50 mg film-coated tablets
ibandronic acid
What Ibandronate Bluefish is and what it is used for
Ibandronate Bluefish contains the active substance ibandronic acid which belongs to a group of medicines called bisphosphonates. Ibandronate Bluefish works by reducing the amount of calcium that is lost from the skeleton. This prevents
the skeleton from becoming more fragile.
Ibandronate Bluefish is used in 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
Ibandronic acid found in Ibandronate Bluefish may also be approved for use in adults to treat 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.
What you need to know before you take Ibandronate Bluefish
Do not take Ibandronate Bluefish:
- 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 (esophagus) 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 have ever had low 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 Bluefish.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Ibandronate Bluefish.
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 Ibandronate Bluefish 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 Bluefish.
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 having dental treatment or are going to have dental surgery (eg extracting a tooth), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronate Bluefish.
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 Bluefish.
- 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 can occur, often with symptoms such as severe chest pain, severe pain after swallowing food and/or fluid, severe nausea or vomiting, especially if you do not drink a full glass of water and/or if you lie down within one hour of taking Ibandronate Bluefish. If you get these symptoms, stop taking Ibandronate Bluefish and contact your doctor immediately (see sections 3 and 4).
Children and young people
Ibandronate Bluefish should not be used in children or adolescents under 18 years of age.
Other medicines and Ibandronate Bluefish
Tell your doctor or pharmacist if you have recently taken or might take any other medicines. The reason is that Ibandronate Bluefish may affect the way other medicines work. Some other medicines may also affect the way Ibandronate Bluefish works.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- dietary supplements containing calcium , magnesium , iron or aluminum
- acetylsalicylic acid and non-steroidal anti-inflammatory drugs, so-called NSAIDs , such as ibuprofen or naproxen , as both NSAIDs and Ibandronate Bluefish can irritate your stomach and intestines
- a type of antibiotic injection called ‘aminoglycoside’ such as gentamicin, as both aminoglycosides and Ibandronate Bluefish can lower the amount of calcium in the blood.
Taking drugs that reduce stomach acids such as cimetidine and ranitidine may slightly increase the effect of Ibandronate Bluefish.
Ibandronate Bluefish with food and drink
Do not take Ibandronate Bluefish with food or other beverages other than water as Ibandronate Bluefish is less effective if taken with food or drink (see section 3).
Take Ibandronate Bluefish no earlier than 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 any other medicines or supplements (see section 3).
Pregnancy and breastfeeding
Do not take Ibandronate Bluefish if you are pregnant, planning to become pregnant, or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You can drive and use machines as Ibandronate Bluefish is expected to have no 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 Bluefish 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.
Ibandronate Bluefish contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to take Ibandronate Bluefish
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Take your tablet no earlier than 6 hours after eating, drinking, or taking any other medicine or
supplements in addition to water. Water with a high calcium concentration (eg mineral water) 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.
Your doctor may perform regular blood tests while you are taking Ibandronate Bluefish. This is to check that you are getting the right amount of medicine.
How much to take
The usual dose of Ibandronate Bluefish is one tablet every day. If you have moderate difficulties
with kidney problems, your doctor may reduce the dose one 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.
Taking this medicine
It is important that you take Ibandronate Bluefish 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 you take your first meal, drink, other medications or supplements.
- 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 take more Ibandronate Bluefish than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center immediately for assessment of the risk 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 take Ibandronate Bluefish
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 stop taking Ibandronate Bluefish
Keep taking Ibandronate Bluefish 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, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Ibandronate Bluefish and contact your doctor immediately if you get any of the following serious side effects:
- itching , swelling of the face, lips and throat, difficulty breathing. You may have had a severe allergic reaction that can be life-threatening (very rare, may affect up to 1 in 10,000 users).
- malaise, heartburn and difficulty swallowing ( inflammation of the esophagus) (common, may affect up to 1 in 10 people).
Talk to a nurse or doctor immediately if you notice any of the following serious side effects – you may need medical treatment:
- severe abdominal pain. This may be a sign of bleeding ulcers in the first part of the small intestine ( duodenum ) or gastritis (less common, may affect up to 1 in 100 people).
- persistent eye pain and inflammation (rare, may affect up to 1 in 1,000 people)
- new pain, weakness or discomfort in the thigh, hip or groin. You may have early signs of an unusual fracture of the femur (rare, may affect up to 1 in 1,000 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) (very rare, may affect up to 1 in 10,000 people).
- asthma attack (no known frequency, can not be calculated from the available data).
- 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 (very rare, may affect up to 1 in 10,000 users).
Other possible side effects are
Common (may affect up to 1 in 10 people)
- indigestion, abdominal pain
- low calcium levels in the blood
- feeling weak.
Uncommon (may affect up to 1 in 100 people)
- dry mouth , strange taste in the mouth or difficulty swallowing
- itching or tingling in the skin ( paresthesia )
- chest pain
- flu-like symptoms , general malaise or pain
- anemia ( anemia )
- high levels of urea in the blood 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 Bluefish
Keep this medicine out of the sight and reach of children.
Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton after “Ed. that. ” and on the blister map after “EXP”. The expiration date is the last day of the specified month.
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 film-coated tablet contains 50 mg of ibandronic acid (as sodium ibandronate monohydrate).
Other ingredients are:
- tablet core: povidone, microcrystalline cellulose, crospovidone, pregelatinized starch (maize), glycerol dibehenate, colloidal anhydrous silica.
- tablet case: Opadry OY-LS-28908 (White II) [contains: lactose monohydrate , macrogol, hypromellose (E464), titanium dioxide (E171)]
What the medicine looks like and contents of the pack
The film-coated tablets are white, round, and biconvex. Available in packs of 28 or 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pharmathen SA
Dervenakion 6, Pallini Attiki, 15351,
Greece
Pharmathen International SA
Sapes Rodopi Prefecture Industrial Park,
Block No 5, Rodopi, 693 00,
Greece
This medicinal product is authorized under the European Economic Area under the names :
| Sweden | Ibandronate Bluefish 50 mg film-coated tablets |
| Germany | Ibandronate Bluefish 50 Mg Film Tablets |