PACKAGE LEAFLET: INFORMATION FOR THE USER KALOSSO 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

1.    What Kalosso 150 mg film-coated tablet is and what it is used for

Kalosso 150 mg film-coated tablet belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.

Kalosso may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won't be able to see or feel a difference. Kalosso may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

Kalosso 150 mg film-coated tablet is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman's ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.

The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis. Other things that can increase the risk of fractures include:

-    not enough calcium and vitamin D in the diet

-    smoking, or drinking too much alcohol

-    not enough walking or other weight-bearing exercise

-    a family history of osteoporosis.

A healthy lifestyle will also help you to get the most benefit from your treatment. This includes:

-    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.

2.    What you need to know before you take Kalosso 150 mg film-coated tablet

Do not take Kalosso 150 mg film-coated tablet

-    If you are allergic to ibandronic acid, or to any of the other ingredients of this medicine (listed in section 6).

-    If you have certain problems with your gullet/food pipe (oesophagus) such as narrowing or difficulty swallowing.

-    If you can't stand or sit upright for at least one hour (60 minutes) at a time.

-    If you have, or had in the past low blood calcium. Please consult your doctor.

Warnings and precautions

Some people need to be especially careful while they're taking Kalosso. Talk to your doctor before taking Kalosso:

-    If you have any disturbances of mineral metabolism (such as vitamin D deficiency).

-    If your kidneys are not functioning normally.

-    If you have any swallowing or digestive problems.

-    If you have or have ever had problems with your oesophagus. For example if you had pain or difficulties swallowing food or if you have been told that you have Barrett's oesophagus (a disease characterized by changes of the cells, that cover the lower part of the oesophagus).

-    If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Kalosso. When you have cancer, tell your dentist as well.

Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a 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 symptoms, stop taking Kalosso 150 mg-film coated tablet and tell your doctor straight away (see section 3).

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 naproxen) may irritate the stomach and intestine. Kalosso 150 mg may also do so. So be especially careful if you take painkillers or anti-inflammatories while you're taking Kalosso 150 mg.

After swallowing your monthly Kalosso, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.

Kalosso with food and drink:

Do not take Kalosso with food. Kalosso is less effective if it's taken with food.

You can drink water but no other drinks. After you have taken Kalosso, please wait for 1 hour before you can have your first food and further drinks (see 3. How to take Kalosso 150 mg film-coated tablet).

Pregnancy and breastfeeding

Kalosso is for use only by postmenopausal women and must not be taken by women who could still have a baby.

Do not take Kalosso 150 mg if you are pregnant or 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 Kalosso has no or negligible effect on your ability to drive and use machines.

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 Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.

3. How to take Kalosso 150 mg film-coated tablet

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of Kalosso 150 mg is one tablet once a month.

Taking your monthly tablet

It's important to follow these instructions carefully. They are designed to help your Kalosso reach your stomach quickly, so it's less likely to cause irritation.

-    Take one Kalosso 150 mg tablet once a month.

-    Choose one day of the month that will be easy to ^member. You can choose either the same date (such as the 1 of each month) or the same day (such as the first Sunday of each month) to take your Kalosso 150 mg tablet. Choose the date that best fits your routine.

-    Take your Kalosso 150 mg tablet at least 6 hours after you last had anything to eat or drink except water.

-    Take your Kalosso 150 mg tablet

•    after you first get up for the day, and

•    before you have anything to eat or drink (on an empty stomach).

-    Swallow your tablet with a full glass of water (at least 180 ml). Do not take your tablet with water with a high concentration of calcium, fruit juice or any other drinks. If there is a 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.

-    Swallow your tablet whole - do not chew it, crush it or let it dissolve in your mouth.

-    For the next hour (60 minutes) after you've taken your tablet

•    do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus

•    do not eat anything

•    do not drink anything (except water if you need it)

•    do not take any other medicines.

-    After you've waited for an hour, you can have your first food and drink of the day. Once you've eaten, it's OK to lie down if you wish, and to take any other medication you need.

Continuing to take Kalosso

It's important to keep taking Kalosso every month, as long as your doctor prescribes it for you.

After 5 years of using Kalosso, please consult with your doctor whether you should continue to take Kalosso.

If you take more Kalosso than you should

If you've taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.

Do not make yourself vomit, and do not lie down — this could cause Kalosso to irritate your oesophagus.

If you forget to take Kalosso

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.

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

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:

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.

Other possible side effects

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.

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: 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 Kalosso 150 mg film-coated tablet

Keep out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine 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.

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 to protect the environment.

6.    Contents of the pack and other information What Kalosso 150 mg film-coated tablet contains

-    Each film-coated tablet contains 168.81 mg of sodium iban-dronate 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

Kalosso are white to off white, of oblong shape and marked ”M24” on one side. The tablets are supplied in blisters containing 1 or 3 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Gedeon Richter Plc H1-1103 Budapest Gyomroi ut 19-21.

Hungary

Manufacturer responsible for batch release:

Gedeon Richter Plc H-1103 Budapest Gyomroi ut 19-21.

Hungary

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

ES    Kalosso    comprimidos    recubiertos con pelicula

FR    Kalosso    150 mg    comprimes pellicules

HU    Kalosso    150 mg    filmtabletta

IT    Kalosso    150 mg    compresse rivestite con    film

This leaflet was last approved in 04/2014

© GEDEON RICHTER