PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

IBANDRONIC ACID 50MG FILM-COATED TABLETS

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

♦    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

♦    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet:

1.    What Ibandronic acid is and what it is used for

2.    What you need to know before you take Ibandronic acid

3.    How to take Ibandronic acid

4.    Possible side effects

5.    How to store Ibandronic acid

6.    Contents of the pack and other information.

1 WHAT IBANDRONIC ACID IS AND WHAT IT IS USED FOR

The name of your medicine is Ibandronic Acid 50mg film-coated tablets (referred to as Ibandronic acid throughout this leaflet). Ibandronic acid belongs to a group of medicines called bisphosphonates.

Ibandronic acid is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases’).

♦    It helps to prevent your bones from breaking (fractures).

♦    It also helps to prevent other bone problems that may need surgery or radiotherapy.

Ibandronic acid with food, drink and alcohol

Do not take Ibandronic acid with food or any other drinks except water as Ibandronic acid is less effective if it is taken with food or drink (see section 3).

Take Ibandronic acid at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water.

After taking, wait at least 30 minutes. Then you can have your first food and drink, and take any medicines or supplements (see section 3).

Pregnancy, breast feeding and fertility

Do not take Ibandronic acid if you are pregnant, planning to get pregnant or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as it is expected that Ibandronic acid has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use machines or tools.

Ibandronic acid works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.

2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBANDRONIC ACID

Ibandronic acid tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3 HOW TO TAKE IBANDRONIC ACID

Do not take Ibandronic acid:

-    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 your food pipe/gullet (oesophagus) such as narrowing or difficulty swallowing.

-    if you cannot stand or sit upright for at least one hour (60 minutes) at a time.

-    if you have or ever had low calcium in your blood.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Ibandronic acid.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibandronic acid if you:

-    are allergic to any other bisphosphonates.

-    have any swallowing or digestion problems.

-    have high or low blood levels of Vitamin D or any other minerals.

-    have kidney problems.

-    are having dental treatment or surgery or know that you need some in the future, tell your dentist that you are being treated with Ibandronic acid for cancer.

Irritation, inflammation or ulceration of the food pipe/gullet (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur; especially if you do not drink a full glass of water and/or if you lie down within an hour of taking Ibandronic acid. If you develop these symptoms, stop taking Ibandronic acid and tell your doctor straight away (see section 3 and 4).

Children and adolescents

Ibandronic acid should not be used in children and adolescents below the age of 18 years.

Other medicines and Ibandronic acid

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ibandronic acid can affect the way some other medicines work. Also some other medicines can affect the way Ibandronic acid works.

In particular, tell 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 medicines called “NSAIDs” such as ibuprofen or naproxen. This is because NSAIDs and Ibandronic acid can both irritate your stomach and gut

♦    a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because aminoglycosides and Ibandronic acid can both lower the amount of calcium in your blood.

Taking medicines that reduce stomach acid such as cimetidine and ranitidine may slightly increase the effects of Ibandronic acid.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take your tablet at least 6 hours after you last had anything to eat, drink or any other medicines or supplements except water. Water with a high concentration of calcium should not be used. If there is concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.

Your doctor may do regular blood tests while you are taking Ibandronic acid. This is to check that you are being given the right amount of medicine.

Taking this medicine

It is important that you take Ibandronic acid at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus). You can help stop this happening by doing the following:

-    Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements.

-    Take your tablet with a full glass of water only (about 200ml). Do not take your tablet with any drink other than water

-    Swallow the tablet whole. Do not chew, suck or crush the tablet. Do not let the tablet dissolve in your mouth.

-    After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink, and take any medicines or supplements.

- Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes). Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus).

How much to take

The usual dose of Ibandronic acid is one tablet each day. If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day. If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.

If you take more Ibandronic acid than you should

If you take too many tablets talk to a doctor or go to hospital straight away. Drink a full glass of milk before you go. Do not make yourself sick. Do not lie down.

If you forget to take Ibandronic acid

Do not take a double dose to make up for a forgotten dose. If you are taking a tablet each day, skip the missed dose completely. Then carry on as usual the next day. If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.

If you stop taking Ibandronic acid

Keep taking Ibandronic acid for as long as your doctor tells you. This is because the medicine will only work if it is taken all the time.

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

4 POSSIBLE SIDE EFFECTS

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects, you may need urgent medical treatment.

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

♦    Feeling sick, heartburn and discomfort in swallowing (inflammation of your food pipe/gullet).

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

♦    Severe stomach pain. This could be a sign of an ulcer of the first section of the bowel (duodenum) that is bleeding, or that your stomach is inflamed (gastritis).

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

♦    Persistent eye pain and inflammation.

♦    New pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone.

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

♦    Pain or soreness in your mouth or jaw. You may have early signs of severe jaw problems (necrosis (dead bone tissue) in the jaw bone).

♦    Itching, swelling of the face, lips, tongue and throat with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction.

Not known (frequency cannot be estimated from the available data):

♦    Asthma attack.

Other possible side effects:

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

♦    Stomach pain, indigestion.

♦    Low calcium levels in your blood.

♦    Weakness.

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

♦    Chest pain.

♦    Itching or tingling skin (paraesthesia).

♦    Flu-like symptoms, feeling generally unwell or in pain.

♦    Dry mouth, strange taste in your mouth or difficulty swallowing.

♦    Anaemia.

♦    High levels of urea or high levels of parathyroid hormone in your blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme: www.mhra.gov.uk/vellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

What Ibandronic Acid 50mg Film-Coated Tablets looks like and contents of the pack

Ibandronic acid tablets are white to off-white, oblong tablets debossed with “I9BE” on one side and “50” on the other side.

They are available in blister packs of 1,28, 30, 84, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Manufacturer:

Synthon Hispania S.L.

Castello 1, Poligono las Salinas,

08830 Sant boi de Llobregat Spain

This leaflet was last revised in April 2015

5 HOW TO STORE IBANDRONIC ACID

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6 CONTENTS OF THE PACK AND OTHER INFORMATION

What Ibandronic Acid 50mg Film-Coated Tablets contains

The active substance is 56.25mg of Ibandronic acid, monosodium salt, monohydrate, equivalent to 50mg of Ibandronic acid.

The other ingredients are:

Tablet core: lactose monohydrate, crospovidone (E1202), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), sodium stearyl fumarate.

Tablet coating: polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171).

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