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 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

Zoledronic Acid contains the active substance zoledronic acid. It belongs to a group of medicines called bisphosphonates and is used to treat Paget’s disease of the bone in adults.

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 nonnal, securing fonnation of nonnal 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 Zoledronic Acid (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

Tell your doctor before you are given Zoledronic Acid:

•    if you are being treated with other medicines that also contain zoledronic acid, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic Acid are unknown.

•    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.

• if you have (or have had) pain, swelling or numbness in your gums, jaw or both, if your jaw feels heavy, or if you have lost a tooth.

Dental treatment / surgery

Before you receive dental treatment or undergo dental surgery, tell your dentist you are receiving treatment with Zoledronic Acid. Monitoring test

Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic Acid. Children and adolescents

Zoledronic Acid is not recoimnended 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 or pharmacist 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.

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.

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 any medicine.

Driving and using machines

Zoledronic Acid lias no or negligible influence on the ability to drive and use machines. If you feel dizzy while taking Zoledronic Acid, do not drive or use machines until you feel better.

Zoledronic Acid contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 100 ml vial of Zoledronic acid 5mg/100ml solution for infusion, i.e. essentially “sodium free”.

3. How Zoledronic Acid is given

Follow carefully all instructions given to you by your doctor or nurse. You should check with your doctor or nurse if you are not sure.

Your doctor should do a blood test to check your kidney functions (levels of creatinine) before each dose of Zoledronic Acid. It is important for you to drink at least one or two glasses of fluid (such as water), within a few hours before receiving Zoledronic Acid, as directed by your doctor or nurse.

Paget’s disease

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 infusion may work for longer than one year. Your doctor will let you know if you need to be treated again.

Your doctor may advise you to take calcimn 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 (low levels of calcium in the blood).

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

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 coimnon (occurring in more than 30% of patients) but are less coimnon 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 recoimnend 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.

If you experience any of the following side effects, you should contact your doctor immediately.

Common (may affect up to 1 in 10 people)

•    Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zolendronic Acid for the treatment of postmenopausal osteoporosis. It is currently unclear whether Zolendronic Acid causes this irregular heart rhythm, but you should report it to your doctor if you experience such symptoms after you have received Zolendronic Acid.

•    Swelling and/or pain at the infusion site may occur.

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.

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Not known (frequency cannot be estimated from the available data)

•    Pain in the mouth, teeth and jaw, swelling or sores inside the mouth, nmnbness 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 dentist immediately if you experience such symptoms.

•    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.

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, anns 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.

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, abnonnal kidney test results, abnonnal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.

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

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. Website: www.mlu-a.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

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 Zoledronic Acid after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of the month.

The unopened bottle does not require any special storage conditions.

After opening the bottle, the product should be used immediately in order to avoid microbial contamination. Allow the refrigerated solution to reach room temperature before administration.

6. Contents of the pack and other information

What Zoledronic Acid contains

•    The active substance is zoledronic acid. Each bottle 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) and water for injections.

What Zoledronic Acid looks like and contents of the pack

Zoledronic Acid is a clear and colourless solution. It comes in 100 ml plastic 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 and Manufacturer Marketing Authorisation Holder

Cipla (EU) Limited

Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom.

Manufacturer

S&D Pharma CZ, spol. sr.o,

Theodor 28, 273 08 Pchery (Phannosa.s. facility), CeskaRepublika Cipla (EU) Limited,

4^th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom This leaflet was last revised in 08/2014 .

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 5 mg 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 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 this medicine out of the sight and reach of children.

•    Do not use Zoledronic Acid after the expiry date which is stated on the carton and bottle after EXP.

•    The unopened bottle does not require any special storage conditions.

•    After first opening, the product should be used immediately. Discard any unused contents.

Cipla

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