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IBANDRONIC ACID HELM 50MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic acid 50 mg film-coated tablets
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 or pharmacist.
In this leaflet:
1. What Ibandronic acid tablets are and what they are used for
2. Before you take Ibandronic acid
3. How to take Ibandronic acid
4. Possible side effects
5. How to store Ibandronic acid
6. Further information
1. WHAT IBANDRONIC ACID 50mg TABLETS ARE AND WHAT THEY ARE USED FOR
Ibandronic acid 50mg tablets contains the active substance ibandronic acid. This belongs to a group of
medicines called bisphosphonates.
This medicine is indicated in adults and prescribed to you if you have breast cancer that has spread to your
bones (called bone “metastases”).



It helps to prevent your bones from breaking (fractures).
It also helps to prevent other bone problems that may need surgery or radiotherapy.

Ibandronic acid works by reducing the amount of calcium that is lost from your bones. This helps to stop your
bones from getting weaker.
2. BEFORE YOU TAKE Do not take if you:





are allergic (hypersensitive) to ibandronic acid or any of the other ingredients.
if you have certain problems with your oesophagus (the tube connecting your mouth with your stomach)
such as narrowing or difficult 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.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or
pharmacist.
These tablets should not be given to children and adolescents.
Take special care if you:
• are hypersensitive (allergic) to other bisphosphonates.
• have high or low blood levels of vitamin D or any other minerals.
• have kidney problems
or when:



you have any swallowing or digestive problems.
you are also taking non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen or
naproxen, since these medicines (NSAIDs and bisphosphonates) may cause irritation to the stomach and
intestine.

During treatment your blood may be monitored to ensure that you are receiving the correct dose of
Ibandronic acid.
If you are under dental treatment or will undergo dental surgery in the future, tell your dentist that you are
being treated with Ibandronic acid 50mg tablets.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
those obtained without a prescription. This is because Ibandronic acid 50 mg tablets can affect the way some
other medicines work. Also some other medicines can affect the way these tablets work.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• supplements containing calcium, magnesium, iron or aluminium.
• non-steroidal anti-inflammatory drugs called “NSAIDs” such as aspirin, ibuprofen or naproxen. This is
because NSAIDs and Ibandronic acid can both irritate your stomach and gut.
• a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because aminoglycosides
and Ibandronic acid can both lower the amount of calcium in your blood. The levels of magnesium in you
blood may also decrease (hypomanesaemia).
After taking your tablet, wait at least 30 minutes before taking any othermedicines, including those for
indigestion, calcium supplements and vitamins.
Taking Ibandronic acid 50mg tablets with food and drink
Your tablets should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the
day. You should not take any other medicines or supplements before taking the tablets. After taking the
tablets, you should not not eat or drink anything (except water), or take any medicines for at least 30 minutes
Plain water may be taken at any time during the course of Ibandronic acid treatment.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant, planning to become pregnant or if you are
breast-feeding.
Driving and using machines
The effects of Ibandronic acid 50mg tablets on the ability to drive or to use machines has not been studied.
Please ask you doctor or pharmacist for advice if you want to drive or operate machinery whilst taking this
medicine.
3. HOW TO TAKE Ibandronic acid 50mg tablets
Always take the tablets exactly as your doctor has told you. You should check with your doctor or pharmacist
if you are not sure.
The usual dose is one tablet per day. If you have moderate kidney problems, your doctor may reduce your
dose to one tablet every other day or to one tablet per week in case of severe kidney problems.
These tablets may cause irritation, inflammation or ulceration of the oesophagus (the tube that connects your
mouth with your stomach) often with symptoms of severe pain in the chest, severe pain after swallowing food
or drink, severe nausea, or vomiting. If you develop these symptoms, stop taking the tablets and tell your
doctor straight away.
To reduce possible irritation, it is important that you follow the instructions below:






Take your Ibandronic acid tablet with a full glass of plain water only (about 200 ml) BEFORE taking your
first food, drink or other medicines,. Do not take your tablet with any drink other than plain water.
Swallow the tablet whole. Do not chew, suck, crush or allow the tablet to dissolve in your mouth.
After taking your tablet, wait at least 30 minutes before having anything to eat or drink or taking any other
medicines.
You should remain in an upright position (sitting or standing) while taking your tablet and remain upright
for the next hour (60 minutes) after taking the tablet. If you do not stay upright, some of the medicine could
leak back into your oesophagus and cause irritation.
It is important to continue taking this medicine for as long as your doctortells you to. Ibandronic acid can
help with your condition only if you continue to take the tablets.

If you take more Ibandronic acid 50mg tablets than you should
If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. Do not
make yourself vomit, and do not lie down.
If you forget to take Ibandronic acid 50mg tablets
Do not take a double dose to make up for a forgotten dose. If you are taking a tablet each day, skip the
missed dose completely and return to taking one tablet per day the following day, as usual. If you are taking
one tablet every other day or one a week, contact your doctor or pharmacist for advice on when to take the
next dose
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Some people may have side-effects when taking this medicine. If you have any unwanted side-effects you
should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make
sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at
www.mhra.gov.uk/yellowcard alternatively you can call Freephone 0808 100 3352 (available between
10am-2pm Monday – Friday) or fill in a paper form available from your local pharmacy.
Stop taking this medicine and see a doctor straight away if you notice any of the following serious
side effects – you may need urgent medical treatment:
• rash, itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having an
allergic reaction to the medicine.
• pain or sore in your mouth or jaw.
• severe chest pain, severe pain after swallowing food or drink, feeling very sick or being sick. This could
be a sign of problems with your food pipe (oesophagus).
• severe stomach pain, being sick, possibly with blood in it. This could be a sign of a stomach ulcer that is
bleeding, or that your stomach lining is inflamed (gastritis).
• eye pain and inflammation (if prolonged).
Other possible side effects
Common (affects less than 1 in 10 people):
• feeling tired
• stomach pain, indigestion
• feeling sick or inflamed food pipe (heart burn)
• low calcium levels in your blood
Uncommon (affects less than 1 in 100 people):
• chest pain
• itching or tingling skin (paraesthesia)
• flu-like symptoms, feeling generally unwell or in pain
• dry mouth, strange taste in your mouth or difficulty swallowing
• anaemia (please add symptoms)
• high levels of urea or high levels of parathyroid hormone in your blood, which will be detected by a blood
test
Rare (affects less than 1 in 1000 people)
• eye pain or inflammation
Very rare (affects less than 1 in 10000 people)
• a condition involving exposed bone in the mouth called “osteonecrosis of the jaw”
Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur
rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this
may be an early indication of a possible fracture of the thigh bone.
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 Ibandronic acid 50mg tablets
Keep out of the reach and sight of children.
Do not take these tablets after the expiry date which is stated on the blister and carton after “EXP”. The expiry
date refers to the last day of that month.
Store in the original package in order to protect from moisture.
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 50mg tablets contain
The active substance is ibandronic acid. Each film-coated tablet contains 50 mg of ibandronic acid (as 56.25
mg of ibandronate sodium monohydrate).
The other ingredients are:
tablet core: maize starch 1500, silica colloidal (anhydrous), cellulose (microcrystalline), croscarmellose
sodium, sodium stearyl fumarate.
tablet coat: hypromellose, titanium dioxide E171, macrogol 400.
What Ibandronic acid 50mg tablets look like and contents of the pack
The film-coated tablets are of oblong shape and white to off-white in colour, engraved “Iba” on the one side
and “50” on the other.
They are available in packs of 28 and 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Strandhaven Ltd t/a Somex Pharma
600 High Road, Seven Kings, Ilford,
Essex, IG3 8BS
United Kingdom
Manufacturer
Bluepharma Indústria Farmacêutica, S.A.
São Martinho do Bispo
3045-016 Coimbra
Portugal
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved in 01/2013

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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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