50 mg film-coated tablets
ibandronic acid
1. What Ibandronate STADA is and what it is used for
Ibandronate Stada contains the active substance ibandronic acid, which belongs to a group of medicines called bisphosphonates.
Ibandronate Stada is used for adults and is prescribed for you if you have breast cancer that has spread to the skeleton (so-called skeletal metastases).
- it helps prevent bone fractures ( fractures ).
- it helps prevent other skeletal problems that may need surgery or radiation therapy.
Ibandronate Stada works by reducing the amount of calcium that is lost from the skeleton. This prevents the skeleton from becoming more fragile.
Ibandronic acid contained in Ibandronate Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Ibandronate STADA
Do not use Ibandronate STADA
Do not take Ibandronat Stada
- 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 the esophagus, e.g. 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 have ever had, a low level of calcium in your blood.
Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ibandronate Stada.
Warnings and cautions
A side effect called osteonecrosis of the jaw (ONJ) (destruction of the bone tissue in the jaw) has been reported in very rare cases aftermarket approval in patients receiving ibandronic acid for cancer-related conditions. ONJ can also occur after the end of treatment.
It is important to try to prevent ONJ from developing as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis in the jaw, there are certain precautions that you should take.
Before receiving treatment, tell your doctor/nurse (healthcare professional) about:
- you have any problems with your mouth or teeth such as e.g. poor dental health, gum problems or a planned tooth extraction
- you do not receive regular dental care or have not undergone a dental examination in a long time
- you are a smoker (because it can increase the risk of dental problems)
- you have previously been treated with a bisphosphonate (used to treat or prevent bone diseases)
- you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
- you have cancer.
Your doctor may ask you to have a dental examination before starting treatment with Ibandronate Stada.
While you are being treated, you should maintain good oral hygiene (including regular toothbrushing) and go for regular dental check-ups. If you have a denture, you should make sure that it fits properly. If you are receiving dental treatment or are about to undergo dental surgery (eg extracting a tooth), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronate Stada.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth such as loose teeth, pain or swelling, or wounds that do not heal or fluid as this may be a sign of osteonecrosis of the jaw.
Talk to your doctor or pharmacist before taking Ibandronate Stada
- if you are allergic to any other bisphosphonates
- if you have difficulty swallowing or digestive problems
- if you have high or low levels of vitamin D in your blood or any other mineral
- if you have kidney problems
Irritation, inflammation, or ulceration of the esophagus (esophagus) can occur, often with symptoms such as severe chest pain, severe pain after swallowing food or fluid, severe nausea or vomiting, especially if you do not drink a full glass of water and/or if you lie down within an hour after taking Ibandronat Stada. If you get these symptoms, stop taking Ibandronate Stada and contact your doctor immediately (see sections 3 and 4).
Children and young people
Ibandronate Stada should not be used in children or adolescents under 18 years of age.
Other medicines and Ibandronate STADA
Tell your doctor or pharmacist if you have recently taken or might take any other medicines. The reason is that Ibandronate Stada may affect the way other medicines work. Some other medicines may also affect the way Ibandronate Stada works.
If you are taking any of the following medicines, tell your doctor or pharmacist in particular:
- dietary supplements containing calcium , magnesium , iron or aluminum.
- non-steroidal anti-inflammatory drugs, so-called NSAIDs such as acetylsalicylic acid , ibuprofen or naproxen , as both NSAIDs and Ibandronate Stada can irritate your stomach and intestines
- a type of antibiotic injection called “aminoglycoside” such as gentamicin, as both aminoglycosides and Ibandronate Stada can lower the amount of calcium in the blood.
Taking drugs that reduce stomach acid such as ranitidine may slightly increase the effect of Ibandronate Stada.
Ibandronate STADA with food, drink and alcohol
Do not take Ibandronate Stada with food or any other beverage other than water as Ibandronate Stada is less effective if taken with food or drink (see section 3).
Take Ibandronate Stada at the earliest 6 hours after eating, drinking, or taking any other medicines or supplements (containing eg calcium (milk), aluminum, magnesium, and iron) in addition to water. After taking your tablet, wait at least 30 minutes before eating, drinking, or taking anything else
medicines or supplements (see section 3).
Water with a high calcium concentration should not be used. If there is a suspicion of possible high calcium levels in the tap water (hard water), it is recommended that bottled water with a low mineral content be used (see section 3).
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Ibandronate Stada if you are pregnant, planning to become pregnant, or breastfeeding.
Driving and using machines
You can drive and use machines as Ibandronate Stada is not expected to have any or negligible effect on your ability to drive and use machines. Talk to your doctor before driving, using machines or tools.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Ibandronate STADA contains lactose and sodium
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 tablet, ie essentially ‘sodium-free. is next to “sodium-free”.
How to use Ibandronate STADA
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose of Ibandronate Stada is one tablet daily.
Impaired renal function
If you have moderate kidney problems, your doctor may reduce the dose to one tablet every other day. If you have severe kidney problems, your doctor may reduce the dose one to one tablet once a week.
Your doctor may perform regular blood tests while you are taking Ibandronate Stada. This is to check that you are getting the right amount of medicine.
Method of administration
Take your tablet at the earliest 6 hours after you have eaten, drunk, or taken any other medicine or dietary supplement other than water. Water with high calcium concentration should not be used. If there is a suspicion of possible high calcium levels in the tap water (hard water), it is recommended that bottled water with a low mineral content be used.
You must take Ibandronate Stada at the right time and in the right way as it may cause irritation, inflammation, or ulceration in your esophagus.
You can help prevent this from happening by doing the following:
- Take your tablet as soon as you get up for the day and before taking your first meal, drink, other medicine or dietary supplement.
- take your tablet with a full glass of water (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 allow the tablet to dissolve in your mouth.
- wait at least 30 minutes after taking your tablet. Then you can take the day’s first meal and drink and take any other medicines or supplements.
- stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes). Otherwise, some of the medicine may leak back into your esophagus.
If you use more Ibandronate STADA than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
Or visit a hospital immediately. Drink a full glass of milk before going to the hospital. Do not induce vomiting yourself. Do not lie down.
If you forget to use Ibandronate STADA
Do not take a double dose to make up for a forgotten dose . If you take one tablet a day, skip the missed dose altogether. Then continue as usual the following day. If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice. If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop using Ibandronate STADA
Continue to take Ibandronate Stada for as long as your doctor tells you to. This is because the medicine only works if it is taken throughout the treatment period.
If you have any further questions on the use of this product, 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 doctor immediately if you notice any of the following serious side effects – you may need immediate medical attention:
Common (may affect up to 1 in 10 people):
- malaise, heartburn and difficulty swallowing ( inflammation of the esophagus).
Uncommon (may affect up to 1 in 100 people):
- severe abdominal pain. This may be a sign of bleeding ulcers in the first part of the small intestine ( duodenum ) or gastritis ( gastritis ).
Rare (may affect up to 1 in 1,000 people):
- persistent eye pain and inflammation
- new pain, weakness or discomfort in the thigh, hip or groin. You may have early signs of an unusual fracture of the femur.
Very rare (may affect up to 1 in 10,000 people):
- pain or soreness in the mouth or jaw. You may have early signs of severe jaw problems ( necrosis (dead bone tissue) in the jawbone)
- itching , swelling of the face, lips and throat, difficulty breathing. You may have had a severe allergic reaction that can be life-threatening.
- Talk to a doctor if you have ear pain, discharge from the ear and / or an ear infection. This may be a sign of a bone injury in the ear
- severe skin reactions.
Has been reported (occurs in unknown number of users):
- asthma attack.
Other possible side effects are
Common (may affect up to 1 in 10 people)
- abdominal pain, indigestion
- low calcium levels in the blood
- feeling weak.
Uncommon (may affect up to 1 in 100 people)
- chest pain
- itching or tingling in the skin ( paresthesia )
- flu-like symptoms , general malaise or pain
- dry mouth , strange taste in the mouth or difficulty swallowing
- anemia ( anemia )
- high levels of urea or high levels of parathyroid hormone in the blood.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Ibandronate STADA
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 expiration date is the last day of the specified month.
No special storage instructions.
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.
6. Contents of the packaging and other information
Content declaration
The active substance is ibandronic acid.
Each tablet contains 56.25 mg of sodium ibandronate 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 the medicine looks like and contents of the pack
Ibandronate Stada is white to off-white, oblong tablets and debossed with “I9BE” on one side and “50” on the other.
They are available in blister packs of 28, 30, 42, 84, 90, 126, 168 and 210 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastr. 2-18
61181 Bad Vilbel
Germany
Other manufacturers
Synthon Hispania, Castelló 1, Polígono las Salinas, 08830 Sant Boi de Llobregat, Spain
Synthon BV, Microweg 22, 6545 CM, Nijmegen, The Netherlands
STADApharm GmbH, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
Eurogenerics NV, Heizel Esplanade B22, 1020 Brussels, Belgium
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Vienna, Austria
Local representative
STADA Nordic Aps
Marielundvej 46 A
2730 Herlev
Denmark