IBANDRONIC ACID TEVA 150 mg FILM-COATED TABLETS

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

Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates and contains ibandronic acid. Ibandronic Acid Teva can reverse bone loss because it prevents further bone loss and increases bone mass in most women who take it, even if they cannot see or feel the difference. Ibandronic Acid Teva may help reduce the risk of bone fractures. This reduction has been shown in spinal fractures but not in hip fractures.

You have been prescribed Ibandronic Acid Teva to treat your postmenopausal osteoporosis because you are at high risk of fractures. Osteoporosis is a condition where bones become thinner and weaker, which is common in women after the menopause. During the menopause, the ovaries stop producing the female hormone - oestrogen - which helps to keep the bones healthy.

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

Other factors that increase the risk of fractures include:

• inadequate intake of calcium and vitamin D in the diet

• smoking or excessive alcohol consumption
• little walking or other weight-bearing exercise
• family history of osteoporosis

Healthy lifestyle habits also help the beneficial effects of treatment. These include a balanced diet rich in calcium and vitamin D; walking or 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 oesophagus (the tube that connects your mouth and stomach) such as narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least one hour (60 minutes)
• if you have or have had low blood calcium levels. Consult your doctor.

Warnings and precautions

A rare side effect has been reported with this medicine called osteonecrosis of the jaw (ONJ) (bone damage in the jaw). This has been reported in patients taking Ibandronic Acid Teva for osteoporosis.

It is very important to try to prevent ONJ as it can be a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, certain precautions need to be taken.

Atypical fractures of the long bones in the legs have also been reported with long-term use of ibandronate. These fractures can occur with little or no trauma and some patients experience pain in the area of the fracture before a complete fracture occurs.

Before receiving treatment, inform your doctor/nurse (healthcare professional) if:

• you have dental problems, poor oral health or are planning to have a tooth extracted
• you do not receive 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 been treated with a bisphosphonate (used to treat or prevent bone disorders) before
• you are taking steroids (such as prednisolone or dexamethasone)
• you have cancer

Your doctor may ask you to have a dental check-up before starting treatment with Ibandronic Acid Teva.

While you are being treated, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups. If you wear dentures, you should make sure they fit properly. If you are having dental treatment or are about to have a dental operation (e.g. tooth extraction), inform your doctor about your dental treatment and inform 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, or difficulty healing after a mouth ulcer or discharge, as these could be signs of osteonecrosis of the jaw.

Certain people need to take special care with Ibandronic Acid Teva. Talk to your doctor before taking Ibandronic Acid Teva:

• if you have a mineral metabolism disorder (such as vitamin D deficiency)
• if your kidneys are not working properly
• if you have swallowing or digestive problems

You may experience irritation, inflammation or ulceration of the oesophagus (the tube that connects your mouth and stomach) sometimes with symptoms of severe chest pain after eating or drinking, severe nausea or vomiting, especially if you have not drunk a full glass of water and/or if you have lain down within an hour of taking Ibandronic Acid Teva. If you develop these symptoms, stop taking Ibandronic Acid Teva and inform your doctor immediately (see section 3).

Children and adolescents:

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

Other medicines and Ibandronic Acid Teva

Inform 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 may interfere with the effects of Ibandronic Acid Teva
• aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium and naproxen) which may irritate the stomach and intestines, as does Ibandronic Acid Teva. Therefore, be very careful when taking painkillers or anti-inflammatory medicines at the same time as Ibandronic Acid Teva

After taking the Ibandronic Acid Teva monthly tablet, wait 1 hour before taking any other medicine, including antacids, calcium supplements or vitamins.

Ibandronic Acid Teva with food and drink

Do not take Ibandronic Acid Teva with food. Ibandronic Acid Teva loses its effect if taken with food.

You can drink water but not other drinks.

After taking Ibandronic Acid Teva, wait 1 hour before taking your first food and other drinks. How to take Ibandronic Acid Teva).

Pregnancy and breastfeeding

Ibandronic Acid Teva is for use in postmenopausal women only and should not be taken by women of childbearing potential.

Do not take Ibandronic Acid Teva if you are pregnant or breastfeeding. If you are breastfeeding, you may need to stop in order to take Ibandronic Acid Teva.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

Ibandronic Acid Teva is not expected to have any effect on the ability to drive and use machines.

Ibandronic Acid Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is essentially “sodium-free”.

3. How to take Ibandronic Acid Teva

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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

How to take the monthly tablet

It is very important that you follow these instructions carefully. They are designed to help Ibandronic Acid Teva reach the stomach quickly and cause less irritation.

• Take one Ibandronic Acid Teva 150 mg tablet once a month.
• Choose a day of the monththat you can easily remember. You can choose the same date (e.g. the first day of each month) or always the same day (e.g. the first Sunday of each month) to take your Ibandronic Acid Teva tablet. Choose what best fits your routine.
• Take the Ibandronic Acid Teva tablet after an interval of at least 6 hours after the last food or drink, except water.

• Take the Ibandronic Acid Teva tablet
• • as soon as you get up, and
  • before you have anything to eat or drink(on an empty stomach)

• Swallow the tablet with a full glass of water(at least 180 ml).

Do nottake the tablet with water with high calcium levels, fruit juice or other drinks. If your tap water contains high levels of calcium, it is recommended to use bottled water with low mineral content.

• Swallow the tablet whole. Do not chew, crush or let it dissolve in your mouth.

• During the next hour (60 minutes)after taking the tablet

• do not lie down; if you do not stay upright (standing or sitting), part of the medicine could come back up into your oesophagus

• do not eat anything

• do not drink anything(except water, if needed)
• do not take any other medicine

• After waiting 1 hour, you can have your breakfast and your first drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medicines you need.

Continuation of treatment with Ibandronic Acid Teva

It is important that you take Ibandronic Acid Teva every month, for as long as your doctor prescribes it.

After 3 - 5 years of taking Ibandronic Acid Teva, consult your doctor to see if you should continue taking Ibandronic Acid Teva.

If you take more Ibandronic Acid Teva than you should

If you accidentally take too many tablets, drink a full glass of milk and contact your doctor immediately. Do not induce vomiting and do not lie down because Ibandronic Acid Teva could irritate your oesophagus

If you forget to take Ibandronic Acid Teva

If you forget to take the tablet on the morning of the day you have chosen, do not take the tablet later.

Instead, consult your calendar to see when your next dose is due

• If you forget to take the tablet on your chosen day and your next dose is within 1 to 7 days

Never take two Ibandronic Acid Teva tablets within the same week. Wait until your next scheduled dose and take it as usual, then continue taking one tablet per month according to the days marked on your calendar.

• If you forget to take the tablet on your chosen day and your next dose is within 1 to 7 days

Take a tablet the next morning after the day you remember you forgot the dose, then continue taking one tablet per month according to the days marked on your calendar.

4. Possible side effects

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

Tell your doctor or nurse immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• severe chest pain, severe pain after swallowing food or drink, severe nausea or vomiting, difficulty swallowing. You may have severe inflammation with ulcers or narrowing of the oesophagus (the tube that connects your mouth and stomach)

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

• itching, swelling of the face, lips, tongue and throat, with difficulty breathing

difficulty breathing

• persistent eye inflammation
• new pain, weakness or discomfort in the thigh, hip or groin. These could be the first signs of an unusual fracture of the thigh bone

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

• pain or ulcers in the mouth or jaw. You may have the first signs of serious jaw problems (necrosis [death of bone tissue] in the jawbone)
• consult your doctor if you have ear pain, discharge from the ear or an ear infection. These could be symptoms of damage to the bones in the ear
• severe allergic reaction, potentially life-threatening

• severe skin reactions

Other possible side effects

Common(may affect up to 1 in 10 people)

• headache
• heartburn, difficulty swallowing, stomach pain or discomfort (due to stomach inflammation), indigestion, nausea, diarrhoea
• muscle cramps, stiffness in joints and limbs
• flu-like symptoms, including fever, chills and shivering, feeling unwell, pain in bones, muscles and joints. Consult your doctor or nurse if any effect becomes troublesome or lasts more than a couple of days
• skin rash

Uncommon(may affect up to 1 in 100 people)

• dizziness
• flatulence (gas, bloating)
• back pain
• feeling tired or weak
• asthma attacks
• 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)

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

Reporting of side effects

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

5. Storage of 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

Composition of Teva Ibandronic Acid

• The active ingredient is ibandronic acid.

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

• The other ingredients are:

tablet core: microcrystalline cellulose, povidone K-A), anhydrous colloidal silica and stearic acid;

tablet coating: titanium dioxide (E171), hypromellose, macrogol 400 and polysorbate 80.

Appearance of the product and container contents

The film-coated tablets of Teva Ibandronic Acid are white, biconvex, capsule-shaped and engraved with "I150" on one side and smooth on the other

Teva Ibandronic Acid is available in blisters (PVC/Aclar/PVC - Aluminum) in packs of 1 and 3 tablets

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder and manufacturer

Teva B.V.

Swensweg 5

Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

4042 Debrecen

Hungary

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

Netherlands

Teva Czech Industries s.r.o

Ostravka 29/305

747 70 Opava-Komarov

Czech Republic

Teva Operations Poland Sp.z o.o

ul.Mogilska 80

31-546 Krakow

Poland

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Date of last revision of this leaflet: {MM/AAAA}

Detailed information on this medicinal product is available on the European Medicines Agency website http://www.ema.europa.eu.