Ibandronic acid Mylan: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic Acid Mylan 150 mg film-coated tablets

Ibandronic acid
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ibandronic Acid Mylan is and what it is used for
What you need to know before taking Ibandronic Acid Mylan
How to take Ibandronic Acid Mylan
Possible side effects
How to store Ibandronic Acid Mylan
Contents of the pack and other information

1. What Acido Ibandronico Mylan is and what it is used for

Acido Ibandronico Mylan belongs to a group of medicines called bisphosphonates. It contains
the active substance ibandronic acid.
Acido Ibandronico Mylan can reverse bone loss by preventing further bone loss and increasing
bone mass in many women who take it, although they may not see or feel a difference.
Acido Ibandronico Mylan can help reduce the risk of bone fractures. This reduction in fractures has been demonstrated for the spine but not for the hip.
Acido Ibandronico Mylan has been prescribed to you for the treatment of postmenopausal osteoporosis
because you are at increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, common in women after menopause. During menopause, a woman's ovaries stop producing the female hormone estrogen, which helps keep her skeleton healthy. The earlier a woman reaches menopause, the greater her risk of osteoporotic fractures.
Other factors that may increase the risk of fractures include:

inadequate calcium and vitamin D intake in the diet
smoking or excessive alcohol consumption
lack of walking or other weight-bearing exercise
a family history of osteoporosis

A healthy lifestyle will also help you get the maximum benefit from your treatment. This includes:

following a balanced diet rich in calcium and vitamin D;
walking or engaging in other weight-bearing exercises;
not smoking; and avoiding excessive alcohol consumption.

2. What you should know before taking Ibandronic Acid Mylan

Do not take Ibandronic Acid Mylan:

If you are allergic 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/digestive tract such as strictures or difficulty swallowing.
If you are unable to stand or sit upright for at least one hour (60 minutes) at a time.
If you have or have previously had low levels of calcium in your blood. Consult your doctor.

Warnings and precautions
A rare adverse effect called osteonecrosis of the jaw (ONJ) has been reported very rarely in the post-marketing period in patients receiving ibandronic acid for osteoporosis. Osteonecrosis of the jaw may also occur after discontinuation of treatment.
It is important to try to prevent the development of osteonecrosis of the jaw, as it is a painful condition that is difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, there are certain precautions you should take.
Talk to your doctor or nurse (healthcare professional) before taking this medicine if:

You have any problems with your mouth or teeth, such as poor dental hygiene, gum disease, or a dental extraction already planned.
You do not have regular dental check-ups 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 bisphosphonate medicines (used to treat or prevent bone diseases).
You are taking medicines called corticosteroids (e.g. prednisolone or dexamethasone).
You have cancer.

Your doctor may recommend that you have a dental examination before starting treatment with Ibandronic Acid Mylan.
During treatment with Ibandronic Acid Mylan, you must maintain good oral hygiene (including regular tooth cleaning) and have routine dental check-ups. If you wear dentures, make sure they fit properly. If you are undergoing dental treatment or need dental surgery (e.g. tooth extraction), inform your doctor about your dental treatments and inform your dentist that you are being treated with ibandronic acid.
Immediately inform your doctor and dentist if you experience any mouth or dental problems such as tooth loss, pain, swelling, failure of wounds to heal, or discharge, as these may be signs of a condition called osteonecrosis of the jaw.
Patients receiving chemotherapy and/or radiotherapy, those taking steroids, those undergoing dental surgery, those not receiving routine dental care, those with gum disease, smokers, or those previously treated with bisphosphonates (used to treat or prevent bone diseases) have a higher risk of developing osteonecrosis of the jaw.
Some people need to be particularly careful when taking ibandronic acid. Talk to your doctor or pharmacist before taking Ibandronic Acid Mylan:

If you have any disorders of bone and mineral metabolism (such as vitamin D deficiency).
If your kidneys do not function normally.
If you have any swallowing or digestive problems. Irritation, inflammation or ulceration of the oesophagus/digestive tract may occur, often with symptoms such as severe chest pain, severe pain after eating food and/or drinking, severe nausea, or vomiting, especially if you do not drink a full glass of water and/or if you lie down within one hour after taking ibandronic acid. If you develop these symptoms, stop taking Ibandronic Acid Mylan and tell your doctor immediately (see section 3).

Children and adolescents
Do not give Ibandronic Acid Mylan to children or adolescents under 18 years of age.
Other medicines and Ibandronic Acid Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

Calcium, magnesium, iron or aluminium-containing supplements, as these may affect the effects of ibandronic acid.
Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac and naproxen) may irritate the stomach and intestines. Bisphosphonates (such as ibandronic acid) may do the same, so be particularly cautious if you are taking painkillers or anti-inflammatory medicines while taking ibandronic acid.

After swallowing your monthly tablet of Ibandronic Acid Mylan, wait for 1 hour before taking any other medicine, including antacids and calcium or vitamin supplements.
Ibandronic Acid Mylan with food and drink
Do not take Ibandronic Acid Mylan with food. Ibandronic Acid Mylan is less effective if taken with food. You may drink water but no other beverages.
After taking Ibandronic Acid Mylan, wait 1 hour before consuming food and other beverages (see section 3. How to take Ibandronic Acid Mylan).
Pregnancy and breastfeeding
Ibandronic Acid Mylan should only be used by post-menopausal women and must not be taken by women who could still have children.
Do not take Ibandronic Acid Mylan if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may drive and operate machinery, as Ibandronic Acid Mylan is very unlikely to have any effect or has negligible effects on your ability to drive and use machines.
Ibandronic Acid Mylan contains lactose
This medicine contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars (e.g. galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption), contact your doctor before taking this medicine.

3. How to take Ibandronic Acid Mylan

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The usual dose of Ibandronic Acid Mylan is one tablet once a month.
How to take the monthly tablet
It is important to follow these instructions carefully – they have been designed to help the tablets of Ibandronic Acid Mylan reach your stomach quickly, thereby reducing the likelihood of causing irritation.

Take Ibandronic Acid Mylan 150 mg once a month
Choose a day of the month that you can easily remember. You may choose 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 Mylan tablet. Choose the date that best fits your routine.
Take your Ibandronic Acid Mylan tablet at least 6 hours after you have eaten or drunk anything, except water.
Take your Ibandronic Acid Mylan tablet
immediately after getting up
before you have eaten or drunk anything (on an empty stomach)
Swallow your tablet with a full glass of water (at least 180 ml).

Do not take your tablet with water that has a high calcium content, fruit juice, or other beverages. If you are concerned that tap water may contain high levels of calcium (hard water), it is recommended to use bottled water with a low mineral content.

Swallow the tablet whole – do not chew, break, or let it dissolve in your mouth.
During the hour (60 minutes) after taking your tablet:
do not lie down; if you are not in an upright position (standing or sitting), part of the medicine may flow back into your oesophagus.
do not eat anything
do not drink anything (except water, if needed)
do not take any other medicines
After waiting one hour, you may have your first meal and drink of the day. Once you have eaten, you may lie down if you wish, or take other medicines if necessary.

Do not take the medicine at bedtime or just before getting up in the morning.
Continuing treatment with Ibandronic Acid Mylan
It is important to continue taking Ibandronic Acid Mylan every month for as long as your doctor prescribes it. After 5 years of using Ibandronic Acid Mylan, consult your doctor to determine whether you should continue taking it.
If you take more Ibandronic Acid Mylan than you should
If you have taken more than one tablet by mistake, drink a full glass of milk and contact your doctor immediately.
Do not induce vomiting and do not lie down – to avoid Ibandronic Acid Mylan irritating your oesophagus.
If you forget to take Ibandronic Acid Mylan

If you forget to take your tablet in the morning on your chosen day, do not take a tablet later on the same day. Instead, check your calendar and identify when your next dose is due.
If you forget to take your tablet on your chosen day and there are only 1 to 7 days remaining until your next scheduled dose:

Never take two tablets of Ibandronic Acid Mylan within the same week.
Wait until the scheduled day for your next dose and take it as usual; then continue taking one tablet once a month on the scheduled dates marked on your calendar.

If you forget to take your tablet on your chosen day and there are more than 7 days remaining until your next scheduled dose: You should take one tablet on the morning after the day you remembered; then continue taking one tablet once a month on the scheduled dates marked on your calendar.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following serious side effects, contact your nurse or doctor immediately – you may need urgent medical treatment:
Uncommon (may affect up to 1 in 100 people)

severe chest pain, severe pain after eating or drinking, severe nausea or vomiting, difficulty swallowing. You may develop severe inflammation of the oesophagus/digestive tract, possibly leading to ulcers or narrowing of the oesophagus/digestive tract.

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

itching, swelling of the face, lips, tongue and throat, with breathing difficulties.
persistent eye pain and inflammation
new or returning pain, weakness or discomfort in the thigh, hip or groin. These may be early signs of an unusual femur fracture.

Very rare (may affect up to 1 in 10,000 people):

pain or sores in the mouth or jaw. These may be early signs of serious jaw problems (jaw bone necrosis (death of bone tissue))
contact your doctor if you experience ear pain, ear discharge, and/or ear infection. These episodes could be signs of bone damage in the ear
severe skin reactions including itchy, red rash with raised patches, and severe blistering and peeling of the skin
severe, potentially life-threatening allergic reaction

Other possible side effects
Common (may affect up to 1 in 10 people):

headache
heartburn, difficulty swallowing, stomach or abdominal pain (possibly due to stomach inflammation), indigestion, nausea, diarrhoea (loose stools)
muscle cramps, joint or back stiffness
flu-like symptoms including fever, shivering and chills, general discomfort, bone pain, and muscle and joint pain. Contact a nurse or doctor if these symptoms become bothersome or last more than a few days
skin rash

Uncommon (may affect up to 1 in 100 people):

dizziness
flatulence (wind, bloating)
back pain
feeling tired and exhausted
asthma attacks

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

inflammation of the duodenum (first part of the intestine), causing stomach pain
hives (urticaria)

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Mylan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Acido Ibandronico Mylan contains
The active substance is ibandronic acid 150 mg (as ibandronate sodium monohydrate).
The other ingredients are:

Tablet core: monohydrate lactose, povidone, microcrystalline cellulose, crospovidone, anhydrous colloidal silica and magnesium stearate.
Tablet coating: hydroxypropylcellulose, macrogol and titanium dioxide (E171).
Printing ink contains: shellac, iron oxide black and propylene glycol.

Description of the appearance of Acido Ibandronico Mylan and package contents
The medicine is available as film-coated tablets, white, capsule-shaped,
biconvex, with "G" over "I-150" printed on one side in black ink and smooth on the other side.
Acido Ibandronico Mylan is available in blister packs containing 1, 3, 6 and 12 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturer responsible for batch release
McDermott Laboratories Limited (t/a Gerard Laboratories)
35/36 Baldoyle Industrial Estate, Grange Road Ireland
Generics [UK] Limited,
Station Close, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary
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