Leaflet: information for the user
Ibandronic Acid Normon 150 mg film-coated tablets
Read this leaflet carefully before you start taking the medicine because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
1.What is Ibandronic Acid Normon 150 mg and what it is used for
2.What you need to know before starting to take Ibandronic Acid Normon 150 mg
3.How to take Ibandronic Acid Normon 150 mg
4.Possible side effects
5.Storage of Ibandronic Acid Normon 150 mg
6.Contents of the pack and additional information
Ibandronic acid belongs to a group of medicines known asbisphosphonates.It contains the active ingredient ibandronic acid.
Ibandronic acid can reverse bone loss as it prevents further bone loss and increases bone mass in most women who take it, even if they cannot see or appreciate the difference. Ibandronic acid may help reduce the number of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.
You have been prescribed ibandronic acid to treat your post-menopausal osteoporosis because you have a high risk of suffering fractures.Osteoporosis is a condition characterized by a thinning and weakening of the bones, a common occurrence in women aftermenopause. Duringmenopause, the ovaries stop producing the female hormone, estrogen, which helps maintain bone health.
The earlier a woman reaches menopause, the greater her risk of suffering fractures due to osteoporosis. Other factors that increase the risk of fractures include:
- inadequate intake of calcium and vitamin D in the diet,
- smoking or excessive alcohol consumption,
- lack of weight-bearing exercise,
- family history of osteoporosis
A healthy lifestyle also facilitates the favorable effects of treatment. These include:
Do not take Ácido Ibandrónico Normon 150 mg
Warnings and precautions
A very rare adverse reaction called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in patients treated with ibandronic acid for osteoporosis during post-marketing experience. ONJ may also appear after stopping treatment.
It is essential to prevent the development of ONJ as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, certain precautions should be taken.
Before receiving treatment, inform your doctor/nurse (healthcare professional) if:
Your doctor may ask you to undergo a dental examination before starting treatment with Ácido Ibandrónico Normon 150 mg.
While on treatment, you should maintain good oral hygiene (including regular brushing of your teeth) and undergo routine dental check-ups. If you wear dentures, ensure they are properly fixed. If you are undergoing dental treatment or are about to undergo dental surgery (e.g., tooth extraction), inform your doctor about your dental treatment and inform your dentist that you are being treated with Ácido Ibandrónico Normon 150 mg.
Contact your doctor and dentist immediately if you experience any problems in your mouth or teeth, such as tooth loss, pain, or swelling, or difficulty in healing ulcers or discharge, as these may be signs of osteonecrosis of the jaw.
Some people require special care during treatment with ibandronic acid. Consult your doctor before taking Ácido Ibandrónico Normon:
Irritation, inflammation, or ulceration of thethroat/food pipe (esophagus) may occur, often with severe chest pain, severe pain after swallowing food and/or drink, intense nausea, or vomiting, especially if patients do not drink a glass of water and/or if they lie down before an hour has passed after taking ibandronic acid. If you develop these symptoms, stop taking Ácido Ibandrónico Normon and inform your doctor immediately (see section 3).
Children and adolescents
Do not administer ibandronic acid to children or adolescents under 18 years old.
Other medicines and Ácido Ibandrónico Normon 150 mg
Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medicine. Especially:
After taking the monthly Ácido Ibandrónico Normon tablet,wait 1 hour before taking any other medicine, including antacids, calcium supplements, or vitamins.
Ácido Ibandrónico Normon 150 mg with food and drinks
Do not take Ácido Ibandrónico Normon with food.Ibandrónico acidNormonloses its effectiveness if taken with food.
You may drink water but not other liquids.
After taking Ácido Ibandrónico Normon, wait 1 hour before taking your first meal and other drinks (see section 3).
Pregnancy and breastfeeding
Ácido IbandrónicoNormon is only for use in postmenopausal women, and they should not take it if they are fertile.
Do not takeÁcido IbandrónicoNormon if you are pregnant or breastfeeding.
Consult your doctor or pharmacist before using this medicine.
Driving and operating machines
You may drive and operate machines as ibandronic acid is expected to have no effect or a negligible effect on your ability to drive and operate machines.
Ácido Ibandrónico Normon 150 mg contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 23 mg of sodium (1mmol) per tablet; it is essentially “sodium-free”.
The normal dose of Ibandronic Acid Normon is one tablet per month.
How to take the monthly tablet
It is essential to follow these instructions carefully. They are designed to ensure that Ibandronic Acid Normon reaches the stomach quickly and causes less irritation.
Do not take the tablet with water with a high concentration of calcium, fruit juice, or other beverages.If you have any doubt about the potential high calcium levels of tap water (hard water), it is recommended to use bottled water with low mineral content.
Continuation of treatment withIbandronic Acid Normon 150 mg
It is essential to take Ibandronic Acid Normon every month until your doctor tells you to stop.
After 5 years of taking Ibandronic Acid Normon, consult your doctor to see if you should continue taking Ibandronic Acid Normon.
If you take more Ibandronic Acid Normon150 mg than you should
If, by mistake, you take too many tablets,drink a full glass of milk and immediately contact your doctor.
Do not induce vomiting and do not lie down- this can cause the ibandronic acid to irritate your esophagus.
In case of overdose or accidental ingestion,consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Ibandronic Acid Normon150 mg
You should never take two ibandronic acid tablets within the same week. Wait until it is time to take your next dose and take it as usual; then, go back to taking one tablet a month according to the days marked on your calendar.
Take a tablet the next morning after the day you remember forgetting the dose; then, go back to taking one tablet a month according to the days marked on your calendar.
Like all medications, this medication may cause side effects, although not everyone will experience them.
Inform your doctor or nurse immediately if you notice any of the following severe side effects, as you may need urgent medical treatment:
Rare(may affect up to 1 in 100 people)
Very rare(may affect up to 1 in 1,000 people)
Extremely rare(may affect up to 1 in 10,000 people)
Other possible side effects
Common(may affect up to 1 in 10 people):
Rare(may affect up to 1 in 100 people)
Very rare(may affect up to 1 in 1,000 people)
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keep out of the reach and sight of children.
Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and medicines that you no longer need at the SIGREcollection pointof the pharmacy. Askyour pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.
Composition of Ibandronic Acid Normon 150 mg
Appearance of the product and contents of the packaging
Coated tablets with a white or off-white film, oblong shape, marked with the inscription “19BE” on one face and “150”on the other.
They are presented in blister packs of 1, 3, 7 or 14 tablets.
Only some sizes of packaging may be commercially available.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Responsible manufacturer
Synthon BV
Microweg 22,
6545CM Nijmegen (Netherlands)
Synthon Hispania SL
Castelló 1, Polígono Las Salinas,
08830 Sant Boi de Llobregat (Spain)
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es
The average price of Acido ibandronico normon 150 mg comprimidos recubiertos con pelicula efg in June, 2025 is around 13 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.