B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Ibandronic Acid Teva 50 mg film-coated tablets ibandronic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – 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.

What is in this leaflet

• 1. What Ibandronic Acid Teva is and what it is used for

• 2. What you need to know before you take Ibandronic Acid Teva

• 3. How to take Ibandronic Acid Teva

• 4. Possible side effects

• 5. How to store Ibandronic Acid Teva

• 6. Contents of the pack and other information

1. What Ibandronic Acid Teva is and what it is used for

Ibandronic Acid Teva contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.

Ibandronic Acid Teva is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone “metastases”).

• It helps to prevent your bones from breaking (fractures).
• It also helps to prevent other bone problems that may need surgery or radiotherapy.

Ibandronic Acid Teva works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.

2. What you need to know before you take Ibandronic Acid Teva

Do not take Ibandronic Acid Teva

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (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 Teva.

Warnings and precautions

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 Teva 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 do not 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 Teva.

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 Teva.

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 Ibandronic Acid Teva:

• – 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 Ibandronic Acid Teva. If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see sections 3 and 4).

Children and adolescents

Ibandronic Acid Teva should not be used in children and adolescents below the age of 18 years.

Other medicines and Ibandronic Acid Teva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ibandronic Acid Teva can affect the way some other medicines work. Also some other medicines can affect the way Ibandronic Acid Teva 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 Teva can both irritate your stomach and gut

• – a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because aminoglycosides and Ibandronic Acid Teva 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 Teva.

Ibandronic Acid Teva with food and drink

Do not take Ibandronic Acid Teva with food or any other drinks except water as Ibandronic Acid Teva is less effective if it is taken with food or drink (see section 3).

Take Ibandronic Acid Teva with 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).

Pregnancy and breast-feeding

Do not take Ibandronic Acid Teva 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.

Driving and using machines

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

Ibandronic Acid Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Ibandronic Acid Teva

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water. Water with a high concentration of calcium should not be used. If there is 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.

Your doctor may do regular blood tests while you are taking Ibandronic Acid Teva. This is to check that you are being given the right amount of medicine.

Taking this medicine

It is important that you take Ibandronic Acid Teva 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).

How much to take

The usual dose of Ibandronic Acid Teva 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 more Ibandronic Acid Teva than you should

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.

If you forget to take Ibandronic Acid Teva

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.

If you stop taking Ibandronic Acid Teva

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects, you may need urgent medical treatment:

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).
• 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.
• 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.

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

• asthma attack

Other possible side effects

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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ibandronic Acid Teva contains

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

The other ingredients are:

• tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid;
• tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80.

What Ibandronic Acid Teva looks like and contents of the pack

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.

What is in this leaflet

• 1. What Ibandronic Acid Teva is and what it is used for

• 2. What you need to know before you take Ibandronic Acid Teva

• 3. How to take Ibandronic Acid Teva

• 4. Possible side effects

• 5. How to store Ibandronic Acid Teva

• 6. Contents of the pack and other information

1. What Ibandronic Acid Teva is and what it is used for

Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. Ibandronic Acid Teva may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they will not be able to see or feel a difference. Ibandronic Acid Teva may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

Ibandronic Acid Teva is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.

The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis.

Other things that can increase the risk of fractures include:

• – not enough calcium and vitamin D in the diet,

• – smoking, or drinking too much alcohol,

• – not enough walking or other weight-bearing exercise,

• – a family history of osteoporosis.

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

• – eating a balanced diet rich in calcium and vitamin D,

• – walking or any other weight-bearing exercise, – not smoking; and not drinking too much alcohol.

2. What you need to know before you take Ibandronic Acid Teva

Do not take Ibandronic Acid Teva

• – 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.

Warnings and precautions

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 Teva 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.

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 do not 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 Teva.

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 Teva.

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.

Some people need to be especially careful while they’re taking Ibandronic Acid Teva. Talk to your doctor before taking Ibandronic Acid Teva:

• – 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 Teva. If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see section 3).

Children and adolescents

Do not give Ibandronic Acid Teva to children or adolescents below 18 years.

Other medicines and Ibandronic Acid Teva

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 Teva.

• – Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including

ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine. Ibandronic Acid Teva may also do so. So be especially careful if you take painkillers or anti-inflammatories while you’re taking Ibandronic Acid Teva.

After swallowing your monthly Ibandronic Acid Teva tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.

Ibandronic Acid Teva with food and drink

Do not take Ibandronic Acid Teva with food. Ibandronic Acid Teva is less effective if it’s taken with food.

You can drink water but no other drinks.

After you have taken Ibandronic Acid Teva, please wait for 1 hour before you can have your first food and further drinks. (see 3. How to take Ibandronic Acid Teva).

Pregnancy and breast-feeding

Ibandronic Acid Teva 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 Teva if you are pregnant or breast feeding. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as it’s expected that Ibandronic Acid Teva has no or negligible effect on your ability to drive and use machines.

Ibandronic Acid Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Ibandronic Acid Teva

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of Ibandronic Acid Teva is one tablet once a month.

Taking your monthly tablet

It’s important to follow these instructions carefully. They are designed to help your Ibandronic Acid Teva tablet reach your stomach quickly, so it’s less likely to cause irritation.

• - Take one Ibandronic Acid Teva 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 1st of each month) or the same day (such as the first Sunday of each month) to take your Ibandronic Acid Teva tablet. Choose the date that best fits your routine.

• – Take your Ibandronic Acid Teva tablet at least 6 hours after you last had anything to eat or drink except water.

• – Take your Ibandronic Acid Teva 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 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’s OK to lie down if you wish, and to take any other medication you need.

Continuing to take Ibandronic Acid Teva

It’s important to keep taking Ibandronic Acid Teva every month, as long as your doctor prescribes it for you. After 5 years of using Ibandronic Acid Teva, please consult with your doctor whether you should continue to take Ibandronic Acid Teva.

If you take more Ibandronic Acid Teva than you should

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 Teva to irritate your oesophagus.

If you forget to take Ibandronic Acid Teva

• – 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 Teva 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.

4. Possible side effects

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects -you may need urgent medical treatment:

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

Rare ( may affect up to 1 in 1000 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

Other possible side effects

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, 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 to 1 in 100 people):

• dizziness
• flatulence (farting, feeling bloated)
• back pain
• feeling tired and exhausted
• asthma attacks

Rare (may affect up to 1 in 1000 people):

• inflammation of the duodenum (first section of the bowel) causing stomach pain
• hives

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ibandronic Acid Teva contains

• The active substance is ibandronic acid.

Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).

• The other ingredients are:

What Ibandronic Acid Teva looks like and contents of the pack

The Ibandronic Acid Teva film-coated tablets are white, biconvex, capsule-shaped, engraved “50” on one side and plain on the other.

Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC – Aluminium) in cartons of 28 or 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva B.V.

Swensweg 5

2031 GA Haarlem

The Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

The Netherlands

Teva Czech Industries s.r.o

Ostravska 29/305,

747 70 Opava-Komarov

Czech Republic

Teva Operations Poland Sp.z.o.o

ul. Mogilska 80

31–546 Krakow

Poland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Tql: +30 2118805000

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Ibandronic Acid Teva 150 mg film-coated tablets ibandronic acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.

What is in this leaflet

• 1. What Ibandronic Acid Teva is and what it is used for

• 2. What you need to know before you take Ibandronic Acid Teva

• 3. How to take Ibandronic Acid Teva

• 4. Possible side effects

• 5. How to store Ibandronic Acid Teva

• 6. Contents of the pack and other information

1. What Ibandronic Acid Teva is and what it is used for

Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. Ibandronic Acid Teva may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they will not be able to see or feel a difference. Ibandronic Acid Teva may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

Ibandronic Acid Teva is prescribed to you to treat postmenopausal osteoporosis because you have an increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.

The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis.

Other things that can increase the risk of fractures include:

• – not enough calcium and vitamin D in the diet,

• – smoking, or drinking too much alcohol,

• – not enough walking or other weight-bearing exercise,

• – a family history of osteoporosis.

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

• – eating a balanced diet rich in calcium and vitamin D,

• – walking or any other weight-bearing exercise, – not smoking; and not drinking too much alcohol.

2. What you need to know before you take Ibandronic Acid Teva

Do not take Ibandronic Acid Teva

• – 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.

Warnings and precautions

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 Teva 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.

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 do not 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 Teva.

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 Teva.

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.

Some people need to be especially careful while they’re taking Ibandronic Acid Teva. Talk to your doctor before taking Ibandronic Acid Teva:

• – 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 Teva. If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see section 3).

Children and adolescents

Do not give Ibandronic Acid Teva to children or adolescents below 18 years.

Other medicines and Ibandronic Acid Teva

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 Teva.

• – Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including

ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine. Ibandronic Acid Teva may also do so. So be especially careful if you take painkillers or anti-inflammatories while you’re taking Ibandronic Acid Teva.

After swallowing your monthly Ibandronic Acid Teva tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.

Ibandronic Acid Teva with food and drink

Do not take Ibandronic Acid Teva with food. Ibandronic Acid Teva is less effective if it’s taken with food.

You can drink water but no other drinks.

After you have taken Ibandronic Acid Teva, please wait for 1 hour before you can have your first food and further drinks. (see 3. How to take Ibandronic Acid Teva).

Pregnancy and breast-feeding

Ibandronic Acid Teva 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 Teva if you are pregnant or breast feeding. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as it’s expected that Ibandronic Acid Teva has no or negligible effect on your ability to drive and use machines.

Ibandronic Acid Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

3. How to take Ibandronic Acid Teva

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of Ibandronic Acid Teva is one tablet once a month.

Taking your monthly tablet

It’s important to follow these instructions carefully. They are designed to help your Ibandronic Acid Teva tablet reach your stomach quickly, so it’s less likely to cause irritation.

• - Take one Ibandronic Acid Teva 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 1st of each month) or the same day (such as the first Sunday of each month) to take your Ibandronic Acid Teva tablet. Choose the date that best fits your routine.

• – Take your Ibandronic Acid Teva tablet at least 6 hours after you last had anything to eat or drink except water.

• – Take your Ibandronic Acid Teva 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 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’s OK to lie down if you wish, and to take any other medication you need.

Continuing to take Ibandronic Acid Teva

It’s important to keep taking Ibandronic Acid Teva every month, as long as your doctor prescribes it for you. After 5 years of using Ibandronic Acid Teva, please consult with your doctor whether you should continue to take Ibandronic Acid Teva.

If you take more Ibandronic Acid Teva than you should

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 Teva to irritate your oesophagus.

If you forget to take Ibandronic Acid Teva

• – 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 Teva 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.

4. Possible side effects

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects -you may need urgent medical treatment:

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

Rare ( may affect up to 1 in 1000 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

Other possible side effects

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, 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 to 1 in 100 people):

• dizziness
• flatulence (farting, feeling bloated)
• back pain
• feeling tired and exhausted
• asthma attacks

Rare (may affect up to 1 in 1000 people):

• inflammation of the duodenum (first section of the bowel) causing stomach pain
• hives

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ibandronic Acid Teva contains

• The active substance is ibandronic acid.

Each film-coated tablet contains 150 mg ibandronic acid (as sodium monohydrate).

• The other ingredients are: