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KALOSSO 50 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

KALOSSO 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:
Taking other medicines
1. What Kalosso 50 mg film-coated tablets is and what it is Please tell your doctor or pharmacist if you are taking or
used for
have recently taken any other medicines, including medicines
2. Before you take Kalosso 50 mg film-coated tablets
obtained without a prescription, or are taking supplements
3. How to take Kalosso 50 mg film-coated tablets
containing calcium, magnesium, iron or aluminium.
4. Possible side effects
5. How to store Kalosso 50 mg film-coated tablets
No interaction was observed when ibandronic acid was
6. Further information
administered concomitantly with tamoxifen, or melphalan/
prednisolone.
1. WHAT KALOSSO 50 MG FILM-COATED TABLETS IS
AND WHAT IT IS USED FOR

When administered with H2-antagonists or other medicines
that increase gastric pH Kalosso 50 mg film-coated tablets
absorption may be slightly increased but no dose adjustment
The active substance of Kalosso 50 mg film-coated tablets is is needed.
ibandronic acid and it belongs to the group of medicines known
as bisphosphonates. It inhibits increased loss of calcium from the Caution is advised when bisphosphonates are administered with
bones (bone resorption), and prevents bone complications and aminoglycosides since both agents can lower serum calcium
fractures related to the spread of cancer cells into bone.
levels for prolonged periods. Caution should also be paid to the
possible existence of simultaneous hypomagnesaemia (reduced
Kalosso 50 mg film-coated tablets are indicated for the magnesium levels).
prevention of skeletal events (pathological fractures, bone
complications requiring radiotherapy or surgery) in patients with After taking your Kalosso 50 mg film-coated tablets, wait at
breast cancer and bone metastases.
least 30 minutes before taking any other medication of the day,
including indigestion tablets/medicine, calcium supplements
and vitamins.
2. BEFORE YOU TAKE
KALOSSO 50 MG FILM-COATED TABLETS
Taking Kalosso 50 mg film-coated tablets with food and drink
Your Kalosso 50 mg film-coated tablets should be taken after an
During treatment your blood may be monitored to ensure that overnight fast (at least 6 hours) and before the first food or drink
you are receiving the correct dose of Kalosso 50 mg film-coated of the day. Medications and supplements (including calcium)
tablets.
should similarly be avoided prior to taking Kalosso 50 mg filmcoated tablets. Fasting, including avoiding other medication and
It is important that you take Kalosso 50 mg film-coated tablets at supplements should be continued for at least 30 minutes after
the right time and in the right way. This is because it can cause taking the tablet. Plain water may be taken at any time during the
irritation, inflammation or ulcers in your food pipe (oesophagus). course of Kalosso 50 mg film-coated tablets treatment.
This is the tube connecting your mouth with your stomach. Stop
taking Kalosso 50 mg film-coated tablets and tell your doctor It is important to take Kalosso 50 mg film-coated tablets at the
straight away, if you get severe chest pain, severe pain after right time and in the right way. See “HOW TO TAKE Kalosso
swallowing food or drink, feel very sick or are being sick.
50 mg film-coated tablets” in Section 3 for the full instructions
about when and how to take.
If you are under dental treatment or will undergo dental surgery,
tell your dentist that you are being treated with Kalosso 50 mg Pregnancy and breast feeding
film-coated tablets.
You should not take Kalosso 50 mg film-coated tablets if you
are pregnant or if you are breast-feeding. Ask your doctor or
Do not take Kalosso 50 mg film-coated tablets
pharmacist for advice before taking any medicines.
– if you are allergic (hypersensitive) to ibandronic acid or any
of the other ingredients.
Driving and using machines
– if you have problems with your food pipe (oesophagus) such The effects of Kalosso 50 mg film-coated tablets on the ability to
as narrowing or difficulty swallowing.
drive or use machines have not been studied. Talk to your doctor
– if you cannot stand or sit upright for at least one hour (60 minutes) first if you want to drive, use machine or tools.
at a time.
– if you have or ever had low calcium in your blood.
Important information about some of the ingredients of
Kalosso 50 mg film-coated tablets
Children and teenagers
Kalosso 50 mg film-coated tablets contain lactose. If you have
Kalosso 50 mg film-coated tablets should not be used in children been told by your doctor that you have an intolerance to some
and teenagers below age 18 years.
sugars, contact your doctor before you start taking this medicine.
Take special care with Kalosso 50 mg film-coated tablets
if you know or believe that you may have:
– hypersensitivity to other bisphosphonates
– low blood calcium
– if you have high or low blood levels of vitamin D or any other
minerals
– other disturbances of mineral metabolism (such as vitamin D
deficiency)
– severe kidney disease (renal insufficiency i.e. creatinine
clearance <30 ml/min)

3. HOW TO TAKE KALOSSO 50 MG FILM-COATED TABLETS
Always take Kalosso 50 mg film-coated tablets exactly as your
doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
It is important that you take Kalosso 50 mg film-coated tablets at
the right time and in the right way. This is because it can cause
irritation, inflammation or ulcers in your food pipe (oesophagus).

or when

The usual dose of Kalosso 50 mg film-coated tablets is one
tablet per day. If you have severe kidney problems, your doctor
may reduce your dose to one tablet per week.

– you have had problems in the past with your oesophagus (the
tube that connects your mouth to your stomach).
– you become aware of any signs or symptoms suggesting a
possible reaction of the oesophagus (this may include: pain in
the chest, heartburn, pain after swallowing drink and/or food).
If this is the case, you should speak to your doctor without delay.
– you are also taking non-steroidal anti-inflammatory drugs
(NSAIDs), since both types of medicinal products (NSAIDs
and bisphosphonates) may cause irritation to the stomach and
intestine.
– you suffer from galactose intolerance, the Lapp lactase
deficiency or have problems with glucose-galactose absorption.

To reduce possible irritation, it is important that you follow the
instructions below:
– Take your Kalosso 50 mg film-coated tablets after a night fasting
(at least 6 hours) and before your first food or drink of the day.
– BEFORE taking your first food, drink or other medicinal
products of the day, take your Kalosso 50 mg film-coated tablets
with a full glass of plain water only (about 200 ml). Do not take
your tablet with any drink other than plain water.
– Do not chew, suck or allow the tablet to dissolve in your mouth.
– After taking your Kalosso 50 mg film-coated tablets, wait at
least 30 minutes before taking your first food, beverage, or other
medication of the day.

– You should remain in an upright (sitting or standing) position Medicines should not be disposed of via wastewater or
while taking Kalosso 50 mg film-coated tablets and remain household waste. Ask your pharmacist how to dispose of
upright for 60 minutes after taking your tablet.
medicines no longer required. These measures will help to
protect the environment.
How long you should take the Kalosso 50 mg film-coated
tablets
It is important to continue taking Kalosso 50 mg film-coated 6. FURTHER INFORMATION
tablets for as long as your doctor prescribes the medicine.
Kalosso 50 mg film-coated tablets can help with your condition What Kalosso 50 mg film-coated tablets contains
only if you continue to take the tablets.
– Each film-coated tablet contains 56.27 mg of sodium
If you take more Kalosso 50 mg film-coated tablets than you ibandronate monohydrate, equivalent to 50 mg of ibandronic
should
acid.
If you take too many tablets by mistake, drink a full glass of – The other ingredients are:
milk and contact your doctor immediately. Do not make yourself tablet core: lactose monohydrate, povidone, microcrystalline
vomit, and do not lie down.
cellulose, crospovidone, magnesium stearate, colloidal
anhydrous silica.
If you forget to take Kalosso 50 mg film-coated tablets
tablet coat: opadry II white 85F18422 contains polyvinil
Do not take a double dose to make up for a forgotten dose. alcohol, titanium dioxide E 171, talc, macrogol.
Return to taking one tablet per day the following day, as usual.
What Kalosso 50 mg film-coated tablets looks like and
If you stop taking Kalosso 50 mg film-coated tablets
contents of the pack
Keep taking Kalosso 50 mg film-coated tablets for as long as
your doctor tells you. This is because the medicine will only work The film-coated tablets are of round, biconvex shape and white
if it is taken all the time.
to off-white in colour, engraved M23. They are available in
packs of 28 and 84 tablets.
If you have any further questions on the use of this product, ask Not all pack sizes may be marketed.
your doctor or pharmacist.
Marketing Authorisation Holder and Manufacturer
4. POSSIBLE SIDE EFFECTS

Gedeon Richter Plc.
H-1103 Budapest
Like all medicines, Kalosso 50 mg film-coated tablets can cause Gyömrői út 19-21
side effects although not everybody gets them.
Hungary
Stop taking Kalosso 50 mg film-coated tablets 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 KALOSSO 50 MG FILM-COATED TABLETS
Keep out of the reach and sight of children.
This medicinal product does not require any special storage
conditions.
Do not use Kalosso 50 mg film-coated tablets after the expiry
date which is stated on the blister and carton after (MM/YYYY).
The expiry date refers to the last day of that month.

This medicinal product is authorised in the Member States of
the EEA under the following names:
ES
FR
HU
IT

Kalosso 50 mg comprimidos recubiertos con película
Kalosso 50 mg comprimés pelliculés
Kalosso 50 mg filmtabletta
Kalosso 50 mg compresse rivestite con film

This leaflet was last approved in 02/2012 

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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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