Ibandronic acid 50mg film-coated tablets

• 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.

1. What this medicine is and what it is used for.
2. What you need to know before you take this medicine.
3. How to take this medicine.
4. Possible side effects.
5. How to store this medicine.
6. Contents of the pack and other information

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are listed in section 6
• if you have problems with your food pipe /gullet (oesophagus) such as narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least one hour (60 minutes) at a time
• if you have or ever had low calcium in your blood.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking ibandronic acid.

A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ibandronate for cancer-related conditions. ONJ can also occur after stopping treatment.

It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.

Before receiving treatment, tell your doctor/nurse (health care professional) if:

• you have any problems with your mouth or teeth such as poor dental health, gum disease, or a planned tooth extraction
• you don’t receive routine dental care or have not had a dental check up for a long time
• you are a smoker (as this may increase the risk of dental problems)
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.

While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with ibandronic acid.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.

Talk to your doctor or pharmacist before taking this medicine:

• if you are allergic to any other bisphosphonates
• if you have any swallowing or digestion problems
• if you have high or low blood levels of vitamin D or any other minerals
• if you have kidney problems

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 this medicine. If you develop these symptoms, stop taking this medicine and tell your doctor straight away (see sections 3 and 4).

This medicine should not be used in children and adolescents below the age of 18 years.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because ibandronic acid can affect the way some other medicines work. Also some other medicines can affect the way ibandronic acid works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• supplements containing calcium, magnesium, iron or aluminium
• acetylsalicylic acid and non-steroidal anti-inflammatory medicines called “NSAIDs”, such as, 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

Taking medicines that reduce stomach acid such as cimetidine and ranitidine, may slightly increase the effects of ibandronic acid.

Do not take this medicine with food or any other drinks except plain water as ibandronic acid is less effective if it is taken with food or drink (see section 3).

Take this medicine at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water. After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink and take any medicines or supplements (see section 3).

Do not take this medicine if you are pregnant, planning to get pregnant or if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking this medicine.

You can drive and use machines as it’s expected that this medicine has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use machines or tools.

If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

It is important that you take this medicine at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).

You can help stop this happening by doing the following:

• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements
• Take your tablet with a full glass of water only (about 200 mL). Do not take your tablet with any drink other than water
• Swallow the tablet whole. Do not chew, suck or crush the tablet. Do not let the tablet dissolve in your mouth
• After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink and take any medicines or supplements
• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes). Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus)

The usual dose of this medicine is one tablet each day. If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day. If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.

If you take too many tablets talk to a doctor or go to hospital straight away. Drink a full glass of milk before you go. Do not make yourself sick. Do not lie down.

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. Then carry on as usual the next day. If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.

Keep taking this medicine for as long as your doctor tells you. This is because the medicine will only work if it is taken all the time.

Common (may affect up to 1 in 10 people):

• feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/ food pipe)

Uncommon (may affect less than 1 in 100 people):

• severe stomach pain. This could be a sign of an ulcer of the first section of the bowel (duodenum) that is bleeding, or that your stomach is inflamed (gastritis)

Rare (may affect up to 1 in 1,000 people)

• 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)
• itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction
• severe adverse skin reactions
• ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear

Not known (frequency cannot be estimated from the available data)

• asthma attack

Common (may affect up to 1 in 10 people):

• tummy pain, indigestion
• low calcium levels in your blood
• weakness

Uncommon (may affect 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 (bloodlessness)
• high levels of urea or high levels of parathyroid hormone in your blood.

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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is ibandronic acid. Each film-coated tablet contains 50mg of ibandronic acid (as sodium monohydrate).

The other ingredients are:

• tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica.
• tablet coat: titanium dioxide (E171), lactose monohydrate, hypromellose (E464), macrogol 4000.

The film-coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC - Aluminium foil blister. They are available in packs of 3, 6, 9, 28 and 84 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Manufacturer

And