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ZOLEDRONIC ACID 5 MG / 100 ML SOLUTION FOR INFUSION

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

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Ver04 – EPAR assessment – approved 01/04/2015
Ver05-IB MHRA mandated update ONJ and imp patient reminder card-approved 13-Nov-2015
Ver06 – PRAC Recommendation

Package leaflet: Information for the User
Zoledronic acid 5mg/100ml solution for infusion
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
The name of your medicine is Zoledronic acid 5mg/100ml solution for infusion (called zoledronic
acid throughout this leaflet). 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, 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

Ver02 COA from Housthon BV to Zentiva – granted 30/01/13
Ver 03 IB mandated MHRA update/innovator update
Ver04 – EPAR assessment – approved 01/04/2015
Ver05-IB MHRA mandated update ONJ and imp patient reminder card-approved 13-Nov-2015
Ver06 – PRAC Recommendation
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, pharmacist or nurse carefully 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 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
Talk to your doctor before you are given zoledronic acid:
if you are being treated with any medicine containing zoledronic acid, which is also the active
substance of Zoledronic acid 5mg/100ml solution for infusion. (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.
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.
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.
Before receiving Zoledronic acid 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);

Ver02 COA from Housthon BV to Zentiva – granted 30/01/13
Ver 03 IB mandated MHRA update/innovator update
Ver04 – EPAR assessment – approved 01/04/2015
Ver05-IB MHRA mandated update ONJ and imp patient reminder card-approved 13-Nov-2015
Ver06 – PRAC Recommendation
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 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, or nonhealing 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 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 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 5mg/100ml solution for infusion contains less than 1 mmol sodium (23 mg) per bag
(100 ml), i.e. essentially “sodium-free”.

3. How zoledronic acid is given

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Ver 03 IB mandated MHRA update/innovator update
Ver04 – EPAR assessment – approved 01/04/2015
Ver05-IB MHRA mandated update ONJ and imp patient reminder card-approved 13-Nov-2015
Ver06 – PRAC Recommendation
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, zoledronic acid should be prescribed only by physicians with
experience in the treatments 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 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 years or 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

Ver02 COA from Housthon BV to Zentiva – granted 30/01/13
Ver 03 IB mandated MHRA update/innovator update
Ver04 – EPAR assessment – approved 01/04/2015
Ver05-IB MHRA mandated update ONJ and imp patient reminder card-approved 13-Nov-2015
Ver06 – PRAC Recommendation
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 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)
– Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Very rare (may affect up to 1 in 10,000 people)
– Bone necrosis of the external ear canal. 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 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.

Ver02 COA from Housthon BV to Zentiva – granted 30/01/13
Ver 03 IB mandated MHRA update/innovator update
Ver04 – EPAR assessment – approved 01/04/2015
Ver05-IB MHRA mandated update ONJ and imp patient reminder card-approved 13-Nov-2015
Ver06 – PRAC Recommendation
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
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
 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

Ver02 COA from Housthon BV to Zentiva – granted 30/01/13
Ver 03 IB mandated MHRA update/innovator update
Ver04 – EPAR assessment – approved 01/04/2015
Ver05-IB MHRA mandated update ONJ and imp patient reminder card-approved 13-Nov-2015
Ver06 – PRAC Recommendation
 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 Yellow card Scheme
at:
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store zoledronic acid

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Ver 03 IB mandated MHRA update/innovator update
Ver04 – EPAR assessment – approved 01/04/2015
Ver05-IB MHRA mandated update ONJ and imp patient reminder card-approved 13-Nov-2015
Ver06 – PRAC Recommendation
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 25°C.
- 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 5mg/100ml solution for infusion 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 5mg/100ml solution for infusion 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 and Manufacturers
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS
Manufacturers Synthon Hispania Castelló, 1, Polígono las Salinas, 08830 Sant Boi de Llobregat,
Spain
Synthon BV, Microweg 22, 6545 CM, Nijmegen, The Netherlands
This leaflet was last revised in November 2015.

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Ver 03 IB mandated MHRA update/innovator update
Ver04 – EPAR assessment – approved 01/04/2015
Ver05-IB MHRA mandated update ONJ and imp patient reminder card-approved 13-Nov-2015
Ver06 – PRAC Recommendation

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Zoledronic acid 5mg/100ml solution for infusion
The following information is intended for medical or healthcare professionals only (see section 3):
How to prepare and administer zoledronic acid 5mg/100ml solution for infusion.
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 this medicine after the expiry date which is stated on the carton and bag after
EXP.
– 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

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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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