Ibandronic Acid Aurovitas

Leaflet accompanying the packaging: patient information

Ibandronic Acid Aurovitas, 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1.

What is Ibandronic Acid Aurovitas and what is it used for

Ibandronic Acid Aurovitas belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.
Ibandronic Acid Aurovitas can reverse the process of bone tissue loss by inhibiting bone loss and increasing bone mass in most women who take this medicine, even if they do not notice or feel this difference. Ibandronic Acid Aurovitas may reduce the risk of bone fractures. A reduction in the number of fractures has been demonstrated in the case of vertebral fractures, but not in the case of hip fractures.

Ibandronic Acid Aurovitas has been prescribed to treat postmenopausal osteoporosis due to an increased risk of bone 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 ovaries stop producing the female hormone - estrogen, whose action allows maintaining the proper structure of the bone system.
The earlier menopause occurs in a woman, the higher her risk of osteoporosis-related fractures.
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 weight-bearing exercises,
• family history of osteoporosis.

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

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

2. Important information before taking Ibandronic Acid Aurovitas

When not to take Ibandronic Acid Aurovitas

• 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 esophagus (the tube through which food passes), such as narrowing or difficulty swallowing.
• If the patient is unable to stand or sit upright for at least 1 hour (60 minutes).
• If the patient has or has had a decrease in calcium levels in the blood.Consult a doctor.

Warnings and precautions

A side effect called jaw necrosis (damage to the jawbone) has been very rarely reported after the marketing of Ibandronic Acid Aurovitas in patients treated with this medicine for osteoporosis. Jaw necrosis may also occur after the end of treatment.
It is essential to take preventive measures to prevent the development of jaw necrosis, as it can be a painful and difficult-to-treat condition. To reduce the risk of jaw necrosis, appropriate precautions should be taken.
In patients receiving long-term ibandronate 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, the patient should inform the doctor or nurse (healthcare professional):

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

The doctor may recommend that the patient undergo a dental examination before starting Ibandronic Acid Aurovitas.
During treatment, it is essential to maintain good oral hygiene (including regular tooth brushing) and attend routine dental check-ups. If the patient uses dentures, they should ensure a proper fit. Patients undergoing dental treatment or dental procedures (e.g., tooth extraction) should inform their doctor and dentist that they are taking Ibandronic Acid Aurovitas.
If the patient experiences any oral or dental problems, such as loose teeth, pain, or swelling, non-healing ulcers, or discharge, they should immediately contact their doctor and dentist, as these may be symptoms of jaw necrosis.
In some cases, special caution is required when taking Ibandronic Acid Aurovitas. Before starting treatment, the patient should discuss this with their doctor:

• if they have any mineral metabolism disorders (such as vitamin D deficiency),
• if their kidneys do not work properly and/or they have kidney disease,
• if they have any swallowing or digestive problems.

Irritation, inflammation, or ulcers of the esophagus may occur, often with symptoms of severe chest pain after swallowing food or drink and/or nausea or vomiting. Severe nausea or vomiting may occur, especially if the patient does not drink a full glass of water and/or lies down within 1 hour of taking Ibandronic Acid Aurovitas. If such symptoms occur, the patient should stop taking Ibandronic Acid Aurovitas and consult their doctor immediately (see section 3).

Children and adolescents

Ibandronic Acid Aurovitas should not be used in children and adolescents under 18 years of age.

Ibandronic Acid Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, and especially about:

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the efficacy of Ibandronic Acid Aurovitas.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, diclofenac sodium, naproxen) may irritate the stomach and intestines. Ibandronic Acid Aurovitas may have a similar effect. Therefore, caution should be exercised when taking painkillers or anti-inflammatory drugs during treatment with Ibandronic Acid Aurovitas.

After taking the monthly tablet of Ibandronic Acid Aurovitas, the patient should wait 1 hourbefore taking any other medicines, including antacids or calcium supplements.

Ibandronic Acid Aurovitas with food and drink

Ibandronic Acid Aurovitas should not be taken with food.Ibandronic Acid Aurovitas taken with food is less effective.

Water can be drunk, but no other drinks should be consumed.

After taking Ibandronic Acid Aurovitas, the patient should wait 1 hour before taking any food or other drinks (see section 3: How to take Ibandronic Acid Aurovitas).

Pregnancy, breastfeeding, and fertility

Ibandronic Acid Aurovitas should only be taken during menopause and should not be taken by women who may still become pregnant.
Ibandronic Acid Aurovitas should not be taken during pregnancy or breastfeeding.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The patient can drive and use machines, as Ibandronic Acid Aurovitas does not affect or has a negligible effect on the ability to drive and use machines.

Ibandronic Acid Aurovitas contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Ibandronic Acid Aurovitas

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.

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

Taking a tablet once a month

It is essential to carefully follow the instructions below. These instructions have been developed to ensure that the Ibandronic Acid Aurovitas tablet reaches the stomach quickly, reducing the risk of irritation.

• The 150 mg Ibandronic Acid Aurovitas tablet should be taken once a month.
• Choose a specific day of the monththat is easy to remember. To take the Ibandronic Acid Aurovitas tablet, 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 time that best suits your habits.
• Ibandronic Acid Aurovitas should be taken at least 6 hours after eating or drinking anything except water.
• The Ibandronic Acid Aurovitas tablet should be taken:
• 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 drink. If there is a concern that the tap water has a high calcium content (so-called hard water), it is recommended to use water with low mineral content.

• 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 the upright position (standing or sitting) is not maintained, part of the medicine may flow back into the esophagus

• do not eat

• do not drink(except water if needed)
• do not take any other medicines
• After 1 hour, the patient can take their first food and drink of the day. After eating, they can lie down and take other medicines if necessary.

Continuing treatment with Ibandronic Acid Aurovitas

It is essential to take Ibandronic Acid Aurovitas every month, as long as the doctor recommends. After 3-5 years of taking Ibandronic Acid Aurovitas, the patient should consult their doctor to determine whether they should continue taking Ibandronic Acid Aurovitas.

Taking more than the recommended dose of Ibandronic Acid Aurovitas

If the patient accidentally takes more than one tablet, they should drink a full glass of milk and immediately contact their doctor.
Do not induce vomiting and do not lie down- this may cause irritation of the esophagus by Ibandronic Acid Aurovitas.

Missing a dose of Ibandronic Acid Aurovitas

• If the patient forgets to take a tablet in the morning on the planned day, they should not take itlater that day.

In such a case, the patient should check when the next planned dose is due.

• If the patient forgets to take a tablet on the planned day, and the next planned dose is due in 1 to 7 days.

Never take two Ibandronic Acid Aurovitas tablets in the same week.

Wait until the next planned dose.Take the tablet according to the established schedule, and then continue taking one tablet per month on the planned days marked in the calendar.

• If the patient forgets to take a tablet on the planned day, and the next planned dose is due in more than 7 days.

Take one tablet the next morning after the day the patient remembers the missed dose, and then continue taking one tablet per month on the planned days marked in the calendar.

4. Possible side effects

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

The patient should immediately inform their nurse or doctor if they experience any of the following serious side effects, as they may require immediate medical attention:

Uncommon(may affect 1 in 100 people)

• severe chest pain, severe pain after swallowing food or drink, severe nausea or vomiting, difficulty swallowing. Severe esophagitis, as well as esophageal ulcers or narrowing, may occur

Rare(may affect 1 in 1,000 people)

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

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

• mouth or jaw pain or ulcers. These may be early symptoms of serious jaw problems [necrosis (dead bone tissue) of the jawbone]
• if the patient experiences ear pain, ear discharge, and/or ear infection, they should tell their doctor. These may be symptoms of bone damage in the ear
• severe, potentially life-threatening allergic reactions
• severe, unwanted skin reactions

Frequency not known(cannot be estimated from the available data)

• atypical fractures of long bones other than the thigh bone

Other possible side effects

Common(may affect 1 in 10 people)

• headache
• heartburn, discomfort when swallowing, stomach or abdominal pain (may be related to gastritis), indigestion, nausea, diarrhea (loose stools)
• muscle cramps, joint stiffness and limb stiffness
• flu-like symptoms, including fever, chills, and shivering, discomfort, fatigue, bone pain, and muscle and joint pain. The patient should talk to their nurse or doctor if any of these symptoms become troublesome or last more than a few days
• rash

Uncommon(may affect 1 in 100 people)

• dizziness
• bloating with gas (feeling bloated)
• back pain
• feeling tired and exhausted
• asthma attacks
• symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or tingling in the fingers or around the mouth

Rare(may affect 1 in 1,000 people)

• duodenitis (inflammation of the duodenum), causing abdominal pain
• hives

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Ibandronic Acid Aurovitas

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

6. Contents of the packaging and other information

What Ibandronic Acid Aurovitas contains

• The active substance of Ibandronic Acid Aurovitas is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as sodium ibandronate monohydrate).
• The other ingredients are: Core:Microcrystalline cellulose, povidone (K-25), colloidal anhydrous silica, crospovidone (type B), sodium stearyl fumarate.

Coating:Hypromellose 2910, triacetin, titanium dioxide (E 171), talc.

What Ibandronic Acid Aurovitas looks like and what the pack contains

Coated tablet
The coated tablets are white to almost white, capsule-shaped, biconvex, with the letter "X" embossed on one side and the number "78" on the other.
Ibandronic Acid Aurovitas coated tablets are packaged in PVC/PE/PVdC/Aluminum blisters, in packs of 1, 3, or 50 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

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

Netherlands:
Ibandroninezuur Aurobindo 150 mg, filmomhulde tabletten
Poland:
Ibandronic Acid Aurovitas
Spain:
Ácido ibandrónico Aurovitas 150 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: 08/2024