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ZOLEDRONIC ACID 5MG/100ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID / ZOLEDRONIC ACID MONOHYDRATE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Zoledronic Acid 5mg/100ml
Solution for Infusion
Solution for Infusion

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(Referred to as Zoledronic Acid
Infusion in the remainder of this leaflet)

Read all of this leaflet carefully
before you are given this
medicine because it contains
important information for you.

Your doctor may ask you to undergo
a dental examination before you
start treatment with Zoledronic
Acid Infusion.

- 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.

While being treated with Zoledronic
Acid Infusion, you should maintain
good oral hygiene (including regular
teeth brushing) and receive routine
dental check-ups. If you wear
dentures you should make sure
these fit properly. If you are under
dental treatment or are due to
undergo dental surgery (e.g. tooth
extractions), inform your doctor
about your dental treatment and tell
your dentist that you are being
treated with Zoledronic Acid
Infusion. Contact your doctor and
dentist immediately if you
experience any problems with your
mouth or teeth such as loose teeth,
pain or swelling, or non-healing of
sores or discharge, as these could be
signs of osteonecrosis of the jaw.

What is in this leaflet
1. What Zoledronic Acid Infusion is
and what it is used for
2. What you need to know before
you are given Zoledronic Acid
Infusion
3. How Zoledronic Acid Infusion is
given
4. Possible side effects
5. How to store Zoledronic Acid
Infusion
6. Contents of the pack and other
information

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1. WHAT ZOLEDRONIC ACID
INFUSION IS AND WHAT IT IS
USED FOR
Zoledronic Acid Infusion contains
the active substance zoledronic
acid. It belongs to a group of
medicines called bisphosphonates
and is used to treat Paget’s disease
of the bone in adults.
Paget’s disease of the bone
It is normal that old bone is
removed and is replaced with new
bone material. This process is called
remodelling. In Paget’s disease,
bone remodelling is too rapid and
new bone is formed in a disordered
fashion, which makes it weaker than
normal. If the disease is not treated,
bones may become deformed and
painful, and may break. Zoledronic
Acid Infusion works by returning the
bone remodelling process to
normal, securing formation of
normal bone, thus restoring
strength to the bone.

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2. WHAT YOU NEED TO KNOW
BEFORE YOU ARE GIVEN
ZOLEDRONIC ACID INFUSION
Follow carefully all instructions
given to you by your doctor or nurse
carefully before you are given
Zoledronic Acid Infusion.
You should not be given
Zoledronic Acid Infusion:
• if you are allergic to zoledronic
acid, other bisphosphonates or
any of the other ingredients of this
medicine (listed in section 6).
- if you have hypocalcaemia (this
means that the levels of calcium in
your blood are too low).
- if you have severe kidney
problems.
- if you are pregnant.
- if you are breast-feeding.
Warnings and precautions
Talk to your doctor before you are
given Zoledronic Acid Infusion:
- if you are being treated with other
medicines containing the active
substance zoledronic acid.
- if you have a kidney problem, or
used to have one.
- if you are unable to take daily
calcium supplements.
- if you have had some or all of the
parathyroid glands in your neck
surgically removed.
- if you have had sections of your
intestine removed.
A side effect called osteonecrosis of
the jaw (ONJ) (bone damage in the
jaw) has been reported in the
post-marketing setting in patients
receiving Zoledronic Acid Infusion
for osteoporosis. ONJ can also occur
after stopping treatment.
It is important to try and prevent
ONJ developing as it 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.
Before receiving Zoledronic Acid
Infusion, 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 time;
- 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 bone disorders);
- you are taking medicines called
corticosteroids (such as
prednisolone or dexamethasone)
- you have cancer.

Monitoring test
Your doctor should do a blood test
to check your kidney function (levels
of creatinine) before each dose of
Zoledronic Acid Infusion. It is
important for you to drink at least
two glasses of fluid (such as water)
within a few hours before receiving
Zoledronic Acid Infusion, as directed
by your healthcare provider.
Children and adolescents
Zoledronic Acid Infusion is not
recommended for anyone under 18
years of age. The use of Zoledronic
Acid Infusion in children and
adolescents has not been studied.
Other medicines and Zoledronic
Acid Infusion
Please tell your doctor, pharmacist
or nurse if you are taking or have
recently taken any other medicines,
including medicines obtained
without a prescription.
It is especially important for your
doctor to know all the medicines
you are taking, especially if you are
taking any medicines known to be
harmful to your kidneys (e.g.
aminoglycosides) or diuretics
(“water pills”) that may cause
dehydration.
Pregnancy and breast-feeding
You must not be given Zoledronic
Acid Infusion if you are pregnant or
breast-feeding, think you may be
pregnant or are planning to have a
baby.
Ask your doctor, pharmacist or nurse
for advice before taking this
medicine.
Driving and using machines
If you feel dizzy while taking
Zoledronic Acid Infusion, do not drive
or use machines until you feel better.
Zoledronic Acid Infusion contains
sodium
This medicinal product contains less
than 1 mmol sodium (23mg) per
dose, i.e. essentially ‘sodium-free’.
3. HOW ZOLEDRONIC ACID
INFUSION IS GIVEN
Follow carefully all instructions
given to you by your doctor or
nurse. Check with your doctor or
nurse if you are not sure.
Paget’s disease
The usual dose is 5 mg, given to you
as one initial infusion into a vein by
your doctor or nurse. The infusion
will take at least 15 minutes.
Zoledronic Acid Infusion may work
for longer than one year, and your
doctor will let you know if you need
to be treated again.
Your doctor may advise you to take
calcium and vitamin D supplements
(e.g. tablets) for at least the first ten
days after being given Zoledronic
Acid Infusion. It is important that
you follow this advice carefully so
that the level of calcium in your
blood does not become too low in
the period after the infusion. Your
doctor will inform you regarding the
symptoms associated with
hypocalcaemia.
Zoledronic Acid Infusion with
food and drink
Make sure you drink enough fluids
(at least one or two glasses) before
and after the treatment with
Zoledronic Acid Infusion, as directed
by your doctor. This will help to
prevent dehydration. You may eat
normally on the day you are treated
with Zoledronic Acid Infusion. This is
especially important in patients who
take diuretics (“water pills”) and in
elderly patients (age 65 years or
over).
If you missed a dose of Zoledronic
Acid Infusion
Contact your doctor or hospital as
soon as possible to re-schedule your
appointment.
106071/3

INFORMATION FOR HEALTHCARE PROFESSIONALS
Zoledronic Acid 5mg/100ml
clear solution free from particles and
Solution for Infusion
discolouration should be used.
(Referred to as
Zoledronic Acid Infusion must not
Zoledronic Acid Infusion in the
be mixed or given intravenously
remainder of this section)
with any other medicinal product
Please refer to the Summary of
and must be given through a
Product Characteristics (SmPC) for
separate vented infusion line at a
further details on this product.
constant infusion rate. The infusion
time must not be less than 15
How to prepare and administer
minutes. Zoledronic Acid Infusion
Zoledronic Acid Infusion
must not be allowed to come into
- Zoledronic Acid 5mg/100ml
contact with any calcium-containing
Solution for Infusion is ready for use. solutions. The infusion must be
conducted according to standard
For single use only. Any unused
medical practice.
solution should be discarded. Only
106071/3

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ART WORK CHECK BOX
PRODUCT :

Process
Black

CUSTOMER :
FP CODE:
PLANT LOCATION :
DIMENSIONS :
PHARMACODE No. :
SAP CODE No. :
TEXT FONT SIZE :
FILE NAME :
SOFTWARE :
TYPEFACES :
ARTWORK (DETAILS)
RECEIVED ON :
PROOF REVISION :

Zoledronic Acid 5mg/100ml
Concentrate for Solution for Infusion
Wockhardt UK
FP3870
EOU
(w)110 x (h)510mm
2523
221980
8 pt.
Zoledronic_4mg-5ml_Lit_106071-3.ai
Adobe Illustrator CS5
Myriad Pro Regular / Italic / Bold
30th November & 3rd December, 2015
R 1st PDF sent on - 7TH DEC. 2015

CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Changes in detail: • New regulatory text

Non-Regulatory

Common (may affect up to 1 in 10
people):
Headache, dizziness, sickness,
vomiting, diarrhoea, pain in the
muscles, pain in the bones and/or
joints, pain in the back, arms or legs,
flu-like symptoms (e.g. tiredness,
chills, joint and muscle pain), chills,
feeling of tiredness and lack of
interest, weakness, pain, feeling
unwell.
In patients with Paget’s disease:
symptoms due to low blood
calcium, such as muscle spasms, or
numbness, or a tingling sensation
especially in the area around the
mouth have been reported.
Uncommon (may affect up to 1 in
100 people):
Flu, upper respiratory tract
infections, decreased red cell count,
loss of appetite, sleeplessness,
sleepiness which may include
reduced alertness and awareness,
tingling sensation or numbness,
extreme tiredness, trembling,
temporary loss of consciousness,
eye infection or irritation or
inflammation with pain and redness,
spinning sensation, increased blood
pressure, flushing, cough, shortness
of breath, upset stomach,
abdominal pain, constipation, dry
mouth, heartburn, skin rash,
excessive sweating, itching, skin
reddening, neck pain, stiffness in
muscles, bones and/or joints, joint
How to store Zoledronic Acid
Infusion
- 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 vial after EXP. The
expiry date refers to the last day of
that month.
- The unopened vial does not
require any special storage
instructions.
- After opening the bottle, the
product should be used
immediately in order to avoid
microbial contamination.

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What Zoledronic Acid Infusion
looks like and contents of the pack
Zoledronic Acid Infusion is a clear,
colourless solution. It comes in 100 ml
plastic bottles as a ready-to-use
solution for infusion. It is supplied in
packs containing one bottle.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.

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What Zoledronic Acid Infusion
contains
• The active substance is zoledronic
acid. Each bottle with 100 ml of
solution contains 5 mg zoledronic
acid anhydrous (as monohydrate).
One ml solution contains 0.05 mg
zoledronic acid (as monohydrate).
• The other ingredients are mannitol
(E421), sodium citrate and water
for injections.

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6. CONTENTS OF THE PACK AND
OTHER INFORMATION

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• 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 bottle after EXP. The
expiry date refers to the last day of
that month.
• The unopened bottle does not
require any special storage
conditions.

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Zoledronic Acid Infusion may also
cause other side effects
Very common (may affect more than
1 in 10 people)
Fever

Your doctor or nurse knows how to
store Zoledronic Acid Infusion
properly.

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If you experience any of the above
side effects, you should contact your
doctor immediately.

5. HOW TO STORE ZOLEDRONIC
ACID INFUSION

Manufacturer
CP Pharmaceuticals Ltd, Ash Road
North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this
leaflet in Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK Only).
Please be ready to give the
following information:
Product name
UK Reference
number
Zoledronic Acid
5mg/100ml
PL 29831/0480
Solution for
Infusion
This is a service provided by the Royal
National Institute of Blind People.
This medicinal product is
authorised in the Member States
of the EEA under the following
names:
UK: Zoledronic Acid 5mg/100ml
Solution for Infusion
Malta: Zoledronic Acid 5mg/100ml
Solution for Infusion
This leaflet was last revised in
12/2015

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Not known (frequency cannot be
estimated from the available data)
• Pain in the mouth and/or jaw,
swelling or non-healing sores in
the mouth or jaw, discharge,
numbness or a feeling of
heaviness in the jaw, or loosening
of a tooth; these could be signs of
bone damage in the jaw
(osteonecrosis). Tell your doctor
and dentist immediately if you
experience such symptoms while
being treated with Zoledronic Acid
Infusion or after stopping treatment.
• Kidney disorders (e.g. decreased
urine output) may occur. Your
doctor should do a blood test to
check your kidney function before
each dose of Zoledronic Acid
Infusion. It is important for you to
drink at least 2 glasses of fluid
(such as water), within a few hours
before receiving Zoledronic Acid
Infusion, as directed by your
healthcare provider.

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

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Very rare (may affect up to 1 in
10,000 people):
• 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.

Malta:
ADR Reporting, The Medicines
Authority, Post-Licensing
Directorate, 203 Level 3,
Rue D'Argens, GŻR-1368 Gżira.
Website:
www.medicinesauthority.gov.mt;
e-mail:
postlicensing.medicinesauthority@gov.mt

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Uncommon (may affect up to 1 in
100 people):
• Skin reactions such as redness.
• Swelling, redness, pain and itching
to the eyes or eye sensitivity to light

United Kingdom:
Yellow Card Scheme
Website:
www.mhra.gov.uk/yellowcard

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Common (may affect up to 1 in 10
people):
• Irregular heart rhythm (atrial
fibrillation). It is currently unclear
whether Zoledronic Acid Infusion
causes this irregular heart rhythm
but you should report it to your
doctor if you experience such
symptoms after you have received
Zoledronic Acid Infusion.
• Swelling and/or pain at the
infusion site may occur.

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 systems
listed below:

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Some side effects could be serious

Not known (frequency cannot be
estimated from the available data)
Severe allergic reactions including
dizziness and difficulty breathing,
swelling mainly of the face and
throat, decreased blood pressure,
dehydration secondary to post-dose
symptoms such as fever, vomiting
and diarrhoea.

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Side effects related to the first
infusion are very common
(occurring in more than 30% of
patients) but are less common
following subsequent infusions. The
majority of the side effects, such as
fever and chills, pain in the muscles
or joints, and headache, occur
within the first three days following
the dose of Zoledronic Acid Infusion.
The symptoms are usually mild to
moderate and go away within three
days. Your doctor can recommend a
mild pain reliever such as ibuprofen
or paracetamol to reduce these side
effects. The chance of experiencing
these side effects decreases with
subsequent doses of Zoledronic
Acid Infusion.

Rare (may affect up to 1 in 1,000
people):
Unusual fracture of the thigh bone
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.

106071/3
221980

Marketing Authorisation Holder
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

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

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4. POSSIBLE SIDE EFFECTS

Marketing Authorisation Number
PL 29831/0480
MA 154/08201
Date of Revision of Text:
December 2015

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If you have any further questions on
the use of this medicine, ask your
doctor, pharmacist or nurse.

swelling, muscle spasms, shoulder
pain, pain in your chest muscles and
rib cage, joint inflammation,
muscular weakness, abnormal
kidney test results, abnormal
frequent urination, swelling of
hands, ankles or feet, thirst,
toothache, taste disturbances.

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Before stopping Zoledronic Acid
Infusion therapy
If you are considering stopping
Zoledronic Acid Infusion treatment,
please go to your next appointment
and discuss this with your doctor.
Your doctor will advise you and
decide how long you should be treated
with Zoledronic Acid Infusion.

106071/3
221980

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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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