Ibandronic acid viatris

Package leaflet: Information for the user

Ibandronic Acid Viatris 150 mg, coated tablets
Acidum ibandronicum
Please read all of this leaflet carefully before 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 personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Ibandronic Acid Viatris is and what it is used for
2. What you need to know 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 Ibandronic Acid Viatris is and what it is 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 preventing bone loss and increasing bone mass in most women who take this medicine, even if they cannot feel or notice this difference themselves. Ibandronic Acid Viatris may help reduce the likelihood of bone fractures (breaks). Reduction in the number of fractures has been demonstrated for vertebral fractures, but not for hip fractures.
Ibandronic Acid Viatris has been prescribed for the treatment of postmenopausal osteoporosis associated with an increased risk of fractures.
Osteoporosis is a disease characterised by reduced bone density and weakened bones, which commonly occurs in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain normal bone structure.
The earlier menopause occurs in a woman, the greater her risk of fractures related to osteoporosis.
Other factors that may 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 exercise
• family history of osteoporosis

A healthy lifestyle will also help you achieve the greatest benefit from treatment. This means:

• eating a balanced diet rich in calcium and vitamin D
• walking or doing other weight-bearing exercises
• not smoking and limiting excessive alcohol consumption

2. Important information before using Ibandronic Acid Viatris

When not to use Ibandronic Acid Viatris

• if the patient is allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6)
• if the patient has problems with the oesophagus, such as narrowing or difficulty swallowing
• if the patient is unable to remain in an upright position (standing or sitting) continuously for at least one hour (60 minutes)
• if the patient has or has previously had low levels of calcium in the blood. Please consult your doctor.

Warnings and precautions

Since ibandronic acid has been marketed, a rare side effect called osteonecrosis of the jaw and (or) mandible (damage to the jaw and (or) mandible bone) has very rarely been reported in patients treated with ibandronic acid for osteoporosis. Osteonecrosis of the jaw and (or) mandible may also occur after treatment has ended.
It is important to take preventive measures to reduce the risk of developing osteonecrosis of the jaw and (or) mandible, as it may be a painful and difficult-to-treat condition. To reduce the risk of osteonecrosis of the jaw and (or) mandible, appropriate precautions should be taken.
In patients receiving long-term treatment with ibandronate, atypical fractures of long bones, such as the forearm (ulna) and tibia, have also been reported. These fractures may occur following minimal trauma or even without trauma, and some patients experience pain at the fracture site before a complete fracture occurs.

Before starting treatment, tell your doctor or nurse (healthcare professional):

• if the patient has any oral or dental conditions, such as poor dental health, gum disease, or planned tooth extraction
• if the patient does not receive routine dental care or has not had a dental check-up for a long time
• if the patient smokes (as this may increase the risk of dental problems)
• if the patient has previously been treated with a bisphosphonate (used in the treatment or prevention of bone diseases)
• if the patient is taking corticosteroids (e.g. prednisolone or dexamethasone)
• if the patient has been diagnosed with cancer

Your doctor may recommend that the patient have a dental examination before starting treatment with Ibandronic Acid Viatris.
During treatment, it is important to maintain good oral hygiene (including regular tooth brushing) and to attend routine dental check-ups. If the patient wears dentures, ensure they are properly fitted. If the patient is undergoing dental treatment or prior to any dental procedures (e.g. tooth extractions), they should inform their doctor and tell their dentist that they are taking ibandronic acid.
If the patient experiences any symptoms in the mouth or teeth, such as loose teeth, pain or swelling, non-healing ulcers or presence of discharge, they should contact their doctor and dentist immediately, as these may be signs of osteonecrosis of the jaw and (or) mandible.
Special caution may be required in some individuals when using ibandronic acid. Before starting Ibandronic Acid Viatris, discuss the following with your doctor or pharmacist:

• if there are any disorders of mineral metabolism (such as vitamin D deficiency)
• if the kidneys are not functioning properly
• if there are any problems with swallowing or digestion

Irritation, inflammation or ulceration of the oesophagus may occur, often accompanied by severe chest pain, severe pain after swallowing food or drink, or severe nausea or vomiting. These symptoms are more likely to occur if the patient does not drink a full glass of plain water and (or) lies down within one hour after taking ibandronic acid. If such symptoms develop, stop taking Ibandronic Acid Viatris and contact your doctor immediately (see section 3).

Children and adolescents
Do not use Ibandronic Acid Viatris in children and adolescents under 18 years of age.

Ibandronic Acid Viatris and other medicines
Tell your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take, especially:

• dietary supplements containing calcium, magnesium, iron or aluminium, as these may affect the effectiveness of ibandronic acid.
• acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac and naproxen), as these may irritate the stomach and intestines. Bisphosphonates (such as ibandronic acid) may have a similar effect. Therefore, extra caution is required when taking painkillers or anti-inflammatory medicines during treatment with ibandronic acid.

After swallowing the monthly tablet of Ibandronic Acid Viatris, do not take any other medicines for 1 hour, including medicines used for indigestion, calcium supplements or vitamins.

Taking Ibandronic Acid Viatris with food and drink
Do not take Ibandronic Acid Viatris with food. Taking Ibandronic Acid Viatris with food reduces its effectiveness.
You may drink plain water, but do not drink any other beverages.
After taking Ibandronic Acid Viatris, wait 1 hour before consuming the first meal or any other drinks (see section 3, "How to take Ibandronic Acid Viatris").

Pregnancy and breastfeeding
Ibandronic Acid Viatris is intended for use only in postmenopausal women and must not be used in women who may become pregnant.
Do not use Ibandronic Acid Viatris during pregnancy or while breastfeeding.
Consult your doctor or pharmacist before taking this medicine.

Driving and operating machinery
Patients may drive and operate machinery, as Ibandronic Acid Viatris has no effect or negligible effect on the ability to drive and operate machinery.

Ibandronic Acid Viatris contains lactose and sodium
This medicine contains monohydrate lactose. If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Ibandronic Acid Viatris

This medicine should always be taken as instructed by your doctor or pharmacist. If in doubt,
consult 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 important to carefully follow the instructions below. These instructions have been designed to ensure
that the Ibandronic Acid Viatris tablet reaches the stomach quickly, thereby reducing the
risk of irritation.

• Take one Ibandronic Acid Viatris tablet once a month.
• Choose one day of the month that will be easy to remember. You may choose the same date (e.g., the first of each month) or the same day (e.g., the first Sunday of each month). Select the option that best fits your routine.
• Ibandronic Acid Viatris should be taken after at least 6 hours have passed since consuming any food or drink, except plain water.
• The Ibandronic Acid Viatris tablet should be taken
  • in the morning after getting up from bed, and
  • before eating or drinking anything (on an empty stomach)
• Swallow the tablet whole with a full glass of water (at least 180 ml).

Do not take the tablet with water high in calcium, fruit juice, or any other beverage. If there is concern about potentially high calcium levels in tap water (hard water), it is recommended to use bottled water low in minerals.

• Swallow the tablet whole – do not chew, crush, or allow it to dissolve in the mouth.
• For the next hour (60 minutes) after taking the tablet:
  • Do not lie down – if you do not remain in an upright position (standing or sitting), some of the medicine may flow back into the oesophagus
  • Do not eat
  • Do not drink (except water, if needed)
  • Do not take any other medicines
• After one hour has passed, you may have your first meal and drink of the day. You may lie down and take other medicines, if needed.

Do not take Ibandronic Acid Viatris before going to bed or before getting up in the morning.
Continuing treatment with Ibandronic Acid Viatris
It is important to take Ibandronic Acid Viatris every month for as long as your doctor recommends. After 3 to 5 years of treatment with Ibandronic Acid Viatris, you should consult your doctor to determine whether continued treatment is necessary.
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 not induce vomiting or lie down – this may cause irritation of the oesophagus by Ibandronic Acid Viatris.
Missing a dose of Ibandronic Acid Viatris

• If you forget to take the tablet in the morning on the scheduled day, do not take the tablet later on the same day. In this case, check when the next scheduled dose is due.
• If you forget to take the tablet on the scheduled day, and the next scheduled dose is due in only 1 to 7 days: Never take two Ibandronic Acid Viatris tablets within the same week. Wait until the next scheduled dose and take the tablet as planned, then continue taking one tablet per month on the previously scheduled dates marked in your calendar.
• If you forget to take the tablet on the scheduled day, and the next scheduled dose is due more than 7 days later: Take one tablet the morning after the day you remember the missed dose, then continue taking one tablet per month on the previously scheduled dates marked in your calendar.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
You should immediately inform a nurse or doctor if any of the following serious adverse reactions occur,
as immediate medical help may be needed:
Uncommon (may affect up to 1 in 100 people):

• severe chest pain, severe pain after eating food or drinking, severe nausea or vomiting, difficulty swallowing. The patient may have severe inflammation of the oesophagus, possibly with ulceration or narrowing of the oesophagus.
• symptoms of low blood calcium levels (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):

• itching, swelling of the face, lips, tongue or throat, difficulty breathing
• chronic pain and inflammation of the eyes
• new pain, weakness or discomfort in the thigh, hip or groin area. Early symptoms may indicate possible atypical fractures of the femur.

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

• pain or ulceration in the mouth or jaw and (or) mandible. Early symptoms of serious jaw and (or) mandible problems may occur (osteonecrosis (dead bone tissue) of the jaw and (or) mandible)
• talk to your doctor if the patient experiences 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 lesions, and severe blistering or peeling of the skin
• serious, potentially life-threatening allergic reaction

Other possible adverse reactions
Common (may affect up to 1 in 10 people):

• headache
• heartburn, discomfort when swallowing, stomach or abdominal pain (may be caused by inflammation of the stomach), indigestion, nausea, diarrhoea (loose stools)
• muscle cramps, stiffness of joints and limbs
• flu-like symptoms, including fever, chills and shivering, feeling unwell, bone pain and muscle and joint aches. Talk to a nurse or doctor if any of these symptoms become troublesome or last longer than a few days
• rash

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

• dizziness
• bloating (passing gas, feeling of fullness)
• back pain
• feeling of tiredness and exhaustion
• asthma attacks

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

• duodenitis (inflammation of the first part of the intestine) causing stomach pain
• urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ibandronic Acid Viatris

Keep this medicine out of sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the outer carton and blister after "EXP". The expiry date refers to the last day of the stated month.
Medicines must 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. 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).
• printing ink contains shellac, iron oxide black, and propylene glycol.

What Ibandronic Acid Viatris looks like and contents of the pack
The medicine is a white, capsule-shaped, film-coated tablet, biconvex, with the imprint “G” over “I-150” 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, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation 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 Budarös
Vasút u. 13
Hungary
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1.
Hungary

For further information about this medicine and its trade names in the European Economic Area countries, please contact the local representative of the marketing authorisation holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00