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.

• 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 pass it on to others even if they have similar symptoms. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. See section 4.

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:

• insufficient intake of calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• limited walking or other weight-bearing exercises
• family history of osteoporosis

Healthy lifestyle habitsalso facilitate the favorable effects of treatment. These include:

• a balanced diet rich in calcium and vitamin D
• walking or any other weight-bearing exercise
• not smoking and moderate alcohol consumption.

Do not takeIbandronic Acid VIR:

• If you are allergic to ibandronic acid or any of the other components of this medication.
• If you have certain problems with your throat/ tube where food passes (esophagus) such as narrowing or difficulty swallowing.
• If you cannot remain upright, both standing and sitting, for at least one hour straight (60 minutes).
• If you have or have had low calcium levels in your blood. Please consult your doctor.

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:

• You have problems in your mouth or teeth, such as poor dental health, gum disease, or a planned tooth extraction.
• You do not receive regular dental care or have not had a dental check-up for a long time.
• You are a smoker (as this can increase the risk of dental problems).
• You have been previously treated with a bisphosphonate (used to treat or prevent bone disorders).
• You are taking medications called corticosteroids (such as prednisolone or dexamethasone).
• You have cancer.

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:

• If you have any mineral metabolism disorder (e.g., vitamin D deficiency).
• If your kidneys do not function normally.
• If you have any swallowing or digestive problems.

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).

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubts, consult your doctor or pharmacist.

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.

• Take one Ibandronic Acid VIR tablet once a month.
• Choose a day of the month that is easiest for you to remember. You can choose the same date (either the first day of each month) or always the same day (such as the first Sunday of each month).
• Take the Ibandronic Acid VIR tablet after a minimum of 6 hours from the last meal or drink, except for water.
• Take the Ibandronic Acid VIR tablet

• nothing after waking up, and
• before taking any food or drink(with an empty stomach)

• Swallow the tablet with a glass of water(at least 180 ml).

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.

• Swallow the tablet whole-do not crush, chew, or leave it to dissolve in your mouth.

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

• After waiting 1 hour, you can take your breakfast and the first drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medications you need.

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

• If you forget to take the tablet in the morning of the day you have chosen,do not take the tablet later.

Instead, check your calendar to see when your next dose is due:

• If you forgot to take the tablet on the day you chose and your next dose is within 1 to 7 days…

• Never take two Ibandronic Acid VIR tablets within the same week. Wait until it is time to take your next dose and take it as usual, then return to taking one tablet per month according to the days marked on your calendar.If you forgot to take your tablet on the day you chose and your next dose is more than 7 days…

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..

• Persistent eye pain and inflammation
• New pain, weakness, or discomfort in the thigh, hip, or groin. These may be early signs of an unusual fracture of the thigh bone.

Very rare (may affect up to 1 in 10,000 people)

• Toothache or jaw pain. These may be early signs of serious jaw problems [jaw necrosis (bone tissue death) of the jawbone
• Consult your doctor if you have ear pain, the ear is discharging, or you have an ear infection. These may be signs of damage to the ear bones.

• Severe allergic reaction, which may be life-threatening. Severe skin reactions

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

• Back pain
• Feeling of fatigue and exhaustion
• Asthma attacks
• Symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.

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:

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/