PACKAGE LEAFLET: INFORMATION FOR THE USER

LICOBONDRAT 150 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.

In this leaflet:

1.    What LICOBONDRAT is and what it is used for

2.    Before you take LICOBONDRAT

3.    How to take LICOBONDRAT

4.    Possible side effects

5.    How to store LICOBONDRAT

6.    Further information

1.    WHAT LICOBONDRAT IS AND WHAT IT IS USED FOR

Licobondrat belongs to a group of medicines called bisphosphonates. It contains acid. It does not contain hormones.

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

Licobondrat is prescribed to you to treat 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

Many people with osteoporosis have no symptoms. If you have no symptoms you may not know if you have the condition. However, osteoporosis makes you more likely to break bones if you fall or hurt yourself. A broken bone after the age of 50 may be a sign of osteoporosis. Osteoporosis can also cause back pain, height loss and a curved back.

Licobondrat prevents loss of bone from osteoporosis, and helps to rebuild bone. Therefore Licobondrat makes bone less likely to break.

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 weightbearing exercise; not smoking; and not drinking too much alcohol.

2.    BEFORE YOU TAKE LICOBONDRAT Do not take Licobondrat

-    If you are allergic (hypersensitive) to ibandronic acid, or to any of the other ingredients of .

-    LICOBONDRATIf you have certain problems with your oesophagus (the tube connecting your mouth with your stomach) 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.

Do not give Licobondrat to children or adolescents.

Take special care with Licobondrat

Some people need to be especially careful while they’re taking . Licobondrat Check with your doctor:

-    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 are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with . Licobondrat

Irritation, inflammation or ulceration of the oesophagus (the tube connecting your mouth with your stomach) 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 plain water and/or if you lie down within an hour of taking . Licobondrat If you develop these symptoms, stop taking Licobondrat and tell your doctor straight away.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without prescription. Especially:

-    Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of . Licobondrat

-    Aspirin and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine. Bisphosphonates (like ) Licobondrat may also do so. So be especially careful if you take painkillers or anti-inflammatories while you’re taking . Licobondrat

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

Taking Licobondrat with food and drink:

Do not take Licobondrat with food. Licobondrat is less effective if it’s taken with food. You can drink plain water but no other drinks (see 3. HOW TO TAKE ).LICOBONDRAT

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking any medicine.

There are no adequate data from the use of Licobondrat in pregnant women. Studies in animals have shown that could be toxic to reproduction. Licobondrat should therefore not be used during pregnancy.

It is not known if the medicine is excreted in human milk. Studies in animals have shown low levels of the active substance in milk. Licobondrat should therefore not be used during breast feeding.

Driving and using machines

You can drive and use machines as it’s very unlikely that Licobondrat will affect your ability to drive and use machines.

Important information about some of the ingredients of Licobondrat

Licobondrat contains an ingredient called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3.    HOW TO TAKE LICOBONDRAT

Always take Licobondrat exactly as your doctor has told you. If you’re not sure about anything, ask your doctor or pharmacist.

The usual dose of Licobondrat is one tablet once a month.

Taking your monthly tablet

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

-    Take one Licobondrat 150 mg tablet once a month.

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

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

-    Take your Licobondrat 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 plain water (at least 180 ml). Do not take your tablet with mineral water, fruit juice or any other drinks.

-    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 drink anything (except plain 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.

Do not take your tablet at bedtime or before you get up for the day.

Continuing to take Licobondrat

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

Licobondrat can treat osteoporosis only as long as you keep taking it.

If you take too much Licobondrat

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 Licobondrat to irritate your oesophagus.

If you forget a dose

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 your next scheduled dose is only 1 to 7 days away...

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 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.

Never take two Licobondrat tablets within the same week.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Licobondrat can cause side effects, although not everybody gets them. These side effects may occur with certain frequencies, which are defined as follows:

-    very common: affects more than 1 user in 10

-    common: affects 1 to 10 users in 100

-    uncommon: affects 1 to 10 users in 1,000

-    rare: affects 1 to 10 users in 10,000

-    very rare: affects less than 1 user in 10,000

-    not known: frequency cannot be estimated from the available data.

Common side effects are heartburn, indigestion, diarrhoea, stomach ache, and nausea. Licobondrat can also irritate the oesophagus, although you can usually avoid this by taking your dose as described in this leaflet. If you develop symptoms such as severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, tell your doctor straightaway.

Other common side effects include rash, cramps in the muscles, pain in the muscles and joints, and headache.

It also includes flu-like symptoms (aches and pains, feeling of discomfort, fatigue) which are usually mild, are short-lasting and disappear soon after you have taken the first dose. So you should be able to carry on taking . Licobondrat Talk to your doctor if any effects become troublesome or last a long time.

Uncommon side effects are dizziness, back pain and flatulence.

Rare side effects are swelling and itching of the face, lips and mouth.

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 LICOBONDRAT

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the carton after “EXP”.

There are no special storage instructions.

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 Licobondrat contains

-    The active substance is ibandronic acid. One tablet contains 150 mg ibandronic acid (as ibandronate sodium hydrate).

-    The other ingredients are:

tablet core: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, silica colloidal anhydrous

tablet coat: hydroxypropylcellulose, titanium dioxide (E171), macrogol 6000 What Licobondrat looks like and contents of the pack

Licobondrat 150 mg Film-coated tablets are white film-coated tablets of oblong shape and scored “LC” on one side.

Licobondrat 150 mg Film-coated tablets is available in pack sizes of 1 and 3 film-coated tablets. The tablets are supplied in blisters containing 1 or 3 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Laboratorios Liconsa, S.A.

Gran Via Carlos III, 98, 7 08028 Barcelona, Spain Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, N° 7, Poligono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara), SPAIN

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

Austria: Licobondrat 150 mg Filmtabletten Belgium: Licobondrat 150 mg Comprimes pellicules Bulgary: Licobondrat 150 mg On^MHpaHa TaO^eTKa Czech Republic: Licobondrat 150 mg potahovane tablety Estonia: Licobondrat 150 mg

Finland: Licobondrat 150 mg Tabletti, kalvopaallysteinen France: Licobondrat 150 mg Comprimes pellicules Germany: Licobondrat 150 mg Filmtabletten Hungary: Licobondrat 150 mg Filmtabletta Italy: Licobondrat 150 mg Compressa rivestita con film Latvia: Licobondrat 150 mg Apvalkotas tabletes Lithuania: Licobondrat 150 mg Plevele dengtos tabletes Luxembourg: Licobondrat 150 mg Comprimes pellicules Netherlands: Licobondrat 150 mg Filmomhulde tabletten Norway: Licobondrat 150 mg Tablett, filmdrasjert Portugal Licobondrat 150 mg Slovak Republic: Licobondrat 150 mg

Spain: Acido Ibandronico Tarbis 150 mg comprimidos recubiertos con pelicula EFG United Kingdom: Licobondrat 150 mg Film-coated tablets

This leaflet was last approved in:

July 2013