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ZOLEDRONIC ACID MYLAN 5 MG/100 ML SOLUTION FOR INFUSION

Active substance(s): ZOLEDRONIC ACID MONOHYDRATE / ZOLEDRONIC ACID MONOHYDRATE / 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. See section 4.
What is in this leaflet
1.
What Zoledronic acid 5 mg/100 ml solution for infusion is and what it is used for
2.
What you need to know before you are given Zoledronic acid 5 mg/100 ml solution for infusion
3.
How Zoledronic acid 5 mg/100 ml solution for infusion is given
4.
Possible side effects
5.
How to store Zoledronic acid 5 mg/100 ml solution for infusion
6.
Contents of the pack and other information

1.

What Zoledronic acid 5 mg/100 ml solution for infusion is and what it is used for

Zoledronic acid 5 mg/100 ml solution for infusion 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.
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 5 mg/100 ml solution for
infusion

Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are
given Zoledronic acid 5 mg/100 ml solution for infusion.

You must not be given Zoledronic acid 5 mg/100 ml solution for infusion:
 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 or nurse before you are given Zoledronic acid 5 mg/100 ml solution for infusion:
 if you have a kidney problem, or used to have one.
 If you have problems absorbing calcium into your blood stream.
 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);

you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)

you have cancer:

you are taking medicines called angiogenesis inhibitors (used to treat cancer or other diseases
involving overgrowth of blood vessels);

you are having chemotherapy;

you are having radiotherapy to the head or neck;

you have low levels of red blood cells (anaemia), blood clotting problems or an infection.
Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic
acid 5 mg/100 ml solution for infusion.
Monitoring test
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each
dose of zoledronic acid.
While being treated with Zoledronic acid 5 mg/100 ml solution for infusion, 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 5 mg/100 ml solution for infusion.

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.
If you have thigh, hip or groin pain during treatment contact your doctor straight away (see section 4
‘Possible side effects’). You may be at risk of breaking your thigh bone.
If you have low levels of calcium in the blood you may have muscle cramps, numbness, or a tingling
sensation especially in the area around the mouth, these may be as a result of low levels of calcium in
your blood. Contact your doctor straight away if you get these during treatment.
Children and adolescents
Zoledronic acid 5 mg/100 ml solution for infusion is not recommended for anyone under 18 years of
age. The use of Zoledronic acid 5 mg/100 ml solution for infusion in children and adolescents has not
been studied.
Other medicines and Zoledronic acid 5 mg/100 ml solution for infusion
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.
 other medicines that also contain zoledronic acid which are used to treat osteoporosis and other
non-cancer diseases of the bone, or any other bisphosphonate.
Pregnancy and breast-feeding
You must not be given Zoledronic acid 5 mg/100 ml solution for infusion 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/100 ml solution for infusion, do not drive or use
machines until you feel better.
Zoledronic acid 5 mg/100 ml solution for infusion contains sodium.
This medicinal product contains less than 1 mmol sodium (23 mg) per infusion, i.e. essentially
’sodium-free’.

3.

How to use Zoledronic acid 5 mg/100 ml solution for infusion

Follow carefully all instructions given to you by your doctor or nurse. Check with your doctor or
nurse if you are not sure.
It is important for you to drink at least 2 glasses of fluid (preferably water), a few hours before
receiving Zoledronic acid 5 mg/100 ml solution for infusion to prevent dehydration. This is especially
important in patients who take diuretics (“water tablets”) and in elderly patients (age 65 years or
over).
Osteoporosis
The recommended 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 5 mg/100 ml solution for
infusion 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/100 ml solution for infusion 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 recommended 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/100 ml solution for infusion
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/100 ml solution for infusion. 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 you missed a dose of Zoledronic acid 5 mg/100 ml solution for infusion
Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Before stopping Zoledronic acid 5 mg/100 ml solution for infusion therapy
If you are considering stopping Zoledronic acid 5 mg/100 ml solution for infusion 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/100 ml solution for infusion.
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.
Contact your doctor immediately or if serious, go to the nearest hospital emergency department
if you get any of the following side effects:
Common (may affect up to 1 in 10 people)
 A very fast and irregular heart rhythm (atrial fibrillation). This 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.
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)
 Severe allergic reactions such as a red itchy skin rash (known as nettle rash or hives), swelling of
the face, lips, mouth, tongue or throat causing difficulty breathing or swallowing, a feeling of light
headedness with possible collapse and unconsciousness.
 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).
 Producing little or no urine, pain when passing urine, urine is cloudy or dark coloured possibly
with lower back pain. These may be signs of serious problems with your kidneys.
Other side effects include:
Very common (may affect more than 1 in 10 people)
 Fever
Common (may affect up to 1 in 10 people)
 Headache, dizziness.
 Redness in the whites of the eyes.
 Feeling sick (nausea), being sick (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, general feeling of being unwell.
 Redness, swelling and/or pain at the infusion site.
 Increase of protein in the blood which can be seen in a blood test.
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.
 Runny or blocked nose, sinus congestion or sore throat. These are signs of an upper
respiratory tract infections.
 Tiredness, shortness of breath, looking pale. These may be signs of low levels of red blood
cells.
 Reduced appetite.
 Difficulty falling asleep, sleepiness which may include reduced alertness and awareness,
tingling sensation or numbness in the hands or feet, extreme tiredness, trembling, fainting.
 Swollen, runny eyes or a feeling of grit in the eyes (conjunctivitis).
 Eye pain.
 Spinning sensation, when standing still (vertigo)
 Fast heart beats that feel like a thumping in the chest (palpitations), increased blood pressure,
flushing.
 Cough, shortness of breath.
 Indigestion, stomach 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 frequent urination, protein in the urine which can be seen in a urine test.
Swelling of hands, ankles or feet, thirst, chest pain.
Toothache, inflammation of the food pipe, inflammation of the stomach causing nausea
(feeling sick), vomiting (being sick), cramps or diarrhoea.
Taste disturbances.
Acute phase reactions.

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.
 Red eye with blurred or cloudy vision, shadows, dots or veils that move across the field of
vision (floaters) in one or both eyes.
 Mild ache or soreness of the eyes.
Not known (frequency cannot be estimated from the available data)
 Other allergic reactions
 Low blood pressure, dehydration as a result of symptoms such as fever, vomiting and diarrhea
after treatment.
 Redness or visible blood vessels on the whites of the eyes with severe eye pain, pain in your
eyebrow, temple or jaw.
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/100 ml solution for infusion

Your doctor, pharmacist or nurse knows how to store Zoledronic acid 5 mg/100 ml solution for
infusion properly.

6.

Contents of the pack and other information

What Zoledronic acid 5 mg/100 ml solution for infusion contains



The active substance is zoledronic acid. Each vial with 100 ml of solution contains 5 mg
zoledronic acid (as monohydrate).
One ml solution contains 0.05 mg zoledronic acid (as monohydrate).
The other ingredients are mannitol (E421), sodium citrate (E331) (see section 2 ‘Zoledronic acid
contains sodium’) and water for injections.

What Zoledronic acid 5 mg/100 ml solution for infusion looks like and contents of the pack
Zoledronic acid 5 mg/100 ml solution for infusion is a clear and colourless solution.

It comes in 100 ml clear Type I silicon dioxide inner coated glass vials, capped with Type I
bromobutyl rubber stoppers and sealed with aluminum polypropylene flip off seals, as a ready-to-use
solution for infusion.
Zoledronic acid 5 mg/100 ml solution for infusion is supplied as packs containing 1, 4or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire EN6 1TL, United Kingdom
Manufacturer
Agila Specialties Polska Sp. Zo.o., 10, Daniszewska Str., 03-230 Warsaw, Poland
Sanochemia Pharmazeutica AG, Landeggerstrasse 7, A - 2491 Neufeld an der Leitha, Austria
This leaflet was last revised in
12/2016
----------------------------------------------------------------------------------------------------------------The following information is intented for healthcare professionals only:
How to prepare and administer Zoledronic acid 5 mg/100 ml solution for infusion
Zoledronic acid 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.
Zoledronic acid 5 mg/100 ml solution for infusion 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/100 ml
solution for infusion 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 5 mg/100 ml solution for infusion
Keep this medicine out of the sight and reach of children.
Do not use Zoledronic acid 5 mg/100 ml solution for infusion after the expiry date which is stated on
the carton and vial. The expiry date refers to the last day of that month.
The unopened vial does not require any special storage conditions.
After first opening: chemical and physical stability has been demonstrated for 24 hours at 2°C - 8°C
and at 25°C. From a microbiological point of view, the solution for infusion should be used

immediately. 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.
Do not throw away any medicines via wastewater. These measures will help protect the environment.

Expand Transcript

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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