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AstraZeneca

Ibandronic Acid Teva
ibandronic acid

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.


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’.


  1. 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.


  2. 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

      image

      If you get 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.


  3. 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.


  4. Contents of the pack and other information What Ibandronic Acid Teva contains


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:


België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373

Lietuva

UAB Teva Baltics

Tel: +370 52660203


България

Тева Фарма ЕАД Teл: +359 24899585

Luxembourg/Luxemburg

Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien

Tél/Tel: +32 38207373


Česká republika

Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111

Magyarország

Teva Gyógyszergyár Zrt.

Tel: +36 12886400


Danmark

Teva Denmark A/S Tlf: +45 44985511

Malta

Teva Pharmaceuticals Ireland L-Irlanda

Tel: +44 2075407117


Deutschland

TEVA GmbH

Tel: +49 73140208

Nederland

Teva Nederland B.V.

Tel: +31 8000228400


Eesti

UAB Teva Baltics Eesti filiaal

Tel: +372 6610801

Norge

Teva Norway AS Tlf: +47 66775590


Ελλάδα

Specifar A.B.E.E.

Τηλ: +30 2118805000

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43 1970070

España

Teva Pharma, S.L.U. Tel: +34 913873280

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel: +48 223459300


France

Teva Santé

Tél: +33 155917800

Portugal

Teva Pharma - Produtos Farmacêuticos, Lda.

Tel: +351 214767550


Hrvatska

Pliva Hrvatska d.o.o.

Tel: +385 13720000

România

Teva Pharmaceuticals S.R.L.

Tel: +40 212306524


Ireland

Teva Pharmaceuticals Ireland Tel: +44 2075407117

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 15890390


Ísland

Teva Pharma Iceland ehf.

Sími: +354 5503300

Slovenská republika

TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911


Italia

Teva Italia S.r.l.

Tel: +39 028917981

Suomi/Finland

Teva Finland Oy

Puh/Tel: +358 201805900


Κύπρος

Specifar A.B.E.E.

Ελλάδα

Τηλ: +30 2118805000

Sverige

Teva Sweden AB Tel: +46 42121100


Latvija

UAB Teva Baltics filiāle Latvijā Tel: +371 67323666

United Kingdom (Northern Ireland)

Teva Pharmaceuticals Ireland Ireland

Tel: +44 2075407117


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


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