Ibandronic Acid 150 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Ibandronic acid 150 mg film-coated tablets
Ibandronic acid
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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you get any side effects, talk to your doctor. 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 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 for the spine but not for the hip.
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, 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.
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 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 problems with your oesophagus (the tube connecting your mouth with your stomach) 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.
Children and adolescents
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 your doctor:
- 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.
- If you had problems with your oesophagus in the past. For example, when you had pain or difficulties during swallowing of food or if you were informed in the past that you had a Barrett's oesophagus (a disease with changes to the cells lining the lower part of the oesophagus).
Irritation, inflammation or ulceration of the oesophagus (the tube connecting your mouth with your stomach) 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 your doctor straight away.
Other medicines and Ibandronic acid
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, 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 plain water but no other drinks (see section 3 ‘How to take Ibandronic acid’).
Pregnancy, breast feeding and fertility
There are no adequate data from the use of Ibandronic acid in pregnant women. Studies in animals have shown that Ibandronic acid 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 breast feeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
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.
Ibandronic acid contains lactose
Ibandronic acid contains an ingredient called 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 IBANDRONIC ACID
Always take Ibandronic acid 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
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 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 plain 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 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.
- F or the next hour (60 minutes) after you’ve taken your tablet
could leak
- do not lie down; if you do not stay upright (standing or sitting), some of the medicine into your oesophagus
- do not eat anything
- do not 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
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 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 a dose
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Ibandronic acid 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:
• 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.
• flu-like symptoms (if any effects become troublesome or last more than a couple of days).
• pain or sore in your mouth or jaw
• eye pain and inflammation (if prolonged)
• new pain, weakness or discomfort in your thigh, hip or groin. This may be early signs of a possible unusual fracture of the thigh bone
• serious, potentially life-threatening allergic reaction
Other possible side effects
Common (may affect up to 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
• flu-like symptoms (including fever, shaking and shivering, feeling of discomfort, fatigue, bone pain and aching muscles and joints)
Uncommon (may affect up to 1 in 100 people)
• back pain
• feeling weak
• dizziness
• flatulence
Rare (may affect up to 1 in 1,000 people):
• hypersensitivity reaction; swelling of the face, lips and mouth (see allergy), hives
• itching
• inflammation of the duodenum causing stomach pain
• eye pain or inflammation
Very rare (may affect up to 1 in 10,000 people)
• a condition involving exposed bone in the mouth called “osteonecrosis of the jaw”.
• 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
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.
5. HOW TO STORE IBANDRONIC ACID
Keep this medicine out of the sight and reach of children.
Do not use after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
There are no special storage instructions.
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 ibandronic acid (as ibandronate sodium hydrate).
- The other ingredients are:
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 is available in pack sizes of 1 and 3 film-coated tablets. The tablets are supplied in blisters containing 1 or 3 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Laboratorios Liconsa, S.A., Gran Via Carlos III, 98,
7th Floor, 08028 Barcelona, Spain
Manufacturer:
Laboratorios LICONSA, S.A.
Avda. Miralcampo, N° 7, Poligono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara), Spain
This leaflet was last revised in November 2015.