Zoledronic acid Teva Pharma
zoledronic acid
zoledronic acid
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 Zoledronic acid Teva Pharma is and what it is used for
What you need to know before you are given Zoledronic acid Teva Pharma
How Zoledronic acid Teva Pharma is given
Possible side effects
How to store Zoledronic acid Teva Pharma
Contents of the pack and other information
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Zoledronic acid Teva Pharma contains the active substance zoledronic acid. It belongs to a group of medicines called bisphosphonates and is used to treat post-menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with corticosteroids used to treat inflammation, and Paget’s disease of the bone in adults.
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 Teva Pharma strengthens the bone and therefore makes it less likely to break. Zoledronic acid Teva Pharma 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.
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 Teva Pharma works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone.
Follow all instructions given to you by your doctor, pharmacist or nurse carefully before you are given Zoledronic acid Teva Pharma.
if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (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.
Talk to your doctor, pharmacist or nurse before you are given Zoledronic acid Teva Pharma:
if you are being treated with any medicine containing zoledronic acid, which is also the active substance of Zoledronic acid Teva Pharma (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
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.
A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis. ONJ can also occur after stopping treatment.
It is important to try and prevent ONJ developing as it a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.
Before receiving Zoledronic acid Teva Pharma treatment, tell your doctor, pharmacist or nurse if
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you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction;
you do not receive routine dental care or have not had a dental check-up for a long time;
you are a smoker (as this may increase the risk of dental problems);
you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders);
you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
you have cancer.
Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic acid Teva Pharma.
While being treated with Zoledronic acid Teva Pharma, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or are due to undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Zoledronic acid Teva Pharma. 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 osteonecrosis of the jaw.
Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Pharma. It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Pharma, as directed by your healthcare provider.
Zoledronic acid Teva Pharma is not recommended for anyone under 18 years of age. The use of Zoledronic acid Teva Pharma in children and adolescents has not been studied.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
It is 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.
You must not be given Zoledronic acid Teva Pharma 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 using this medicine.
If you feel dizzy while taking Zoledronic acid Teva Pharma, do not drive or use machines until you feel better.
This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium–free.”
Follow carefully all instructions given to you by your doctor or nurse. Check with your doctor or nurse if you are not sure.
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The usual dose is 5 mg given as one infusion per year into a vein by your doctor or nurse. The infusion will take at least 15 minutes.
In case you recently broke your hip, it is recommended that Zoledronic acid Teva Pharma 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 Teva Pharma works for one year. Your doctor will let you know when to return for your next dose.
For the treatment of Paget’s disease, Zoledronic acid Teva Pharma should be prescribed only by physicians with experience in the treatment of Paget’s disease of the bone.
The usual 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 Teva Pharma 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 Teva Pharma. 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.
Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with Zoledronic acid Teva Pharma, as directed by your doctor. This will help prevent dehydration. You may eat normally on the day you are treated with Zoledronic acid Teva Pharma. This is especially important in patients who take diuretics (“water pills”) and in elderly patients (age 65 years or over).
Contact your doctor or hospital as soon as possible to re-schedule your appointment.
If you are considering stopping Zoledronic acid Teva Pharma 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 Teva Pharma.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 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 Teva Pharma. 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 reduce these side effects. The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Pharma.
Common (may affect up to 1 in 10 people)
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Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving Zoledronic acid Teva Pharma for the treatment of postmenopausal osteoporosis. It is currently unclear whether Zoledronic acid Teva Pharma causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received Zoledronic acid Teva Pharma.
Uncommon (may affect up to 1 in 100 people)
Swelling, redness, pain and itching to the eyes or eye sensitivity to light.
Very rare (may affect up to 1 in 10,000 people)
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.
Not known (frequency cannot be estimated from the available data)
Pain in the mouth, and/or jaw, swelling or non-healing sores in 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 Zoledronic acid Teva Pharma or after stopping treatment.
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 Zoledronic acid Teva Pharma. It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving Zoledronic acid Teva Pharma, as directed by your healthcare provider.
If you experience any of the above side effects, you should contact your doctor immediately.
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, arms 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, swelling and/or pain at the infusion site.
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, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Rare (may affect up to 1 in 1,000 people)
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.
Not known (frequency cannot be estimated from the available data)
Medicinal product no longer authorised
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.
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 thenationalreportingsystem listedinAppendixV. By reporting side effects, you can help provide more information on the safety of this medicine.
Your doctor, pharmacist or nurse knows how to store Zoledronic acid Teva Pharma properly. Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP. The expiry date refers to the last day of that month.
The unopened bottle does not require any special storage conditions.
After opening the bottle, chemical and physical in-use stability has been demonstrated for
24 hours at 2 to 8ºC and 25ºC. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C. Allow the refrigerated solution to reach room temperature before administration.
Do not use this medicine if you notice any discolouration or particles in the solution.
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 to protect the environment.
The active substance is zoledronic acid. One bottle contains 5 mg zoledronic acid (as monohydrate). Each ml of solution contains 0.05 mg zoledronic acid (as monohydrate).
The other ingredients are mannitol, sodium citrate and water for injections.
Zoledronic acid Teva Pharma is a clear and colourless solution. It comes in a clear plastic bottle. Each bottle contains 100 ml of solution. It is supplied in packs sizes of 1, 5 and 10. The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Not all pack sizes may be marketed.
Teva B.V. Swensweg 5 2031GA Haarlem Netherlands Manufacturer
Teva Pharmaceutical Works Private Limited Company
Táncsics Mihály út 82 H-2100 Gödöllő Hungary
Pharmachemie B.V. | ||
Swensweg 5 | ||
2031 GA Haarlem | ||
The Netherlands | ||
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For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma Belgium N.V./S.A./AG Tel/Tél: +32 3 820 73 73
UAB"Sicor Biotech" Tel: +370 5 266 02 03
Тева Фармасютикълс България ЕООД Teл: +359 2 489 95 82
Teva Pharma Belgium N.V./S.A./AG, Belgique/Belgien
Tél/Tel: +32 3 820 73 73
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111
Teva Gyógyszergyár Zrt
Tel.: +36 1 288 64 00
Teva Denmark A/S Tlf: +45 44 98 55 11
Teva Pharmaceuticals Ireland, L-Irlanda
Tel: +353 51 321740
TEVA GmbH
Tel: +49 731 402 08
Teva Nederland B.V.
Tel: +31 800 0228400
UAB "Sicor Biotech" Eesti filiaal Tel: +372 661 0801
Teva Norway AS Tlf: +47 66 77 55 90
Teva Ελλάς Α.Ε.
Τηλ: +30 210 72 79 099
ratiopharm Arzenimittel Vertriebs-GmbH
Tel: +43 1 97007-0
Teva Pharma S.L.U. Tél: +34 91 387 32 80
Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +48 22 345 93 00
Teva Santé
Tél: +33 1 55 91 7800
Teva Pharma - Produtos Farmacêuticos Lda
Tel: +351 214 235 910
Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000
Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 24
Teva Pharmaceuticals Ireland
Tel: +353 51 321 740
Pliva Ljubljana d.o.o.
Tel: +386 1 58 90 390
ratiopharm Oy, Finnland Sími: +358 20 180 5900
Teva Pharmaceuticals Slovakia s.r.o.
Tel: +421 2 5726 7911
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Teva Italia S.r.l.
Tel: +39 028917981
ratiopharm Oy
Puh/Tel: +358 20 180 5900
Teva Ελλάς Α.Ε., Ελλάδα
Τηλ: +30 210 72 79 099
Teva Sweden AB Tel: +46 42 12 11 00
UAB "Sicor Biotech" filiāle Latvijā Tel: +371 673 23 666
Teva UK Limited
Tel: +44 1323 501 111
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The following information is intended for healthcare professionals only:
Zoledronic acid Teva Pharma 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 Teva Pharma 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
Teva Pharma 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
The unopened bottle does not require any special storage conditions.
Medicinal product no longer authorised
After opening the bottle, the product should be used immediately in order to avoid microbial contamination. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C - 8°C. Allow the refrigerated solution to reach room temperature before administration.