Ibandronic acid aurovitas

Patient Information Leaflet

Ibandronic Acid Aurovitas, 150 mg, film-coated tablets
Acidum ibandronicum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents

1. What Ibandronic Acid Aurovitas is and what it is 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 pack and other information

1. What Ibandronic Acid Aurovitas is and what it is 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 bone loss by inhibiting bone loss and increasing bone mass in most women taking this medicine, even if they cannot notice or feel this difference themselves. Ibandronic Acid Aurovitas may reduce the likelihood of bone fractures. A reduction in fractures has been demonstrated for vertebral fractures, but not for hip fractures.
Ibandronic Acid Aurovitas has been prescribed for the treatment of postmenopausal osteoporosis associated with an increased risk of bone fractures.
Osteoporosis is a disease characterized 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, the greater the risk of fractures related to osteoporosis.
Other factors that may increase the risk of fractures include:

• insufficient dietary intake of calcium and vitamin D,
• smoking or excessive alcohol consumption,
• lack of walking or other weight-bearing exercises,
• a family history of osteoporosis.

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

• eating a balanced diet rich in calcium and vitamin D,
• walking or engaging in 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 you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have problems with your oesophagus (the tube through which food passes), such as narrowing or difficulty swallowing.
• If you are unable to remain upright (standing or sitting) continuously for at least one hour (60 minutes).
• If you have or have previously had low levels of calcium in your blood. Please consult your doctor.

Warnings and precautions
A rare side effect called osteonecrosis of the jaw and (or) mandible (damage to the jaw and (or) mandible bone) has been very rarely reported after marketing of Ibandronic Acid Aurovitas in patients treated with this medicine for osteoporosis. Osteonecrosis of the jaw and (or) mandible may also occur after stopping treatment.
It is important to take preventive measures against 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 ibandronate treatment, atypical fractures of long bones, such as the forearm (ulna) and tibia, have also been reported. These fractures may occur after minimal trauma or without trauma, and some patients may experience pain at the fracture site before a complete fracture occurs.
Before starting treatment, you should inform your doctor or nurse (healthcare professional):

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

Your doctor may recommend a dental examination before starting treatment with Ibandronic Acid Aurovitas.
During treatment, maintain good oral hygiene (including regular tooth brushing) and attend routine dental check-ups. If you wear dentures, ensure they are properly fitted. You should inform your treating doctor and dentist that you are taking Ibandronic Acid Aurovitas before any dental treatment or procedures (e.g. tooth extraction).
If you experience any symptoms in the mouth or teeth, such as loose teeth, pain or swelling, non-healing ulcers or discharge, contact your doctor and dentist immediately, as these may be signs of osteonecrosis of the jaw and (or) mandible.
Special caution may be required when taking Ibandronic Acid Aurovitas in certain individuals. Before starting Ibandronic Acid Aurovitas, discuss the following with your doctor:

• if you have any disorders of mineral metabolism (e.g. vitamin D deficiency),
• if your kidneys are not functioning properly and (or) you have kidney disease,
• if you have any problems with swallowing or digestion.

Irritation, inflammation, or ulceration of the oesophagus may occur, often with symptoms of severe chest pain after swallowing food and (or) drink. Severe nausea or vomiting may occur, particularly if you did not drink a full glass of water and (or) lie down within less than 1 hour after taking Ibandronic Acid Aurovitas. If such symptoms occur, stop taking Ibandronic Acid Aurovitas and contact your doctor immediately (see section 3).
Children and adolescents
Do not use Ibandronic Acid Aurovitas in children and adolescents under 18 years of age.
Ibandronic Acid Aurovitas and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, especially:

• Calcium, magnesium, iron, or aluminium-containing supplements, as they may affect the effectiveness of Ibandronic Acid Aurovitas.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac, naproxen) may irritate the stomach and intestines. Ibandronic Acid Aurovitas may have a similar effect. Therefore, take particular care when using painkillers or anti-inflammatory medicines during treatment with Ibandronic Acid Aurovitas.

After swallowing the monthly tablet of Ibandronic Acid Aurovitas, do not take any other medicines for 1 hour, including antacids, calcium supplements, or vitamins.
Ibandronic Acid Aurovitas with food and drink
Do not take Ibandronic Acid Aurovitas with food. Ibandronic Acid Aurovitas taken with food is less effective.
You may drink water, but do not drink any other beverages.
After taking Ibandronic Acid Aurovitas, wait 1 hour before consuming 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 postmenopause and must not be taken by women who could still bear a child.
Do not take Ibandronic Acid Aurovitas during pregnancy or while breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.
Driving and using machines
You may drive and use machines, as Ibandronic Acid Aurovitas has no effect or a negligible effect on the ability to drive and operate machinery.
Ibandronic Acid Aurovitas contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; this means the medicine is considered "sodium-free".

3. How to take Ibandronic Acid Aurovitas

This medicine should always be taken as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
The usual dose of Ibandronic Acid Aurovitas is one tablet once a month.
Taking one tablet per month
It is important to carefully follow the instructions below. These instructions are designed to ensure
that the Ibandronic Acid Aurovitas tablet reaches the stomach quickly, thereby reducing the risk of irritation.

• Take one 150 mg Ibandronic Acid Aurovitas tablet once a month.
• Choose a specific day of the month that will be easy to remember. For taking Ibandronic Acid Aurovitas, 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). Choose a day that best fits your routine.
• Ibandronic Acid Aurovitas should be taken after at least 6 hours have passed since consuming any food or drink, except water.
• Take the Ibandronic Acid Aurovitas tablet:
• in the morning after getting up 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 you are concerned that your tap water may have a high calcium content (so-called hard water), it is recommended to use 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 upright (standing or sitting), some of the medicine may flow back into the oesophagus

• do not eat anything

• do not drink anything (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. After eating, you may lie down and take other medicines, if necessary.

Continuing treatment with Ibandronic Acid Aurovitas
It is important to take Ibandronic Acid Aurovitas every month for as long as your doctor recommends. After 3 to 5 years of taking Ibandronic Acid Aurovitas, you should consult your doctor to determine whether continued treatment with Ibandronic Acid Aurovitas is necessary.
Taking more than the recommended dose of Ibandronic Acid Aurovitas
If you accidentally take more than one tablet, you should 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 Aurovitas.
Missed dose of Ibandronic Acid Aurovitas

• If you forget to take the tablet in the morning on your planned day, do not take it later on the same day.

In this case, check when your next scheduled dose is due.

• If you forget to take the tablet on your planned day and your next scheduled dose is due in only 1 to 7 days,

Never take two Ibandronic Acid Aurovitas tablets within the same week. Wait until the next scheduled dose day, take the tablet according to your established schedule, and then continue taking one tablet per month on the previously planned dates marked in your calendar.

• If you forget to take the tablet on your planned day and your next scheduled dose is due more than 7 days later,

Take one tablet in the morning on the day after you remember the missed dose, then continue taking one tablet per month on the previously planned dates marked in your calendar.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should immediately inform your nurse or doctor if you experience any of the following
serious adverse events, as immediate medical intervention may be required:

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. A severe inflammatory condition of the oesophagus may occur, as well as ulceration or narrowing of the oesophagus

Rare (may affect up to 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 groin, hip or thigh area. These may be early signs indicating a risk of 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. These may be early signs of serious jaw problems [osteonecrosis (dead bone tissue) of the jaw and (or) mandible]
• if a patient experiences ear pain, ear discharge and (or) ear infection, this should be reported to the doctor. These may be symptoms of bone tissue damage in the ear
• serious, potentially life-threatening allergic reactions
• severe skin reactions

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

• atypical fractures of long bones other than the femur

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

• headache
• heartburn, discomfort when swallowing, stomach or abdominal pain (may be related to stomach inflammation), indigestion, nausea, diarrhoea (loose stools)
• muscle cramps, joint and limb stiffness
• flu-like symptoms including fever, chills and shivering, feeling unwell, fatigue, bone pain and muscle and joint aches. You should talk to your 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 with gas (feeling of bloating)
• back pain
• feeling tired and exhausted
• asthma attacks
• symptoms of low blood calcium levels (hypocalcaemia), including muscle spasms or cramps and (or) tingling sensations in the fingers or around the mouth

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

• duodenitis (inflammation of the first part of the small intestine), causing abdominal pain
• urticaria (hives)

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Aurovitas

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 carton after EXP. The expiry date refers to the last day of the month indicated.
Medicines should 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 packaging and other information

What Ibandronic Acid Aurovitas contains

• The active substance is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).
• Other ingredients are:
  Tablet core: Microcrystalline cellulose, povidone (K-25), colloidal anhydrous silica, crospovidone (type B), sodium stearyl fumarate.
  Tablet coating: Hypromellose 2910, triacetin, titanium dioxide (E 171), talc.

What Ibandronic Acid Aurovitas looks like and contents of the pack
Film-coated tablet
Film-coated tablets, white to almost white in colour, capsule-shaped, biconvex, with the letter “X” engraved on one side and the number “78” on the other side.
Ibandronic Acid Aurovitas film-coated tablets are packed in blisters made of PVC/PE/PVdC/Aluminium foil, in pack sizes of 1, 3 or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 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 authorised in the European Economic Area countries 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