Ibandronic Acid Teva 50 mg film-coated tablets

The active substance of Ibandronic Acid Teva, ibandronic acid, belongs to the group of medicines known as bisphosphonates. It inhibits increased loss of calcium from the bones (bone resorption), and prevents bone complications and fractures related to the spread of cancer cells into bone.

Ibandronic Acid Teva is indicated for the prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.

During treatment your blood may be monitored to ensure that you are receiving the correct dose of Ibandronic Acid Teva.

If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Ibandronic Acid Teva.

Do not take Ibandronic Acid Teva

• if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients of Ibandronic Acid Teva.
• if you have certain problems with your oesophagus (the tube connecting your mouth with your stomach) 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.

Do not give Ibandronic Acid Teva to children.

Take special care with Ibandronic Acid Teva

if you know or believe that you may have:

• allergies to other bisphosphonates,
• other disturbances of mineral metabolism (such as vitamin D deficiency),
• moderate kidney disease (creatinine clearance ?30 and <50 mL/min ) or severe kidney disease (renal insufficiency i.e. creatinine clearance <30 mL/min),</li>

or when

• you have any swallowing or digestive problems

Irritation, inflammation or ulceration of the oesophagus (the tube that connects your mouth with your stomach) 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 plain 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, or are taking supplements containing calcium, magnesium, iron or aluminium.

No interaction was observed when ibandronic acid was administered in combination with tamoxifen (used in the treatment of breast cancer), or melphalan/prednisolone.

Caution is advised when bisphosphonates are administered with aminoglycosides since both agents can lower serum calcium levels for prolonged periods. Caution should also be paid to the possible existence of simultaneous hypomagnesaemia (reduced magnesium levels).

Take special care if you are also taking non-steroidal anti-inflammatory drugs (NSAIDs), since both types of medicinal products (NSAIDs and bisphosphonates) may cause irritation to the stomach and intestine.

After taking your Ibandronic Acid Teva tablet, wait at least 30 minutes before taking any other medication of the day, including indigestion tablets/medicine, calcium supplements and vitamins.

Taking Ibandronic Acid Teva with food and drink

Your Ibandronic Acid Teva tablet should be taken after an overnight fast (at least 6 hours) and before the first food or drink of the day. Medications and supplements (including calcium, aluminium, magnesium and iron) should similarly be avoided prior to taking Ibandronic Acid Teva . Fasting, including avoiding other medication and supplements should be continued for at least 30 minutes after taking the tablet. Plain water may be taken at any time during the course of Ibandronic Acid Teva treatment.

Pregnancy and breast-feeding

Do not take Ibandronic Acid Teva if you are pregnant or if you are breast-feeding.

Driving and using machines

The effects of Ibandronic Acid Teva on the ability to drive or to use machines has not been studied.

Always take Ibandronic Acid Teva exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose of Ibandronic Acid Teva is one tablet per day. If you have kidney problems, your doctor may reduce your dose to one tablet every second day in case of moderate kidney disease or to one tablet per week in case of severe kidney disease.

To reduce possible irritation, it is important that you follow the instructions below:

• Take Ibandronic Acid Teva BEFORE taking your first food, drink or other medicinal products of the day.
• Take your Ibandronic Acid Teva tablet with a full glass of plain water only (about 200 ml).
• Do not take your tablet with any drink other than plain water.
• Do not chew, suck , crush or allow the tablet to dissolve in your mouth.
• After taking your Ibandronic Acid Teva tablet, wait at least 30 minutes before taking your first food, beverage, or other medication of the day.
• You should remain in an upright (sitting or standing) position while taking Ibandronic Acid Teva and remain upright for 60 minutes after taking your tablet. If you do not stay upright (standing or sitting), some of the medicine could leak back into your oesophagus.
• It is important to continue taking Ibandronic Acid Teva for as long as your doctor prescribes the medicine, Ibandronic Acid Teva can help with your condition only if you continue to take the tablets.

If you take more Ibandronic Acid Teva than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately.
Do not make yourself vomit, and do not lie down.

If you forget to take Ibandronic Acid Teva
Do not take a double dose to make up for a forgotten tablet. Return to taking one tablet per day the following day, as usual.

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

Like all medicines, Ibandronic Acid Teva can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

very common affects more than 1 user in 10 common affects 1 to 10 users in 100 uncommon affects 1 to 10 users in 1,000 rare affects 1 to 10 users in 10,000 very rare affects less than 1 user in 10,000 not known frequency cannot be estimated from the available data

• Common:
• indigestion,
• nausea,
• abdominal pain,
• oesophagitis (inflammation of the gullet),
• tiredness,
• low calcium levels in the blood.

Ibandronic Acid Teva can also irritate the oesophagus, although you can usually avoid this by taking your dose as described in this leaflet. If you develop symptoms such as severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, stop taking Ibandronic Acid Teva and tell your doctor straight away.

• Uncommon:
• strange taste,
• paraesthesia (tingling sensation)
• dry mouth,
• bleeding gastrointestinal ulcer,
• difficulty swallowing,
• gastritis,
• itching,
• chest pain,
• flu-like symptoms,
• feeling unwell and pain,
• anaemia (low hemoglobin in the blood),
• high levels of urea and high levels of parathyroid hormone have been reported from blood tests.
• Not known:
• jaw problems associated with delayed healing and infection, often following tooth extraction.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Ibandronic Acid Teva 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.

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 to protect the environment.

What Ibandronic Acid Teva contains

• The active substance is ibandronic acid.Each film-coated tablet contains 50 mg ibandronic acid (as ibandronate 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 (E171), hypromellose, macrogol 400, polysorbate 80.

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 Pharma B.V.,
Computerweg 10,
3542 DR Utrecht,
The Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen
Hungary

Teva Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82,

H-2100 Gödöll-

Hungary

Teva UK Ltd

Brampton Road, Hampden Park, Eastbourne,

East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

Teva Santé SA

Rue Bellocier,

89107 Sens

France

Teva Czech Industries s.r.o

Ostravska 29/305,

747 70 Opava-Komarov

Czech Republic

PLIVA Krakow Zaklady Farmaceutyczne SA

ul. Mogilska 80

31-546 Krakow

Poland

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TélTel 32 3 820 73 73 Te. 359 2 489 95 82 eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Danmark Teva Denmark AS Tlf 45 44 98 55 11 Deutschland Teva GmbH LuxembourgLuxemburg Teva Pharma Belgium S.A . TélTel 32 3 820 73 73 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00 Malta Teva .. Tel 302107279099 Nederland Teva Nederland B.V. Tel 31 0 800 0228400 Norge Teva Sweden AB

Tlf 46 42 12 11 00 Österreich Teva GmbH Tel 49 351 834 0 Polska Teva Pharmaceuticals Polska Sp. z o.o Tel. 48 22 345 93 00 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910 România Teva Pharmaceuticals S.R.L Tel 4021 2306524 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00 Sverige Teva Sweden AB Tel 46 42 12 11 00 United Kingdom Teva UK Limited Tel 44 1323 501 111 Tel 49 351 834 0 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409 Teva .. 30 210 72 79 099 España Teva Pharma, S.L.U. Tel 34 91 387 32 80 France Teva Santé Tél 33 1 55 91 7800 Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Ísland Teva UK Limited Sími 44 1323 501 111 Italia Teva Italia S.r.l. Tel 39 0289179805 Teva .. 30 210 72 79 099 Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 Lietuva UAB Sicor Biotech Tel 370 5 266 02 03

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