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IBANDRONIC ACID 150 MG FILM-COATED TABLETS

Active substance(s): IBANDRONIC ACID / SODIUM IBANDRONATE MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Ibandronic acid 150 mg film-coated tablets

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

The name of your medicine is Ibandronic acid 150mg film-coated Tablets (referred to as
ibandronic acid throughout this leaflet).
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.

 

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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 and 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.
 

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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 have your first food
and further drinks (see section 3 “How to take ibandronic acid”).).
Pregnancy, breast-feeding and fertility
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 have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
3. HOW TO TAKE IBANDONIC 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’s important to follow these instructions carefully. They are designed to help your
ibandronic acid tablet reach your stomach 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
st
same date (such as the 1 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
 

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 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 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 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 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.

 

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Rare (may affect up to 1 in 1,000 people):
- itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You
may be having an allergic reaction to this medicine.
- 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.
- bone necrosis of the external ear canal. Talk to your doctor if you have ear pain,
discharge from the ear, and/or an ear infection. These could be signs of bone damage
in the ear.
- severe adverse skin reactions.
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 to1 in 100 people):
- dizziness,
- flatulence (farting, feeling bloated)
- back pain
- feeling tired and exhausted.
- asthma attacks.
Rare (may affect up to 1 in 1,000 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, pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

 

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5. HOW TO STORE IBANDRONIC ACID
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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
sodium monohydrate).
 The other ingredients are: Core: Ludipress (Lactose, Povidone 40, Crospovidone),
Magnesium Stearate. Coating: Opadry® II 85F18422 White (mixture of Polyethylene
glycol, Titanium Dioxide, Talc and Polyvinyl alcohol)
What Ibandronic acid 150mg tablets looks like and contents of the pack
Ibandronic acid 150mg tablets are white, oblong biconvex film coated tablets.
Pack sizes:
1, 3 or 6 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder:
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer
Zentiva, k.s., Prague, Czech Republic
This leaflet was last revised in February 2016
© 2016 Zentiva 

 

 

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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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