Skip to Content

IBANDRONIC ACID HELM 150 MG FILM-COATED TABLETS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

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.
What is in this leaflet:
1. What Ibandronic acid tablets are and what they are used for.
2. Before you take .
3. How to take.
4. Possible side effects.
5. How to store
6. Further information
1. What Ibandronic acid 150mg tablets are and what they are used for
Ibandronic acid 150mg tablets contain the active substance Ibandronic acid. This belongs to a group of medicines
called bisphosphonates. This medicine has been prescribed for 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.
Ibandronic acid 150mg tablets act on bone tissue to prevent bone loss without affecting bone formation. This
results in an increase in bone mass in most women who take it, even though they won’t be able to see or feel a
difference. The tablets help to lower the chances of breaking bones (fractures). A reduction in fractures has been
shown for bones in the spine but not for the hip bones.
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.
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 (hypersensitive) to ibandronic acid, or to any of the other ingredients of this medicine (listed
in section 6).
- if you have certain disorders of the oesophagus (the tube that connects your mouth with your stomach) such
as narrowing or difficulty swallowing.
- if you are unable to stand or sit upright for at least 60 minutes.
- if you have, or have had 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
● have high or low blood levels of vitamin D or any other minerals
● have kidney problems
● have any swallowing or digestive problems
● have ever had problems with your oesophagus (the tube connecting your mouth to your stomach). Problems
in your oesophagus might give you symptoms including: severe pain in the chest, severe pain after swallowing
food and/or drink, severe nausea, or vomiting. If you develop these symptoms, speak to your doctor straight
away.
● are under dental treatment or will undergo dental surgery in the future, tell your dentist that you are being
treated with Ibandronic acid 150mg 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 Inandronic acid 150mg tablets can affect the way some
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.
- aspirin and other non-steroidal anti-inflammatory medicines (NSAIDs) ( including ibuprofen, diclofenac sodium
and naproxen). This is because NSAIDs and ibandronic acid can both irritate your stomach and gut.
After swallowing your monthly Ibandronic acid 150mg tablet, wait for 1 hour before taking any other medicines,
including those for indigestion, calcium supplements, or vitamins.
Taking Ibandronic acid 150mg tablets with food and drink
Your tablet 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 eat or drink anything else for at least 1 hour. Plain water may be taken at any time during the course
of Ibandronic acid treatment.
Fertility, 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
You can drive and use machines as it’s very unlikely that Ibandronic acid will affect your ability to drive and use
machines.
3. How to take Ibandronic acid 150mg tablets
Always take the tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not
sure.The recommended dose of Ibandronic acid is one tablet once a month.
Taking your monthly tablet
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 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 tablet. Choose
the date that best fits your routine.
- Take your tablet when you first get up for the day and at least 6 hours after you last had anything to eat or drink
except plain water.
- 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 and cause irritation.
- do not eat or 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 Ibandronic acid 150mg tablets
It’s important to keep taking one tablet every month, as long as your doctor prescribes it for you. This medicine
can treat osteoporosis only as long as you keep taking it.
If you take more Ibandronic acid 150mg tablets 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 150mg tablets
Do not take a double dose to make up for a forgotten tablet. 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 Ibandronic acid tablets within the same week.
If you stop taking Ibandronic acid
If you have any further questions on the use of this medicine, 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.
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:
• rash, itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having an
allergic reaction to the medicine.
• severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting. This could be
a sign of problems with your food pipe (oesophagus)
• flu-like symptoms (including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching
muscles or joints) if they become troublesome or last more than a couple of days).
• pain or sore in your mouth or jaw.
• eye pain and inflammation (if prolonged).
Other possible side effects
Common (affects less than 1 in 10 people)
• headache.
• heartburn, stomach pain (such as “gastroenteritis” or “gastritis”), indigestion, nausea, having diarrhoea or
constipation.
• rash.
• pain or stiffness in your muscles, joints, or back.
• fatigue.
Uncommon (affects less than 1 in 100 people)
• bone pain.
• feeling weak.
• dizziness.
• flatulence.
Rare (affects less than 1 in 1000 people):
vt• itching.
• eye pain or inflammation.
• 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.
Very rare (affects less than 1 in 10000 people)
• a condition involving exposed bone in the mouth called “osteonecrosis of the jaw”.
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
5. How to store Ibandronic acid 150mg tablets
Keep this medicine out of the sight and reach of children
Store in the original package in order to protect from moisture.
Do not use this medicine 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.
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 150mg tablets contain
The active substance is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as 168.75
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 150mg 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 150
on the other. They are available in packs of 1 and 3 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
This leaflet was last revised in 01/2013.

Expand Transcript

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.

Hide