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Ibandronic Acid Sandoz (ibandronic acid) – Package leaflet - M05BA06

Updated on site: 07-Oct-2017

Medication nameIbandronic Acid Sandoz
ATC CodeM05BA06
Substanceibandronic acid
ManufacturerSandoz GmbH

Package leaflet: Information for the patient

Ibandronic acid Sandoz 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 Sandoz is and what it is used for

2.What you need to know before you take Ibandronic acid Sandoz

3.How to take Ibandronic acid Sandoz

4.Possible side effects

5.How to store Ibandronic acid Sandoz

6.Contents of the pack and other information

1.What Ibandronic acid Sandoz is and what it is used for

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

Ibandronic acid Sandoz tablets 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 Sandoz 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 Sandoz

Do not take Ibandronic acid Sandoz:

if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are 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 Sandoz.

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 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 don’t 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 Sandoz.

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 Sandoz.

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 Sandoz

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 Sandoz. If you develop these symptoms, stop taking Ibandronic acid Sandoz and tell your doctor straight away (see sections 3 and 4).

Children and adolescents

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

Other medicines and Ibandronic acid Sandoz

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

a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because aminoglycosides and Ibandronic acid Sandoz 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 Sandoz.

Ibandronic acid Sandoz with food and drink

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

Take Ibandronic acid Sandoz at least 6 hours after you 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 Sandoz 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 Sandoz 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 Sandoz contains lactose

If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose absorption), talk to your doctor before taking this medicine.

3.How to take Ibandronic acid Sandoz

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 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 Sandoz. 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 Sandoz 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 Sandoz 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 Sandoz 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 Sandoz

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 Sandoz

Keep taking Ibandronic acid Sandoz 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).

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

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.

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. 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.How to store Ibandronic acid Sandoz

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.

Store in the original package in order to protect from moisture.

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 Sandoz contains

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

The other ingredients are:

-tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica.

-tablet coat: titanium dioxide, lactose monohydrate, hypromellose, macrogol 4000

What Ibandronic acid Sandoz looks like and contents of the pack

The film-coated tablets are white, round biconvex tablets supplied in Polyamide/Al/PVC - Aluminum foil blister. They are available in packs of 3, 6, 9, 28 and 84 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz GmbH

Biochemiestraße 10

A-6250 Kundl

Austria

Manufacturer

Pharmathen S.A.

Dervenakion 6

Pallini 15351

Attiki

Greece

And

Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece

And

Lek S.A.

ul. Domaniewska 50 C 02-672 Warszawa Poland

And

Lek Pharmaceuticals d.d.

Verovškova 57, 1526 Ljubljana

Slovenia

And

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179 Barleben

Germany

And

Salutas Pharma GmbH

Dieselstrasse 5, 70839 Gerlingen

Germany

And

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A, RO-540472 Targu-Mures

Romania

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

België/Belgique/Belgien

Κύπρος

Sandoz n.v./s.a.

Π.T.Χατζηγεωργίου εταιρεία Ltd

Telecom Gardens

CY-3042 Λεμεσός, Γιλντίζ 31

Medialaan 40

Τηλ: 00357 25372425

B-1800 Vilvoorde

Φαξ: 00357 25376400

Tél/Tel: +32 27229797

e-mail: hapanicos@cytanet.com.cy

България

Sandoz d.d Representative office Business Park Sofia, buil. 8B, fl. 6 BG-1766 Sofia

Teл.: + 359 2 970 47 47

Česká republika

Sandoz s.r.o.

U Nákladového nádraží 10 CZ 130 00, Praha 3

Tel: +420 221 421 611 office.cz@sandoz.com

Danmark, Ísland, Norge, Suomi/Finland, Sverige

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S Danmörk/Danmark/Tanska info.sandoz-dk@sandoz.com Tlf: +45 6395 1000

Deutschland, Luxembourg/Luxemburg

Hexal AG Industriestr. 25 D-83607 Holzkirchen

Deutschland/Allemagne Tel: +49 8024/908-0 service@hexal.com

Eesti

Sandoz d.d. Eesti filiaal

Pärnu mnt 105

EE – 11312 Tallinn

Tel: +372 6652 40

Ελλάδα

Sandoz Pharmaceuticals D.D.

Κηφισίας 18 & Γκύζη

GR - 151 25 Μαρούσι Τηλ: +30 216 600 500 0

España

Sandoz Farmacéutica, S.A. / BEXAL FARMACÉUTICA, S.A.

Centro Empresarial Osa Mayor Avda. Osa Mayor, nº 4 E-28023 (Aravaca) Madrid Tel: +34 91 548 84 04 Registros.spain@sandoz.com

Latvija

Sandoz d.d. Representative Office in Latvia K.Valdemāra Str. 33 – 30

LV-1010 Riga

Tel: +371 67892006

Lietuva

Sandoz Pharmaceuticals d.d Branch Office Lithuania Šeimyniškių g. 3A

LT – 09312 Vilnius

Tel: +370 5 2636 037

Magyarország

Sandoz Hungaria Kft. Bartók Béla út 43-47 H-1114 Budapest Tel: +36 1 430 2890

info.hungary@sandoz.com

Malta, United Kingdom

Sandoz Ltd

Frimley Business Park Frimley, Camberley UK-GU16 7SR Surrey Renju Unit/United Kingdom Tel: +44 1276 69 8020 uk.drugsafety@sandoz.com

Nederland

Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel: +31 36 52 41 648

info.sandoz-nl@sandoz.com

Österreich

Sandoz GmbH Biochemiestr. 10 A-6250 Kundl

Tel: +43 5338 2000

Polska

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C PL – 02 672 Warszawa Tel.: +48 22 549 15 00

France

Sandoz SAS

49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tél: + 33 1 49 64 48 00

Hrvatska

Sandoz d.o.o.

Maksimirska 120

HR – 10 000 Zagreb

Tel : +385 1 235 3111

Ireland

ROWEX LTD

Newtown

IE-Bantry Co. Cork

Tel: +353 27 50077

Italia

Sandoz S.p.A.

Largo Umberto Boccioni, 1

I-21040 Origgio / VA

Tel: +39 02 96541

Portugal

Sandoz Farmacêutica Lda.

Avenida Professor Doutor Cavaco Silva, n.º 10E Taguspark

P-2740–255 Porto Salvo

Tel: +351 21 924 1911

România

SC Sandoz S.R.L.

Str Livezeni nr. 7A,

Targu Mures, 540472 - RO

Romania

Tel: +40 265 208 120

Slovenija

Lek Pharmaceuticals d.d.

Verovškova 57

SI-1526 Ljubljana

Tel: +386 1 580 21 11

Info.lek@sandoz.com

Slovenská republika

Sandoz d.d. - organizačná zložka

Galvaniho 15/C

SK-821 04 Bratislava

Tel: +421 2 48 200 600

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

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