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ZOLEDRONIC ACID DR. REDDYS 5 MG/100 ML SOLUTION FOR INFUSION

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Zoledronic acid 5 mg/100 ml solution for infusion
Zoledronic acid
Read all of this leaflet carefully before you are given Zoledronic acid 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. 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, nurse or pharmacist. This includes any possible side effects not listed in this
leaflet. See section 4.
x

In this leaflet:
1.
2.
3.
4.
5.
6.

What Zoledronic acid is and what it is used for
What you need to know before you use Zoledronic acid
How to use Zoledronic acid
Possible side effects
How to store Zoledronic acid
Contents of the pack and other information

1.

What Zoledronic acid is and what it is used
for

Zoledronic acid solution contains the active substance
zoledronic acid. It belongs to a group of medicines
called bisphosphonates and is used to treat post
menopausal women and men with osteoporosis or
osteoporosis caused by treatment with steroids, and
Paget’s disease of the bone.

Other medicines and Zoledronic acid

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 works by returning the
bone remodelling process to normal, securing formation of
normal bone, thus restoring strength to the bone.

Warnings and precautions

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. You must not be given Zoledronic acid if you are
pregnant or plan to become pregnant.
You must not be given Zoledronic acid if you are breastfeeding.
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.

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.

For osteoporosis, Zoledronic acid works for one year. Your
doctor will let you know when to return for your next dose.

Paget’s disease
The usual dose is 5 mg, 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.

If a dose of Zoledronic acid is missed
Contact your doctor or hospital as soon as possible to reschedule 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 may occur with certain frequencies, which are
defined as follows:
x very common: affects more than 1 user in 10
x common: affects 1 to 10 users in 100
x uncommon: affects 1 to 10 users in 1,000
x rare: affects 1 to 10 users in 10,000
x very rare: affects less than 1 user in 10,000
x not known: frequency cannot be estimated from the
available data.
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.

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

Uncommon side effects
x
x
x
x
x
x
x
x
x
x
x
x
x
x

x

x
x
x
x

Reporting of side effects

5.

x
x
x

x

How to store Zoledronic acid

Your doctor, pharmacist or nurse knows how to store
Zoledronic acid properly.
x
x
x
x

fever
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
skin reactions such as redness, swelling and/or pain at the
infusion site
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
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

severe allergic reactions including dizziness and difficulty
breathing, swelling mainly of the face and throat
decreased blood pressure
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
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.

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 at: www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information
on the safety of this medicine.

Common side effects
x
x
x
x
x

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, eye sensitivity to light
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
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

Frequency not known
x
x
x

Very common side effects

Osteoporosis
The usual dose is 5 mg given as one infusion per year into a
vein by your doctor or nurse. The infusion will take at least 15
minutes.

Keep this medicine out of sight and reach of children.
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.
After opening the bottle, the product should be used immediately in order
to avoid microbial contamination. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the user and
would normally not be longer than 24 hours at 2°C - 8°C.
Allow the refrigerated solution to reach room temperature before
administration.

How to store Zoledronic acid

x
x

x

x

x

Zoledronic acid is ready for use.
For single use only. Any unused solution should be discarded. Only clear
solution free from particles and discoloration 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.
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.
x

x
x

How to prepare and administer Zoledronic acid

Tell your doctor before you are given Zoledronic acid:
x if you are being treated with another medicinal product,
which contains the same active substance as
Zoledronic acid solution
x if you have a kidney problem, or used to have one
x if you are unable to take daily calcium supplements

The following information is intended for healthcare professionals only:

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.

3. How to use Zoledronic acid

if you are allergic (hypersensitive) to zoledronic acid, other
bisphosphonates or any of the other ingredients in 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.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

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 (“waterpills”) that may cause
dehydration.

This medicine contains less than 1 mmol sodium (23 mg) per
dose, i.e. essentially ‘sodium- free’.

You should not be given Zoledronic acid

x
x
x

Please tell your doctor, pharmacist or nurse if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.

Zoledronic acid solution contains sodium

What you need to know before you use
Zoledronic acid

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

x

Before you receive dental treatment or undergo dental
surgery, tell your dentist you are receiving treatment with
Zoledronic acid.

Use in children and adolescents

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
woman’s 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.

x

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.

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.

Osteoporosis

2.

x

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.

x

-

x
x

-

It is important to take calcium and vitamin D supplements (for
example tablets) as directed by your doctor.

6.

Keep this medicine out of sight and reach of children.
Do not use Zoledronic acid after the expiry date which is
stated on the carton and bottle after EXP.
The unopened bottle does not require any special storage
conditions.
After opening the vial, the product should be used
immediately in order to avoid microbial contamination. If
not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and would
normally not be longer than 24 hours at 2°C – 8°C. Allow
the refrigerated solution to reach room temperature before
administration.

Contents of the pack and other information

What Zoledronic acid solution contains
x
x
x

The active substance is zoledronic acid. One vial with 100
ml of solution contains 5 mg zoledronic acid (anhydrous).
One ml solution contains zoledronic acid (as monohydrate)
corresponding to 0.05 mg zoledronic acid (anhydrous)
The other ingredients are mannitol, sodium citrate and
water for injection.

What Zoledronic acid looks like and contents of the
pack
Zoledronic acid solution is a clear and colourless solution. It
comes in 100 ml clear glass or plastic vials as a ready-to-use
solution for infusion. Zoledronic acid is supplied as packs
containing 1 or 5 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, HU17 0LD, United Kingdom
This leaflet was last revised in 01/2014

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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