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pACRAGETEOTlIFrnNROT/morc FURTHFUSER"

jZoledronic Acid 4mg/5ml Concentrate for solution for infusion

^oledronic acid

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|n this leaflet

d. What Zoledronic Acid Concentrate is and what it is used for

2. What you need to know before you are given Zoledronic Acid Concentrate b. How Zoledronic Acid Concentrate is used ft. Possible sideeffects . How to store ZoledronicAcid Concentrate . Contents of the packand other information

1. WhatZoledronic Acid Concentrate is and what it is used for

W active substance in ZoledronicAcid Concentrate is zoledronic acid, which belongs lo a group of substances called bisphosphonates. Zoledronic acid works by attaching Itself to the bone and slowing down the rate of bone change. It is used:

To prevent bone complications e.g. fractures, in adult patients with bone metastases (spread of cancer from the primary cancer site to the bone).

To reduce the amount of calcium in the blood in adult patients where it is too high due to the presence of a tumour. Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased. This condition is known as tumour-induced hypercalcaemia (TIH).

2. Whatyou need to know before you are given ZoledronicAcid Concentrate

Follow carefully all instructions given to you by your doctor.

Your doctor will carry out blood tests before you start treatment with Zoledronic Acid fconcentrate and will check your response to treatment at regular intervals.

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.You should not be given ZoledronicAcid Concentrate: bVarningsand precautions

peforeyou are given ZoledronicAcid Concent rate, tellyourdoctor:

•    if you have or have had a kidney problem.

•    if you have or have had pain, swelling or numbness of the jaw, a feeling of I heaviness in the jaw or loosening of a tooth.

| if you are having dental treatment or are due to undergo dental surgery, tell your jlentist that you are being treated with ZoledronicAcid Concentrate.

deduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle tramps, dry skin, burning sensation, have been reported in patients treated with ^oledronic Acid Concentrate. Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe Tiypocalcaemia. In some instances the hypocalcaemia may be life-threatening. If any of these apply to you, tell your doctor straight away. If you have pre-existing jiypocalcaemia, it must be corrected before initiating the first dose of ZoledronicAcid ^Concentrate. You will be given adequate calcium and vitamin D supplements.

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Patients aged 65 years and over

ZoledronicAcid Concentrate can be given to people aged 65 years and over. There id no evidence to suggest that any extra precautions are needed.

Children and adolescents

ZoledronicAcid Concentrate is not recommended for use in adolescents and childreid below the age of 18 years.

Other medicines and ZoledronicAcid Concentrate

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important that yoi| tell yourdoctor if you are also taking:

•    Aminoglycosides (medicines used to treat severe infections), calcitonin (a type or medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loopl diuretics (a type of medicine to treat high blood pressure or oedema) or othe| calcium-lowering medicines, since the combination of these withj bisphosphonates may cause the calcium level in the blood to become too low.

•    Thalidomideorany other medicines which may harm your kidneys.

•    Aclasta (a medicine that also contains zoledronic acid and is used to trea osteoporosis and other non-cancer diseases of the bone), or any othei bisphosphonate, since the combined effects of these medicines taken togethei with ZoledronicAcid Concentrate are unknown.

•    Anti-angiogenic medicines (used to treat cancer), since the combination of these) with ZoledronicAcid Concentrate has been associated with an increased risk o^ osteonecrosis of the jaw (ON J).

Pregnancy and breast-feeding

You should not be given Zoledronic Acid Concentrate if you are pregnant. Tell your| doctor if you are or think that you may be pregnant.

You must not be given ZoledronicAcid Concentrate if you are breast-feeding.

Askyour doctor for advice before taking any medicine while you are pregnant or breast-1 feeding.

Driving and using machines

There have been very rare cases of drowsiness and sleepiness with the use ol Zoledronic Acid Concentrate. You should therefore be careful when driving, using machinery or performing other tasks that need full attention.

3. How ZoledronicAcid Concentrate is used

•    Zoledronic Acid Concentrate must only be given by healthcare professional^ trained in administering bisphosphonates intravenously, i .e. through a vein.

•    Your doctor will recommend that you drink enough water before each treatment td help prevent dehydration.

•    Carefully follow all the other instructions given to you by your doctor, nurse o pharmacist.

How much ZoledronicAcid Concentrate is given

•    Theusualsingledosegivenis4mg.

•    If you have a kidney problem, your doctorwill give you a lower dose depending oi theseverity of your kidney problem.

How often you will be given ZoledronicAcid Concentrate

•    If you are being treated for bone metastases, you will be given one infusion ZoledronicAcid Concentrate every three tofourweeks.

•    If you are being treated to reduce the amount of calcium in your blood, you wil normally only begiven one infusion of ZoledronicAcid Concentrate.

Information forthe Healthcare Professional

Howto prepare and administerZoledronicAcid Concentrate

[to prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Eoledronic Acid Concentrate (5.0 ml) with 100 ml of calcium-free or other divalent fcation-free infusion solution.

|f a lower dose of Zoledronic Acid Concentrate is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution. To avoid potential incompatibilities, the infusion solution used for dilution must beeither0.9%w/vsodiumchlorideor5%w/vglucose solution.

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Do not mix Zoledronic Acid Concentrate with calcium-containing or otheJ divalent cation-containing solutions such as lactated Ringer's solution.

Instructions for preparing reduced doses of ZoledronicAcid Concentrate:

Withdraw the appropriate volume of the liquid concentrate, as follows:

•    4.4mlfor3.5mgdose

•    4.1 mlfor3.3mgdose

•    3.8mlfor3.0mgdose

For single use only. Any unused solution should be discarded. Only clear solution freel from particles and discolouration should be used. Aseptic techniques must be follower^ during the preparation of the infusion.

flow Zoledronic Acid Concentrate is given

.ZoledronicAcid Concentrate is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a beparate infusion line.

patients whose blood calcium levels are not too high will also be prescribed calcium pnd vitamin D supplements to be taken each day.

If you are given more Zoledronic Acid Concentrate than you should be

|f you have received doses higher than those recommended, you must be carefully pnonitored by your doctor. This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or fchangesin kidney function, including severe kidney impairment. If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.

4. Possible side effects

pike all medicines, this medicine can cause side effects, although not everybody gets ihem. The most common ones are usually mild and will probably disappear after a short time.

bellyourdoctor about any of the following serious side effects straight away:

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Common (may affect up to 1 in 10 people):

•    Severe kidney impairment (will normally be determined by your doctorwith certain specific blood tests).

b Low level of calcium in the blood.

Ilncommon (may affect up to 1 in 100 people):

l Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness I 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.

I Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving I    zoledronic acid for 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.

I Severe allergic reaction: shortness of breath, swelling mainly of the face and I throat.

Rare (may affect up to 1 in 1,000 people):

•    As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; I secondary to hypocalcaemia).

■Very rare (may affect up to 1 in 10,000 people):

•    As a consequence of low calcium values: seizures, numbness and tetany

I    (secondary to hypocalcaemia).

.Tell yourdoctor about any of thefollowing side effects as soon as possible:

•    Very common:

L Low level of phosphate in the blood.

Common:

•    Headache and a flu-like syndrome consisting of fever, fatigue, weakness,

I    drowsiness, chills and bone, joint and/or muscle ache. In most cases no specific

|    treatment is required and the symptoms disappear after a short time (couple of

I    hours or days).

•    Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite. I Conjunctivitis

b Low level of red blood cells (anaemia).

Uncommon:

l Hypersensitivity reactions, b Low blood pressure, f Chest pain.

^rom a microbiological point of view, the diluted solution for infusion should be used Immediately. If not used immediately, in-use storage times and conditions prior to use ere the responsibility of the user and would normally not be longer than 24 hours at z°C - 8°C when diluted with 100ml of 0.9% w/v sodium chloride solution or 5% w/v [glucose solution. The refrigerated solution should then be equilibrated to room (emperature prior to administration.

[fhe solution containing zoledronic acid is given as a single 15-minute intravenous Infusion in a separate infusion line. The hydration status of patients must be assessed |orior to and following administration of Zoledronic Acid Concentrate to ensure that they pre adequately hydrated.

(studies with several types of infusion lines made from polyvinylchloride, polyethylene land polypropylene showed no incompatibility with ZoledronicAcid Concentrate.

•    Skin reactions (redness and swelling) atthe infusion site, rash, itching.

•    High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances,

taste disturbances, trembling, tingling or numbness of the hands or feet) diarrhoea, constipation, abdominal pain, dry mouth.    |

•    Low counts of white blood cells and blood platelets.

•    Low level of magnesium and potassium in the blood. Your doctor will monitor this

and take any necessary measures.    I

•    Weight increase.    |

•    Increased sweating.

•    Sleepiness.

•    Blurred vision, tearing of the eye, eye sensitivity to light.

•    Sudden coldnesswith fainting, limpness orcollapse.    |

•    Difficulty in breathing with wheezing orcoughing.

•    Urticaria.

Rare:    |

•    Slow heart beat.

•    Confusion.

•    Unusual fracture of the thigh bone particularly in patients on    long-term treatmeni

for osteoporosis may occur rarely. Contact your doctor if you experience painj weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.

•    Interstitial lung disease (inflammation of the tissue around    the    air sacks of the)

lungs).    |

•    Painful rednessand/orswelling oftheeye.    i

Very rare:

•    Fainting due to low blood pressure.    |

•    Severe bone, joint and/or muscle pain, occasionally incapacitating.    i

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes an^l possible side effects not listed in this leaflet. You can also report side effects directly viy the Yellow Card Scheme at: www.mhra.qov.uk/vellowcard By reporting side effects you can help provide more information on the safety of this) medicine.

5. Howto store ZoledronicAcid Concentrate

Your doctor, nurse or pharmacist knows how to store Zoledronic Acid Concentrate! properly (seesection 6).    |

6. Contents of the pack and other information

WhatZoledronicAcid Concentrate contains    |

•    The active substance of ZoledronicAcid Concentrate iszoledronicacid.

•    The other ingredients are: mannitol, sodium citrate, waterfor injection.

WhatZoledronicAcid Concentrate looks like and contents of the pack    |

Zoledronic Acid Concentrate is supplied as a liquid concentrate in a vial. One viaL contains4 mg of zoledronic acid.

ZoledronicAcid Concentrate is supplied in packs containing 1,4,10 or25 vials.

Not all pack sizes may be marketed.    |

Marketing Authorisation Holder

Morningside Healthcare Ltd

115 Narborough Road, Leicester LE3 0PA, UK    |

Manufacturer

Morningside Pharmaceuticals Ltd

5 Pavilion Way, Castle Business Park    I

Loughborough, LE115GW, UK

This leaflet was last revised in January 2015.

Since no data are available on the compatibility of Zoledronic Acid Concentrate witf| other intravenously administered substances, ZoledronicAcid Concentrate must not by mixed with other medications/substances and should always be given through a separate infusion line.

Howto store ZoledronicAcid Concentrate    ■

-KeepZoledronicAcidConcentrateoutof the sight and reach of children.

-Do not use ZoledronicAcid Concentrate after the expiry date stated on the pack.

-The unopened vial does not require any specific storage conditions.    |

-The diluted ZoledronicAcid Concentrate infusion solution should be used immediately in order to avoid microbial contamination.