Package leaflet: Information for the patient

Ibandronate SIGA 50 mg film-coated tablets

ibandronic acid

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 Ibandronate SIGA is and what it is used for.

2.    What you need to know before you take Ibandronate SIGA.

3.    How to take Ibandronate SIGA.

4.    Possible side effects.

5.    How to store Ibandronate SIGA.

6.    Contents of the pack and other information.

1. What Ibandronate SIGA is and what it is used for

Ibandronate SIGA contains the active substance ibandronic acid. This belongs to the group of medicines called bisphosphonates.

Ibandronate SIGA 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.

Ibandronate SIGA 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 Ibandronate SIGA

It is important that you take Ibandronate SIGA 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). This is the tube connecting your mouth with your stomach.

Stop taking Ibandronate SIGA and tell your doctor straight away, if you get severe chest pain, severe pain after swallowing food or drink, feel very sick or are being sick.

Do not take Ibandronate SIGA:

•    if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are 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 applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ibandronate SIGA.

Warnings and precautions:

-    if you are allergic to any other bisphosphonates

-    if you have any swallowing or digestion problems

-    if you have high or low blood levels of vitamin D or any other minerals

-    if you have kidney problems

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Ibandronate SIGA.

If you are having dental treatment or surgery or know that you need some in the future, tell your dentist that you are being treated with Ibandronate SIGA.

Children and adolescents

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

Other medicines and Ibandronate SIGA:

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

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

•    supplements containing calcium, magnesium, iron or aluminium

•    non-steroidal anti-inflammatory medicines called “NSAIDs” such as aspirin, ibuprofen or naproxen. This is because NSAIDs and Ibandronate SIGA can both irritate your stomach and gut

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

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

Ibandronate SIGA with food and drink:

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

Take Ibandronate SIGA 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), aluminum, magnesium and iron) except water. After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink, and take any medicines or supplements (see section 3).

Pregnancy and breast feeding:

Do not take Ibandronate SIGA 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’s expected that Ibandronate SIGA 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 of tools.

Ibandronate SIGA contains lactose.

If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.

3. How to take Ibandronate SIGA

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 had 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 Ibandronate SIGA. This is to check that you are being given the right amount of medicine.

Taking this medicine

It is important that you take Ibandronate SIGA 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 200 mL). 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 Ibandronate SIGA 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 Ibandronate SIGA than you should:

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

If you forget to take Ibandronate SIGA:

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 Ibandronate SIGA:

Keep taking Ibandronate SIGA 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:

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 sore 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 your face, lips, tongue and throat, with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction.

Other possible side effects

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

•    tummy pain, indigestion

•    feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe)

•    low calcium levels in your blood.

•    weakness

Uncommon (may affect less than 1 in 100 people):

•    chest pain

•    itching or tingling skin (paraesthesia)

•    flu-like symptoms, feeling generally unwell or in pain

•    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)

•    dry mouth, strange taste in your mouth or difficulty swallowing

•    anaemia (bloodlessness)

•    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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ibandronate SIGA

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.

Store in the original package in order to protect from moisture.

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 Ibandronate SIGA contains

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

The other ingredients are:

-    tablet core: povidone, microcrystalline cellulose, crospovidone, starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica.

-    tablet coat: Opadry OY-LS-28908 (White II) [consisting of: titanium dioxide (E171), lactose monohydrate, macrogol 4000, hypromellose (E464)]

What Ibandronate SIGA looks like and contents of the pack

The film-coated tablets are white, round biconvex tablets. They are available in packs of 28, 30 and 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sigapharm GmbH Temmlerstrasse 2 D-35039 Marburg Germany

Manufacturer

Pharmathen S.A., Dervenakion 6, Pallini 15351, Attiki Hellas Pharmathen International S.A., Dervenakion 4, Pallini 15351, Attiki Hellas

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom    Ibandronate SIGA 50 mg film coated tablet

Germany    Ibandronat SIGA 50 mg Filmtabletten

This leaflet was last revised in 09/2013

TA201310101611590005

25.10.2013