PATIENT INFORMATION LEAFLET
Ibandronic AcidVIR150 mg film-coated tablets
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
1.What is Ibandronic AcidVIRand what it is used for
2.Before taking Ibandronic AcidVIR
3.How to take Ibandronic AcidVIR
4.Possible side effects
5.Storage of Ibandronic AcidVIR
6.Contents of the pack and additional information
Ibandronic AcidVIR belongs to a group of medications calledbisphosphonates.It contains the active ingredientibandronic acid.
Ibandronic AcidVIR 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 VIRcan help reduce the number of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.
You have been prescribedIbandronic AcidVIR to treat your postmenopausal 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 after menopause. During menopause, the ovaries stop producing the female hormone —estrogens— that helps maintain bone health.
The sooner a woman reaches menopause, the higher her risk of suffering fractures due to osteoporosis. Other factors that increase the risk of fractures include:
Healthy lifestyle habitsalso facilitate the favorable effects of treatment. These include:
Do not takeIbandronic Acid VIR:
Warnings and precautions
A rare adverse reaction called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in patients treated with Ibandronic Acid VIR for osteoporosis during post-marketing experience. ONJ can 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 Ibandronic Acid VIR.
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 Ibandronic Acid VIR.
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 VIR.
Consult your doctor before taking Ibandronic Acid VIR:
It may cause irritation, inflammation, or ulceration of the throat/tube where food passes (esophagus), often with symptoms of intense chest pain, intense pain after swallowing food and/or drink, intense nausea, or vomiting, especially if patients do not drink a full glass of water and/or if they lie down before an hour after taking ibandronic acid.If you develop these symptoms, stop taking ibandronic acid and inform your doctor immediately (see section 3).
Children and adolescents
Do not administer Ibandronic Acid VIR to children or adolescents under 18 years old.
Other medications and Ibandronic Acid VIR
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
Especially:
Supplements containing calcium, magnesium, iron, or aluminumas they may influence the effects of Ibandronic Acid VIR.
Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen)which can irritate the stomach and intestine, just like ibandronic acid.Therefore, be careful when taking analgesics or anti-inflammatory medications at the same time as Ibandronic Acid VIR.
After ingesting the monthly Ibandronic Acid VIR tablet, wait 1 hour before taking any other medication, including antacids, calcium supplements, or vitamins.
Ibandronic Acid VIR with food and drinks:
Do not take Ibandronic Acid VIR with food.Ibandronic Acid VIR loses effectiveness if taken with food.
You may drink water but not other liquids.
After taking ibandronic acid, wait 1 hour before taking your first meal and other drinks (see section 3 How to take Ibandronic Acid VIR).
Pregnancy and breastfeeding
Ibandronic Acid VIR is only for use in postmenopausal women, and they should not take it if they are fertile.
Do not take Ibandronic Acid VIR if you are pregnant or breastfeeding.
Consult your doctor or pharmacist before using any medication.
Driving and operating machines
You can 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.
Ibandronic Acid VIR contains lactose and sodium.
If your doctor has indicated that you have a certain sugar intolerance, consult with him before taking this medication.
This medication contains less than 1mmol of sodium (23 mg) per tablet, which is essentially (sodium-free).
The usual dose of Ibandronic Acid VIR 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 VIR reaches the stomach quickly and causes less irritation.
Do nottake the tablet with water with a high concentration of calcium, fruit juice, or other beverages. If you have any doubts about the potential high calcium levels of tap water (hard water), it is recommended to use bottled water with low mineral content.
During the hour following (60 minutes)after taking the tablet
Do not lie down; if you do not remain upright (standing or sitting), part of the medication could return to the esophagus
No eat anything
No drink anything(except water, if you need it)
do not take any other medication
Continuation of treatment withIbandronic Acid VIR
It is essential to take Ibandronic Acid VIR every month, for the duration prescribed by your doctor.After 5 years of taking ibandronic acid, consult your doctor to determine if you should continue taking ibandronic acid..
If you take more Ibandronic AcidVIRthan you should
If you have taken, by mistake, one or more tablets, drink a full glass of milk and inform your doctor immediately
or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
Do not induce vomiting or lie downbecause you could irritate your esophagus.
If you forget to takeIbandronic Acid VIR
Instead, check your calendar to see when your next dose is due:
Take a tablet the next morning after the day you remember forgetting the dose, then return to taking one tablet per month according to the days marked on your calendar.
Like all medications,this medicationmay cause side effects, although not everyone will experience them.
Inform your doctor or nurse immediately ifyou noticeany of the following serious side effects, as you may need urgent medical treatment:
Rare (may affect up to 1 in 100 people)
•Intense chest pain, intense painwhen swallowing food ordrink, intense nausea orvomiting, difficulty swallowing. You may have intense inflammation, possibly with a sensation of pain or constriction, in the throat/food pipe.
Rare (may affect up to 1 in 1,000 people)
Itching, swelling of the face, lips, tongue, and throat with difficulty breathing..
Very rare (may affect up to 1 in 10,000 people)
Other possible side effects
Common (may affect up to 1 in 10 people)
•Headache
•Heartburn, discomfort when swallowing, stomach pain or cramps (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses).
•Muscle cramps
•Joint stiffness and limb stiffness.
•Flu-like symptoms (including fever, chills, and shivering, feeling unwell, bone and muscle pain, and joint pain). Consult your nurse or doctor if any side effect becomes bothersome or lasts more than a couple of days.
•Skin rash
Rare (may affect up to 1 in 100 people)
•
•Dizziness
•Flatulence
Rare (may affect up to 1 in 1,000 people)
•Inflammation of the duodenum (first section of the intestine) that causes stomach pain.
•Hives
Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: http;//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keep out of sight and reach of children.
Do not use this medication afterthe expiration date thatappearson the packaging afterCAD.The expiration date is the last day of the month indicated.
This medication does not require special storage conditions.
Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the Pharmacy Take-Back Point. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines.This will help protect the environment.
Composition of Ibandronic AcidVIR
The active ingredient is ibandronic acid.One tablet contains 150 mg of ibandronic acid (as sodium monohydrate)
The other components are lactose monohydrate, crospovidone (E1202), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), sodium stearyl fumarate (core of the tablet); polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171) (tablet coating).
Appearance of Ibandronic Acid VIR and contents of the package
Ibandronic Acid VIR tablets are white or off-white, oblong in shape, marked with the inscription “I9BE” on one face and “150” on the opposite face.
They are presented in packages of
1 or 3 tablets
Only some package sizes may be marketed.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization
Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-70
Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Responsible for manufacturing
Synthon BV
Microweg 22,
6545 CMNijmegen
Netherlands
Synthon Hispania, S.L.
Castello, 1
Poligono Las Salinas
08830 Sant Boi de Llobregat
Spain
Industria Química y Farmacéutica VIR,S.A.
Laguna66-70
PolígonoIndustrialUrtinsaII
28923Alcorcón
Spain
This medicine is authorized in the member states of the European Economic Area with the following names:
Greece | Ibandronic acid Synthon 150 mg | ||
Spain | Ibandronic Acid VIR 150 mg film-coated tablets | ||
France | Acide Ibandronique Synthon 150 mg, comprimé pelliculé | ||
Netherlands | Ibandroninezuur Synthon 150mg, filmhulde tabletten | ||
Portugal | Ibandronic Acid Synthon 150 mg tablets | ||
Italy | Ibandronic acid Synthon 150 mg | ||
Last review date of this leaflet: November 2022
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 vir 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.