Bondronat 50 mg film-coated tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Bondronat 50 mg film-coated tablets

ibandronic acid

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again
• If you have any questions, consult your doctor or pharmacist
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Package leaflet:

1. What Bondronat is and what it is used for
2. What you need to know before taking Bondronat
3. How to take Bondronat
4. Possible side effects
5. How to store Bondronat
6. Contents of the pack and other information

1. What Bondronat is and what it is used for

Bondronat contains the active substance ibandronic acid. It belongs to a group of medicines called bisphosphonates.

Bondronat is used in adults and has been prescribed to you if you have breast cancer that has spread to the bones (called bone metastases).

• It helps prevent your bones from breaking (fractures).
• It helps prevent other bone problems that might require surgery or radiotherapy.

Bondronat works by reducing the amount of calcium lost from your bones. This helps slow down the weakening of your bones.

2. What you need to know before taking Bondronat

Do not take Bondronat

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine listed in section 6
• if you have problems with the food pipe/throat (the oesophagus), such as narrowing or difficulty swallowing
• if you cannot remain upright, either standing or sitting, for at least one continuous hour (60 minutes)
• if you have or have had low levels of calcium in your blood.

Do not take this medicine if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Bondronat.

Warnings and precautions

Very rarely, an adverse reaction called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported during post-marketing experience in patients treated with Bondronat for cancer-related conditions. ONJ may also occur after stopping treatment.

It is important to try to prevent the development of ONJ, as it is a painful condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, certain precautions should be taken.

Before starting treatment, inform your doctor/nurse (healthcare professional) if:

• You have mouth or dental problems, such as poor dental health, gum disease, or planned tooth extraction
• You do not receive routine dental care or have not had a dental check-up 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 Bondronat.

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and have routine dental check-ups. If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or are scheduled for dental surgery (e.g. tooth extraction), inform your doctor about your dental treatment and inform your dentist that you are being treated with Bondronat.

Contact your doctor and dentist immediately if you experience any problems in your mouth or teeth, such as tooth loss, pain or swelling, or difficulty healing of ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Atypical fractures of long bones, such as the forearm bone (ulna) and shin bone (tibia), have also been reported in patients receiving long-term treatment with ibandronate. These fractures occur following minimal or no trauma, and some patients experience pain in the affected area before a complete fracture occurs.

Consult your doctor or pharmacist before taking Bondronat:

• If you are allergic to any other bisphosphonate
• You have any swallowing or digestive problems
• You have high or low levels of vitamin D or any other mineral
• You have kidney problems

Irritation, inflammation, or ulceration of the throat/food pipe (oesophagus) may occur, often with symptoms such as severe chest pain, severe pain after swallowing food and/or drink, severe nausea or vomiting, especially if you do not drink a full glass of water and/or if you lie down before one hour has passed after taking Bondronat. If you develop these symptoms, stop taking Bondronat and inform your doctor immediately (see sections 3 and 4).

Children and adolescents

Bondronat must not be used in children and adolescents under 18 years of age.

Taking Bondronat with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is because Bondronat may affect how other medicines work. Also, other medicines may affect how Bondronat works.

Specifically, inform your doctor or pharmacist if you are taking any of the following medicines:

• supplements containing calcium, magnesium, iron, or aluminium
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen. This is because both NSAIDs and Bondronat can irritate the stomach and intestine
• a type of injected antibiotic called an aminoglycoside, such as gentamicin. This is because both aminoglycosides and Bondronat can reduce the amount of calcium in your blood.

Taking medicines that reduce stomach acidity, such as cimetidine and ranitidine, may slightly increase the effects of Bondronat.

Bondronat with food and drinks

Do not take Bondronat with food or other beverages except water, as Bondronat loses efficacy when taken with food or drinks (see section 3).

Take Bondronat after at least 6 hours have passed since your last meal, drink, or intake of any other medication or supplement (e.g. products containing calcium (milk), aluminium, iron, and magnesium), except water. After taking the tablet, wait at least 30 minutes before consuming the first food or drink, or taking any other medication or supplement (see section 3).

Pregnancy and breastfeeding

Do not take Bondronat if you are pregnant, planning to become pregnant, or breastfeeding.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You may drive and use machines, as Bondronat is not expected to have any effect or its effect is considered negligible on your ability to drive and use machines. However, consult your doctor first if you intend to drive or operate machinery or tools.

Bondronat contains lactose.

If your doctor has informed you that you cannot tolerate or digest certain sugars (e.g. if you have galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption), consult your doctor before taking this medicine.

3. How to take Bondronat

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again. Take the tablet at least 6 hours after the last meal, drink, or any other medication or supplement, except water. It should not be taken with water that has a high calcium concentration. If you are unsure about potentially high calcium levels in tap water (hard water), it is recommended to use bottled water with a low mineral content.

Your doctor may carry out periodic blood tests while you are taking Bondronat. This is to ensure that you are receiving the correct dose of this medicine.

Taking this medicine

It is important to take Bondronat at the right time and in the correct manner. This is because it may cause irritation, inflammation, or ulcers in the food pipe/throat (oesophagus).

You can help reduce this by doing the following:

• Take your tablet as soon as you get up in the morning, before your first meal, drink, or any medication or supplement

• Take the tablet with a full glass of water (approx. 200 ml). Do not take the tablet with any drink other than water

• Swallow the tablet whole. Do not chew, suck, or crush the tablet. Do not allow the tablet to dissolve in the mouth

• After taking the tablet, you must wait at least 30 minutes before taking your first meal or drink, or any other medication or supplement

• Remain upright (standing or sitting) when taking the tablet and for the following hour (60 minutes). If you do not, some of the medicine may flow back into the food pipe/throat (oesophagus).

Dosage

The usual dose of Bondronat is one tablet daily. If you have moderate kidney problems, your doctor should reduce your dose to one tablet every two days. If you have severe kidney problems, your doctor should reduce your dose to one tablet per week.

If you take more Bondronat than you should

If you take too many tablets, inform your doctor or go to hospital immediately. Drink a full glass of milk before going. Do not induce vomiting and do not lie down.

If you forget to take Bondronat:

Do not take a double dose to make up for missed doses. If you are taking one tablet daily, skip the missed dose and take the next dose as usual the following day. If you are taking one tablet every two days or once a week, consult your doctor or pharmacist.

If you interrupt treatment with Bondronat

Continue taking Bondronat for as long as your doctor advises. The medicine will only work if you take it for the full prescribed duration.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Tell your doctor or nurse immediately if you notice any of the following serious adverse effects as you may need urgent medical treatment:

Common (may affect up to 1 in 10 people):

• Dizziness, heartburn, and discomfort when swallowing (inflammation of the tube through which food passes/throat)

Uncommon (may affect up to 1 in 100 people):

• Severe stomach pain. This could be a sign of a bleeding ulcer in the first part of the intestine (duodenum) or inflammation of the stomach (gastritis).

Rare (may affect up to 1 in 1,000 people):

• Persistent eye pain and inflammation
• New pain, weakness, or discomfort in the thigh, hip, or groin. These may be early signs of an unusual fracture of the thigh bone.

Very rare (may affect up to 1 in 10,000 people):

• Pain or a sensation of pain in the mouth or jaw. These may be early signs of serious jaw problems [necrosis (death of bone tissue) of the jaw bone]
• Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be signs of damage to the ear bones
• Itching, swelling of the face, lips, tongue, and throat, with difficulty breathing. You may be experiencing a severe allergic reaction which could be life-threatening
• Serious skin adverse reactions

Frequency not known (cannot be estimated from the available data):

• Asthma attack

Other possible adverse effects

Common (may affect up to 1 in 10 people):

• Stomach pain, indigestion
• Decreased levels of calcium in the blood
• Weakness

Uncommon (may affect up to 1 in 100 people):

• Chest pain
• Itching or tingling of the skin (paresthesia)
• Flu-like symptoms, usually with general discomfort or pain
• Dry mouth, bad taste in the mouth, or difficulty swallowing
• Anemia (reduced blood)
• High levels of urea or parathyroid hormone in the blood

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Bondronat

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack and outer carton following "EXP". The expiry date refers to the last day of the month indicated.
• Store in the original packaging to protect from moisture.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Bondronat

• The active substance is ibandronic acid. Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate).

The other components are:

• tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, anhydrous colloidal silica
• tablet coating: hypromellose, titanium dioxide (E 171), talc, macrogol 6000.

Appearance of the product and contents of the pack

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

Marketing Authorization Holder and Manufacturing Responsible

Marketing Authorization Holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers,

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer Responsible

IL CSM Clinical Supplies Management GmbH

Marie-Curie-Strasse 8

Lörrach

Baden-Württemberg

79539, Germany

Atnahs Pharma Denmark ApS

Copenhagen Towers,

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Date of the most recent review of this leaflet: MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.