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ZOLENDRONIC ACID SYNTHON 5 MG/100 ML 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
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.
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.
Zoledronic acid 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.

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
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 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
Tell your doctor before you are given Zoledronic acid:
• if you are being treated with Zoledronic acid 4 mg/5 ml
concentrate for solution for infusion, which contains the same
active substance as 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.

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. 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 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 contains less than 1 mmol sodium (23 mg)
per bag (100 ml), i.e. essentially “sodium-free”.

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.
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
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 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.

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.

4. POSSIBLE SIDE EFFECTS

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.

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.

Other medicines and Zoledronic acid
Please tell your doctor, pharmacist or nurse if you are taking or
have recently taken 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

Like all medicines, this medicine can cause side effects, although
not everybody gets them. In most cases, no specific treatment is
required.

Very common side effects (may affect more than 1 in 10 people)
• Fever

INFORMATION FOR THE HEALTHCARE
PROFESSIONAL

Common side effects (may affect up to 1 in 10 people)
• Headache • Dizziness • Sickness • Vomiting • Diarrhea • 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.

The following information is intended for medical or healthcare
professionals only (see section 3):

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.
Uncommon side effects (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 • 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 (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 • 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.

How to prepare and administer Zoledronic acid
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.
How to store Zoledronic acid
• Keep out of the sight and reach of children.
• Do not use Zoledronic acid after the expiry date which is
stated on the carton and bag.
• Store the unopened bag below 25ºC.
• 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.

If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any side effects not listed in this
leaflet.

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 and bag after EXP. The first two digits indicate the
month and the last four digits indicate the year. The expiry date
refers to the last day of that month.
• Store the unopened bag below 25ºC.
• 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 anhydrous
• The other ingredients are: mannitol (E421), sodium citrate
dihydrate (E331), sodium hydroxide (E524) for pH-adjustment,
hydrochloric acid (E507) for pH-adjustment 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 a
transparent 100 ml plastic bag with one port and one connector
with a grey rubber membrane as a ready-to-use solution for
infusion. It is supplied in packs containing one bag.
Marketing Authorisation Holder:
Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands
Manufacturers:
Synthon BV, Microweg 22, 6545 CM Nijmegen, The Netherlands
Synthon Hispania SL , Castelló 1, Polígono Las Salinas
08830 Sant Boi de Llobregat, Spain
Distributed by: Consilient Health (UK) Ltd., 500 Chiswick High
Road, London, W4 5RG.
This leaflet was last revised in May 2012

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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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