Ibandronic Acid 150mg 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 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

• 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.

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 ibandronic acid for osteoporosis. 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.

Atypical fractures of the long bones, such as in the forearm bone (ulna) and the shinbone (tibia), have also been reported in patients receiving long-term treatment with Ibandronate. These fractures occur after minimal, or no trauma and some patients experience pain in the area of the fracture prior to presenting with a completed fracture.

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
• don’t receive routine dental care or have not had a dental check up for a long time
• are a smoker (as this may increase the risk of dental problems)
• have previously been treated with a bisphosphonate (used to treat or prevent bone disorders)
• are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• 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, or non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.

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

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).

Do not give ibandronic acid to children or adolescents below 18 years.

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. 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.

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”).

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.

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.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

It is important to follow these instructions carefully. They are designed to help your ibandronic acid tablet reach your stomach quickly, so it is 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 1^st 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
  • 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 is OK to lie down if you wish, and to take any other medication you need.

It is important to keep taking ibandronic acid every month, as long as your doctor prescribes it for you. After 3-5 years of using ibandronic acid, consult with your doctor whether you should continue to take this medicine.

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 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.

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.
• symptoms of low blood calcium levels (hypocalcaemia) including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.

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

• itching, swelling of your face, lips, tongue and throat, with difficulty breathing.
• 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).
• 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.
• serious, potentially life-threatening allergic reaction.
• severe adverse skin reactions.

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, a 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.

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 Yellow Card Scheme, 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. 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)

Ibandronic acid 150 mg tablets are white, oblong biconvex film coated tablets.

Pack sizes: 1, 3 or 6 film-coated tablets

Not all pack sizes may be marketed