50 mg film-coated tablets
ibandronic acid
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1. What Ibandronic acid Sandoz is and what it is used for
Ibandronic acid Sandoz tablets are used in adults and are prescribed to 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 require surgery or radiation therapy.
Ibandronic acid Sandoz works by reducing the amount of calcium that is lost from the skeleton. This prevents the skeleton from becoming more fragile.
2. What you need to know before using Ibandronic acid Sandoz
Do not use Ibandronic acid Sandoz
- 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 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 apply to you. If you are not sure, talk to your doctor or pharmacist before using Ibandronic acid, Sandoz.
Warnings and cautions
Talk to your doctor or pharmacist before using Ibranoic acid Sandoz
- if you are allergic to other bisphosphonates
- if you have difficulty swallowing or digestive problems
- if you have high or low blood levels of vitamin D or other minerals
- if you have kidney problems
- If you are receiving dental treatment or dental surgery or know that you will need it in the future, inform your dentist that you are being treated with Ibandronic acid Sandoz for cancer.
Irritation, inflammation, and sores in the esophagus (esophagus), often accompanied by acute chest pain, acute pain after swallowing food and/or drink, acute nausea or vomiting may occur, especially if you do not drink a full glass of water and/or if you go to bed within one hour of taking Ibandronic Acid Sandoz. If these symptoms occur, stop taking Ibandronic Acid Sandoz and contact your doctor immediately (see sections 3 and 4).
Children and young people
Ibandronic acid Sandoz should not be used by children and adolescents under 18 years of age.
Other medicines and Ibandronic acid Sandoz
Tell your doctor or pharmacist if you have recently taken or might take any other medicines. This is because Ibandronic acid Sandoz can affect the way other medicines work. Some other drugs affect the effect of Ibandronic acid Sandoz.
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 , ibuprofen or naproxen , ie non-steroidal anti-inflammatory drugs or so-called NSAIDs . This is because both NSAIDs and Ibandronic acid Sandoz can irritate the stomach and intestines.
- a type of antibiotic injection called ‘aminoglycoside’, e.g. gentamicin. This is because both aminoglycosides and Ibandronic acid Sandoz can lower the level of calcium in the blood.
Intake of gastric acid-lowering drugs, such as cimetidine and ranitidine, may slightly enhance the effect of Ibandronic acid Sandoz.
Ibandronic acid Sandoz with food, drink and alcohol
Do not take Ibandronic acid Sandoz with food or drink other than water as the medicine will be less effective if taken with food or drink (see section 3).
Take Ibandronic acid Sandoz at least 6 hours after you last ate or drank something or took any other medicines or supplements (eg products containing calcium (milk), aluminum, magnesium, and iron) in addition to water. After taking your tablet, wait at least 30 minutes. Then you can eat and drink and take your other medications and supplements (see section 3).
Pregnancy, breastfeeding and fertility
Do not use Ibandronic acid Sandoz if you are pregnant, planning to have a baby or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You can drive and use machines because Ibandronic acid Sandoz is not expected to have any or negligible effect on your ability to drive and use machines. Talk to a doctor before driving or using machines or tools.
Ibandronic acid Sandoz contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (for example, if you have galactose intolerance, the Lapp lactase deficiency, or glucose-galactose absorption problem), talk to your doctor before taking this medicine.
3. How to use Ibandronic acid Sandoz
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Take your tablet at least 6 hours after you last ate, drank, or took any other medicines or supplements besides water. Water with a high calcium content should not be used. If you think that tap water contains a lot of calcium (hard water), it is recommended that you use bottled water with low mineral content.
Your doctor may perform regular blood tests while you are using Ibandronic acid, Sandoz. The purpose of this is for the doctor to check that you are getting the right amount of medication.
How to use Ibandronic acid Sandoz
It is important that you take Ibandronic acid Sandoz at the right time and in the right way. The reason for this is that it can cause irritation, inflammation, and ulcers in the esophagus.
You can help prevent this from happening by doing the following:
- Take your tablet as soon as you get up for the day, before taking the day’s first food, drink, 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 first meal and drink of the day and take any medications 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 the esophagus.
How much to take
The usual dose of Ibandronic acid Sandoz is one tablet a day. If you have moderate kidney problems, your doctor may reduce the dose to one to two tablets every other day. If you have severe kidney problems, your doctor may reduce the dose one to one tablet per week.
If you use more Ibandronic acid Sandoz than you should
If you have taken too many tablets, talk to a doctor or go to a hospital straight away. Drink a whole glass of milk before you go. Do not induce vomiting yourself. Do not lie down.
If you forget to use Ibandronic acid Sandoz
Do not take a double dose to make up for a forgotten dose. If you take one tablet a day, skip the missed dose completely. Then continue as usual the next day. If you are taking a tablet every other day or once a week, consult your doctor or pharmacist.
If you stop using Ibandronic acid Sandoz
Continue to take Ibandronic acid Sandoz for as long as your doctor prescribes it, as the medicine only works if it is taken regularly.
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):
- Nausea, heartburn and difficulty swallowing ( inflammation of the esophagus)
Uncommon (may affect 1 to 100 users).
- Severe abdominal pain. This may be a sign of a wound in the first part of the intestine ( duodenum ) that is bleeding or that the duct is inflamed ( 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 (see section 2).
Has been reported (occurs in an 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
- weakness.
Uncommon (may affect less than 1 user in 100)
- chest pain
- itching or stinging sensation 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 Ibandronic acid Sandoz
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the carton after EXP. and on the blister after EXP. The expiration date is the last day of the specified month.
- Store in the original package. Moisture sensitive.
- 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. One tablet contains 50 mg of ibandronic acid (as ibandronic acid sodium monohydrate).
Other ingredients are:
– tablet core: povidone, microcrystalline cellulose, crospovidone, pregelatinised maize starch, glycerol dibehenate, colloidal anhydrous silicon.
– tablet case: titanium dioxide (E171), lactose monohydrate, hypromellose (E464), macrogol 4000.
What the medicine looks like and contents of the pack
Film-coated tablets, white, round, biconvex. Available in polyamide / Al / PVC aluminum foil blisters in packs of 3, 6, 9, 28, and 84 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder and Manufacturer
Sandoz Pharmaceuticals GmbH
Raiffeisenstraße 11, 83607 Holzkirchen
Germany
Manufacturer
Lek Pharmaceuticals dd
Verovškova 57, 1526 Ljubljana
Slovenia