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IBANDRONATE SIGA 50 MG FILM-COATED TABLETS

Active substance(s): SODIUM IBANDRONATE MONOHYDRATE / SODIUM IBANDRONATE MONOHYDRATE

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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.
a
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
Germany

Ibandronate SIGA 50 mg film coated tablet
Ibandronat SIGA 50 mg Filmtabletten

This leaflet was last revised in 09/2013

TA201310101611590005
25.10.2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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