Ibandroninezuur CT 50 mg, filmomhulde tabletten

Ibandroninezuur CT  50 mg, filmomhulde tabletten
Werkzame stof(fen)Ibandroninezuur
Farmacologische groepenGeneesmiddelen die botstructuur en mineralisatie beïnvloeden


Wat is het en waarvoor wordt het gebruikt?

1. What is and what it is used for

<Ibandronic acid 50 mg> contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.

<Ibandronic acid 50 mg> is indicated 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 50 mg> works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.

Wat moet u weten voordat u het gebruikt?

2. What you need to know before you take

It is important that you take <Ibandronic acid 50 mg> at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe (oesophagus). This is the tube connecting your mouth with your stomach.

Stop taking <Ibandronic acid 50 mg> and tell your doctor straight away, if you get severe chest pain, severe pain after swallowing food or drink, feel very sick or are being sick.

Do not take <Ibandronic acid 50 mg>:

  • if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
  • if you have problems with your food pipe (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 50 mg>.

Take special care with <Ibandronic acid 50 mg>:

  • if you are allergic (hypersensitive) 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
  • if you have a galactose intolerance, the Lapp lactase deficiency or have problems with glucose- galactose absorption

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking <Ibandronic acid 50 mg>.

If you are having dental treatment or surgery or know that you need some in the future, tell your dentist that you are being treated with <Ibandronic acid 50 mg>.

Children and teenagers

<Ibandronic acid 50 mg> should not be used in children and teenagers below age 18 years.

Other medicines and <Ibandronic acid 50 mg>

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. This is because <Ibandronic acid 50 mg> can affect the way some other medicines work. Also some other medicines can affect the way <Ibandronic acid 50 mg> works.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

  • supplements containing magnesium,calcium,iron or aluminium
  • non-steroidal anti-inflammatory drugs called “NSAIDs” such as aspirin, ibuprofen or naproxen. This is because NSAIDs and <Ibandronic acid 50 mg> can both irritate your stomach and gut
  • a type of antibiotic injection called “aminoglycoside” such as gentamicin. This is because aminoglycosides and <Ibandronic acid 50 mg> 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 50 mg>.

When to take your other medicines

Do not take any other medicines or supplements for at least 6 hours before taking <Ibandronic acid 50 mg>. Once you have taken <Ibandronic acid 50 mg>, wait at least 30 minutes before taking any other medicines or supplements.

<Ibandronic acid 50 mg> with food and drink

It is important to take <Ibandronic acid 50 mg> at the right time and in the right way. See “Taking this medicine” in section 3 for the full instructions about when and how to take.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

It is not known if <Ibandronic acid 50 mg> affects your ability to drive, use machines or tools. Talk to your doctor first if you want to drive, use machine or tools.

Important information about some of the ingredients of <Ibandronic acid 50 mg>

<Ibandronic acid 50 mg> tablets contain a type of sugar called lactose. If you have been told by your doctor that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.

Hoe wordt het gebruikt?

3. How to take

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor may do regular blood tests while you are taking <Ibandronic acid 50 mg>. 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 50 mg> at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe (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 plain water only (about 200 mL). Do not take your tablet with any drink other than plain 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 (oesophagus).

How much to take

The usual dose of <Ibandronic acid 50 mg> 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 50 mg> 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 50 mg>

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 50 mg>

Keep taking <Ibandronic acid 50 mg> 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.

Wat zijn mogelijke bijwerkingen?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking <Ibandronic acid 50 mg> and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

  • rash, itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having an allergic reaction to the medicine
  • pain or sore in your mouth or jaw
  • severe chest pain, severe pain after swallowing food or drink, feeling very sick or being sick. This could be a sign of problems with your food pipe (oesophagus)
  • severe stomach pain, being sick, possibly with blood in it. This could be a sign of a stomach ulcer that is bleeding, or that your stomach lining is inflamed (gastritis).
  • eye pain and inflammation (if prolonged).

Other possible side effects

Common (affects less than 1 in 10 people): - feeling tired

  • stomach pain, indigestion
  • feeling sick or inflamed food pipe (heart burn)
  • low calcium levels in your blood.

Uncommon (affects 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
  • high levels of urea or high levels of parathyroid hormone in your blood.

Rare (affects less than 1 in 1000 people)

  • eye pain or inflammation
  • unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.

Very rare (affects less than 1 in 10000 people)

  • a condition involving exposed bone in the mouth called “osteonecrosis of the jaw”.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Hoe moet het worden bewaard?

5. How to store
  • Keep out of the reach and sight of children.
  • Do not use <Ibandronic acid 50 mg> 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 medicinal product does not require any special storage conditions.
  • 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.

Verdere informatie

What <Ibandronic acid 50 mg> contains

The active substance is 56.25 mg of ibandronic acid, monosodium salt, monohydrate, equivalent to 50 mg of ibandronic acid.

The other ingredients are lactose monohydrate, crospovidone (E1202), microcrystalline cellulose (E460), colloidal anhydrous silica (E551), sodium stearyl fumarate (tablet core); polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171) (tablet coating).

What <Ibandronic acid 50 mg> looks like and contents of the pack

Ibandronic acid tablets are white to off-white, oblong tablets inscripted with “I9BE” on one side and “50” on the other side.

They are available in blister packs of 7, 10, 14, 20, 21, 28, 30, 42, 50, 56, 60, 84, 90, 100, 126, 168, 210 and 1x7 tablets. (NL/H/1831,1833)

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Teva Pharma B.V. Computerweg 10 3542 DR Utrecht Nederland


Synthon BV

Microweg 22

6545 CM Nijmegen


Synthon Hispania

Castello 1, Poligono las Salinas 08830 Sant Boi de Llobregat Spanje

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 Blaubeuren-Weiler


Dit geneesmiddel is geregistreerd onder

Ibandroninezuur CT 50 mg, filmomhulde tabletten RVG 106019

Dit geneesmiddel is geregistreerd in lidstaten van de EEA onder de volgende namen:

Duitsland (DE) Ib andronsäure-CT 50 mg Filmtabletten
Nederland (NL) Ib androninezuur CT 50 mg, filmomh

This leaflet was last revised in oktober 2013.

Laatst bijgewerkt op 24.08.2022

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