Ibandronic Acid Teva
ibandronic acid
ibandronic acid
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 Ibandronic Acid Teva is and what it is used for
What you need to know before you take Ibandronic Acid Teva
3. How to take Ibandronic Acid Teva
Possible side effects
How to store Ibandronic Acid Teva
Contents of the pack and other information
Ibandronic Acid Teva contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.
Ibandronic Acid Teva 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 Teva works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.
if you are allergic to ibandronic acid or any of the other ingredients of this medicine (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 Teva.
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 Teva 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 do not 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 Teva.
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 Teva.
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 Teva:
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 Teva. If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see sections 3 and 4).
Ibandronic Acid Teva should not be used in children and adolescents below the age of 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ibandronic Acid Teva can affect the way some other medicines work. Also some other medicines can affect the way Ibandronic Acid Teva works.
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 Teva can both irritate your stomach and gut
a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because aminoglycosides and Ibandronic Acid Teva 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 Teva.
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).
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.
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.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.
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.
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).
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 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.
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/food pipe)
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)
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.
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.
asthma attack
tummy pain, indigestion
low calcium levels in your blood
weakness.
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.
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.
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.
The active substance is ibandronic acid. Each film-coated tablet contains 50 mg ibandronic acid (as 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 (E 171), hypromellose, macrogol 400, polysorbate 80.
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.
Teva B.V. Swensweg 5
2031 GA Haarlem
The Netherlands
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:
Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373
UAB Teva Baltics
Tel: +370 52660203
Тева Фарма ЕАД Teл: +359 24899585
Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien
Tél/Tel: +32 38207373
Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111
Teva Gyógyszergyár Zrt.
Tel: +36 12886400
Teva Denmark A/S Tlf: +45 44985511
Teva Pharmaceuticals Ireland L-Irlanda
Tel: +44 2075407117
TEVA GmbH
Tel: +49 73140208
Teva Nederland B.V.
Tel: +31 8000228400
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801
Teva Norway AS Tlf: +47 66775590
Specifar A.B.E.E.
Τηλ: +30 2118805000
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070
Teva Pharma, S.L.U. Tel: +34 913873280
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300
Teva Santé
Tél: +33 155917800
Teva Pharma - Produtos Farmacêuticos, Lda.
Tel: +351 214767550
Pliva Hrvatska d.o.o.
Tel: +385 13720000
Teva Pharmaceuticals S.R.L.
Tel: +40 212306524
Teva Pharmaceuticals Ireland Tel: +44 2075407117
Pliva Ljubljana d.o.o.
Tel: +386 15890390
Teva Pharma Iceland ehf.
Sími: +354 5503300
TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Teva Italia S.r.l.
Tel: +39 028917981
Teva Finland Oy
Puh/Tel: +358 201805900
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000
Teva Sweden AB Tel: +46 42121100
UAB Teva Baltics filiāle Latvijā Tel: +371 67323666
Teva Pharmaceuticals Ireland Ireland
Tel: +44 2075407117