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ZOLEDRONIC ACID 5 MG SOLUTION FOR INFUSION

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

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5 mm

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Package leaflet: Information for the user

Zoledronic Acid 5 mg solution for infusion
Zoledronic acid
1831

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);
- you are taking medicines called corticosteroids (such as
prednisolone or dexamethasone)
- you have cancer.

Read all of this leaflet carefully before you start using 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 use Zoledronic
3
4
5
6

Acid
How to use Zoledronic Acid
Possible side effects
How to store Zoledronic Acid
Contents of the pack and other information

Your doctor may ask you to undergo a dental examination
before you start treatment with Zoledronic Acid.
While being treated with this medicine, 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 non-healing of sores or
discharge, as these could be signs of osteonecrosis of the jaw.

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.

Monitoring test
Your doctor should do a blood test to check your kidney
function (levels of creatinine) before each dose of this
medicine. 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 this medicine 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.

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.

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 this medicine, do not drive or use
machines until you feel better.

2 What you need to know before you use

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

Zoledronic Acid contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per
100 ml; i.e. essentially "sodium-free."

You must not be given Zoledronic Acid:
3 How to use 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.

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.

Warnings and precautions
Talk to your doctor before you are given Zoledronic Acid:

In case you recently broke your hip, it is recommended that
Zoledronic Acid is administered two or more weeks after your
hip repair surgery.

- if you are being treated with any medicine containing
zoledronic acid, which is also the active substance of
Zoledronic Acid. (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.

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
treatment of Paget's disease of the bone.

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.

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

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.

INFORMATION FOR THE HEALTHCARE PROFESSIONAL
The following information is intended for medical or healthcare professionals only (see section 3):
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. This medicine 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.
5 mm
V2G
270717

Front

Product Name

Zoledronic Acid Injection 5 mg/100 mL

Sap code :

Reference Artwork

Party Artwork

Packaging Material

Pack Insert Artwork

Reason of change : New Development

Proof 1

06.01.2017

Size : Foil Width

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Country :

UK

Proof 2

05.04.2017

Size : Foil Repeat Length

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Pack Size :

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Proof 3

27.07.2017

Size : Strip Size

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Barcode No. :

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Size : Carton/Label

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Pharmacode :

1831

Size : PI - Open Size
PI - Close Size

L. 180 x H. 480 mm
L. 45 x H.80 mm

No. of colours :

1

PM Style/Type :

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Min. Font Size :

9 Pt.

Remark (If any) :

Change in product name for Italy.

Developed For :

Emcure - Hinjawadi
Trupti Kale

Black

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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.

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.

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).

! 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.

If you forget to use Zoledronic Acid
Contact your doctor or hospital as soon as possible to reschedule your appointment.
If you stop using 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 this medicine.

! 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 postdose symptoms such as fever, vomiting and diarrhoea.

If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.

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 listed in the Yellow Card Scheme
www.mhra.gov.uk/yellowcard. By reporting side effects you
can help provide more information on the safety of this
medicine.

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 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 and vial after EXP.
- The unopened vial does not require any special storage
conditions.
- 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.

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 this medicine.

6 Contents of the pack and other information

! Uncommon (may affect up to 1 in 100 people)
Skin reactions such as redness.
Swelling, redness, pain and itching to the eyes or eye
sensitivity to light.

What Zoledronic Acid contains
- The active substance is zoledronic acid. Each vial with 100
ml of solution contains 5 mg zoledronic acid anhydrous (as
monohydrate).
- The other ingredients are mannitol, sodium citrate and
water for injections.

! 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.

What Zoledronic Acid looks like and contents of the pack
Zoledronic Acid is a clear and colourless solution. It comes in
100 ml glass vials as a ready-to-use solution for infusion. It is
supplied in packs containing one vial as unit pack, or in
multipacks comprising five packs, each containing one vial.
Not all pack sizes may be marketed.

! 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 with this medicine.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon, St Neots
Cambridgeshire, PE19 8ET
UK

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 this medicine. 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.

Manufacturer
Emcure Pharma UK Ltd,
Basepoint Business Centre,
110 Butterfield,
Great Marlings,
Luton, LU2 8DL
UK

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

This medicinal product is authorised in the Member States
of the EEA under the following names:
United Kingdom Zoledronic acid 5 mg Solution for Infusion
Austria
Zoledronsäure Tillomed 5 mg
Infusionslösung
Germany
Zoledronsäure Tillomed 5 mg
Infusionslösung
Spain
Ácido zoledrónico Tillomed 5 mg solución
para perfusión EFG
Italy
Acido zoledronico Emcure Pharma

! Common (may affect up to 1 in 10 people)
Headache, dizziness, feeling or being sick, 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.

This leaflet was last revised in 07/2017

! Uncommon (may affect up to 1 in 100 people)
Flu, infection of the nose, sinuses or throat (upper
respiratory tract infections), decreased red cell count
which may make you look pale and feel tired, loss of
appetite, sleeplessness, sleepiness which may include
reduced alertness and awareness, tingling sensation or
numbness, extreme tiredness, trembling, temporary loss of

-

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 vial after EXP.
The unopened vial does not require any special storage conditions.
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.

1831

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510008861GB02

How to store Zoledronic Acid

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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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