5 mg infusion fluid, solution
zoledronic acid
What Zoledronic acid SUN 5 mg is and what it is used for
Zoledronic acid SUN 5 mg contains the active substance zoledronic acid. Zoledronic acid SUN 5 mg belongs to a group of medicines called bisphosphonates and is used to treat:
– osteoporosis in postmenopausal women and in adult men with osteoporosis or osteoporosis caused by treatment with corticosteroids used to treat inflammation
– Paget’s disease in adults.
Osteoporosis
Osteoporosis is a disease that consists of the thinning and weakening of the bone tissue and is common in women after menopause, but can also occur in men. In menopause, a woman’s ovaries stop producing the female hormone estrogen, which helps keep the bone tissue healthy. After menopause, there is a loss of bone tissue, which means that the skeleton weakens and breaks more easily. Osteoporosis can also occur in men and women due to the long-term use of corticosteroids, which can affect bone strength. Many patients with osteoporosis have no symptoms, but they are still at risk of breaking bones because osteoporosis has made the skeleton weaker. Decreased circulating levels of sex hormones, mainly estrogens converted from androgens, also play a role in the more gradual bone loss observed in men. In both women and men, Zoledronic acid SUN 5 mg strengthens the skeleton and therefore there is less risk of it breaking. Zoledronic acid SUN 5 mg is also used in patients who have recently broken their hip in a minor accident such as a fall and therefore have a risk of subsequent bone fractures.
Paget’s disease
Normally, old bone tissue is replaced with new. This process is called remodeling. In Paget’s disease, this remodeling is too rapid and new bone tissue is formed in a disorderly manner, making it weaker than normal. If the disease is not treated, the bones can deform and cause pain and possibly break. Zoledronic acid SUN 5 mg works by restoring the remodeling process in the bone to normal, ensuring the formation of normal bone tissue and thus rebuilding the strength of the bone tissue.
Zoledronic acid contained in Zoledronic acid SUN 5 mg may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you receive Zoledronic acid SUN 5 mg
Carefully follow all instructions given to you by your doctor, pharmacist, or nurse before you receive Zoledronic acid SUN 5 mg.
Zoledronic acid SUN 5 mg should not be used:
- if you are allergic to zoledronic acid, or any of the other ingredients of this medicine (listed in section 6), or to other bisphosphonates
- if you have hypocalcemia (calcium level in the blood is too low).
- if you have severe kidney problems.
- if you are pregnant.
- if you are breastfeeding.
Warnings and precautions
Talk to your doctor before receiving Zoledronic acid SUN 5 mg:
- if you are treated with other products, which contain the same active substance, zoledronic acid, such as Zoledronic acid SUN 5 mg. Other products, which contain the same active substance zoledronic acid, are used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium
- if you have or have had any kidney disease
- if you cannot take a daily calcium supplement
- if you have had surgery to remove any or all of the parathyroid glands in your neck
- if you have had parts of your small intestine removed.
After marketing approval, a side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in patients treated with zoledronic acid for osteoporosis. ONJ can also occur after stopping treatment.
It is important to try to prevent ONJ from developing as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, there are certain precautions you should take.
Before receiving Zoledronic acid SUN 5 mg treatment, talk to your doctor, pharmacist, or nurse if
- Do you have any problems with your mouth or teeth such as poor dental health, gum problems, or a planned tooth extraction
- you do not receive regular dental care or have not had a dental examination 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 starting treatment with Zoledronic acid SUN 5 mg.
While you are being treated with Zoledronic acid SUN 5 mg, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups. If you wear dentures, make sure they fit properly. If you are receiving dental treatment or are going to undergo dental surgery (e.g. tooth extraction), inform your doctor about your dental care and tell your dentist that you are being treated with
Zoledronic acid SUN 5 mg. Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or sores that do not heal or drain, as these may be signs of osteonecrosis of the jaw.
Monitoring of kidney function
Your doctor should take a blood test to check your kidney function (creatinine levels) before each dose of Zoledronic acid SUN 5 mg. You must drink at least 2 glasses of liquid (such as water) a few hours before you receive Zoledronic acid SUN 5 mg, as instructed by a healthcare professional.
Children and young people
Zoledronic acid SUN 5 mg is not recommended for anyone under the age of 18.
Other medicines and Zoledronic acid SUN 5 mg
Tell your doctor or pharmacist if you are using, have recently taken, or might use any other medicines.
Your doctor must know all the medicines you are taking, especially if you are taking any medicine that can be harmful to the kidneys (eg aminoglycosides ) or diuretics (‘fluids’) which can cause dehydration.
Pregnancy and breastfeeding
Zoledronic acid SUN 5 mg should not be given to you if you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant.
Consult a doctor, pharmacist, or nurse before using this medicine.
Driving ability and use of machinery
If you feel dizzy while being treated with Zoledronic acid SUN, do not drive or use machines until you feel better.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zoledronic acid SUN 5 mg contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per its single maximum dose, i.e. it is almost ‘sodium-free’.
How Zoledronic acid SUN 5 mg is used
Carefully follow all instructions given to you by your doctor or nurse. Consult a doctor or nurse if you are unsure.
Osteoporosis
The usual dose is 5 mg given as an infusion into a vein once a year by your doctor or nurse. Infusion one takes at least 15 minutes.
If you have recently broken your hip, it is recommended that Zoledronic acid SUN be given two or more weeks after your hip operation.
It is important to take calcium and vitamin D supplements (eg in tablet form) according to the instructions given to you by your doctor.
In osteoporosis, Zoledronic acid SUN works for one year. Your doctor will tell you when to return for your next dose.
Paget’s disease
For the treatment of Paget’s disease: Zoledronic acid SUN 5 mg should only be prescribed by a doctor with experience in the treatment of Paget’s disease.
The recommended dose is 5 mg, given as an infusion into a vein at one time by your doctor or nurse. Infusion one takes at least 15 minutes. Zoledronic acid SUN 5 mg can work for a longer period than a year and your doctor will inform you if you need to be treated again.
Your doctor may recommend that you take calcium and vitamin D supplements (eg tablets) for at least the first ten days after receiving Zoledronic acid SUN 5 mg. You must follow this advice carefully so that the level of calcium in the blood does not become too low in the period after infusion one. Your doctor will inform you about the symptoms associated with hypocalcemia.
Zoledronic acid SUN 5 mg with food and drink
Make sure you drink enough fluids (at least one or two glasses) before and after treatment with Zoledronic acid SUN 5 mg as instructed by your doctor. This helps prevent dehydration. You can eat normally on the day you have treated with Zoledronic acid SUN 5 mg. This is especially important in patients taking diuretics (“fluids”) and in elderly patients (65 years or older).
If you have missed a dose of Zoledronic acid SUN 5 mg
Contact your doctor or the hospital as soon as possible to book a new appointment.
If you stop using Zoledronic acid SUN 5 mg
If you are considering stopping treatment with Zoledronic acid SUN 5 mg, 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 SUN 5 mg.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects associated with the first infusion are very common (occurring in 30% of patients), but are less common with subsequent infusions. The majority of side effects, such as fever and chills, muscle and joint pain, and headache, occur within the first three days after a dose of Zoledronic acid SUN 5 mg. Symptoms are usually mild to moderate and disappear within three days. Your doctor may recommend a mild pain reliever such as ibuprofen or paracetamol to reduce side effects. The likelihood of experiencing these side effects decreases with continued treatment with Zoledronic acid SUN 5 mg.
Some side effects can be serious
Common (may affect up to 1 in 10 people)
Irregular heart rhythm ( atrial fibrillation ) has been noted in patients treated with Zoledronic acid SUN 5 mg for postmenopausal osteoporosis. It is currently unclear whether Zoledronic acid SUN 5 mg causes an irregular heart rhythm, but you should report to your doctor if you experience such symptoms after being treated with Zoledronic acid SUN 5 mg.
Uncommon (may affect up to 1 in 100 people)
- swelling, redness, pain, and itching in the eyes or sensitivity to light.
Very rare (may affect up to 1 in 10,000 people)
- talk to a doctor if you have ear pain, discharge from the ear, and/or an ear infection. This could be a sign of a bone injury in the ear.
Has been reported (occurring in an unknown number of users)
- pain in the mouth and/or jaw
- swelling or sores that do not heal in the mouth or jaw
- suppuration
- numbness or a feeling of heaviness in the jaw, or tooth loss.
This may be a sign of bone damage in the jaw ( osteonecrosis ). Tell your doctor or dentist immediately if you experience such symptoms while being treated with Zoledronic acid SUN 5 mg or after stopping treatment.
Renal impairment (e.g. decreased urine production) may occur. Your doctor should take a blood test to check your kidney function (creatinine levels) before each dose of Zoledronic acid SUN 5 mg. You must drink at least 2 glasses of liquid (such as water) a few hours before you receive Zoledronic acid SUN 5 mg, as instructed by a healthcare professional.
If you experience any of the above side effects, you should contact your doctor immediately.
Zoledronic acid SUN 5 mg can 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
- nausea
- vomiting
- diarrhea
- muscle pain
- pain in bones and/or joints
- pain in the back, arms, or legs
- flu-like symptoms (eg fatigue, chills, joint and muscle pain)
- overindulge
- feeling tired and disinterested
- weakness
- pain
- malaise
- swelling and/or pain at the infusion site.
In patients with Paget’s disease, symptoms due to low levels of calcium in the blood, such as muscle spasms or numbness or a tingling sensation especially around the mouth, have been reported.
Uncommon (may affect up to 1 in 100 people)
- influenza
- upper respiratory tract infections
- decreased number of red blood cells
- loss of appetite
- insomnia
- sleepiness which may include reduced alertness and attention
- pins and needles or numbness
- extreme fatigue
- tremors
- temporary loss of consciousness
- eye infection or irritation or inflammation with pain and redness
- dizziness
- increase in blood pressure et
- redness
- cough
- shortness of breath
- indigestion
- stomach pain
- constipation
- dry mouth
- heartburn
- rash
- sweating
- itching
- red skin
- pain in the neck
- stiffness in muscles, bones, and/or joints
- joint swelling
- muscle spasms
- shoulder pain
- pain in chest muscles and chest
- arthritis
- muscle weakness
- abnormal laboratory results regarding kidney function
- frequent urination
- swelling of the hands, ankles, and feet
- thirst
- toothache
- taste disturbances.
Rare (may affect up to 1 in 1,000 people)
- low blood phosphate levels.
- unusual femur fractures, especially in patients who are treated long-term for osteoporosis, may occur in rare cases.
Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin as this may be an early sign of a possible femur fracture.
Very rare (may affect up to 1 in 10,000 people)
- talk to a doctor if you have ear pain, discharge from the ear, and/or an ear infection. This could be a sign of a bone injury in the ear.
Has been reported (occurring in an unknown number of users)
- severe allergic reactions including dizziness and difficulty breathing, swelling especially of the face and throat
- lowered blood pressure
- dehydration secondary to symptoms such as fever, vomiting, and diarrhea which appeared after dosing.
How to store Zoledronic acid SUN 5 mg
Your doctor, pharmacist, or nurse knows how to store Zoledronic acid SUN 5 mg correctly.
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and vials after EXP. The expiration date is the last day of the specified month.
Unopened vials do not require special storage instructions.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
After opening, the solution should be used immediately to avoid bacteria coming into contact with the solution. If not used immediately, the user is responsible for storage time and conditions until use. Normally this time should not exceed 24 hours at 2°C – 8°C. Allow the cooling solution to reach room temperature before administration.
Contents of the packaging and other information
Contents declaration
- The active substance is zoledronic acid. Each vial of 100 ml solution contains 5 mg anhydrous zoledronic acid (as monohydrate). One ml of solution contains 0.05 mg of anhydrous zoledronic acid (as monohydrate).
- Other ingredients are mannitol (E421), sodium citrate (E331), and water for injections.
Appearance and package sizes of the medicine
Zoledronic acid SUN 5 mg is a clear and colorless solution. It is supplied in a 100 ml glass vial as a ready-to-use solution for infusion. The label has a built-in edge that can be detached and used as a hanger.
Zoledronic acid SUN 5 mg is supplied in packs with one vial as a whole pack or multipacks of 5 packs, where each pack contains one vial.
Not all pack sizes may be marketed.
Sun Pharmaceutical Industries Europe BV
87 Polaris Avenue
2132 JH Hoofddorp
Netherlands
This medicine is approved in the European Economic Area under the names:
Denmark: Zoledronic acid SUN
Finland: Zoledronic acid SUN 5 mg infusion, liuos
Germany: Zoledronsäure SUN 5 mg Infusionslösung
The Netherlands: Zoledroninezuur SUN 5 mg oplossing voor infusie
United Kingdom: Zoledronic acid SUN 5 mg solution for infusion