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ZOLEDRONIC ACID SUN 5 MG SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

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It is important to try and prevent ONJ developing as it is 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.

Zoledronic acid 5 mg 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 corticosteroids used to treat inflammation
- 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 5 mg strengthens the bone and therefore
makes it less likely to break. Zoledronic acid 5 mg 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 5 mg
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 5 mg
Follow all instructions given to you by your doctor, pharmacist or nurse carefully before
you are given Zoledronic acid 5 mg.
You must not be given Zoledronic acid 5 mg
- if you are allergic to zoledronic acid or any of the other ingredients of this medicine
(listed in section 6), or to other bisphosphonates
- 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, pharmacist or nurse before you are given Zoledronic acid 5 mg:
- if you are being treated with other products containing the same active substance
zoledronic acid as Zoledronic acid 5 mg. Other products containing the active substance
zoledronic acid are 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.

Folding
350--2 --87.5 mm
430--8 zigzag--48 mm

Before stopping Zoledronic acid 5 mg therapy
If you are considering stopping Zoledronic acid 5 mg 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 5 mg.
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 5 mg. 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 5 mg.
Some side effects could be serious

Children and adolescents
Zoledronic acid 5 mg is not recommended for anyone under 18 years of age. The use of
Zoledronic acid 5 mg in children and adolescents has not been studied.
Other medicines and Zoledronic acid 5 mg
Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any
other medicines.
It is 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 5 mg 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 5 mg, do not drive or use machines until you
feel better.
Zoledronic acid 5 mg contains sodium
Zoledronic acid 5 mg contains less than 1 mmol sodium (23 mg) per its single maximum
dose, i.e. it is essentially “sodium-free”.

Common (may affect up to 1 in 10 people)
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid
5 mg for post-menopausal osteoporosis. It is currently unclear whether Zoledronic acid
5 mg causes this irregular heart rhythm but you should report it to your doctor if you
experience such symptoms after you have received Zoledronic acid 5 mg.
Uncommon (may affect up to 1 in 100 people)
- swelling, redness, pain and itching to the eyes or eye sensitivity to light.
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.
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 5 mg or after stopping treatment.

3. How Zoledronic acid 5 mg is used

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 5 mg. It is important
for you to drink at least 2 glasses of fluid (such as water), within a few hours before
receiving Zoledronic acid 5 mg, as directed by your healthcare provider.

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

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

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.

Zoledronic acid 5 mg may also cause other side effects

In case you recently broke your hip, it is recommended that Zoledronic acid 5 mg 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 5 mg 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, Zoledronic acid 5 mg 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 5 mg 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 5 mg. 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.

For single use only. Any unused solution should
be discarded. Only clear solution free from
particles and discolouration should be used.
Zoledronic acid 5 mg 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 5 mg must not be
allowed to come into contact with any calciumcontaining 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.

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

How to prepare and administer Zoledronic
acid 5 mg

Please see the Summary of Product
Characteristics for more information.

INFORMATION FOR THE HEALTHCARE
PROFESSIONAL

The following information is intended for
healthcare professionals only:

zoledronic acid

Zoledronic acid 5 mg solution
for infusion

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 for
osteoporosis. ONJ can also occur after stopping treatment.

Monitoring test
Your doctor should do a blood test to check your kidney function (levels of creatinine)
before each dose of Zoledronic acid 5 mg. It is important for you to drink at least 2 glasses
of fluid (such as water), within a few hours before receiving Zoledronic acid 5 mg, as
directed by your healthcare provider.

If you missed a dose of Zoledronic acid 5 mg
Contact your doctor or hospital as soon as possible to re-schedule your appointment.

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.
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.

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.

1. What Zoledronic acid 5 mg is and what it is used for

While being treated with Zoledronic acid 5 mg, 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 you dental
treatment and tell your dentist you are being treated with Zoledronic acid 5 mg. 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.

Chemical and physical in-use stability has been
demonstrated for 24 hours at 2 to 8°C.

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

Your doctor may ask you to undergo a dental examination before you start treatment with
Zoledronic acid 5 mg.

The unopened vial does not require any special
storage conditions.

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 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.

Do not use this medicine after the expiry date
which is stated on the carton and vial after EXP.

zoledronic acid

Keep this medicine out of the sight and reach of
children.

Zoledronic acid 5 mg solution for infusion

Before receiving Zoledronic acid 5 mg 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.

How to store Zoledronic acid 5 mg

Package leaflet: Information for the user

Continued overleaf...

044BP2174F

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Zoledronic acid 5 mg with food and drink
Make sure you drink enough fluids (at least one or two glasses) before and after the
treatment with Zoledronic acid 5 mg, as directed by your doctor. This will help to prevent
dehydration. You may eat normally on the day you are treated with Zoledronic acid 5 mg.
This is especially important in patients who take diuretics (“water pills”) and in elderly
patients (age 65 or over).

350 mm
EUUK- UNITED KINGDOM
Size: 350x430 mm

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Zoledronic acid SUN 5 mg-100ml-350x430mm-EUUK-REV4-24-02-16
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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 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.

6. Contents of the pack and other information
What Zoledronic acid 5 mg contains
- The active substance is zoledronic acid. Each vial with 100 ml of solution contains 5 mg
zoledronic acid (as monohydrate). Each ml of the solution contains 0.05 mg zoledronic
acid anhydrous, corresponding to 0.0533 mg zoledronic acid monohydrate.
- The other ingredients are mannitol (E421), sodium citrate (E331) and water for injection.
What Zoledronic acid 5 mg looks like and contents of the pack
Zoledronic acid 5 mg is a clear and colourless solution.
It comes in 100 ml glass vials as a ready-to-use solution for infusion. The label has a built
in edge, that can be peeled and used as a hanger.
Zoledronic acid 5 mg is supplied in packs containing one vial as unit pack or in multi-packs
comprising 5 packs, each containing 1 vial.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands
This medicinal product is authorised in the Member states of the EEA under the following
names:
Denmark:
Zoledronsyre SUN
Finland:
Tsoledronihappo SUN 5 mg infuusioneste, liuos
France:
Acide zolédronique SUN 5 mg solution pour perfusion
Germany:
Zoledronsäure SUN 5 mg Infusionslösung
Italy:
Acido Zoledronico SUN Pharmaceutical Industries Europe BV 5 mg
soluzione per infusione
The Netherlands:
Zoledroninezuur SUN 5 mg oplossing voor infusie
Norway:
Zoledronsyre SUN 5 mg infusjonsvæske, oppløsning
Spain:
Ácido zoledrónico SUN 5 mg solución para perfusión EFG
Sweden:
Zoledronsyra SUN 5 mg infusionsvätska, lösning
United Kingdom:
Zoledronic acid SUN 5 mg solution for infusion
This leaflet was last revised in 02/2016

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.

044BP2174F

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 at: 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 5 mg
Your doctor, pharmacist or nurse knows how to store Zoledronic acid 5 mg properly.
Suppliers LOGO / ID here

This medicine must be kept out of the sight and reach of children.
This medicine must not be used 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 conditions.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C.
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.

Folding
350--2 --87.5 mm
430--8 zigzag--48 mm

350 mm
Size: 350x430 mm

100

95

75

25

5

0

Zoledronic acid SUN 5 mg-100ml-350x430mm-EUUK-REV4-24-02-16
24 February 2016 15:05:20

Expand view ⇕

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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