Relon 3 ;m

IBANDRONIC ACID 1S0 mg Film-coated tablets

Ibandronic acid

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you haveanyfurtherquestions.askyourdoctororpharmacist.

•    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 Ibandronic acid is and what it is used for

2.    Before you take Ibandronic acid

3.    How to take Ibandronic acid

4.    Possible side effects

5.    Howto store Ibandronic acid

6.    Further information

1.    WHAT IBANDRONIC ACID IS AND WHAT IT IS USED FOR

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

Ibandronic acid 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. Ibandronic acid may help lower the chances of breaking bones (fractures). This reduction in fractures was shown forthe spine butnotforthehip.

Ibandronic acid 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, ordrinking too much alcohol

•    not enough walking or other weight-bearing exercise

•    afamilyhistoryofosteoporosis

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.

Ibandronic acid prevents loss of bone from osteoporosis and helps to rebuild bone. Therefore Ibandronic acid 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 orany other weight-bearing exercise; notsmoking; and not drinking too much alcohol.

2.    BEFORE YOU TAKE IBANDRONIC ACID Do not take Ibandronic acid

•    If you are allergic (hypersensitive) to ibandronic acid orto any of the other ingredients of Ibandronic acid

•    If you have certain problems with youroesophagus (the tube connecting your mouth with yourstomach) such as narrowing or difficulty swallowing.

•    If you can't stand orsit uprightforat 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 Ibandronic acid to children or adolescents.

Take special care with Ibandronic acid

Some people need to be especially careful while they're taking Ibandronic acid, Check with yourdoctor:

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

•    If your kidneys are notfunctioning normally.

•    If you have any swallowing ordigestive problems.

•    If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Ibandronic acid.

Irritation, inflammation or ulceration of the oesophagus (the tube connecting your mouth with yourstomach) 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 Ibandronic acid. If you develop these symptoms, stop taking Ibandronic acid and tell yourdoctor 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 Ibandronic acid.

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

After swallowing your monthly Ibandronic acid tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements orvitamins.

Taking Ibandronic acid with food and drink:

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

You can drink plain water but no other drinks (see 3. HOWTO TAKE) IBANDRONICACID.

Pregnancy and breastfeeding

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

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

Driving and using machines

You can drive and use machines as it's very unlikely that Ibandronic acid will affect your ability to drive and use machines.

Important information about some of the ingredients of Ibandronic acid

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

3.    HOWTO TAKE IBANDRONIC ACID

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

The usual dose of Ibandronic acid is one tablet once a month.

Taking your monthly tablet

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

•    Take one Ibandronic acid 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 1⁵¹ of each month) or the same day (such as the first Sunday of each month) to take your Ibandronic acid tablet. Choose the date that best fits your routine.

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

•    Takeyourlbandronicacid 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 orany otherdrinks.

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

•    Forthe next hour (60 minutes) afteryou'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 youroesophagus

•    donoteatanything

■

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

•    donottakeanyothermedicines

•    Afteryou've waited for an hour, you can have yourfirst food and drinkof 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 yourtablet at bedtime or before you get up for the day.

Continuing to take Ibandronic acid

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

Ibandronic acid can treat osteoporosis only as long as you keep taking it.

If you take too much Ibandronic acid

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 Ibandronic acid to irritate your oesophagus.

If you forget a dose

If you forget to take yourtablet on the morning of your chosen day, do not take a tablet later in the day. Instead, consultyourcalendarandfind 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 yourcalendar.

Nevertake two Ibandronic acid tablets within the same week.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Ibandronic acid can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows:

•    verycommon: affects more than 1 userin 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. Ibandronic acid 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 afteryou have taken the first dose. So you should be able to carry on taking Ibandronic acid. 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 yourdoctor or pharmacist.

5.    HOWTOSTORE IBANDRONICACID

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 Ibandronic acid contains

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

•    Theotheringredientsare:

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

tablet coat: hydroxypropylcellulose, titanium dioxide (E171), macrogol 6000.

What Ibandronic acid looks like and contents of the pack

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

Ibandronic acid 150 mg Film-coated tablets are available in pack sizes of 1 and 3 film-coated tablets. The tablets are supplied in blisters containing 1 or3 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Laboratories, S.A.

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

Manufacturer:

Laboratories, S.A.

Avda. Miralcampo, N⁰7, Poligono Industrial Miralcampo,19200 Azuqueca de Henares (Guadalajara), SPAIN Distributor:

Relonchem Limited.Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.

PL 23218/0054

POM

This leaflet was last revised in: July 2013