IBANDRONIC ACID VIATRIS 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibandronic Acid Viatris 150 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 experience 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 Viatris is and what it is used for
2. What you need to know before you take Ibandronic Acid Viatris
3. How to take Ibandronic Acid Viatris
4. Possible side effects
5. Storing Ibandronic Acid Viatris
6. Contents of the pack and other information

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

Ibandronic Acid Viatris belongs to a group of medicines called bisphosphonates, which contains the active substance ibandronic acid.

Ibandronic Acid Viatris can reverse bone loss, as it prevents further bone loss and increases bone mass in most women who take it, even if they are not able to see or appreciate the difference. Ibandronic Acid Viatris can help reduce the number of bone fractures. This reduction has been shown in spinal fractures, but not in hip fractures.

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

The earlier a woman reaches the menopause, the greater 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 not consuming excessive alcohol.

2. What you need to know before you take Ibandronic Acid Viatris

Do not takeIbandronic Acid Viatris:

• If you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have certain problems in the 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 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 during post-marketing experience in patients treated with ibandronic acid for osteoporosis. ONJ can also occur after stopping treatment.

It is important 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, some precautions should 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 trauma 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 about to undergo 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.

While you are being treated, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups. If you wear dentures, you should ensure they fit properly. 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.

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 healing of ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Some people need special care when taking ibandronic acid. Consult your doctor or pharmacist before starting treatment with Ibandronic Acid Viatris:

• If you have any mineral metabolism disorder (e.g. vitamin D deficiency).
• If you have any kidney problems.
• If you have any swallowing or digestive problems.

Irritation, inflammation or ulceration of the throat/oesophagus can 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 to children or adolescents under 18 years of age.

Other medicines and Ibandronic Acid Viatris

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 aluminium, as they may affect the action of ibandronic acid.
• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium and naproxen) can irritate the stomach and intestines. Bisphosphonates (such as ibandronic acid) can also do this. Therefore, be careful when taking painkillers or anti-inflammatory drugs at the same time as ibandronic acid.

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

Taking Ibandronic Acid Viatris with food and drinks

Do not take Ibandronic Acid Viatris with food.Ibandronic acid loses its effectiveness if taken with food. You can drink water, but not other liquids.

After taking Ibandronic Acid Viatris, wait 1 hour before taking any food or drink(see section 3, How to take Ibandronic Acid Viatris).

Pregnancy and breastfeeding

Ibandronic acid is only for use in postmenopausal women and should not be taken by women of childbearing age.

Do nottake ibandronic acid if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You can drive and use machines, as ibandronic acid has no or negligible influence on the ability to drive and use machines.

Ibandronic Acid Viatris contains lactose and sodium

This medicine contains lactose. 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 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Ibandronic Acid Viatris

Follow exactly the instructions of administration of this medicine indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

The usual dose of Ibandronic Acid Viatris is one tablet per month.

How to take the monthly tablet

It is important that you follow these instructions carefully. They are designed to help the Ibandronic Acid Viatris tablet reach the stomach quickly and cause less irritation.

• Take one Ibandronic Acid Viatris 150 mg 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), to take the Ibandronic Acid Viatris tablet. Choose what best fits your routine.
• Take the Ibandronic Acid Viatris tablet after a minimum of 6 hours of the last meal or drink (except water).
• Take the Ibandronic Acid Viatris tablet

• as soon as you get up, and
• before breakfast or drinking(on 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 drinks. If you are unsure about the potentially high levels of calcium in tap water (hard water), it is recommended to use bottled water with low mineralization.
• 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 the 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 breakfast and your first drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medicines you need.

• Do not take this medicine at bedtime or before getting up.

Continuation of treatment with Ibandronic Acid Viatris

It is important that you take Ibandronic Acid Viatris every month, until your doctor tells you to stop. After 3-5 years of taking Ibandronic Acid Viatris, consult your doctor to see if you should continue taking it.

If you take more Ibandronic Acid Viatris than you should

If you have taken too many tablets by mistake, drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie down, as Ibandronic Acid Viatris could irritate your oesophagus.

If you forget to take Ibandronic Acid Viatris

• 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 forget to take the tablet on the day you have chosen and your next dose is within 1 to 7 days:

Never take two Ibandronic Acid Viatris tablets in 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 forget to take the tablet on the day you have chosen and your next dose is more than 7 days away:

Take a tablet the next morning after the day you remember you forgot 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 inflammation of the throat/oesophagus, possibly with ulcers or narrowing of the oesophagus.
• Symptoms of low calcium levels in the blood (hypocalcaemia) 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):

• Hives, swelling of the face, lips, tongue and throat, with difficulty breathing.
• Persistent eye inflammation and pain.
• New pain, weakness or discomfort in the thigh, hip or groin. You may be experiencing the first signs of a possible 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. You may be experiencing the first signs 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 an ear infection. These could be symptoms of damage to the bones of the ear.
• Severe skin reactions, including red rash on the skin with intense itching and blisters or peeling of the skin.
• Severe allergic reaction, which can be life-threatening.

Other possible side effects

Common(may affect up to 1 in 10 people):

• Headache.
• Heartburn, difficulty swallowing, stomach pain or abdominal pain (may be due to inflammation of the stomach), indigestion, nausea, diarrhoea (soft stools).
• Muscle cramps, stiffness of joints and limbs.
• Flu-like symptoms, including fever, chills and shivering, feeling unwell, pain in bones, muscles and joints. Consult your doctor or nurse if any of these effects become troublesome or last more than a couple of days.
• Rash.

Uncommon(may affect up to 1 in 100 people):

• Dizziness.
• Flatulence (gas, feeling bloated).
• Back pain.
• Feeling tired or weak.
• Asthma attacks.

Rare(may affect up to 1 in 1,000 people):

• Inflammation of the duodenum (the 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 Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ibandronic Acid Viatris

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

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.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition ofViatris Ibandronic Acid

The active ingredient is ibandronic acid 150 mg (as sodium monohydrate).

The other components are:

• Core of the tablet: lactose monohydrate, povidone (E1201), microcrystalline cellulose (E460), crospovidone (E1202), anhydrous colloidal silica, and magnesium stearate (E470b).

• Tablet coating:hydroxypropylcellulose (E463),macrogol, and titanium dioxide (E171).
• The printing ink contains shellac, black iron oxide, and propylene glycol.

Appearance ofViatris Ibandronic Acidand Container Content

Film-coated tablets, white in color, capsule-shaped, and biconvex, with "G" above "I-150" printed in black ink on one side and smooth on the other.

Viatris Ibandronic Acid is available in packs of 1, 3, 6, and 12 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

McDermott Laboratories Ltd. t/a Gerard Laboratories

35/36 Baldoyle Industrial Estate. Grange Road

Dublin – 13

Ireland

or

Mylan Hungary Kft.

Mylan utca 1

H-2900 Komárom

Hungary

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

Denmark: Ibandronic Acid Mylan

Slovakia: Ibandronic Acid Viatris 150 mg

Spain: Ácido Ibandrónico Viatris 150 mg film-coated tablets EFG

Ireland: Ibandronic Acid Viatris 150 mg

Italy: Acido Ibandronico Mylan 150 mg

Malta: Ibandronic Acid Mylan 150 mg

Netherlands: Ibandroninezuur Viatris 150 mg

Poland: Ibandronic Acid Viatris

Portugal: Ácido ibandrónico Mylan 150 mg

United Kingdom: Ibandronic Acid Mylan 150 mg

Czech Republic: Ibandronic Acid Viatris 150 mg Film-coated Tablets

Date of the last revision of this leaflet: May 2025

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