IBANDRONIC ACID 3MG/3ML SOLUTION FOR INJECTION
Active substance(s): IBANDRONIC ACID
19 October 2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibandronic Acid 3mg/3ml 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 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
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.
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 3mg/3ml Solution for Injection in
Ibandronic Acid 3mg/3ml Solution for Injection in pre-filled syringe 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
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 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.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e.
Warnings and precautions
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
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.
No specific information is available on the treatment of overdosage with
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.
Uncommon (affects less than 1 in 100 people)
• Bone pain
• Feeling weak
• 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)
• Eye pain or inflammation
The solution for injection must be administered into a vein only, and not anywhere else • Unusual fracture of the thigh bone particularly in patients on long-term treatment
in the body.
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
Continuing to receive Ibandronic Acid To get the most benefit from the treatment it is
of a possible fracture of the thigh bone.
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
Very rare (affects less than 1 in 10000 people)
you keep receiving the treatment, even though you will not be able to see or feel a
• A condition involving exposed bone in the mouth called “osteonecrosis of the jaw”.
You should also take calcium and vitamin-D supplements, as recommended by your
5 How to store Ibandronic Acid
The injection should be given into the vein by a physician or qualified/trained health
care worker. Do not administer the injection to yourself.
Before receiving treatment, tell your doctor, pharmacist or nurse if:
- you have any problems with your mouth or teeth such as poor dental health, gum
disease or a planned tooth extraction.
- you do not receive routine dental care or have not had a dental check up for a long
- you are a smoker (as this may increase the risk of dental problems).
- you have previously been treated with a bisphosphonate (used to treat or prevent
- you are taking medicines called corticosteroids (such as prednisolone or
- you have cancer.
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.
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.
Your doctor may ask you to undergo a dental examination before starting treatment
with 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 While being treated, you should maintain good oral hygiene (including regular teeth
a difference. Ibandronic acid may help lower the chances of breaking bones (fractures). brushing) and receive routine dental check-ups. If you wear dentures you should make
This reduction in fractures was shown for the spine but not for the hip.
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
Ibandronic Acid 3mg/3ml Solution for Injection in pre-filled syringes is a solution for
dentist that you are being treated with Ibandronic acid.
intravenous injection by a health care professional. Do not inject 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, non-healing of sores or discharge,
Ibandronic acid is prescribed to you to treat postmenopausal osteoporosis because
as these could be signs of osteonecrosis of the jaw.
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
Talk to your doctor of pharmacist before using Ibandronic Acid.
woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep
Some patients need to be especially careful when using Ibandronic Acid. Tell your
her skeleton healthy.
The earlier a woman reaches the menopause, the greater her risk of fractures in
• if you have or have ever had kidney problems, kidney failure or have needed
osteoporosis. Other things that can increase the risk of fractures include:
dialysis, or if you have any other disease that may affect your kidneys
− not enough calcium and vitamin D in the diet
− smoking cigarettes, or drinking too much alcohol
• if you have any disturbance of mineral metabolism (such as vitamin D deficiency)
− not enough walking or other weight-bearing exercise
− a family history of osteoporosis
• You should take calcium and vitamin-D supplements while receiving ibandronic
Many people with osteoporosis have no symptoms. If you have no symptoms you may
acid. If you are unable to do so, you should inform your doctor.
not know if you have the condition. However, osteoporosis makes you more likely to
Other medicines and Ibandronic Acid
break bones if you fall or hurt yourself. A broken bone after the age of 50 may be a
Tell your doctor, nurse or pharmacist if you are taking, or have recently taken, any
sign of osteoporosis. Osteoporosis can also cause back pain, height loss and a curved
other medicines. Mention to your doctor, nurse or pharmacist anything you are taking
which you bought over the counter, without a prescription.
Ibandronic acid prevents loss of bone from osteoporosis, thus helping to rebuild lost
Pregnancy and breast-feeding
bone. Therefore, Ibandronic acid makes bones less likely to break.
You should not be given ibandronic acid if you are pregnant, or if there is a possibility
A healthy lifestyle will also help you to get the most benefit from your treatment. This you may become pregnant. If you are breast-feeding, you will need to stop
includes eating a balanced diet rich in calcium and vitamin D, walking or other
breast-feeding in order to receive ibandronic acid.
weight-bearing exercise, not smoking and not drinking too much alcohol.
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 • Pain or stiffness in your muscles, joints, or back
• Flu-like symptoms (including fever, shaking and shivering, feeling of discomfort,
ability to drive and use machines.
fatigue, bone pain and aching muscles and joints)
Ibandronic Acid 3mg/3ml Solution for Injection contains sodium
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
If you receive 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 miss a dose of 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.
Possible side effects
Like all medicines this medicine can cause side effects, although not everybody gets
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:
231-30-40412-C LEA IBANDRONIC ACID 3mg/ml SOL TEVAH
• 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,
• flu-like symptoms (if any effects become troublesome or last more than a couple of
• 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.
• severe adverse skin reactions.
Other possible side effects
Common (affects less than 1 in 10 people)
• Heartburn, stomach pain (such as “gastroenteritis” or “gastritis”), indigestion,
nausea, having diarrhoea or constipation
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/3ml Solution for Injection in pre-filled syringes contains
The active substance is ibandronic acid. One pre-filled syringe contains 3 mg of
ibandronic acid in 3 ml of solution (as 3.375 mg of ibandronic acid, monosodium salt,
The other ingredients are sodium chloride, sodium hydroxide (E524) (for pH adjustment),
acetic acid, glacial (E2600, sodium acetate trihydrate and water for injections.
What Ibandronic Acid 3mg/3ml Solution for Injection in pre-filled syringes looks like
and contents of the pack
Ibandronic Acid 3mg/3ml Solution for Injection in pre-filled syringes 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.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Teva UK Limited, Eastbourne, BN22 9AG, UK
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
This leaflet was last revised in October 2016
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.
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.