Prospecto: Information for the User

Ibandronic Acid Viatris 150 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What is Ibandronic Acid Viatrisand what is it used for

2. What you need to knowbefore starting to take Ibandronic Acid Viatris

3. How to take Ibandronic Acid Viatris

4. Possible adverse effects

5. Storage of Ibandronic Acid Viatris

6. Contents of the package and additional information

Viatris Ibandronate belongs to a group of medications calledbisphosphonates,which contains the active ingredient ibandronate.

Viatris Ibandronate may 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. Viatris Ibandronate may help reduce the number of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures, but not in hip fractures.

You have been prescribed Viatris Ibandronate to treat your postmenopausal osteoporosis because you have a high risk of suffering fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, a common occurrence among women after menopause. During menopause, the ovaries stop producing the female hormone, estrogen, which helps maintain bone health.

The earlier a woman reaches menopause, the greater her risk of suffering fractures due to osteoporosis.

Other factors that increase the risk of suffering fractures include:

• Inadequate calcium and vitamin D intake in the diet.
• Tobacco use or excessive alcohol consumption.
• Little walking or other weight-bearing exercise.
• 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 takeViats Ibandronic Acid:

• If you are allergic to ibandronic acid or any of the other components of this medication (listed in section 6).
• If you have certain problems in the throat/ digestive tube (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 very 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 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, take some precautions.

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 corticosteroid medications (such as prednisolone or dexamethasone)

•You have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.

While on treatment, maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, ensure they are properly secured. 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 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.

Consult your doctor or pharmacist before starting to take Viats Ibandronic Acid:

• 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/digestive tube (esophagus) may occur, 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 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 to children or adolescents under 18 years old.

Other medications and Viats Ibandronic Acid

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Especially:

-Supplements containingcalcium, magnesium, iron, or aluminumas they may affect the effects of ibandronic acid.

-Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen) may irritate the stomach and intestines. Bisphosphonates (such as ibandronic acid) may also do this. Therefore, be careful when takinganalgesics or anti-inflammatory medicationsat the same time as ibandronic acid.

After taking the monthly Viats Ibandronic Acid tablet, wait 1 hour to take any other medication, including antacids, calcium supplements, or vitamins.

Taking Viats Ibandronic Acid with food and drinks

Do not take Viats Ibandronic Acid with food.Ibandronic acidloses its effectiveness if taken with food.You may drink water, but not other liquids..

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

Pregnancy and breastfeeding

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

Do not take ibandronic acid if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before taking this medication.

Driving and operating machines

You may drive and operate machines, as ibandronic acid has no or insignificant effect onyour ability to drive and operate machines.

Viats Ibandronic Acid contains lactose

This medication contains lactose.Consult your doctor if you have been told that you have a certain sugar intolerance before taking this medication.

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

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

How to take the monthly tablet

It is essential that you follow these instructions carefully.They are designed to ensure that the Viatris Ibandronic Acid tablet reaches your stomach quickly and causes less irritation.

• Take one Viatris Ibandronic Acid 150 mg tablet once a month..
• Choose the 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) to take the Viatris Ibandronic Acid tablet. Choose what best suits your routine.
• Take the Viatris Ibandronic Acid tabletafter a minimum of 6 hours from the last meal or drink (except water).
• Take the Viatris Ibandronic Acid tablet

• as soon as you get up, and
• before breakfast or consuming liquids(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 doubt about the potential high calcium levels of tap water (hard water), it is recommended to use bottled mineral water with low mineralization.
• Swallow the tablet whole-do not chew, crush, 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.
• Do not eat anything.
• Do not drink anything (except water, if needed).
• Do not take any other medication.

After waiting 1 hour, you cantake 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.

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

Continuation of treatment with Viatris Ibandronic Acid

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

If you take moreViatris Ibandronic Acidthan you should

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

Do not induce vomiting or lie down,because Viatris Ibandronic Acid could irritate your esophagus.

If you forget to takeViatris Ibandronic Acid

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

Never take two Viatris Ibandronic Acid tablets in the same week.Wait until it is time to take the next dose and take it as usual, then go back to taking one tablet a month according to the marked days 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 go back to taking one tablet a month according to the marked days on your calendar.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• Intense chest pain, intense pain when swallowing food or drink, intense nausea or vomiting, difficulty swallowing. You may experience inflammation of the throat/esophagus, possibly with ulcers or narrowing of the throat/esophagus passage.

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. You may be experiencing the first signs of an unusual femur fracture.

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 severe jaw problems: necrosis (death of bone tissue) of the jawbone.
• Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These may be symptoms of damage to the ear bones.
• Severe skin reactions, including red rash on the skin with intense itching and blisters or skin peeling.
• Severe allergic reaction, which may be life-threatening.

Other possible side effects

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

• Headache.
• Heartburn, difficulty swallowing, stomach pain or abdominal pain (may be due to stomach inflammation), indigestion, nausea, diarrhea (soft stools).
• Muscle cramps, joint stiffness and extremities.
• Flu-like symptoms, including fever, chills, and shivering, feeling unwell, bone, muscle, and joint pain. Consult your doctor or nurse if any of these side effects become bothersome or last more than two days.
• Skin rash.

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

• Dizziness.
• Flatulence (gas, feeling bloated).
• Symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or tingling in the fingers or around the mouth.
• Back pain.
• Feeling tired or exhausted.
• Asthma attacks.

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

• Inflammation of the duodenum (the first section of the intestine) causing stomach pain.
• Urticaria.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofIbandronic Acid Viatris

The active ingredient is ibandronic acid150 mg (as sodium monohydrate).

The other components are:

• Tablet core: lactose monohydrate, povidone (E1201), microcrystalline cellulose (E460), crospovidone (E1202), anhydrous colloidal silica, and magnesium stearate (E470b).

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

Appearance ofIbandronic Acid Viatrisand contents of the package.

Coated tablets, white in color, in the form of capsules and biconvex, with "G" above "I-150" printed in black ink on one face and smooth on the other.

Ibandronic Acid Viatrisis available in packages of 1, 3, 6, and 12 tablets. Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

Belgium:Ibandronate Mylan 150 mg film-coated tablets

Cyprus:Ibandronic Acid Mylan 150 mg

Denmark:Ibandronic Acid Mylan

Slovakia: Ibandronic Acid Mylan 150 mg

Slovenia:Ibandronska kislina Mylan 150 mg film-coated tablets

Spain: Ibandronic Acid Viatris 150 mg coated tablets EFG

Greece:Ibandronic AcidMylan 150 mg

Ireland:Ibandronic Acid Mylan 150 mg

Italy:Acido Ibandronico Mylan 150 mg

Malta:Ibandronic Acid Mylan 150 mg

Netherlands:Ibandroninezuur Mylan 150 mg

Poland:Ibandronic Acid Mylan

Portugal:Ácido ibandrónico Mylan 150 mg

United Kingdom:Ibandronic Acid Mylan 150 mg

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

Romania:Acid ibandronic Mylan 150 mg

Last review date of this leaflet: 12/2022

More detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/