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KALOSSO 150 MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

K ALOSSO 150 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 Kalosso 150 mg film-coated tablet is and what it is
used for
2. What you need to know before you take Kalosso 150 mg
film-coated tablet
3. How to take Kalosso 150 mg film-coated tablet
4. Possible side effects
5. How to store Kalosso 150 mg film-coated tablet
6. Contents of the pack and other information

Children and adolescents
Do not give Kalosso 150 mg film-coated tablet to children or
adolescents below 18 years.

Other medicines and Kalosso 150 film-coated tablet
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines. Especially:
–– Supplements containing calcium, magnesium, iron or aluminium,
as they could possibly influence the effects of Kalosso.
–– Acetylsalicylic acid and other non-steroidal anti-inflammatory
medicines (NSAIDs) (including ibuprofen, diclofenac sodium and
1. What Kalosso 150 mg film-coated tablet is and what it is naproxen) may irritate the stomach and intestine. Kalosso 150 mg
used for
may also do so. So be especially careful if you take painkillers or
anti-inflammatories while you’re taking Kalosso 150 mg.
Kalosso 150 mg film-coated tablet belongs to a group of medicines called bisphosphonates. It contains the active substance After swallowing your monthly Kalosso, wait for 1 hour before
ibandronic acid.
taking any other medication, including indigestion tablets, calcium
Kalosso may reverse bone loss by stopping more loss of bone supplements, or vitamins.
and increasing bone mass in most women who take it, even
though they won’t be able to see or feel a difference. Kalosso Kalosso with food and drink:
may help lower the chances of breaking bones (fractures). Do not take Kalosso with food. Kalosso is less effective if it’s
This reduction in fractures was shown for the spine but not taken with food.
for the hip.
You can drink water but no other drinks. After you have taken
Kalosso, please wait for 1 hour before you can have your first
Kalosso 150 mg film-coated tablet is prescribed to you to food and further drinks (see 3. How to take Kalosso 150 mg
treat postmenopausal osteoporosis because you have an film-coated tablet).
increased risk of fractures. Osteoporosis is a thinning and
weakening of the bones, which is common in women after Pregnancy and breastfeeding
the menopause. At the menopause, a woman’s ovaries stop Kalosso is for use only by postmenopausal women and must not
producing the female hormone, oestrogen, which helps to be taken by women who could still have a baby.
keep her skeleton healthy.
Do not take Kalosso 150 mg if you are pregnant or breast feeding
Ask your doctor or pharmacist for advice before taking this
The earlier a woman reaches the menopause, the greater her medicine.
risk of fractures in osteoporosis. Other things that can increase
the risk of fractures include:
Driving and using machines
–– not enough calcium and vitamin D in the diet
You can drive and use machines as it’s expected that Kalosso has
–– smoking, or drinking too much alcohol
no or negligible effect on your ability to drive and use machines.
–– not enough walking or other weight-bearing exercise
–– a family history of osteoporosis.
Kalosso 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
A healthy lifestyle will also help you to get the most benefit from Lapp lactase deficiency or have problems with glucose-galacyour treatment. This includes:
tose absorption), talk to your doctor before taking this medicine.
–– eating a balanced diet rich in calcium and vitamin D;
–– walking or any other weight-bearing exercise;
–– not smoking; and not drinking too much alcohol.
3. How to take Kalosso 150 mg film-coated tablet
Always take this medicine exactly as your doctor has told you.
2. What you need to know before you take Kalosso 150 mg Check with your doctor or pharmacist if you are not sure.
film-coated tablet
The usual dose of Kalosso 150 mg is one tablet once a month.
Do not take Kalosso 150 mg film-coated tablet
–– If you are allergic to ibandronic acid, or to any of the other Taking your monthly tablet
ingredients of this medicine (listed in section 6).
It’s important to follow these instructions carefully. They are de–– If you have certain problems with your gullet/food pipe signed to help your Kalosso reach your stomach quickly, so it’s
(oesophagus) such as narrowing or difficulty swallowing.
less likely to cause irritation.
–– If you can’t stand or sit upright for at least one hour (60 minutes)
at a time.
–– Take one Kalosso 150 mg tablet once a month.
–– If you have, or had in the past low blood calcium. Please
consult your doctor.
–– Choose one day of the month that will be easy to remember.
st
You can choose either the same date (such as the 1 of each
Warnings and precautions
month) or the same day (such as the first Sunday of each month)
Some people need to be especially careful while they’re taking to take your Kalosso 150 mg tablet. Choose the date that best
Kalosso. Talk to your doctor before taking Kalosso:
fits your routine.
–– If you have any disturbances of mineral metabolism (such as
vitamin D deficiency).
–– Take your Kalosso 150 mg tablet at least 6 hours after you
–– If your kidneys are not functioning normally.
last had anything to eat or drink except water.
–– If you have any swallowing or digestive problems.
–– If you have or have ever had problems with your oesophagus. –– Take your Kalosso 150 mg tablet
For example if you had pain or difficulties swallowing food or if • after you first get up for the day, and
you have been told that you have Barrett’s oesophagus (a disease • before you have anything to eat or drink (on an empty stomach).
characterized by changes of the cells, that cover the lower part
of the oesophagus).
–– Swallow your tablet with a full glass of water (at least 180 ml).
–– If you are under dental treatment or will undergo dental sur- Do not take your tablet with water with a high concentration
gery, tell your dentist that you are being treated with Kalosso. of calcium, fruit juice or any other drinks. If there is a concern
When you have cancer, tell your dentist as well.
regarding potentially high levels of calcium in the tap water (hard
water), it is advised to use bottled water with a low mineral
Irritation, inflammation or ulceration of the gullet/food pipe content.
(oesophagus) often with symptoms of severe pain in the chest,
severe pain after swallowing food and/or drink, severe nau- –– Swallow your tablet whole - do not chew it, crush it or let it
sea, or vomiting may occur, especially if you do not drink a dissolve in your mouth.
full glass of water and/or if you lie down within an hour of
taking Kalosso 150 mg film-coated tablet. If you develop these –– For the next hour (60 minutes) after you’ve taken your tablet
symptoms, stop taking Kalosso 150 mg-film coated tablet and • do not lie down; if you do not stay upright (standing or sitting),
tell your doctor straight away (see section 3).
some of the medicine could leak back into your oesophagus

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:
–– After you’ve waited for an hour, you can have your first food www.mhra.gov.uk/yellowcard. By reporting side effects you can
and drink of the day. Once you’ve eaten, it’s OK to lie down if help provide more information on the safety of this medicine.
you wish, and to take any other medication you need.
• do not eat anything
• do not drink anything (except water if you need it)
• do not take any other medicines.

Continuing to take Kalosso
5. How to store Kalosso 150 mg film-coated tablet
It’s important to keep taking Kalosso every month, as long as
your doctor prescribes it for you.
Keep out of the sight and reach of children.
After 5 years of using Kalosso, please consult with your doctor
whether you should continue to take Kalosso.
This medicinal product does not require any special storage
conditions.
If you take more Kalosso than you should
If you’ve taken more than one tablet by mistake, drink a full glass Do not use this medicine after the expiry date which is stated on
of milk and talk to your doctor straight away.
the blister and carton after (MM YYYY). The expiry date refers to
the last day of that month.
Do not make yourself vomit, and do not lie down — this could
cause Kalosso to irritate your oesophagus.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
If you forget to take Kalosso
longer use. These measures will help to protect the environment.
If you forget to take your tablet on the morning of your chosen
day, do not take a tablet later in the day. Instead, consult your
calendar and find out when your next scheduled dose is.
6. Contents of the pack and other information
If you forgot to take your tablet on your chosen day and your
next scheduled dose is only 1 to 7 days away…
Never take two Kalosso tablets within the same week. You
should wait until the next scheduled dose is due and take it as
normal; then, continue taking one tablet once a month on the
scheduled days you’ve marked on your calendar.
If you forgot to take your tablet on your chosen day and your
next scheduled dose is more than 7 days away…
You should take one tablet the next morning after the day you
remember; then, continue taking one tablet once a month on the
scheduled days you’ve marked on your calendar.
4. Possible side effects

What Kalosso 150 mg film-coated tablet contains
–– Each film-coated tablet contains 168.81 mg of sodium ibandronate monohydrate, equivalent to 150 mg of ibandronic acid.
–– The other ingredients are:
tablet core: lactose monohydrate, povidone, microcrystalline
cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica.
tablet coat: opadry II white 85F18422 contains polyvinyl alcohol,
titanium dioxide (E171), talc, macrogol.
What Kalosso 150 mg film-coated tablet looks like and
contents of the pack

Like all medicines, this medicine can cause side effects, although Kalosso are white to off white, of oblong shape and marked
not everybody gets them.
“M24” on one side. The tablets are supplied in blisters containing
1 or 3 tablets.
Talk to a nurse or a doctor straight away if you notice any Not all pack sizes may be marketed.
of the following serious side effects - you may need urgent
medical treatment:
Marketing Authorisation Holder and Manufacturer:
Uncommon (may affect up to 1 in 100 people):
–– severe pain in the chest, severe pain after swallowing food or
drink, severe nausea, or vomiting, difficulty in swallowing. You
may have a severe inflammation of your gullet/food pipe, possibly with sores or constriction of the gullet/food pipe.
Rare (may affect up to 1 in 1000 people):
–– itching, swelling of your face, lips, tongue and throat, with
difficulty breathing
–– 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)
–– serious, potentially life-threatening allergic reaction.

Gedeon Richter Plc
H-1103 Budapest
Gyömrői út 19-21.
Hungary
Manufacturer responsible for batch release:
Gedeon Richter Plc
H-1103 Budapest
Gyömrői út 19-21.
Hungary
This medicinal product is authorised in the Member States of
the EEA under the following names:
ES
FR
HU
IT

Kalosso comprimidos recubiertos con película
Kalosso 150 mg comprimés pelliculés
Kalosso 150 mg filmtabletta
Kalosso 150 mg compresse rivestite con film

Other possible side effects
This leaflet was last approved in 04/2014
Common (may affect up to 1 in 10 people):
–– headache
–– heartburn, discomfort in swallowing, stomach or tummy pain
(may be due to an inflammation of the stomach), indigestion,
nausea
–– having diarrhoea (loose bowels)
–– muscle cramps, stiffness of your joints and limbs
–– flu-like symptoms, including fever, shaking and shivering, feeling
of discomfort, bone pain and aching muscles and joints. Talk to a
nurse or doctor if any effects become troublesome or last more than
a couple of days.
–– rash.
Uncommon (may affect up to 1 in 100 people):
–– dizziness
–– flatulence (farting, feeling bloated)
–– back pain
–– feeling tired and exhausted
–– asthma attacks.
Rare (may affect up to 1 in 1000 people):
–– inflammation of the duodenum (first section of the bowel)
causing stomach pain
–– hives.

RG 0000, K-18819-1.4, 00000000

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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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