A SANDOZ SZ00000LT000

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic acid Sandoz 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 Ibandronic acid is and what it is used for

2.    What you need to know before you take Ibandronic acid

3.    How to take Ibandronic acid

4.    Possible side effects

5.    How to store Ibandronic acid

6.    Contents of the pack and other information

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

Ibandronic acid belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.

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 for the spine but not for the hip.

Ibandronic acid 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 IBANDRONIC ACID

Do not take Ibandronic acid

•    If you are allergic to ibandronic acid, or 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 Ibandronic acid. Talk to your doctor before taking Ibandronic acid:

•    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 Ibandronic acid. 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 Ibandronic acid. If you develop these symptoms, stop taking Ibandronic acid and tell your doctor straight away (see section 3).

Children and adolescents

Do not give Ibandronic acid to children or adolescents below 18 years.

Other medicines and Ibandronic acid

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 Ibandronic acid.

•    Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine. 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, or vitamins.

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 water but no other drinks After you have taken Ibandronic acid, please wait for 1 hour before you can have your first food and further drinks (see 3. How to take Ibandronic acid)

Pregnancy and breast-feeding

Ibandronic acid is for use only by postmenopausal women and must not be taken by women who could still have a baby. Do not take Ibandronic acid 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 Ibandronic acid has no or negligible effect on your ability to drive and use machines.

Ibandronic acid 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 IBANDRONIC ACID

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 Ibandronic acid is one tablet once a month.

Taking your monthly tablet

It is important to follow these instructions carefully. They are designed to help your Ibandronic acid tablet reach your stomach quickly, so it is 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 1st 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 water.

•    Take your Ibandronic acid 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

X

-    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.

00000000

% -re re

■o £

Continuing to take Ibandronic acid

It’s important to keep taking Ibandronic acid every month, as long as your doctor prescribes it for you. After 5 years of using Ibandronic acid, please consult with your doctor whether you should continue to take Ibandronic acid.

If you take more Ibandronic acid 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 Ibandronic acid to irritate your oesophagus.

If you forget to take Ibandronic acid

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

Never take two Ibandronic acid 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 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.

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 IBANDRONIC ACID

Keep this medicine out of the sight and reach of children.

There are no special storage instructions.

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

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ibandronic acid contains

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

•    The other ingredients are:

tablet core: Povidone, cellulose microcrystalline, maize starch pregelatinised, crospovidone, silica colloidal anhydrous, Glycerol Dibehenate.

tablet coat: Opadry OY-LS-28908 (white II) consisting of: hypromellose, lactose monohydrate, titanium dioxide (E171), Macrogol 4000.

What Ibandronic acid looks like and contents of the pack

Ibandronic acid 150 mg film-coated tablets are white, round biconvex tablets.

Ibandronic acid 150 mg film-coated tablets are supplied in a cardboard box containing the appropriate number (1, 3 or 6 tablets) of PA/Aluminium/PVC-Aluminium foil blisters (alu-alu blister) with an instruction leaflet.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Sandoz Ltd,

Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Lek Pharmaceuticals d.d.

Verovskova 57 1526 Ljubljana Slovenia or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A RO-540472 Targu-Mures Romania or

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany or

Pharmathen S.A.

Dervenakion 6 Pallini 15351 Attikis Greece or

LEK S.A.

ul. Domaniewska 50 C,

02-672 Warszawa Poland or

Lek Pharmaceuticals d.d.

Trimlini 2D 9220 Lendava Slovenia or

Pharmathen International S.A Industrial park Sapes, Street block 5 693 00 Sapes, Prefecture of Rodopi Greece.

This leaflet was last revised in 09/2014.

00000000

SZ00000LT000

% -re re

■3 £