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IBANDREENOS 50 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibandreenos 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 Ibandreenos is and what it is used for.
2. Before you take Ibandreenos.
3. How to take Ibandreenos.
4. Possible side effects.
5. How to store Ibandreenos.
6. Further information.

1. WHAT IBANDREENOS IS AND WHAT IT IS USED FOR
The active substance of Ibandreenos, 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.
Ibandreenos 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 IBANDREENOS
It is important that you take Ibandreenos at the right time and in the right way. This is
because it can cause irritation, inflammation or ulcers in your food pipe (oesophagus). This is the
tube connecting your mouth with your stomach.
Stop taking Ibandreenos 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 Ibandreenos:
• if you are allergic (hypersensitive) 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 (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 Ibandreenos.
Take special care with Ibandreenos:
• if you are allergic (hypersensitive) 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 you have a galactose intolerance, the Lapp lactase deficiency or have problems with
glucosegalactose absorption
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before
taking Ibandreenos.
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 Ibandreenos.
Children and teenagers
Ibandreenos should not be used in children and teenagers below age 18 years.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those obtained without a prescription. This is because Ibandreenos can affect the
way some other medicines work. Also some other medicines can affect the way Ibandreenos
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 drugs called “NSAIDs” such as aspirin, ibuprofen or naproxen.
This is because NSAIDs and Ibandreenos can both irritate your stomach and gut.
• a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because
aminoglycosides and Ibandreenos 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 Ibandreenos.
When to take your other medicines
Do not take any other medicines or supplements for at least 6 hours before taking
Ibandreenos. Once you have taken Ibandreenos, wait at least 30 minutes before taking
any other medicines or supplements.
Taking Ibandreenos with food and drink
It is important to take Ibandreenos at the right time and in the right way. See “Taking this
medicine” in Section 3 for the full instructions about when and how to take.

Pregnancy and breast feeding
Do not take Ibandreenos if you are pregnant, planning to get pregnant or if you are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicines.
Driving and using machines
It is not known if Ibandreenos affects your ability to drive, use machines or tools. Talk to
your doctor first if you want to drive, use machine or tools.
Important information about some of the ingredients of Ibandreenos
Ibandreenos tablets contain a type of sugar called lactose. If you have been told by your
doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this
medicine.
3. HOW TO TAKE IBANDREENOS
Always take Ibandreenos exactly as your doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Your doctor may do regular blood tests while you are taking Ibandreenos. This is to check
that you are being given the right amount of medicine.
Taking this medicine
It is important that you take Ibandreenos at the right time and in the right way. This is
because it can cause irritation, inflammation or ulcers in your food pipe (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 plain water only (about 200 ml). Do not take your tablet
with any drink other than plain 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 (oesophagus).
How much to take
The usual dose of Ibandreenos 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 Ibandreenos 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 Ibandreenos

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 Ibandreenos
Keep taking Ibandreenos 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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibandreenos can cause side effects although not everybody gets them.
Stop taking Ibandreenos and see a doctor straight away if you notice any of the
following serious side effects – you may need urgent medical treatment:
• rash, itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may
be having an allergic reaction to the medicine
• pain or sore in your mouth or jaw
• severe chest pain, severe pain after swallowing food or drink, feeling very sick or being sick.
This could be a sign of problems with your food pipe (oesophagus)
• severe stomach pain, being sick, possibly with blood in it. This could be a sign of a stomach
ulcer that is bleeding, or that your stomach lining is inflamed (gastritis).
• eye pain and inflammation (if prolonged).
Other possible side effects
Common (affects less than 1 in 10 people):
• feeling tired
• stomach pain, indigestion
• feeling sick or inflamed food pipe (heart burn)
• low calcium levels in your blood.
Uncommon (affects less than 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.
Rare (affects less than 1 in 1000 people)

• eye pain or inflammation.
• unusual fracture of the thigh bone particularly in patients on long-term treatment for
osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or
discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of
the thigh bone.
Very rare (affects less than 1 in 10000 people)
• a condition involving exposed bone in the mouth called “osteonecrosis of the jaw”.
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 IBANDREENOS
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 Ibandreenos 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 Ibandreenos 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,
starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica.
tablet coat: Opadry OY-LS-28908(White II) [consisting of: titanium dioxide (E171),
lactose monohydrate, hypromellose (E464), Macrogol 4000]

What Ibandreenos looks like and contents of the pack
The film-coated tablets are white, round biconvex tablets. They are available in packs of 28 and
84 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mithra Pharmaceuticals S.A.
Rue Saint-Georges, 5
B-4000 Liège
Belgium

Manufacturer
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki
Hellas

This leaflet was last approved in 05/2012.

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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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