Ibandronic Acid Viatris

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Ibandronic Acid Viatris 150 mg, coated tablets

Ibandronic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ibandronic Acid Viatris and what is it used for
• 2. Important information before taking Ibandronic Acid Viatris
• 3. How to take Ibandronic Acid Viatris
• 4. Possible side effects
• 5. How to store Ibandronic Acid Viatris
• 6. Contents of the pack and other information

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

Ibandronic Acid Viatris belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.
Ibandronic Acid Viatris can reverse bone loss by inhibiting bone loss and increasing bone mass in most women taking this medicine, even if they do not notice or feel the difference. Ibandronic Acid Viatris may help reduce the risk of fractures (breaks) in bones. A reduction in the number of fractures has been shown in the case of vertebral fractures, but not in the case of hip fractures.

Ibandronic Acid Viatris has been prescribed to treat postmenopausal osteoporosis due to an increased risk of fractures.

Osteoporosis is a disease characterized by a decrease in bone density and weakening of bones, which often occurs in women after menopause. During menopause, the female ovaries stop producing the female hormone - estrogen, which helps maintain normal bone structure.
The earlier menopause occurs in a woman, the higher her risk of fractures related to osteoporosis.
Other factors that may increase the risk of fractures include:

• insufficient calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• insufficient walking or other intense exercise
• family history of osteoporosis

A healthy lifestylewill also help achieve the greatest benefits from treatment. This means:

• following a balanced diet rich in calcium and vitamin D
• walking or other intense exercise
• not smoking and limiting excessive alcohol consumption

2. Important information before taking Ibandronic Acid Viatris

When not to take Ibandronic 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 problems with the esophagus, such as narrowing or difficulty swallowing
• if you are unable to stand or sit upright for at least 1 hour (60 minutes)
• if you have or have had a decrease in calcium levels in the blood. You should consult your doctor

Warnings and precautions

After the marketing of ibandronic acid, a rare side effect called necrosis of the jawbone and (or) jaw (damage to the jawbone and (or) jaw) has been reported in patients treated with ibandronic acid for osteoporosis. Necrosis of the jawbone and (or) jaw may also occur after treatment has stopped.
It is essential to take preventive measures to avoid the development of necrosis of the jawbone and (or) jaw, as it can be a painful and difficult condition to treat. To reduce the risk of necrosis of the jawbone and (or) jaw, appropriate precautions should be taken.
In patients receiving long-term ibandronic acid treatment, atypical fractures of long bones, such as the forearm (ulna) and shinbone, have also been reported. These fractures occur with minimal trauma or without trauma, and some patients experience pain at the fracture site before the fracture occurs.
Before starting treatment, you should tell your doctor or nurse (healthcare professional):

• if you have any oral or dental problems, such as poor dental condition, gum disease, or planned tooth extraction
• if you do not receive routine dental care or have not had dental check-ups for a long time
• if you smoke (as this may increase the risk of dental problems)
• if you have been treated with bisphosphonates (used to treat or prevent bone diseases) before
• if you are taking corticosteroids (e.g., prednisolone or dexamethasone)
• if you have been diagnosed with cancer

Your doctor may recommend that you have a dental check-up before starting treatment with Ibandronic Acid Viatris.
During treatment, 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 dental procedures (e.g., tooth extraction), you should inform your doctor and dentist that you are taking ibandronic acid.
If you experience any oral or dental problems, such as loose teeth, pain, or swelling, non-healing ulcers, or discharge, you should contact your doctor and dentist immediately, as these may be symptoms of necrosis of the jawbone and (or) jaw.
Some people need to be more careful when taking ibandronic acid. Before starting treatment with Ibandronic Acid Viatris, you should discuss this with your doctor or pharmacist:

• if you have any mineral metabolism disorders (such as vitamin D deficiency)
• if your kidneys do not function properly
• if you have any swallowing or digestive problems

There may be irritation, inflammation, or ulcers of the esophagus, often with symptoms of severe chest pain, severe pain after swallowing food or drink, severe nausea, or vomiting, especially if you do not drink a full glass of plain water or lie down within an hour of taking ibandronic acid. If such symptoms occur, you should stop taking Ibandronic Acid Viatris and consult your doctor immediately (see section 3).

Children and adolescents

Do not give Ibandronic Acid Viatris to children and adolescents under 18 years of age.

Ibandronic Acid Viatris and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, especially:

• calcium, magnesium, iron, or aluminum-containing dietary supplements, as they may affect the efficacy of ibandronic acid.
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, diclofenac sodium, and naproxen), as they may irritate the stomach and intestines. Bisphosphonates (like ibandronic acid) may have a similar effect. Therefore, be careful when taking painkillers or anti-inflammatory medicines during treatment with ibandronic acid.

After taking the monthly tablet of Ibandronic Acid Viatris, wait for 1 hour
before taking any other medicines, including antacids or calcium and vitamin supplements.

Taking Ibandronic Acid Viatris with food and drink

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

You can drink plain water, but do not drink any other beverages.

After taking Ibandronic Acid Viatris, wait for 1 hour before eating or drinking anything else (see section 3 "How to take Ibandronic Acid Viatris").

Pregnancy and breastfeeding

Ibandronic Acid Viatris is used only in postmenopausal women and should not be used by women who may become pregnant.
Do nottake Ibandronic Acid Viatris during pregnancy or breastfeeding.
Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You can drive and use machines, as Ibandronic Acid Viatris has no or negligible influence on the ability to drive and use machines.

Ibandronic Acid Viatris contains lactose and sodium

This medicine contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Ibandronic Acid Viatris

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

Taking the tablet once a month

It is essential to follow these instructions carefully. These instructions have been designed to help the tablet reach the stomach quickly, reducing the risk of irritation.

• Take one Ibandronic Acid Viatris tablet once a month.
• Choose a day of the monththat is easy to remember. You can choose the same date (e.g., the first day of each month) or the same day (e.g., the first Sunday of each month). Choose a day that best fits your routine.
• Ibandronic Acid Viatris should be taken at least 6 hours after eating or drinking anything, except for plain water.
• Take the Ibandronic Acid Viatris tablet
• in the morning after getting upand
• before eating or drinking anything("on an empty stomach")
• Swallow the tablet with a full glass of water(at least 180 ml).

Do notdrink water with high calcium content, fruit juice, or any other beverage. If you are concerned 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 let it dissolve in your mouth.
• For the next hour (60 minutes)after taking the tablet
• do not lie down; if you do not stay upright (standing or sitting), some of the medicine may flow back into the esophagus
• do not eat
• do not drink(except for water, if needed)
• do not take any other medicines
• After 1 hour, you can eat and drink normally. After eating, you can lie down and take other medicines if needed.

Do nottake Ibandronic Acid Viatris before going to bed or before getting up in the morning.

Continuing treatment with Ibandronic Acid Viatris

It is essential to take Ibandronic Acid Viatris every month, as long as your doctor recommends. After 3-5 years of taking Ibandronic Acid Viatris, you should consult your doctor to determine if you should continue taking Ibandronic Acid Viatris.

Taking more than the recommended dose of Ibandronic Acid Viatris

If you accidentally take more than one tablet, drink a full glass of milk
and contact your doctor immediately.
Do notinduce vomiting and do not lie down- this may cause irritation of the esophagus by Ibandronic Acid Viatris.

Missing a dose of Ibandronic Acid Viatris

• If you forget to take a tablet in the morning on the scheduled day, do not take the tablet later that day.Check when your next scheduled dose is due

If you miss a dose and your next scheduled dose is only 1 to 7 days away:

Never take two Ibandronic Acid Viatris tablets in the

same week.Wait until your next scheduled dose and take one tablet according to your original schedule.

If you miss a dose and your next scheduled dose is more than 7 days away:

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

4. Possible side effects

Like all medicines, Ibandronic Acid Viatris can cause side effects, although not everybody gets them.

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

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

• severe chest pain, severe pain after eating or drinking, severe nausea, or vomiting, difficulty swallowing. You may have severe esophagitis, with possible ulcers or narrowing of the esophagus.
• symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and (or) tingling sensation in fingers or around the mouth.

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

• itching, swelling of the face, lips, tongue, and throat, difficulty breathing
• chronic eye pain and inflammation
• new pain, weakness, or discomfort in the thigh, hip, or groin area. These may be early signs of atypical fractures of the thigh bone.

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

• pain or ulcers in the mouth or jaw and (or) jaw. These may be early signs of serious jaw problems (necrosis (dead bone tissue) of the jawbone and (or) jaw)
• you should talk to your doctor if you experience ear pain, ear discharge, and (or) ear infection. These may be symptoms of bone damage in the ear
• severe skin reactions, including itchy, red rash with raised patches, and increased blistering or peeling of the skin
• serious, potentially life-threatening allergic reaction

Other possible side effects

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

• headache
• heartburn, discomfort when swallowing, stomach or abdominal pain (may be caused by gastritis), indigestion, nausea, diarrhea (loose stools)
• muscle cramps, stiffness in joints and limbs
• flu-like symptoms, including fever, chills, and shivering, feeling unwell, bone pain, and muscle and joint pain. You should talk to your nurse or doctor if any of these symptoms become troublesome or last more than a few days
• rash

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

• dizziness
• bloating (passing gas, feeling bloated)
• back pain
• feeling tired and weak
• asthma attacks

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

• duodenitis (inflammation of the duodenum) causing stomach pain
• hives

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Viatris

Keep this medicine out of the sight and reach of children.
There are no special storage precautions.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ibandronic Acid Viatris contains

The active substance is ibandronic acid in a dose of 150 mg (as sodium ibandronate monohydrate).
The other ingredients are:

• tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, colloidal anhydrous silica, and magnesium stearate.
• tablet coating: hydroxypropylcellulose, macrogol 3350, macrogol 400, and titanium dioxide (E 171).
• the printing ink containsshellac, iron oxide black, and propylene glycol.

What Ibandronic Acid Viatris looks like and contents of the pack

The medicine is a white, coated tablet, capsule-shaped, biconvex, with "G" over "I-150" printed in black ink on one side and a smooth surface on the other.
Ibandronic Acid Viatris is available in blisters of 1 and 3 tablets, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Manufacturer/Importer:
McDermott Laboratories Limited (t/a Gerard Laboratories)
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Pharma Pack Kft
2040 Budaörs
Vasút u. 13
Hungary
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Hungary
To obtain more detailed information on this medicine and its authorized names in the Member States of the European Economic Area, please contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00
Date of last revision of the leaflet:May 2025