Bonazoll 5 mg/100 ml Solution

BONAZOLL 5 is given as a single infusion into a vein by a doctor or nurse. It belongs to a group of medicines called bisphosphonates, and is used to:

• treat osteoporosis in post-menopausal women.
• treat osteoporosis in men.
• prevent additional clinical fractures in postmenopausal women who have recently had a hip fracture due to low level trauma/injury.
• treat osteoporosis in men and women caused by treatment with steroid medicines such as prednisone.
• treat Paget’s disease of the bone.

For osteoporosis and the prevention of additional fractures, BONAZOLL 5 works for one year and you will need the next dose after one year. For Paget’s disease, BONAZOLL 5 may work for longer than one year, and your doctor will let you know if you need to be treated again.

Carefully follow all instructions given to you by your doctor. On the day of treatment with BONAZOLL 5 you should eat and drink normally. Follow your doctor’s instructions on how much water to drink; this is important as it will help to prevent you becoming dehydrated.

You should not be given BONAZOLL 5:

• If you are allergic (hypersensitive) to zoledronic acid, other bisphosphonates, or any of the other ingredients of BONAZOLL 5 listed in section 6.
• If you have hypocalcaemia (this means that the levels of calcium in your blood are too low).
• If you are pregnant or plan to become pregnant.
• If you are breastfeeding.
• If you have severe kidney disease.

Warnings and precautions

Tell your doctor or health care provider before being given the injection if you:

• are being treated with other products containing the same active substance zoledronic acid as in BONAZOLL 5. Other products containing the 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)
• have a kidney problem or used to have one.
• suffer from a calcium or Vitamin D deficiency.
• have had some or all of the parathyroid glands in your neck surgically removed.
• 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 for osteoporosis. ONJ can also occur after stopping treatment.

It is important to try and prevent ONJ developing as it is 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 BONAZOLL 5 treatment, tell your doctor if you:

• have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction.
• do not receive routine dental care or have not had a dental check-up for a long time.
• are a smoker (as this may increase the risk of dental problems)
• have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
• are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• have cancer.

Your doctor may ask you to undergo a dental examination before you start treatment with BONAZOLL 5. While being treated with BONAZOLL 5, 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 you are being treated with BONAZOLL 5. 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.

Monitoring test

Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of BONAZOLL 5. It is important for you to drink at least 2 glasses of fluid (such as water), within a few hours before receiving BONAZOLL 5, as directed by your healthcare provider.

Children and adolescents:

BONAZOLL 5 is not recommended for anyone under 18 years of age.

Other medicines and BONAZOLL 5:

Always tell your healthcare provider if you are taking any other medicine. (This includes all complementary and traditional 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 (“water pills”) that may cause dehydration.

Pregnancy and breastfeeding and fertility:

You must not be given BONAZOLL 5 if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist, or other health care provider for advice before taking this medicine.

Driving and using machines:

If you feel dizzy or sleepy during BONAZOLL 5 treatment, do not drive or use machines until you feel better. It is not always possible to predict to what extent BONAZOLL 5 may interfere with your daily activities. You should ensure that you do not engage in the above activities until you are aware of the measure to which ONLAST affects you.

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per 100 ml vial, that is to say essentially ‘sodium-free’.

You will not be expected to give yourself BONAZOLL 5. It will be given to you by a person who is qualified to do so. Your doctor will tell you how long your treatment with BONAZOLL 5 will last.

BONAZOLL 5 with food, drink, and alcohol: Make sure you drink enough fluids (at least one or two glasses) before and after the treatment with BONAZOLL 5, as directed by your doctor. This will help to prevent dehydration. You may eat normally on the day you are treated with BONAZOLL 5.

The usual dose is:

Osteoporosis in men and women and prevention of clinical fractures after hip fracture in postmenopausal women:

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.

Since most people do not get enough calcium and vitamin D in their diet, it is important to take calcium and vitamin D supplements (for example tablets) as directed by your doctor. For osteoporosis and prevention of clinical fractures BONAZOLL 5 works for one year so you will need another dose after one year.

Paget’s disease:

The usual dose is 5 mg, given to you as one single infusion into a vein by your doctor or nurse. The infusion will take at least 15 minutes. Because BONAZOLL 5 works for a long time, you may not need another dose of BONAZOLL 5 for a year or longer. Your doctor will let you know if you need to be treated again.

Your doctor might advise you to take calcium and vitamin D supplements (e.g. tablets) for at least the first ten days after being given BONAZOLL 5. It is important that you follow this advice carefully in order to reduce the risk of hypocalcaemia (too low blood calcium) in the period after infusion. Your doctor will inform you regarding the symptoms associated with hypocalcaemia.

If you are administered more BONAZOLL 5 than you should: Since a healthcare provider will administer BONAZOLL 5, he/she will control the dosage, however, in the event of overdosage your doctor will manage it.

If administration of a dose of BONAZOLL 5 is forgotten: Since a health care provider will administer BONAZOLL 5, it is unlikely that the dose will be missed.

If you stop BONAZOLL 5 administration If you are considering stopping BONAZOLL 5 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 BONAZOLL 5.

BONAZOLL 5 can have side effects. Not all side effects reported for BONAZOLL 5 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BONAZOLL 5, please consult your health care provider for advice.

If any of the following happens, administration of BONAZOLL 5 should be stopped, your doctor should be informed or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat
• Difficulty breathing
• Rash or itchy skin

These are all very serious side effects. If you have them, you may have had a serious reaction to BONAZOLL 5. You may need urgent medical attention or hospitilisation.

If any of the following happens, tell your doctor immediately or go to the casualty department at your nearest hospital:

• irregular heart rhythm (atrial fibrillation)
• swelling, redness, pain and itching to the eyes or eye sensitivity to light.
• ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.
• pain in the mouth and/or jaw
• swelling, non-healing or discharging sores in the mouth or jaw
• numbness or a feeling of heaviness in the jaw or loosening of a tooth.
• kidney disorders (e.g. decreased or increased urine output)
• muscle spasms, numbness, cramps, stiffness or seizures (these may be signs of low calcium levels)
• dizziness or light-headedness, headache, tiredness, dry mouth, lips and eyes, passing small amounts of urine infrequently -these may be signs that you are dehydrated.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• fever
• 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.

Less frequent side effects:

• runny or stuffy nose, sneezing, coughing, sore or scratchy throat, watery or itchy eyes, headache, tiredness, body aches. (these may be signs of influenza or an upper respiratory tract infection)
• fatigue, weakness, paleness (may be signs that you are anaemic)
• loss of appetite
• sleeplessness
• sleepiness which may include reduced alertness and awareness
• tingling sensation or numbness
• trembling
• temporary loss of consciousness (fainting)
• 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
• itchy skin
• skin reddening
• neck pain
• stiffness in muscles, bones and/or joints
• joint swelling or inflammation
• muscle spasms or weakness
• shoulder pain
• pain in your chest muscles and rib cage
• abnormal kidney test results
• thirst
• toothache
• taste disturbances.
• low levels of phosphate in the blood – you may experience muscle pain or weakness, confusion, irritability.
• unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
• decreased blood pressure

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: hppts://www.sahpra.or.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of BONAZOLL 5.

Your doctor, nurse or pharmacist knows how to store BONAZOLL 5 properly. Store at or below 25 °C. Keep product in outer container until required for use. Do not use this medicine after the expiry date which is stated on the vial label and carton.

Reconstituted and Infusion Solutions: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of zoledronic acid were demonstrated for 24 hours at refrigerated temperature. This medicine is for single use only; any unused solution must be disposed of in accordance with local requirement.

STORE ALL MEDICINE OUT OF REACH OF CHILDREN