Natzold 5mg Infusion is used to:

• Treat osteoporosis in postmenopausal women: To strengthen bones and reduce the risk of fractures.

• Prevent osteoporosis in postmenopausal women: When there is a risk of bone loss.

• Treat osteoporosis in men: To increase bone mass.

• Treat and prevent glucocorticoid-induced osteoporosis: In men and women who are starting or continuing long-term corticosteroid treatment.

• Treat Paget’s disease of bone: In men and women whose disease is active or at risk of complications.

The 5 mg strength is not the strength used for high blood calcium or bone metastases in cancer. A different zoledronic acid product is used for those conditions.

Zoledronic acid binds to bone and is taken up by bone-resorbing cells called osteoclasts. It blocks their activity, which slows the breakdown of bone.

As bone is lost more slowly than it is rebuilt, bone density can improve and bones become stronger. Its effect lasts a long time, which is why it is given only once a year or less often.

Tell your doctor about all prescription medicines, over-the-counter medicines, supplements and herbal products you use.

• Medicines that can harm the kidneys: NSAIDs such as ibuprofen, aminoglycoside antibiotics and some other medicines can add to kidney risk. Your doctor may check kidney function more closely.

• Other zoledronic acid and bisphosphonate products: Do not receive another zoledronic acid product, such as the 4 mg strength, or another bisphosphonate at the same time unless your doctor advises it.

• Medicines that lower calcium: Loop diuretics and aminoglycoside antibiotics can add to the risk of low calcium. Blood calcium is checked.

• Calcium and vitamin D supplements: These are important for people receiving zoledronic acid. Your doctor will advise the amounts.

• Medicines that raise jaw problem risk: Corticosteroids, chemotherapy and angiogenesis inhibitors can add to the risk of jaw bone problems. Tell your dentist about your treatment.

• Store the unopened bottle at room temperature, as stated on the pack, in the original carton.

• The solution is for single use only. Discard any unused portion.

• If the solution is not used immediately after opening, it may be kept in a refrigerator at 2°C to 8°C for up to 24 hours. Let it reach room temperature before the infusion.

• Do not use the solution after the expiry date, or if it is cloudy or contains particles.

• Keep out of the reach of children.

Natzold 5mg Infusion is given only by a healthcare professional as a slow infusion into a vein. The infusion must take no less than 15 minutes and be given at a steady rate. It must not be mixed with solutions containing calcium and should be given through a separate line.

The dosing schedule depends on the condition. Treatment of osteoporosis is usually one 5 mg infusion once a year. Prevention of postmenopausal osteoporosis is one infusion every 2 years. Paget’s disease is treated with a single 5 mg infusion.

• Kidney function (creatinine clearance) and calcium levels are checked before each dose.

• Drink plenty of fluids before and after the infusion, as your doctor advises.

• Take calcium and vitamin D as advised. For Paget’s disease, 1500 mg of calcium and 800 units of vitamin D daily are recommended.

• Have a dental check-up before treatment, and keep your mouth and teeth well cared for.

• Your doctor may suggest paracetamol if you develop fever or aches after the infusion.

Common side effects of Natzold 5mg Infusion may include:

• Fever

• Flu-like symptoms

• Headache

• Muscle pain

• Joint pain

• Bone pain

• Back pain

• Nausea

• Tiredness

These reactions usually start within the first 3 days after the infusion and settle within a few days.

Serious side effects

Seek medical attention if you develop:

• Reduced urine output, swelling or signs of kidney problems.

• Muscle cramps, spasms, tingling around the mouth or numbness, which can be signs of low calcium.

• Jaw pain, swelling, loose teeth or a sore that does not heal in the mouth.

• New pain in the thigh, hip or groin, which can be a sign of an unusual thigh bone fracture.

• An irregular or fast heartbeat.

• A red, painful eye, or blurred vision.

• A severe allergic reaction, such as swelling of the face, lips or throat or difficulty breathing.

• Drink plenty of fluids before and after the infusion.

• Take calcium and vitamin D exactly as your doctor advises.

• Have a dental check-up before treatment, and tell your dentist that you receive zoledronic acid.

• Report new thigh, hip or groin pain without delay.

• Keep your kidney and calcium tests before every dose.

• Do not receive other bisphosphonates or zoledronic acid products at the same time unless advised.

• Ask your doctor before taking NSAIDs such as ibuprofen.

• Use paracetamol for fever or aches after the infusion only as your doctor advises.

• Treatment duration is reviewed regularly. For people at low fracture risk, stopping after 3 to 5 years may be considered.