What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 42357/0175.

Zoledronic Acid 4 mg/100 ml solution for infusion

Package leaflet: Information for the user

Zoledronic Acid 4 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 used
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

The active substance in Zoledronic Acid is zoledronic acid, which belongs to 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 primary 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. What you need to know before you are given Zoledronic Acid

Follow carefully all instructions given to you by your doctor.

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

You should not be given Zoledronic Acid:

  • if you are breast-feeding.
  • if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic Acid belongs), or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before you are given Zoledronic Acid:

  • 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 heaviness in the jaw or loosening of a tooth. Your doctor may recommend a dental examination before you start treatment with Zoledronic acid
  • if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic Acid and inform your doctor about your dental treatment.

While being treated with Zoledronic acid, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups.

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 a condition called osteonecrosis of the jaw.

Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have a higher risk of developing osteonecrosis of the jaw.

Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin, burning sensation, have been reported in patients treated with zoledronic acid. Irregular heart beat (cardiac arrhythmia), seizures, spasm and twitching (tetany) have been reported as secondary to severe hypocalcaemia. 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 hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid You will be given adequate calcium and vitamin D supplements.

Patients aged 65 years and over

Zoledronic Acid can be given to people aged 65 years and over. There is no evidence to suggest that any extra precautions are needed.

Children and adolescents

Zoledronic Acid is not recommended for use in adolescents and children below the age of 18 years.

Other medicines and Zoledronic Acid

Tell your doctor if you are taking, have recently taken or might take any other medicines. It is especially important that you tell your doctor if you are also taking:

  • Aminoglycosides (medicines used to treat severe infections), since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
  • Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys.
  • Other medicines that also contain zoledronic acid or any other bisphosphonate, since the combined effects of these medicines are unknown.
  • Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).

Pregnancy and breast-feeding

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

You must not be given Zoledronic Acid if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

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

Zoledronic Acid contains sodium

This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially "sodium-free".

3. How Zoledronic Acid is used

  • Zoledronic Acid must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
  • Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
  • Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.

How much Zoledronic Acid is given

  • The usual single dose given is 4 mg.
  • If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.

How often Zoledronic Acid is given

  • If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic Acid every three to four weeks.
  • If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid.

How Zoledronic Acid is given

  • Zoledronic Acid 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 separate infusion line.

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

If you are given more Zoledronic Acid than you should be

If you have received doses higher than those recommended, you must be carefully monitored by your doctor. This is because you may develop serum electrolyte abnormalities (e.g. abnormal levels of calcium, phosphorus and magnesium) and/or changes in 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

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

Tell your doctor about any of the following serious side effects straight away:

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

  • Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
  • Low level of calcium in the blood.

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

  • Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, 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 Zoledronic Acid or after stopping treatment
  • Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving 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.
  • Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.

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

  • As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia), seizures, numbness and tetany (secondary to hypocalcaemia).
  • 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.

Tell your doctor about any of the following side effects as soon as possible:

Very common (may affect more than 1 in 10 people):

  • Low level of phosphate in the blood.

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

  • Headache and a flu-like syndrome consisting of fever, fatigue, weakness, 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 hours or days).
  • Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
  • Conjunctivitis.
  • Low level of red blood cells (anaemia).

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

  • Hypersensitivity reactions.
  • Low blood pressure.
  • Chest pain.
  • Skin reactions (redness and swelling) at the 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.
  • Weight increase
  • Increased sweating
  • Sleepiness
  • Blurred vision, tearing of the eye, eye sensitivity to light.
  • Sudden coldness with fainting, limpness or collapse.
  • Difficulty in breathing with wheezing or coughing.
  • Urticaria.

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

  • Slow heart beat.
  • Confusion.
  • 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.
  • Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
  • Flu-like symptoms including arthritis and joint swelling.
  • Painful redness and/or swelling of the eye

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

  • Fainting due to low blood pressure.
  • Severe bone, joint and/or muscle pain, occasionally incapacitating.

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

MHRA Yellow Card Scheme
Website: 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

Your doctor, pharmacist or nurse knows how to store Zoledronic Acid properly (see section 6).

6. Contents of the pack and other information

What Zoledronic Acid contains

  • The active substance of Zoledronic Acid is zoledronic acid. One bag contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.
  • The other ingredients are: mannitol (E-421), sodium citrate (E-331) and water for injections.

What Zoledronic Acid looks like and contents of the pack

Zoledronic Acid is supplied as a clear and colourless solution. It comes in 100 ml bags as a ready-to-use solution for infusion.

Zoledronic Acid is supplied as a unit pack containing one bag.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Amneal Pharma Europe Limited
70 Sir John Rogerson's Quay
Dublin 2
Ireland

Manufacturer

Laboratorios NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos
Madrid
SPAIN

This leaflet was last revised in July 2016

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