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ZOLEDRONIC ACID 5 MG / 100 ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE

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Version: 9
Date: December 2015

Common Technical Document
Module 1
1.3 Product Information
1.3.1 SmPC, Labelling and Package Leaflet

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PACKAGE LEAFLET
Package leaflet: information for the user
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 of the 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 is and what it is used for
2.
What you need to know before you are given
3.
How is used
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.

What is and what it is used for

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,
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.

Zoledronic acid 5 mg/100 ml solution for infusion

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Version: 9
Date: December 2015

Common Technical Document
Module 1
1.3 Product Information
1.3.1 SmPC, Labelling and Package Leaflet

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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

Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given
.
You must not be given
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 :
if you are being treated with zoledronic acid 4 mg/100 ml solution for infusion or zoledronic
acid 4 mg/5 ml concentrate for solution for infusion, which contain the same active substance as
and 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.
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 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);

Zoledronic acid 5 mg/100 ml solution for infusion

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Version: 9
Date: December 2015

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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 name>.
While being treated with , 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 . 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
is not recommended for anyone under 18 years of age. The use of
in children and adolescents has not been studied.
Other medicines and
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 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 , do not drive or use machines until you feel better.
contains sodium
This medicinal product contains less than 1 mmol sodium (as sodium citrate anhydrous) per dose of
zoledronic acid, being essentially sodium free.

Zoledronic acid 5 mg/100 ml solution for infusion

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Version: 9
Date: December 2015

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Common Technical Document
Module 1
1.3 Product Information
1.3.1 SmPC, Labelling and Package Leaflet

How is used

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 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, 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 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. 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 . 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.
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 a dose of is missed
Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Before stopping therapy
If you are considering stopping 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 .
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

Zoledronic acid 5 mg/100 ml solution for infusion

UK/H/5299/001/DC

Version: 9
Date: December 2015

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Common Technical Document
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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 (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 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 . It is important for you to drink at least 2
glasses of fluid (such as water), within a few hours before receiving , as directed by
your healthcare provider.
If you experience any of the above side effects, you should contact your doctor immediately.
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,

Zoledronic acid 5 mg/100 ml solution for infusion

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Version: 9
Date: December 2015

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Common Technical Document
Module 1
1.3 Product Information
1.3.1 SmPC, Labelling and Package Leaflet

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, 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 national
reporting system: . By reporting side effects you can help provide
more information on the safety of this medicine.
5.

How to store

Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the carton and bottle after EXP.
Store below 30°C.
After first opening, the product should be used immediately. Discard any unused contents.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

Zoledronic acid 5 mg/100 ml solution for infusion

UK/H/5299/001/DC

Version: 9
Date: December 2015

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Common Technical Document
Module 1
1.3 Product Information
1.3.1 SmPC, Labelling and Package Leaflet

Contents of the pack and other information

What contains
The active substance is zoledronic acid. Each vial with 100 ml of solution contains 5 mg
zoledronic acid anhydrous (as monohydrate). One ml of solution contains 0.05 mg zoledronic
acid (as monohydrate).
The other ingredients are mannitol, sodium citrate anhydrous and water for injections.
What looks like and contents of the pack
is a clear and colourless solution. It comes in 100 ml glass bottles as a ready-to-use
solution for infusion. It is supplied in packs containing one bottle as unit pack or in multi-packs
comprising 5 packs, each containing 1 bottle. Not all pack sizes may be marketed.
Marketing Authorisation Holder
<[To be completed nationally]>
Manufacturer
<[To be completed nationally]>
This medicinal product is authorised in the Member States of the EEA under the following
names:
<[To be completed nationally]>
This leaflet was last revised in {MM/YYYY}
<[To be completed nationally]>
Other sources of information

----------------------------------------------------------------------------------------------------------------The following information is intended for healthcare professionals only
The following information is intended for medical or healthcare professionals only (see
section3):
How to prepare and administer
5 mg/100 ml 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.
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. 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.
Zoledronic acid 5 mg/100 ml solution for infusion

UK/H/5299/001/DC

Version: 9
Date: December 2015

Common Technical Document
Module 1
1.3 Product Information
1.3.1 SmPC, Labelling and Package Leaflet

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Aseptic techniques must be followed during preparation of the infusion. The infusion must be
conducted according to standard medical practice.
How to store
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the carton and bottle.
Store below 30°C.
After first opening, the product should be used immediately. Discard any unused contents.

Zoledronic acid 5 mg/100 ml solution for infusion

UK/H/5299/001/DC

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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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