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AstraZeneca

Zometa
zoledronic acid

Package leaflet: Information for the user


Zometa 4 mg powder and solvent for solution for infusion

zoledronic acid


Read all of this leaflet carefully before you are given this medicine because it contains important information for you.


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 Zometa 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.


  1. 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 non-healing sores inside 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 while being treated with Zometa 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.


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

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

    • A kidney function disorder called Fanconi syndrome (will normally be determined by your doctor with certain urine tests).


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

    • As a consequence of low calcium values: 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.

    • Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh. Tell your doctor immediately if you experience symptoms such as new onset or worsening of aches, pain or stiffness while being treated with Zometa or after stopping treatment.

      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

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      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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


  2. How to store Zometa


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


  3. Contents of the pack and other information What Zometa contains