Patient leaflet - Ibandronic Acid Sandoz
B. PACKAGE LEAFLET
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.
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– Keep this leaflet. You may need to read it again.
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– If you have any further questions, ask your doctor or pharmacist.
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– 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
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1. What Ibandronic acid Sandoz is and what it is used for
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2. What you need to know before you take Ibandronic acid Sandoz
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3. How to take Ibandronic acid Sandoz
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4. Possible side effects
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5. How to store Ibandronic acid Sandoz
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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 breastfeeding.
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 and sodium
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, that is to say essentially sodium free.
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
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– The active substance is ibandronic acid. Each film-coated tablet contains 50 mg of ibandronic acid (as ibandronate sodium monohydrate).
The other ingredients are:
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– tablet core: povidone, microcrystalline cellulose, crospovidone, maize starch pregelatinised, glycerol dibehenate, colloidal anhydrous silica.
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– 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.
Verovskova 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
Sandoz nv/sa
Tél/Tel: +32 27229797
Kûnpoç
Sandoz Pharmaceuticals d.d.
Verovskova Ulica 57,
SI-1000 Ljubljana, Slovenia
Tql: +357 22 69 0690
| Etnrapua BO Sandoz Bulgaria 55 Nikola Vaptsarov blvd, EXPO 2000, build.4, fl.4 BG-1407 Sofia Ten.: + 359 2 970 47 47 | Latvija Sandoz d.d. Branch Office Latvia K.Valdemära Str. 33 – 29 LV-1010 Riga Tel: +371 67892006 |
| Česká republika Sandoz s.r.o. Na Pankráci 1724/129 CZ 140 00, Praha 4 – Nusle Tel: +420 225 775 111 | Lietuva Sandoz Pharmaceuticals d.d Branch Office Lithuania Seimynisk^ g. 3A LT – 09312 Vilnius Tel: +370 5 2636 037 |
| Danmark, Ísland, Norge Sandoz A/S Edvard Thomsens Vej 14 DK-2300 K0benhavn S Danmörk/Danmark/Tanska | Magyarorszag Sandoz Hungaria Kft. Tel: +36 1 430 2890 |
Tlf: +45 6395 1000
| Deutschland, Luxembourg/Luxemburg Hexal AG Industriestr. 25 D-83607 Holzkirchen Deutschland/Allemagne Tel: +49 8024/908–0 | Malta Sandoz Pharmaceuticals d.d. Verovskova Ulica 57, SI-1000 Ljubljana, Slovenia Tel: +356 21222872 |
| Eesti Sandoz d.d. Eesti filiaal Pärnu mnt 105 EE – 11312 Tallinn Tel: +372 6652 40 | Nederland Sandoz B.V. Veluwezoom 22 NL-1327 AH Almere Tel: +31 36 52 41 600 |
| EXXáSa Novartis (Hellas) A.E.B.E. Tql: +30 210 281 17 12 | Österreich Sandoz GmbH Biochemiestr. 10 A-6250 Kundl Tel: +43 5338 2000 |
| España Sandoz Farmacéutica, S.A. / BEXAL FARMACÉUTICA, S.A. Centro Empresarial Osa Mayor Avda. Osa Mayor, n° 4 E-28023 (Aravaca) Madrid | Polska Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02 672 Warszawa Tel.: +48 22 209 70 00 |
Tel: +34 91 548 84 04
| France Sandoz SAS 49, avenue Georges Pompidou F-92593 Levallois-Perret Cedex Tel: + 33 1 49 64 48 00 | Portugal Sandoz Farmacéutica Lda. Avenida Professor Doutor Cavaco Silva, n° 10E Taguspark P-2740–255 Porto Salvo Tel: +351 21 196 40 00 |
| Hrvatska Sandoz d.o.o. Maksimirska 120 HR – 10 000 Zagreb Tel : +385 1 235 3111 | Romania Sandoz S.R.L. Strada Livezeni 7A 540472 Targu Mures Tel: +40 21 407 51 60 |
| Ireland ROWEX LTD Newtown IE-Bantry Co. Cork P75 V009 Tel: +353 27 50077 | Slovenija Lek Pharmaceuticals d.d. Verovškova 57 SI-1526 Ljubljana Tel: +386 1 580 21 11 |
| Italia Sandoz S.p.A. Largo Umberto Boccioni, 1 I-21040 Origgio / VA Tel: +39 02 96541 | Slovenská republika Sandoz d.d. – organizačná zložka Žižkova 22B SK-811 02 Bratislava Tel: +421 2 48 200 600 |
| United Kingdom Sandoz Ltd Park View, Riverside Way Watchmoor Park Camberley, Surrey GU15 3YL United Kingdom | Sverige Sandoz A/S Edvard Thomsens vej 14 DK-2300 Köpenhamn S Tlf: +45 6395 1000 |
Tel: +44 1276 69 8020
Suomi/Finland
Sandoz A/S
Edvard Thomsens vej 14
DK-2300 Kööpenhamina S/Köpenhamn S
Tlf: +45 6395 1000
This leaflet was last revised in {MM/YYYY}.
Detailed information on this medicine is available on the European Medicines Agency web site:
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