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ZOLEDRONIC ACID SANDOZ 5MG/100ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Zoledronic acid 5 mg/100 ml
Solution for Infusion

SZ00000LT000

Zoledronic acid

Read all of this leaflet carefully before you are given 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.
• This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
• If you get any of the side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this leaflet.
See section 4.

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

1

What Zoledronic acid is
and what it is used for

Zoledronic acid solution for infusion
contains the active substance
zoledronic acid. It belongs to a group
of medicines called bisphosphonates
and is used to treat postmenopausal women and men with
osteoporosis or osteoporosis caused
by treatment with steroids, and
Pagetʼs disease of the bone.

Osteoporosis
Osteoporosis is a disease that
involves the thinning and weakening
of the bones and is common in
women after the menopause, but
can also occur in men. At the
menopause, a womanʼs ovaries stop
producing the female hormone
oestrogen, which helps keep bones
healthy. Following the menopause
bone loss occurs, bones become
weaker and break more easily.
Osteoporosis could also occur in
men and women because of the long
term use of steroids, which can
affect the strength of bones.
Many patients with osteoporosis
have no symptoms but they are still
at risk of breaking bones because
osteoporosis has made their bones
weaker. Decreased circulating levels
of sex hormones, mainly oestrogens
converted from androgens, also play
a role in the more gradual bone loss
observed in men. In both women
and men, Zoledronic acid
strengthens the bone and therefore
makes it less likely to break.
Zoledronic acid is also used in
patients who have recently broken
their hip in a minor trauma such as a
fall and therefore are at risk of
subsequent bone breaks.
Pagetʼs 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 Pagetʼs 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 works by returning
the bone remodelling process to
normal, securing formation of normal
bone, thus restoring strength to the
bone.

2

What you need to know
before you are given
Zoledronic acid

Follow all instructions given to you
by your doctor carefully before you
are given Zoledronic acid.

You should not be given
Zoledronic acid
• if you are allergic to zoledronic
acid, other bisphosphonates or any
of the other ingredients of
Zoledronic acid solution for
infusion (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
Tell your doctor before you are given
Zoledronic acid
• if you are being treated with other
medicines containing zoledronic
acid (e.g. for treatment of bone
metastases or tumour-induced
high calcium blood levels).
• 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.
Before you receive treatment with
Zoledronic acid, tell your doctor if
you have (or have had) pain,
swelling or numbness in your gums,
jaw or both, if your jaw feels heavy,
or if you have lost a tooth. Before
you receive dental treatment or
undergo dental surgery, tell your
dentist you are receiving treatment
with Zoledronic acid.

Children and adolescents
Zoledronic acid is not recommended
for anyone under 18 years of age.
The use of zoledronic acid in
children and adolescents has not
been studied.

Other medicines and Zoledronic
acid
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.

Zoledronic acid with food and
drink
Make sure you drink enough fluids
(at least one or two glasses) before
and after the treatment with
Zoledronic acid, as directed by your
doctor. This will help to prevent
dehydration.
You may eat normally on the day you
are treated with Zoledronic acid. This
is especially important in patients
who take diuretics (“water pills”) and
in elderly patients.
Pregnancy and breast-feeding
There is no adequate information on
the use of zoledronic acid in
pregnant women. Studies in animals
have shown reproductive
toxicological effects. Additionally,
there is no information on the use of
zoledronic acid in breast-feeding
women.
Pregnancy
You must not be given Zoledronic
acid if you are pregnant or plan to
become pregnant.
Breast-feeding
You must not be given Zoledronic
acid if you are breast-feeding.

Ask your doctor, pharmacist or nurse
for advice before taking any
medicine.
Driving and using machines
If you feel dizzy while taking
Zoledronic acid, do not drive or use
machines until you feel better.

Zoledronic acid solution for
infusion contains sodium.
This medicinal product contains less
than 1 mmol sodium (23 mg) per
dose, i.e. essentially ʻsodium- freeʼ.

3

How Zoledronic acid is
given

Follow carefully all instructions given
to you by your doctor or nurse. You
should check with your doctor or
nurse if you are not sure.

Your doctor should do a blood test to
check your kidney functions (levels
of creatinine) before each dose of
Zoledronic acid. It is important for
you to drink at least one or two
glasses of fluid (such as water),
within a few hours before receiving
Zoledronic acid, as directed by your
doctor or nurse.
Osteoporosis
The usual dose is 5 mg zoledronic
acid given as one infusion per year
into a vein by your doctor or nurse.
The infusion will take at least 15
minutes.

In case you recently broke your hip,
it is recommended that Zoledronic
acid is administered two or more
weeks after your hip repair surgery.

It is important to take calcium and
vitamin D supplements (for example
tablets) as directed by your doctor.
For osteoporosis, Zoledronic acid
works for one year. Your doctor will
let you know when to return for your
next dose.

Pagetʼs disease
The usual dose is 5 mg zoledronic
acid, given to you as one single
infusion into a vein by your doctor or
nurse. The infusion will take at least
15 minutes. Zoledronic acid 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. 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.

Continued on the next page >>

The following information is
intended for healthcare
professionals only:

How to prepare and administer
Zoledronic acid

• Zoledronic acid 5 mg solution for
infusion is ready for use.

For single use only. Any unused
solution should be discarded. Only
clear solution free from particles and

discolouration should be used.
Zoledronic acid must not be mixed or
given intravenously with any other
medicinal product and must be given
through a separate vented infusion
line at a constant infusion rate. The
infusion time must not be less than
15 minutes.
Zoledronic acid must not be allowed
to come into contact with any
calcium-containing solutions.

Continued on the next page >>

If a dose of Zoledronic acid is
missed
Contact your doctor or hospital as
soon as possible to re-schedule your
appointment.
Before stopping Zoledronic acid
therapy
If you are considering stopping
Zoledronic acid 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.
If you have any further questions on
the use of this medicine, ask your
doctor, pharmacist or nurse.

4

Possible side effects

Like all medicines, Zoledronic acid
can cause side effects, although not
everybody gets them. In most cases,
no specific treatment is required.
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. 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.
Very common (may affect more
than 1 in 10 people):
• fever.

Common (may affect up to 1 in 10
people):
• headache
• dizziness
• redness and irritation of the eye
• sickness, vomiting, diarrhoea
• pain in the muscles, 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
• skin reactions such as redness,
swelling and/or pain at the infusion
site.
In patients with Pagetʼs disease:
symptoms due to low blood calcium,
such as muscle spasms, or
numbness, or a tingling sensation
especially in the area around the
mouth.

Irregular heart rhythm (atrial
fibrillation) has been seen in patients
receiving zoledronic acid for
post-menopausal osteoporosis. It is
currently unclear whether zoledronic
acid causes this irregular heart
rhythm but you should report it to
your doctor if you experience such
symptoms after you have received
Zoledronic acid.
Uncommon (may affect up to 1 in
100 people):
• flu, upper respiratory tract
infections
• decreased red cell count
• decreased or 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
• eye sensitivity to light
• spinning sensation
• increased blood pressure, flushing
• strong heartbeat
• cough, shortness of breath
• upset stomach, abdominal pain,
constipation
• gastritis
• dry mouth
• indigestion, heartburn,
inflammation of the oesophagus
• skin rash, excessive sweating,
itching, skin reddening
• neck pain, stiffness in muscles,
bones and/or joints, joint swelling,
muscle spasms
• shoulder pain, pain in your chest
muscles and rib cage
• joint inflammation
• muscular weakness
• abnormal kidney test results
• abnormal frequent urination
• blood calcium decreased
• swelling of hands, ankles or feet
• thirst
• toothache
• taste disturbances.

Rare (may affect up to 1 in 1,000
people):
• Painful redness and/or swelling of
the eye
• 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.

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
• inflammation of the eye (scleritis),
inflammation of the eyeʼs cavity
• pain in the mouth, teeth and jaw,
swelling or sores inside the mouth,
numbness or a feeling of
heaviness in the jaw, or loosening
of a tooth
• kidney disorder (e.g. decreased
urine output)
• dehydration secondary to
post-dose symptoms such as
fever, vomiting and diarrhoea.
If you notice any of these side
effects, tell your doctor.

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 Yellow Card Scheme
(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 Zoledronic
acid

Your doctor, pharmacist or nurse
knows how to store this medicine
properly.

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.

After first opening, the product
should be used immediately. Discard
any unused contents.

Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw
away medicines you no longer use.
These measures will help protect the
environment.

6

Contents of the pack
and other information

What Zoledronic acid solution for
infusion contains
The active substance is zoledronic
acid.
Each bottle of 100 ml solution for
infusion contains 5 mg zoledronic
acid anhydrous (as monohydrate).
1 ml solution for infusion contains
0.05 mg zoledronic acid
One ml solution contains 0.05 mg
zoledronic acid (as monohydrate).

The other ingredients are mannitol
(E421), sodium citrate (E331) and
water for injections.

What Zoledronic acid solution for
infusion looks like and contents
of the pack
Zoledronic acid solution for infusion
is a clear and 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 as unit pack or in multi-packs
comprising 4 or 10 packs, each
containing 1 bottle of 100 ml solution
for infusion.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Lek Pharmaceuticals d.d.,
Verovškova 57,
1526 Ljubljana,
Slovenia
or

EBEWE Pharma GmbH Nfg. KG,
Mondseestrasse 11,
A-4866 Unterach,
Austria
or

Novartis Pharma GmbH,
Roonstrasse 25 und Obere
Turnstrasse 8;
90429 Nurnberg,
Germany.
This leaflet was last revised in
05/2013.

00000000

If refrigerated, allow the refrigerated
solution to reach room temperature
before administration. Aseptic
techniques must be followed during
preparation of the infusion. The
infusion must be conducted
according to standard medical
practice.

SZ00000LT000

• Do not use Zoledronic acid after
the expiry date which is stated on
the carton and bottle.
• The unopened bottle does not
require any special storage
conditions.

How to store Zoledronic acid

• Keep out of the sight and reach of
children.

SZ00000LT000
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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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