patient information leaflet bondronat film-coated tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bondronat 50 mg film-coated tablets

ibandronic acid

Read all of this leaflet carefully before you start taking 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 take Bondronat.
3. How to take 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), and prevents bone complications and fractures related to the spread of cancer cells into bone.

Bondronat tablets are indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

2. BEFORE YOU TAKE 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 take Bondronat:

if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients.

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 <30 mL/min)

or when

you have had problems in the past with your oesophagus (the tube that connects your mouth to your stomach).
you become aware of any signs or symptoms suggesting a possible reaction of the oesophagus (this may include: pain in the chest, heartburn, pain after swallowing drink and / or food). If this is the case, you should speak to your doctor without delay.
you are also taking non-steroidal anti-inflammatory drugs (NSAIDs), since both types of medicinal products (NSAIDs and bisphosphonates) may cause irritation to the stomach and intestine.
You suffer from galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or are taking supplements containing calcium, magnesium, iron or aluminium.

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

When administered with H2-antagonists or other drugs that increase gastric pH Bondronat absorption may be slightly increased but no dose adjustment is needed.

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).

After taking your Bondronat tablet, wait at least 30 minutes before taking any other medication of the day, including indigestion tablets/medicine, calcium supplements and vitamins.

Taking Bondronat with food and drink:

Your Bondronat tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day. Medications and supplements (including calcium) should similarly be avoided prior to taking Bondronat tablets. Fasting, including avoiding other medication and supplements should be continued for at least 30 minutes after taking the tablet. Plain water may be taken at any time during the course of Bondronat treatment.

Pregnancy and breast feeding:

You should not take 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 used machines has not been studied.

Important information about some of the ingredients of Bondronat

Bondronat tablets contain lactose.

3. HOW TO TAKE BONDRONAT

Always take Bondronat exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Bondronat is one tablet per day. If you have severe kidney problems, your doctor may reduce your dose to one tablet per week.

To reduce possible irritation, it is important that you follow the instructions below:

BEFORE taking your first food, drink or other medicinal products of the day, take your Bondronat tablet with a full glass of plain water only (about 200 mL). Do not take your tablet with any drink other than plain water.
Do not chew, suck or allow the tablet to dissolve in your mouth.
After taking your Bondronat tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day.
You should remain in an upright (sitting or standing) position while taking Bondronat tablets and remain upright for 60 minutes after taking your tablet.
It is important to continue taking Bondronat for as long as your doctor prescribes the medicine. Bondronat can help with your condition only if you continue to take the tablets.

If you take more Bondronat than you should:

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not make yourself vomit, and do not lie down.

If you forget to take Bondronat:

Do not take a double dose to make up for a forgotten dose. Return to taking one tablet per day the following day, as usual.

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.

Common side effects include indigestion, nausea, abdominal pain, oesophagitis, tiredness, and low calcium levels in the blood.

Symptoms reported uncommonly include strange taste, tingling sensation (paraesthesia), dry mouth, bleeding gastrointestinal ulcer, difficulty swallowing, gastritis, itching, chest pain, flu-like symptoms, feeling unwell, and pain. Uncommonly, low haemoglobin, high levels of urea and high levels of parathyroid hormone have been reported from blood tests.

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.

5. HOW TO STORE BONDRONAT

Keep out of the reach and sight of children.

Store in the original package in order to protect from moisture. Keep blister in the outer carton.

Do not use Bondronat after the expiry date which is stated on the blister and carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Bondronat contains

Each film-coated tablet contains 56.25 mg of ibandronic acid, monosodium salt, monohydrate, equivalent to 50 mg of ibandronic acid.

The other ingredients are:

tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, colloidal anhydrous silica.
tablet coat: hypromellose, titanium dioxide, talc, macrogol 6,000.

What Bondronat looks like and contents of the pack

The film-coated tablets are of oblong shape and white to off-white in colour, engraved L2/IT. They are available in packs of 28 and 84 tablets. Not all pack sizes may be marketed.

Medicine: bondronat film-coated tablets