Ibandronic acid Aurobindo

Package leaflet: Information for the user

Ibandronic Acid Aurobindo 150 mg film-coated tablets

Equivalent 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 they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Acido Ibandronico Aurobindo belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. Acido Ibandronico Aurobindo can reduce bone fragility by preventing further loss of bone tissue and increasing bone mass in most women who take it, although they may not see or feel any difference. Acido Ibandronico Aurobindo can help reduce the likelihood of bone 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 postmenopausal 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. After menopause, a woman's ovaries stop producing female hormones, the estrogens, which help keep her bones healthy. The earlier a woman reaches menopause, the higher her risk of fractures due to osteoporosis. Other factors that may increase the risk of fractures include:

• not getting enough calcium and vitamin D from the diet
• smoking or drinking too much alcohol
• not doing enough weight-bearing exercise such as walking
• a family history of osteoporosis

In addition, a healthy lifestyle will help you get the maximum benefit from treatment. This includes:

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

2. What you need to know before taking Ibandronic Acid Aurobindo

Do not take Ibandronic Acid Aurobindo

• 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 oesophageal disorders, such as narrowing or difficulty swallowing;
• if you are unable to stand or sit upright in an erect position for at least one hour (60 minutes) continuously;
• if you have, or have previously had low levels of calcium in your blood, please consult your doctor.

Warnings and precautions
The side effect known as osteonecrosis of the jaw (a serious deterioration of the bone tissue in the jaw) has been reported very rarely after marketing in patients taking Ibandronic Acid Aurobindo for osteoporosis. Osteonecrosis of the jaw may also occur after treatment has ended.
It is important to try to prevent the development of osteonecrosis of the jaw, as it is a painful condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, several precautions should be taken.
Before starting treatment, inform your doctor or nurse (healthcare professional) if:

• you have any problems with your mouth or teeth, such as poor dental health, gum disease, or if you are scheduled for a tooth extraction;
• 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 previously been 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 examination before starting treatment with Ibandronic Acid Aurobindo.

During treatment, you must maintain good oral hygiene (including regular tooth cleaning) and attend routine dental check-ups. If you wear dentures, ensure they fit properly in your mouth. If you are undergoing dental treatments or need dental surgery (e.g. tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Ibandronic Acid Aurobindo.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain or swelling, or non-healing sores or discharge, as these may be signs of osteonecrosis of the jaw.
Some people need to be particularly careful when taking Ibandronic Acid Aurobindo. Talk to your doctor before taking Ibandronic Acid Aurobindo:

• if you have mineral metabolism disorders (e.g. vitamin D deficiency),
• if your kidneys do not function normally,
• if you have problems with swallowing or digestion.

Irritation, inflammation or ulceration of the oesophagus may occur, often with symptoms such as severe chest pain, severe pain after eating or drinking, severe nausea or vomiting, particularly if you do not drink a full glass of water and/or if you lie down within one hour after taking Ibandronic Acid Aurobindo. If you develop these symptoms, stop taking Ibandronic Acid Aurobindo and inform your doctor immediately (see section 3).
Children and adolescents
Do not give Ibandronic Acid Aurobindo to children or adolescents under 18 years of age.
Other medicines and Ibandronic Acid Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular:

• calcium, magnesium, iron or aluminium-containing supplements, as they may affect the action of Ibandronic Acid Aurobindo;
• 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 Aurobindo) may also cause such irritation. Therefore, take particular care if you are taking painkillers or anti-inflammatory medicines while being treated with Ibandronic Acid Aurobindo.

After taking your monthly dose of Ibandronic Acid Aurobindo, wait 1 hour before taking any other medicine, including antacids, calcium supplements or vitamins.
Ibandronic Acid Aurobindo with food and drink
Do not take Ibandronic Acid Aurobindo with food. Ibandronic Acid Aurobindo is less effective if taken with food.
You may drink plain water, but no other beverages.
After taking Ibandronic Acid Aurobindo, wait 1 hour before eating food or drinking other beverages (see section 3 “How to take Ibandronic Acid Aurobindo”).
Pregnancy, breast-feeding and fertility
Ibandronic Acid Aurobindo may only be used by postmenopausal women and must not be taken by women who are still able to have children.
Do not take Ibandronic Acid Aurobindo if you are pregnant or breastfeeding. If you are breastfeeding, you may need to stop breastfeeding while taking Ibandronic Acid Aurobindo.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
You may drive and operate machinery, as Ibandronic Acid Aurobindo does not affect, or affects only negligibly, the ability to drive and use machines.

3. How to take Ibandronic Acid Aurobindo

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 Aurobindo is one tablet once a month.

Taking your monthly tablet
It is important to follow these instructions carefully. They are designed to help the Ibandronic Acid Aurobindo tablet reach your stomach quickly, reducing the likelihood of irritation.

• Take one tablet of Ibandronic Acid Aurobindo once a month.

• Choose a day of the month that will be easy for you to remember. For taking your Ibandronic Acid Aurobindo tablet, you may choose the same date (e.g., the 1st of each month) or the same day (e.g., the first Sunday of each month). Choose the option that best fits your routine.

• Take your Ibandronic Acid Aurobindo tablet after having had no food or drink for at least 6 hours, except water.

• Take your Ibandronic Acid Aurobindo tablet

• in the morning, immediately after waking up, and

• before eating or drinking anything (on an empty stomach).

• Swallow the tablet with a full glass of plain water (at least 180 ml). Do not take the tablet with highly calcium-enriched water, 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 low mineral content.

• Swallow the tablet whole – do not chew, crush, or allow it to dissolve in your mouth.

• For the following hour (60 minutes) after taking the tablet:

• do not lie down – if you do not remain in an upright position (standing or sitting), part of the medicine may reflux into your oesophagus.

• do not eat anything

• do not drink anything (except plain water, if necessary)
• do not take any other medicines
• After waiting one hour, you may eat and drink normally. After eating, you may lie down and take any other medicines you require.

Continue taking Ibandronic Acid Aurobindo
It is important to continue taking Ibandronic Acid Aurobindo every month as long as your doctor prescribes it. After you have taken Ibandronic Acid Aurobindo for 5 years, consult your doctor to determine whether you should continue taking the medicine.

If you take more Ibandronic Acid Aurobindo than you should
If you accidentally take more than one tablet, drink a full glass of milk and contact your doctor immediately.
Do not induce vomiting and do not lie down – this could cause Ibandronic Acid Aurobindo to irritate your oesophagus.

If you forget to take Ibandronic Acid Aurobindo

• If you forget to take the tablet on the morning of your chosen day, do not take a tablet later that day. Instead, check your calendar to see when your next scheduled dose is due.
• If you forgot to take the tablet on your chosen day and there are only 1 to 7 days left until your next scheduled dose:
• Never take two tablets of Ibandronic Acid Aurobindo within the same week. Wait until the next scheduled dose day and take the tablet as usual. Continue taking one tablet once a month on the scheduled dates marked on your calendar.
• If you forgot to take the tablet on your chosen day and there are more than 7 days until your next scheduled dose: Take one tablet on the morning after you remember; then continue taking one tablet once a month on the scheduled dates marked on your calendar. Never take two tablets of Ibandronic Acid Aurobindo within the same week.

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, speak to a 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 have severe inflammation of the oesophagus, possibly with ulcers and narrowing of the oesophagus.

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 be experiencing early signs of an atypical femoral fracture (a break in the thigh bone).

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

• mouth or jaw pain. You may be experiencing early signs of serious jaw problems (osteonecrosis (dead bone tissue) of the jaw bone);
• 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 allergic reaction, potentially life-threatening;
• serious skin adverse reactions.

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

• headache;
• heartburn, discomfort when swallowing, stomach ache or abdominal pain (which may be due to inflammation of the stomach), indigestion, nausea, diarrhoea (loose stools);
• muscle cramps, stiffness in joints and limbs;
• flu-like symptoms, including fever, shivering and chills, feeling unwell, bone pain and muscle and joint pain. Talk to a nurse or doctor if any effect becomes bothersome or lasts more than a few days;
• skin rash.

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

• dizziness;
• flatulence (feeling bloated);
• 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;
• hives (urticaria).

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via 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 special storage conditions.
Do not use this medicine after the expiry date stated on the blister and carton 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 Aurobindo contains

• The active substance is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).
• The other components are: Tablet core: microcrystalline cellulose, povidone (K-25), anhydrous colloidal silica, crospovidone (type B), sodium stearate 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.
White to off-white, film-coated, elongated, biconvex tablets, with "X" engraved on one side and "78" on the other.
Acido Ibandronico Aurobindo tablets are available in packs of 1 or 3 tablets in transparent triple-laminated PVC/PE/PVdC-aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorization 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, Ħal Far, BBG 3000 – Malta

This medicinal product is authorized in the European Economic Area countries under 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