Zoledronic Acid Sandoz 5mg/100ml Solution For Infusion
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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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the 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
Zoledronic acid solution for infusion contains the active substance zoledronic acid. It belongs to a group of medicines called bisphosphonates and is used to treat postmenopausal women and men with osteoporosis or osteoporosis caused by treatment with steroids, and Paget’s disease of the bone.
Other medicines and Zoledronic acid
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
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 (“water pills”) that may cause dehydration.
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.
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
There is no adequate information on the use of zoledronic acid in pregnant women. Studies in animals have shown reproductive toxicological effects. Additionally, there is no information on the use of zoledronic acid in breast-feeding women.
Pregnancy
You must not be given Zoledronic acid if you are pregnant or plan to become pregnant.
Breast-feeding
You must not be given Zoledronic acid if you are breast-feeding.
Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Driving and using machines
If you feel dizzy while taking Zoledronic acid, do not drive or use machines until you feel better.
Zoledronic acid solution for infusion contains sodium.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
Follow all instructions given to you
by your doctor carefully before you
are given Zoledronic acid.
You should not be given
Zoledronic acid
• if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of Zoledronic acid solution for infusion (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.
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.
Osteoporosis
The usual dose is 5 mg zoledronic acid given as one infusion per year into a vein by your doctor or nurse. The infusion will take at least 15 minutes.
Warnings and precautions
Tell your doctor before you are given Zoledronic acid
• if you are being treated with other medicines containing zoledronic acid (e.g. for treatment of bone metastases or tumour-induced high calcium blood levels).
• 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.
Before you receive treatment with Zoledronic acid, tell your doctor 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. Before you receive dental treatment or undergo dental surgery, tell your dentist you are receiving treatment with Zoledronic acid.
Children and adolescents
Zoledronic acid is not recommended for anyone under 18 years of age. The use of zoledronic acid in children and adolescents has not been studied.
In case you recently broke your hip, it is recommended that Zoledronic acid 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 works for one year. Your doctor will let you know when to return for your next dose.
Paget’s disease
The usual dose is 5 mg zoledronic acid, given to you as one single infusion into a vein by your doctor or nurse. The infusion will take at least 15 minutes. Zoledronic acid 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. 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.
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The following information is intended for healthcare professionals only:
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
discolouration 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.
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If a dose of Zoledronic acid is |
Not known (frequency cannot be |
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missed 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. |
estimated from the available data): • severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat • decreased blood pressure • inflammation of the eye (scleritis), inflammation of the eye’s cavity • pain in the mouth, teeth and jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth • kidney disorder (e.g. decreased urine output) • dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea. |
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If you notice any of these side effects, tell your doctor. | |
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4 Possible side effects Like all medicines, Zoledronic acid can cause side effects, although not everybody gets them. In most cases, no specific treatment is required. 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 |
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 (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine. |
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of the side effects, such as fever and chills, pain in the muscles or joints, and headache, occur within the first |
How to store Zoledronic 5 acid |
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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 |
Your doctor, pharmacist or nurse knows how to store this medicine properly. |
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reduce these side effects. The chance of experiencing these side effects decreases with subsequent |
Keep this medicine out of the sight and reach of children. |
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doses of Zoledronic acid. Very common (may affect more than 1 in 10 people): • fever. |
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month. |
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Common (may affect up to 1 in 10 people): • headache • dizziness |
The unopened bottle does not require any special storage conditions. |
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• redness and irritation of the eye • sickness, vomiting, diarrhoea • pain in the muscles, bones and/or joints, pain in the back, arms or |
After first opening, the product should be used immediately. Discard any unused contents. |
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legs • flu-like symptoms (e.g. tiredness, chills, joint and muscle pain) • chills • feeling of tiredness and lack of interest • weakness |
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. |
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• pain • feeling unwell • skin reactions such as redness, swelling and/or pain at the infusion site. |
Contents of the pack and other information |
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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. |
What Zoledronic acid solution for infusion contains The active substance is zoledronic acid. |
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Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for post-menopausal osteoporosis. It is currently unclear whether zoledronic |
Each bottle of 100 ml solution for infusion contains 5 mg zoledronic acid anhydrous (as monohydrate). 1 ml solution for infusion contains 0.05 mg zoledronic acid |
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acid causes this irregular heart rhythm but you should report it to your doctor if you experience such |
One ml solution contains 0.05 mg zoledronic acid (as monohydrate). |
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symptoms after you have received Zoledronic acid. Uncommon (may affect up to 1 in |
The other ingredients are mannitol (E421), sodium citrate (E331) and water for injections. |
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100 people): • flu, upper respiratory tract infections • decreased red cell count • decreased or 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 |
What Zoledronic acid solution for infusion looks like and contents of the pack Zoledronic acid solution for infusion 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 4 or 10 packs, each containing 1 bottle of 100 ml solution for infusion. |
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inflammation with pain and redness |
Not all pack sizes may be marketed. |
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• eye sensitivity to light • spinning sensation • increased blood pressure, flushing • strong heartbeat • cough, shortness of breath |
Marketing Authorisation Holder Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. |
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• upset stomach, abdominal pain, constipation • gastritis • dry mouth • indigestion, heartburn, inflammation of the oesophagus |
Manufacturer Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia |
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• skin rash, excessive sweating, itching, skin reddening |
or |
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• neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms • shoulder pain, pain in your chest muscles and rib cage |
EBEWE Pharma GmbH Nfg. KG, Mondseestrasse 11, A-4866 Unterach, Austria |
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• joint inflammation • muscular weakness |
or |
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• abnormal kidney test results • abnormal frequent urination • blood calcium decreased • swelling of hands, ankles or feet • thirst • toothache • taste disturbances. |
Novartis Pharma GmbH, Roonstrasse 25 und Obere Turnstrasse 8; 90429 Nurnberg, Germany. |
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Rare (may affect up to 1 in 1,000 people): • Painful redness and/or swelling of the eye • 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. |
This leaflet was last revised in 05/2013. |
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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 |
• Do not use Zoledronic acid after the expiry date which is stated on the carton and bottle. • The unopened bottle does not require any special storage conditions. |
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• Keep out of the sight and reach of children. |
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