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ZOLEDRONIC ACID 5MG/100 ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

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Zoledronic Acid Amneal 5 mg/100 ml solution for infusion - UK - PIL

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 Aclasta
(zoledronic acid) 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.

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

2. What you need to know before you are
given Zoledronic Acid

You must not be given Zoledronic Acid:
− if you are allergic to zoledronic acid, other
bisphosphonates or any of the other ingredients of
Zoledronic Acid (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:
− if you are being treated with other medicine
which contains zoledronic acid which is also the
active substance of Aclasta (zoledronic acid is
used in adult patients with certain types of cancer
to prevent bone complications or to reduce the
amount of calcium). 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.
INFORMATION FOR THE HEALTHCARE
PROFESSIONAL
The following information is intended for healthcare
professionals only (see section 3):
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
discoloration should be used. Zoledronic Acid must not
be mixed or given intravenously with any other

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Date: 29/06/16

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Before receiving Aclasta 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 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.
Your doctor may ask you to undergo a dental
examination before you start treatment with Zoledronic
acid.
While being treated with Zoledronic acid, 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 Aclasta. 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.
Monitoring test
Your doctor should do a blood test to check your kidney
function (levels of creatinine) before each dose of
Zoledronic Acid. It is important for you to drink at least
2 glasses of fluid (such as water), within a few hours
before receiving Zoledronic Acid, as directed by your
healthcare provider.
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
Tell your doctor, pharmacist or nurse if you are taking,
have recently taken or might take any other medicines.
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.
Pregnancy and breast-feeding
You must not be given Zoledronic Acid 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, do not
drive or use machines until you feel better.
Zoledronic Acid contains sodium
This medicinal product contains less than 1 mmol
sodium (23 mg) per vial, i.e. essentially “sodium-free”.

3. How Zoledronic Acid is given

Follow all instructions given to you by your doctor,
pharmacist or nurse carefully before you are given
Zoledronic Acid.

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Follow carefully all instructions given to you by your
doctor or nurse. Check with your doctor or nurse if you
are not sure.
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.
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.
Paget’s disease
For the treatment of Paget’s disease, Aclasta should be
prescribed only by physicians with experience in the
treatment of Paget’s disease of the bone.
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
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
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.

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Zoledronic Acid Amneal 5 mg/100 ml solution for infusion - UK - PIL

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.
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 (age 65 and over).
If you missed a dose of Zoledronic Acid
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, this medicine can cause side
effects, although not everybody gets them.
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.
Some side effects could be serious
Common (may affect up to 1 in 10 people)
Irregular heart rhythm (atrial fibrillation) has been seen
in patients receiving zoledronic acid for the treatment
of postmenopausal 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)
Swelling, redness, pain and itching to the eyes or eye
sensitivity to light.
Very rare:
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.
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 Aclasta 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. It
is important for you to drink at least 2 glasses of fluid
(such as water), within a few hours before receiving
Zoledronic Acid, as directed by your healthcare
provider.
If you experience any of the above side effects, you
should contact your doctor immediately.
Zoledronic Acid may also cause other side effects
Very common (may affect more than 1 in 10 people)
Fever
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, swelling and/or pain at the infusion site.

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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 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.
Rare (may affect up to 1 in 1,000 people)
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, dehydration
secondary to post-dose symptoms such as fever,
vomiting and diarrhoea.
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 MHRA Yellow Card Scheme,
Website – 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
Zoledronic Acid 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 after EXP.
− The unopened bag does not require any special
temperature storage conditions. Store in the
original package.
− After opening the bag, 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.

6. Contents of the pack and other
information
What Zoledronic Acid contains
− The active substance is zoledronic acid. Each bag
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 (E-421),
sodium citrate (E-331) and water for injections.
What Zoledronic Acid looks like and contents of the
pack
Zoledronic Acid is a clear and colourless solution. It
comes in 100 ml bags as a ready-to-use solution for
infusion. It is supplied in packs containing one bag as
unit pack.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Amneal Pharma Europe Limited
70 Sir John Rogerson’s Quay
Dublin 2, Ireland
Manufacturer
Laboratorios NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos – Madrid
SPAIN
This leaflet was last revised in July 2016

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,
How to store Zoledronic Acid
− 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 after EXP.
− The unopened bag does not require any special
temperature storage conditions. Store in the
original package.
− After opening the bag, 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

PIL Size : 155 x 460 mm
Min. Font Size: 9 pt
Date: 29/06/16

Printed Colours
Black

be longer than 24 hours at 2°C - 8°C. Allow the
refrigerated solution to reach room temperature
before administration.

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Back

Patient Reminder Card
Zoledronic Acid
This reminder card contains important safety information that you need to be aware of before and during
treatment with Zoledronic Acid injections for cancer-related conditions
Your doctor has recommended that you receive Zoledronic Acid injections to help prevent bone complications (e.g.
fractures) caused by bone metastases, or bone cancers or to help reduce the amount of calcium in the blood in adult
patients where it is too high due to the presence of a tumour.
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in very rare occasions in
patients receiving Zoledronic Acid injections for cancer-related conditions. ONJ can also occur after stopping treatment.
In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take:
Before starting treatment:
• Ask your doctor to tell you about ONJ before you start treatment
• Check with your doctor whether a dental examination is recommended before you start treatment with Zoledronic Acid.
• Tell your doctor/nurse (health care professional) if you have any problems with your mouth or teeth.
Patients undergoing dental surgery (e.g. tooth extractions), who do not receive routine dental care or have gum disease,
are smokers, who get different types of cancer treatments or who were previously treated with a bisphosphonate (used to
treat or prevent bone disorders) may have a higher risk of developing ONJ.
While being treated:
• You should maintain good oral hygiene, make sure your dentures fit properly and receive routine dental check-ups.
• If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor and tell your
dentist that you are being treated with Zoledronic 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, as these could be signs of osteonecrosis of the jaw
Read the package leaflet for further information.

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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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