IBANDRONIC ACID VIR 150 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Ibandronic AcidVIR150 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Ibandronic Acid VIR is and what it is used for
2. Before you take Ibandronic Acid VIR
3. How to take Ibandronic Acid VIR
4. Possible side effects
5. Storage of Ibandronic Acid VIR
6. Package contents and further information

1. What Ibandronic Acid VIR is and what it is used for

Ibandronic Acid VIR belongs to a group of medicines called bisphosphonates.It contains the active substance ibandronic acid.

Ibandronic Acid VIR can reverse bone loss because 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 VIR may help reduce the risk of bone fractures (broken bones). This reduction has been shown in spinal fractures but not in hip fractures.

You have been prescribedIbandronic Acid VIR to treat your postmenopausal osteoporosis because you are at high risk of fractures. Osteoporosis is a condition where bones become thinner and weaker, often in women after the menopause. During the menopause, the ovaries stop producing the female hormone - estrogen - which helps keep the skeleton healthy.

The earlier a woman reaches the menopause, the higher her risk of fractures due to osteoporosis. Other factors that increase the risk of fractures are:

• inadequate intake of calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• little walking or other weight-bearing exercise
• family history of osteoporosis

Healthy lifestyle habitsalso help the beneficial 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.

2. What you need to know before you start taking Ibandronic Acid VIR

Do not takeIbandronic Acid VIR:

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine.
• if you have certain problems with your throat/oesophagus such as narrowing or difficulty swallowing.
• if you cannot stand or sit upright for at least one hour (60 minutes).
• if you have or have had low blood calcium levels. Please consult your doctor.

Warnings and precautions

A rare side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported during post-marketing experience in patients treated with Ibandronic Acid VIR for osteoporosis. ONJ can also occur after stopping treatment.

It is essential to try 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 must be taken.

Atypical fractures of long bones, such as the forearm (ulna) and shin (tibia), have also been reported in patients receiving long-term treatment with ibandronate. These fractures occur after minimal or no trauma and some patients experience pain in the area of the fracture before a complete fracture occurs.

Before receiving treatment, inform your doctor/nurse (healthcare professional) if:

• You have dental problems or are planning to have dental surgery.
• You do not receive regular dental check-ups or have not had a dental check-up for a long time.
• You are a smoker (as this may increase the risk of dental problems).
• You have been previously treated with a bisphosphonate (used to treat or prevent bone disorders).
• 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 Ibandronic Acid VIR.

While you are being treated, you must maintain good oral hygiene (including regular toothbrushing) and have regular dental check-ups. If you wear dentures, ensure they fit properly. If you are undergoing dental treatment or are going to have 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 with your mouth or teeth, such as tooth loss, pain or swelling, or difficulty healing ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Some people require special care while taking 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.

Irritation, inflammation, or ulceration of the throat/oesophagus may occur, often with symptoms of severe chest pain, severe pain after swallowing food and/or drink, severe nausea, or vomiting, especially if patients do not drink a full glass of water and/or if they lie down before one hour has passed 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 give Ibandronic Acid VIR to children or adolescents under 18 years of age.

Other medicines and Ibandronic Acid VIR

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Especially:

Supplements containing calcium, magnesium, iron, or aluminiumas they may affect the action of Ibandronic Acid VIR.

Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) which may irritate the stomach and intestine, as does ibandronic acid. Therefore, be careful when taking analgesics or anti-inflammatory drugsat the same time as Ibandronic Acid VIR.

After taking the monthly Ibandronic Acid VIR tablet, wait 1 hour before taking any other medicine,including antacids, calcium supplements, or vitamins.

Ibandronic Acid VIR with food and drinks:

Do not take Ibandronic Acid VIR with food.Ibandronic Acid VIR is less effective if taken with food.

You can drink water but no other liquids

After taking ibandronic acid, wait 1 hour before taking your first food 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 must not be taken by women of childbearing potential.

Do not take Ibandronic Acid VIR if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

You can drive and use machines as ibandronic acid is not expected to affect your ability to drive or use machines.

Ibandronic Acid VIR containslactose and sodium.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1mmol of sodium (23mg) per tablet, which is essentially "sodium-free".

3. How to take Ibandronic Acid VIR

Follow the instructions for administration of this medicine exactly as prescribed by your doctor, 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 that you follow these instructions carefully. They are designed to help Ibandronic Acid VIR reach your stomach quickly and cause less irritation.

• Take one Ibandronic Acid VIR tablet once a month.
• Choose a day of the monththat you can easily remember. You can choose the same date (e.g. the first day of each month) or always the same day (e.g. the first Sunday of each month). Choose what best fits your routine.
• Take the ibandronic acid tablet after a minimum of 6 hours of not eating or drinking anything except water.
• Take the ibandronic acid tablet

• as soon as you get up,and
• before you take any food or drink(on an empty stomach)

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

Do nottake the tablet with water that has a high concentration of calcium, fruit juice, or other drinks. If you are unsure about the potentially high calcium levels in your tap water (hard water), it is recommended to use bottled water with low mineral content.

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

During the next hour (60 minutes)after taking the tablet

Do not lie down; if you do not remain upright (standing or sitting), part of the medicine could come back up into your oesophagus

Do not eat anything

Do not drink anything(except water if needed)

do not take any other medicine

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

Continuation of treatment with Ibandronic Acid VIR

It is essential that you take Ibandronic Acid VIR every month, for as long as your doctor prescribes it. After 5 years of taking ibandronic acid, consult your doctor to see if you should continue taking ibandronic acid.

If you take more Ibandronic Acid VIR than you should

If you have taken an extra tablet by mistake, drink a full glass of milk and contact your doctor immediately

Do not induce vomiting or lie downbecause you could irritate your oesophagus.

If you forget to take Ibandronic Acid VIR

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

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

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

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

Take a tablet the next morning after the day you remembered you missed the dose, then continue taking one tablet per month according to the days marked on your calendar.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

Uncommon (may affect up to 1 in 100 people)

• Severe chest pain, severe pain after swallowing food or drink, severe nausea, or vomiting, difficulty swallowing. You may have severe inflammation, possibly with a feeling of pain or constriction, in your throat/oesophagus.

• Symptoms of low blood calcium levels (hypocalcemia), including muscle cramps or spasms and/or tingling sensation in your fingers or around your mouth.

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 symptoms of an unusual fracture of the thigh bone.

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

• Pain or sensation of pain in the mouth or jaw. These may be early symptoms of serious jaw problems [necrosis (death of bone tissue) of the jawbone]
• Tell your doctor if you have ear pain, discharge from the ear, or ear infection. These could be symptoms of damage to the bones of the ear.

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

Other possible side effects

Common(may affect up to 1 in 10 people)

• headache
• heartburn, difficulty swallowing, stomach pain or discomfort (due to inflammation of the stomach), indigestion, nausea, diarrhoea (loose stools).
• muscle cramps
• stiffness of joints and limbs.
• flu-like symptoms (including fever, chills, and sweating, feeling unwell, pain in bones, muscles, and joints). Consult your doctor or nurse if any effect becomes troublesome or lasts more than a couple of days.
• rash

Uncommon(may affect up to 1 in 100 people)

• dizziness
• flatulence
• back pain
• feeling tired and weak
• asthma attacks
• symptoms of low blood calcium levels (hypocalcemia), including muscle cramps or spasms and/or tingling sensation in your fingers or around your 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: http;//www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid VIR

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Container Content and Additional Information

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 (tablet core); polyvinyl alcohol, macrogol/PEG 3350, talc (E553b) and titanium dioxide (E171) (tablet coating).

Appearance of Ibandronic Acid VIR and Container Content

Ibandronic Acid VIR tablets are white or off-white, oblong in shape, marked with the inscription “I9BE” on one side and “150” on the opposite side.

They are available in packs of

1 or 3 tablets

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.C/ Laguna 66-70Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Manufacturer

Synthon BV

Microweg 22,

6545 CM Nijmegen

Netherlands

Synthon Hispania, S.L.

Castello, 1 Poligono Las Salinas 08830 Sant Boi de Llobregat Spain Industria Química y Farmacéutica VIR, S.A. Laguna 66-70

Polígono Industrial Urtinsa II

28923 Alcorcón Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this prospectus: January 2025

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/