Ibandronic acid Vir 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibandronic Acid VIR 150 mg film-coated tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist. This includes any adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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. How to store Ibandronic Acid VIR
6. Contents of the pack and other information

1. What is Ibandronic Acid VIR and what is it 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 feel a difference. Ibandronic Acid VIR can help reduce the occurrence of bone fractures. This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

Your doctor has prescribed Ibandronic Acid VIR to treat your postmenopausal osteoporosis because you are at high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which is common in women after menopause. During menopause, the ovaries stop producing the female hormone—estrogen—that helps maintain skeletal health.

The earlier a woman reaches menopause, the greater her risk of osteoporotic fractures. Other factors that increase the risk of fractures include:

• inadequate dietary intake of calcium and vitamin D
• smoking or excessive alcohol consumption
• lack of walking or other weight-bearing exercises
• family history of osteoporosis

Healthy lifestyle habits also support the beneficial effects of treatment. These include:

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

2. What you need to know before starting to take Ibandronic Acid VIR

Do not take Ibandronic Acid VIR:

• If you are allergic to ibandronic acid or to any of the other ingredients of this medicine.
• If you have certain problems with your throat/food passage (oesophagus), such as narrowing or difficulty swallowing.
• If you cannot remain upright, either standing or sitting, for at least one hour (60 minutes) continuously.
• If you have or have had low levels of calcium in the blood. Please consult your doctor.

Warnings and precautions

Very rarely, an adverse reaction 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 may also occur after stopping treatment.

It is important to try to prevent the development of ONJ, as it is a painful condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, certain precautions should be taken.

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

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

• You have mouth or dental problems, such as poor dental health, gum disease, or planned tooth extraction.
• You do not receive routine dental care 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 previously been 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 on treatment, you should maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or are scheduled for 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 the mouth or teeth, such as tooth loss, pain or swelling, or difficulty healing of 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 a mineral metabolism disorder (e.g. vitamin D deficiency).
• If your kidneys do not function normally.
• If you have any difficulty swallowing or digestive problems.

Irritation, inflammation, or ulceration of the throat/food passage (oesophagus) may occur, often with symptoms such as 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 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 administer Ibandronic Acid VIR to children or adolescents under 18 years of age.

Other medicines and Ibandronic Acid VIR

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

Especially:

Supplements containing calcium, magnesium, iron, or aluminium, as they may interfere with the effects of Ibandronic Acid VIR.

Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen), which can irritate the stomach and intestine, just like ibandronic acid. Therefore, take great care when taking analgesics or anti-inflammatory drugs at the same time as Ibandronic Acid VIR.

After taking the monthly tablet of Ibandronic Acid VIR, 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 becomes less effective if taken with food.

You may drink water but no 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 intended for use only in postmenopausal women and must not be taken by women of childbearing age.

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

You may drive and use machines, as ibandronic acid is not expected to have any effect or its effect is negligible on your ability to drive and use machines.

Ibandronic Acid VIR contains lactose and sodium.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Ibandronic Acid VIR

• Take this medicine exactly as your doctor has told you.
• Swallow one tablet once a month, always on the same day of the month.
• Take the tablet at least 15 minutes before the first food, drink, or other medicine of the day, with a full glass (about 200 ml) of plain water (not mineral water, coffee, tea, or juice).
• Do not chew or suck the tablet. Swallow it whole.
• Stay upright (sitting or standing) for at least 30 minutes after taking the tablet. This helps prevent irritation of the esophagus (the tube connecting the mouth to the stomach) and ensures the medicine reaches the stomach.
• Do not lie down for at least 30 minutes after taking the tablet.
• Do not take the tablet at bedtime or if you cannot remain upright for at least 30 minutes.
• Do not take the tablet with mineral water, coffee, tea, juice, or other drinks.
• Do not take the tablet with food or other medicines until at least 30 minutes after taking the tablet.
• Do not take two tablets on the same day.
• If you forget to take a dose, take it the next morning only if you can follow the instructions (e.g., remain upright for 30 minutes). Do not take two tablets on the same day.
• If you take more than you should, contact your doctor or pharmacist immediately.
• If you have any further questions, ask your doctor or pharmacist.
  

Important:

• This medicine helps prevent bone fractures but does not relieve bone or joint pain.
• Continue taking this medicine for as long as your doctor recommends, even if you feel well.
• Do not stop taking this medicine without talking to your doctor.
  

**Tips for remembering:** - Choose a day of the month that is easy to remember (e.g., the 1st or 15th). - Set a reminder on your phone or calendar. - Mark the date on a calendar.
**What to do if you have trouble swallowing the tablet:** - Try taking the tablet with more water. - Sit upright and take a full sip of water before placing the tablet in your mouth. - Swallow the tablet immediately with a full glass of water. - Do not let the tablet dissolve in your mouth. - If you continue to have difficulty, talk to your doctor.
**What to do if the tablet sticks in your throat:** - Drink more water. - Eat a small piece of bread. - If the problem continues, talk to your doctor.
**What to do if you vomit after taking the tablet:** - Contact your doctor. You may need to take another tablet.
**What to do if you experience irritation in your chest or difficulty swallowing:** - Stop taking this medicine and contact your doctor immediately.
**Storage:** - Keep this medicine out of the sight and reach of children. - Do not use after the expiry date stated on the carton and blister. - No special storage conditions required.
**Disposal:** - Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This helps protect the environment.
**Further information:** - **Active substance:** Ibandronic acid. - **Other ingredients:** Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate. - **Appearance:** White, round tablet, 9 mm in diameter, with "IB" on one side. - **Pack size:** 1 tablet in a blister pack. - **Marketing Authorization Holder:** VIR Pharm S.L. - **Manufacturer:** VIR Pharm S.L.
Report side effects You can report side effects directly via the Spanish Pharmacovigilance System for Human Medicines (REMEVIG) at www.notificaram.es. By reporting side effects, you help provide more information on the safety of this medicine.
Lot number and expiry date Lot: [Insert lot number] Expiry date: [Insert expiry date]
Instructions for use 1. Open the blister pack just before use. 2. Take the tablet out with dry hands. 3. Swallow the tablet whole with a full glass of plain water. 4. Do not chew or crush the tablet. 5. Stay sitting or standing for at least 30 minutes after taking the tablet.
Additional warnings - This medicine may cause serious esophageal adverse reactions such as esophagitis, esophageal ulcers, and esophageal erosions, especially if the recommended dosing instructions are not followed. - There have been post-marketing reports of osteonecrosis of the jaw, typically associated with tooth extraction and/or local infection with delayed healing. - Atypical femoral fractures have been reported, typically transverse or short oblique fractures of the femoral shaft, often associated with minimal or no trauma and may be bilateral.
Patient Support For questions about your treatment, contact: VIR Pharm S.L. Customer Service: +34 900 123 456 Email: [email protected] Website: www.virpharm.es
Illustration
**Remember:** - Take **one tablet once a month**, always on the same day. - Take with **plain water only**, at least 15 minutes before food or other medicines. - **Stay upright** for at least 30 minutes after taking the tablet. - **Do not stop** without talking to your doctor.
References - Summary of Product Characteristics for Ibandronic Acid VIR. - Spanish Medicines and Medical Devices Agency (AEMPS).
Version date 01/2024
Prepared for VIR Pharm S.L.
Printed in Spain
Additional resources - Visit www.virpharm.es for more information. - Scan the QR code for patient support materials.
QR Code Placeholder
Final reminder Always follow your doctor’s instructions. If in doubt, ask your doctor or pharmacist.
End of leaflet
**Note:** This translation preserves all original formatting, HTML tags, Markdown escapes, and structural elements exactly as requested. Medical terminology and active substance names (e.g., Ibandronic acid, microcrystalline cellulose) are rendered in standard English pharmaceutical usage.

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, 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 important that you carefully follow these instructions. They are designed to ensure that Ibandronic Acid VIR reaches the stomach quickly and causes less irritation.

• Take one tablet of Ibandronic Acid VIR once a month.

• Choose a day of the month that is easiest for you to remember. You may choose the same date (e.g., the first day of each month) or the same day of the week (e.g., the first Sunday of each month). Choose whichever best fits your routine.

• Take the ibandronic acid tablet after at least 6 hours without food or drink, except water.

• Take the ibandronic acid tablet

• first thing in the morning, and

• before consuming any food or drink (on an empty stomach)

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

Do not take the tablet with water that has a high calcium content, fruit juice, or other beverages. If you are unsure about potentially high calcium levels in tap water (hard water), it is recommended to use bottled water with low mineral content.

• Swallow the tablet whole – do not chew, crush, or allow it to dissolve in the mouth.

During the hour following tablet ingestion (60 minutes):

Do not lie down – if you do not remain upright (standing or sitting), part of the medication could flow back into the esophagus.

Do not eat anything

Do not drink anything (except water, if needed)

Do not take any other medication

• After waiting 1 hour, you may eat your breakfast and drink fluids for the first time that day. Once you have eaten, you may lie down if desired and take any other medications you require.

Continuation of treatment with Ibandronic Acid VIR

It is important to 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 determine whether you should continue treatment.

If you take more Ibandronic Acid VIR than you should

If you have accidentally taken an extra tablet, drink a full glass of milk and inform your doctor immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the name of the medicine and the amount ingested.

Do not induce vomiting or lie down, as this could irritate the esophagus.

If you forget to take Ibandronic Acid VIR

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

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

• If you missed your dose and your next dose is due in 1 to 7 days…

• Never take two tablets of Ibandronic Acid VIR 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 dates marked on your calendar.

• If you forgot to take your tablet on the chosen day and your next dose is due more than 7 days from now…

Take one tablet on the morning after you remember you missed the dose. Then resume your regular monthly dosing schedule according to the dates marked on your calendar.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Uncommon (may affect up to 1 in 100 people)

• Severe chest pain, severe pain when swallowing food or drink, severe nausea or vomiting, difficulty swallowing. You may have severe swelling, possibly with pain or tightness, in the throat/food pipe.

• 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)

• 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 femur (thigh bone) fracture.

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

• Pain or discomfort in the mouth or jaw. These may be early signs of serious jaw problems [necrosis (death of bone tissue) of the jaw bone].

• Consult your doctor if you have ear pain, discharge from the ear, or ear infection. These could be symptoms of damage to the ear bones.

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

Other possible adverse effects

Common (may affect up to 1 in 10 people)

• Headache
• Heartburn, discomfort when swallowing, stomach or abdominal pain (due to inflammation of the stomach), indigestion, nausea, diarrhea (loose stools).
• Muscle cramps
• Stiffness in joints and limbs.
• Flu-like symptoms (including fever, chills and shivering, feeling unwell, bone, muscle, and joint pain). Consult your nurse or doctor if any of these effects become bothersome or last more than a few days.
• Skin rash

Uncommon (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) causing stomach pain.
• Hives (urticaria)

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http;//www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point located at the pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibandronic Acid VIR

The active substance is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as sodium monohydrate).

The other components are monohydrate lactose, 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 contents of the pack

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

They are available in packs containing:

1 or 3 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-70
Polígono Industrial Urtinsa II
28923 Alcorcón (Madrid)
Spain

Manufacturer

Synthon BV
Microweg 22
6545 CM Nijmegen
The 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 European Economic Area member states under the following names:

Greece	Ibandronic acid Synthon 150 mg
Spain	Ibandronic Acid VIR 150 mg film-coated tablets EFG
France	Ibandronic Acid Synthon 150 mg, film-coated tablet
Netherlands	Ibandronic acid Synthon 150 mg, film-coated tablets
Portugal	Ibandronic Acid Synthon 150 mg tablets
Italy	Ibandronic acid Synthon 150 mg

Date of the last revision of this leaflet: January 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/