patient information leaflet bondronat 2mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bondronat 2mg concentrate for solution for infusion

ibandronic acid

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Bondronat is and what it is used for
2. Before you use Bondronat
3. How to use Bondronat
4. Possible side effects
5. How to store Bondronat
6. Further information

1. WHAT BONDRONAT IS AND WHAT IT IS USED FOR

The active substance of Bondronat, ibandronic acid, belongs to the group of medicines known as bisphosphonates. It inhibits increased loss of calcium from the bones (bone resorption), thus normalising elevated serum calcium levels. It also prevents bone complications and fractures related to the spread of cancer cells into bone.

Bondronat is indicated for:

Pathologically (abnormally) elevated serum calcium levels (hypercalcaemia) as a result of tumours.
Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

2. BEFORE YOU USE BONDRONAT

During treatment your blood may be monitored to ensure that you are receiving the correct dose of Bondronat.

If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Bondronat.

Do not use Bondronat:

if you are allergic (hypersensitive) to the active substance or any of the other ingredients of Bondronat.

Bondronat should not be used in children.

Take special care with Bondronat:

if you know or believe that you may have:

hypersensitivity to other bisphosphonates.
low blood calcium
other disturbances of mineral metabolism (such as vitamin D deficiency)
severe kidney disease (renal insufficiency i.e. creatinine clearance less than 30 millilitres per minute).

Using other medicines

Please inform your doctor of pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

No interaction was observed when ibandronic acid was administered concomitantly with tamoxifen, or melphalan/prednisolone.

Caution is advised when bisphosphonates are administered with aminoglycosides since both agents can lower serum calcium levels for prolonged periods. Caution should also be paid to the possible existence of simultaneous hypomagnesaemia (reduced magnesium levels).

Pregnancy and breast-feeding

You should not be given Bondronat if you are pregnant or if you are breast-feeding.

Driving and using machines:

The effects of Bondronat on the ability to drive or to use machines has not been studied.

3. HOW TO USE BONDRONAT

You will be given Bondronat as an infusion. Your doctor will determine how much Bondronat you will be given depending on your illness. Your doctor may adjust your dose if you have kidney problems.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bondronat can cause side effects although not everybody gets them.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The side effects listed below were seen when Bondronat was given intravenously.

Side effects described as very common were experienced in more than 1 in 10 patients.
Side effects described as common were experienced by up to 1 in 10 patients.
Side effects described as rare or very rare were experienced by fewer than 1 in 100 patients.

A very common side effect is a rise in body temperature. Common side effects are flu-like symptoms (including fever, chills, bone pain and aching muscles), tiredness, diarrhoea, indigestion, vomiting, headache, dizziness, gastrointestinal pain, sore throat, and swelling of the lower limbs. These symptoms usually disappear within a couple of hours or days. Less commonly patients have reported infections, strange taste, cataracts, bundle branch block, tooth disorder, skin problems, aching joints, arthritis, and thirst.

In rare cases, patients have reported the following: gastroenteritis, oral thrush, vaginitis, benign skin growth, sleep disturbance, anxiety, affect lability, memory loss, numbness round the mouth (paraesthesia circumoral), hyperaesthesia, hypertonia, nerve root lesion, neuralgia, migraine, cerebrovascular disorder, parosmia, deafness, heart and circulatory problems (including palpitations, myocardial ischaemia, hypertension, varicose veins), lymphoedema, lung oedema, stridor, gastritis, cheilitis, difficulty swallowing (dysphagia), mouth ulceration, gall stones, cholelithiasis, rash, hair loss, cystitis, renal cyst, urinary retention, pelvic pain, injection site pain, weight loss, and hypothermia.

Bondronat may also cause changes in laboratory tests carried out by your doctor, these include; low calcium (metal), low phosphate (mineral), raised liver enzyme and raised creatinine, parathyroid disorder (hormone) in the blood, low haemoglobin (and rarely blood dyscrasia).

Very rarely, patients have had an allergic reaction to Bondronat which may cause wheezing and breathlessness or skin rashes.

5. HOW TO STORE BONDRONAT

The shelf-life of Bondronat 2 mg is 5 years.

After dilution the infusion solution is stable for 24 hours at 2 - 8 ºC (in a refrigerator).

Keep out of the reach and sight of children.

Do not use Bondronat after the expiry date which is stated on the folding box and on the label.

Do not use Bondronat if you notice that the solution is not clear or contains particles.

Unused solution should be discarded.

Medicine: bondronat 2mg