hydroxide (E524) (for pH
adjustment), acetic acid, glacial (E2600, sodium acetate trihydrate and water
4 Possible side effects
for injections.
Like all medicines this medicine can cause side effects, although not
What Ibandronic Acid 3mg/3ml Solution for Injection in pre-filled syringes
everybody gets them.
looks like and contents of the pack
Ibandronic Acid 3mg/3ml Solution for Injection in pre-filled syringes is a clear
Talk to a nurse or a doctor straight away if you notice any of the following
colourless solution. Each pre-filled syringe contains 3 ml of solution.
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. You may have early signs of severe jaw
problems ( necrosis [dead bone tissue] in the jaw bone).
• eye pain and inflammation (if prolonged)
• 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 is available in
Packs of 1 pre-filled syringe and 1 injection needle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturers:
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
This leaflet was last revised in March 2016
PL 00289/1759

Other possible side effects
Common (affects less than 1 in 10 people)
Headache • Heartburn, stomach pain (such as “gastroenteritis” or
“gastritis”), indigestion, nausea, 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 (affects less than 1 in 100 people)
Bone pain • Feeling weak • Dizziness • Flatulence • Inflammation of a vein
and pain or injury at the injection site
Rare (affects less than 1 in 1000 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 (affects less than 1 in 10000 people)
A condition involving exposed bone in the mouth called “osteonecrosis of
the jaw”.

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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.
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General advice:
Ibandronic acid 3 mg solution for injection 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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