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1. Acido Ibandronico Aurobindo 150 mg film-coated tablets
   1. What is Acido Ibandronico Aurobindo and what is it used for
   2. What you need to know before taking Acido Ibandronico Aurobindo
   3. How to take Acido Ibandronico Aurobindo
   4. Possible side effects
   5. How to store Acido Ibandronico Aurobindo
   6. Contents of the pack and other information

Acido Ibandronico Aurobindo 150 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start to take this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Acido Ibandronico Aurobindo belongs to a group of medicines called bisphosphonates. It contains the
active ingredient ibandronic acid. Acido Ibandronico Aurobindo can reverse bone fragility
by blocking further loss of bone tissue and increasing bone mass in most women
who take it, even if they will not be able to see or feel the difference. Acido Ibandronico
Aurobindo can help reduce the likelihood of bone breakage (fractures). This reduction in fractures
has been demonstrated for the spine, but not for the hip.

Acido Ibandronico Aurobindo has been prescribed to you for the treatment of post-menopausal osteoporosis
because you have developed an increased risk of bone fractures.Osteoporosis is a thinning and
weakening of the bones, which is common in women after menopause. During menopause, a woman's ovaries
stop producing female hormones, estrogens, which help keep her bones healthy.
The sooner a woman reaches menopause, the greater her risk of fractures in osteoporosis.
Other factors that can increase the risk of fractures are:

• not getting enough calcium and vitamin D from your diet
• smoking, or drinking too much alcohol;
• not doing enough walking or other weight-bearing exercise;
• a family history of osteoporosis.

Also a healthy lifestylewill help you get the most benefit from treatment. This includes:

• a balanced diet rich in calcium and vitamin D;
• walking or doing other weight-bearing exercise;
• not smoking and not drinking too much alcohol.

2. What you need to know before taking Acido Ibandronico Aurobindo

Do not take Acido Ibandronico Aurobindo

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6);
• if you have certain disorders of the esophagus, such as narrowing or difficulty swallowing;
• if you are unable to stand or sit upright for at least one hour (60 minutes) consecutively;
• if you have, or have had in the past, low blood calcium levels, please consult your doctor.

Warnings and precautions
A side effect called osteonecrosis of the jaw/maxilla (severe degeneration of the bone tissue of the jaw and maxilla) has been reported very rarely after marketing in patients taking Acido Ibandronico Aurobindo for osteoporosis. Osteonecrosis of the jaw/maxilla can also occur after stopping treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/maxilla as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/maxilla, there are several precautions to take.
Before receiving treatment, tell your doctor or nurse (healthcare professional) if:

• you have any mouth or dental problems such as poor dental health, gum disease or if you are planning to have a tooth extracted;
• you do not receive routine dental care or have not had a dental check-up for a long time;
• you are a smoker (this may increase the risk of dental problems);
• you have been previously treated with bisphosphonates (used to treat or prevent bone problems);
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
• you have cancer. Your doctor may ask you to have a dental check-up before starting treatment with Acido Ibandronico Aurobindo.

During treatment, you must maintain good oral hygiene (including regular teeth cleaning) and have routine dental check-ups. If you wear dentures, make sure they fit properly. If you are undergoing dental treatments or if you are to undergo dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Acido Ibandronico Aurobindo.
Contact your doctor and dentist immediately if you experience any mouth or dental problems such as tooth loss, pain or swelling, or sores that do not heal or discharge, as these could be signs of osteonecrosis of the jaw/maxilla.
Some people need to be particularly careful when taking Acido Ibandronico Aurobindo.
Talk to your doctor before taking Acido Ibandronico Aurobindo:

• if you have disorders of mineral metabolism (e.g. Vitamin D deficiency),
• if your kidneys do not function normally,
• if you have difficulty swallowing or digesting;

Irritation, inflammation or ulceration of the esophagus may occur, often with symptoms of severe chest pain, severe pain after eating food and/or drinks, severe nausea or vomiting, especially if you do not drink a full glass of water and/or if you lie down within one hour of taking Acido Ibandronico Aurobindo. If you develop these symptoms, stop taking Acido Ibandronico Aurobindo and inform your doctor immediately (see section 3).

Children and adolescents
Do not give Acido Ibandronico Aurobindo to children or adolescents under 18 years of age.

Other medicines and Acido Ibandronico Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular:

• supplements containing calcium, magnesium, iron or aluminum, as they may affect the effect of Acido Ibandronico Aurobindo;
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) can irritate the stomach and intestines. Bisphosphonates (such as Acido Ibandronico Aurobindo) can also cause such irritation. Therefore, be particularly careful if you take painkillers or anti-inflammatory drugs while taking Acido Ibandronico Aurobindo.

After swallowing your monthly dose of Acido Ibandronico Aurobindo, wait 1 hour before taking any other medicine, including antacids, calcium supplements or vitamins.

Acido Ibandronico Aurobindo with food and drinks
Do not take Acido Ibandronico Aurobindo with food. Acido Ibandronico Aurobindo is less effective if taken with food.

You can drink plain water, but not other drinks
After taking Acido Ibandronico Aurobindo, wait 1 hour before consuming food and other drinks (see section 3 “How to take Acido Ibandronico Aurobindo”).

Pregnancy, breastfeeding and fertility
Acido Ibandronico Aurobindo can only be used by postmenopausal women and should not be taken by women who are still able to have children.
Do not take Acido Ibandronico Aurobindo if you are pregnant or if you are breastfeeding. If you are breastfeeding, you may need to stop breastfeeding to take Acido Ibandronico Aurobindo.
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
You can drive vehicles and use machines as Acido Ibandronico Aurobindo does not impair or impairs negligibly the ability to drive vehicles and use machines.

3. How to take Acido Ibandronico Aurobindo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
The usual dose of Acido Ibandronico Aurobindo is one tablet once a month.

Taking your monthly tablet
It is important to follow these instructions carefully. They have been planned to help the Acido Ibandronico Aurobindo tablet reach your stomach quickly, so it is unlikely to
cause irritation.

• Take one Acido Ibandronico Aurobindo tablet once a month.
• Choose a day of the monththat will be easy for you to remember. To take your Acido Ibandronico Aurobindo tablet, you can choose the same date (such as the 1st of each month) or the same day (such as the first Sunday of each month). Choose the date that best suits your habits.
• Take your Acido Ibandronico Aurobindo tablet after being at least 6 hours withouthaving consumed any type of food or drink, with the exception of water.
• Take your Acido Ibandronico Aurobindo tablet
• in the morning just after getting upand
• before having eaten or drunk anything(on an empty stomach)
• Swallow the tablet with a glass of plain water(at least 180 ml). Do nottake the tablet with water with a high calcium concentration, fruit juices 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, crush or dissolve it in your mouth
• For the next hour (60 minutes)after taking the tablet:
• do not lie down; if you do not remain in an upright position (standing or sitting), some of the medicine may reflux into your esophagus.

• do not eat anything

• do not drink anything(except plain water, if necessary)
• do not take any other medicines
• After waiting for an hour, you can have the first foods and drinks of the day. After eating, if you wish, you can lie down and take any other medicine you need.

Continue to take Acido Ibandronico Aurobindo
It is important to continue to take Acido Ibandronico Aurobindo every month, until your doctor tells you to stop. After taking Acido Ibandronico Aurobindo for 5 years, ask your doctor if
you should continue to take the medicine.

If you take more Acido Ibandronico Aurobindo than you should
If you have accidentally taken more than one tablet, drink a whole glass of milk and contact your doctor
immediately.

Do not induce vomiting and do not lie down- this could cause Acido Ibandronico Aurobindo to irritate your
esophagus.

If you forget to take Acido Ibandronico Aurobindo

• If you forget to take the tablet on the morning of the chosen day, do not take a tabletduring the day. Instead, check your calendar to see when the next dose is scheduled.
• If you have forgotten to take the tablet on the chosen day and only 1 to 7 days remainuntil the next scheduled dose.
• Never take two Acido Ibandronico tablets in the same week.You must wait until the day of the next scheduled dose and take the tablet as usual, then continue to take one tablet once a month on the scheduled days marked on the calendar.
• If you have forgotten to take the tablet on the chosen day and more than 7 days remain until thenext scheduled dose.You must take a tablet the morning after the day you remembered; then continue to take one tablet once a month on the scheduled days marked on the calendar. Never take two Acido Ibandronico Aurobindo tablets in the same week.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following serious side effects, speak to a nurse or doctor immediately – you may need urgent medical attention:
Not common(may affect up to 1 in 100 people):

• severe chest pain, severe pain after swallowing food or drinks, severe nausea or vomiting, difficulty swallowing. You may have a severe inflammation of the esophagus, with possible ulcers and narrowing of the esophagus.

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

• itching, swelling of the face, lips, tongue and throat, with difficulty breathing;
• persistent pain and inflammation of the eye;
• new pain, weakness or discomfort in the thigh, hip or groin. You may have early signs of a possible atypical fracture of the thigh bone. Very rare(may affect up to 1 in 10,000 people):
• pain in the mouth or jaw/jawbone. You may have early signs of serious problems with the jaw/jawbone (necrosis (dead bone tissue) of the jawbone);
• see a doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear;
• severe allergic reaction, potentially life-threatening.
• serious skin reactions.

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

• headache;
• heartburn, difficulty swallowing, stomach pain or abdominal pain (which may be due to inflammation of the stomach), indigestion, nausea, diarrhea (loose stools);
• muscle cramps, stiffness of joints and limbs;
• flu-like symptoms, including fever, tremors and chills, feeling unwell, bone and muscle pain and aching joints. Talk to a nurse or doctor if any effect becomes troublesome or lasts more than a couple of days;
• rash.

Not common(may affect up to 1 in 100 people)

• dizziness;
• flatulence (feeling of bloating);
• back pain;
• feeling tired or exhausted;
• asthma attacks.

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

• inflammation of the duodenum (the first part of the intestine) causing stomach pain;
• urticaria (hives).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Acido Ibandronico Aurobindo

Keep out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use the medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido Ibandronico Aurobindo contains

• The active ingredient is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).
• The other ingredients are: Tablet core: microcrystalline cellulose, povidone (K-25), anhydrous colloidal silica, crospovidone (Type B), sodium stearyl fumarate. Tablet coating: hypromellose, triacetin, talc, titanium dioxide (E171).

Description of the appearance of Acido Ibandronico Aurobindo and contents of the pack
Film-coated tablets.
Tablets of colour from white to off-white, film-coated, elongated shape, biconvex, with imprinted
“X” on one side and “78” on the other side.
Acido Ibandronico Aurobindo tablets are available in blister packs made of triple laminated
transparent PVC/PE/PVdC-aluminium in packs of 1 or 3 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurobindo Pharma (Italia) s.r.l., via San Giuseppe 102 - 21047 Saronno (VA) - Italy

Manufacturers
Milpharm Limited – Ares Block, Odyssey Business Park, West End Road, ruislip HA4 6QD – United Kingdom
APL Swift Services (Malta) Limited – HF26, HalFar Industrial Estate, Hal Far , Hirzebbugia, BBG 3000 –
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Czech Republic: Ibandronic Acid Aurobindo 150 mg potahované tablety
Italy: Acido ibandronico Aurobindo
Malta: Ibandronic Acid Aurobindo 150 mg film-coated tablets
Portugal: Ácido Ibandrónico Aurobindo
Romania: Acid ibandronic Aurobindo 150 mg comprimate filmate
Spain: ACIDO IBANDRONICO AUROBINDO 150 mg comprimidos recubiertos con
película EFG