IBANDRONIC ACID AUROVITAS 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibandronic Acid Aurovitas 150 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Ibandronic Acid Aurovitas is and what it is used for
2. What you need to know before you take Ibandronic Acid Aurovitas
3. How to take Ibandronic Acid Aurovitas
4. Possible side effects
5. Storing 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 as it prevents further bone loss and increases bone mass in most women who take it, even if they cannot see or feel the difference. Ibandronic Acid Aurovitas may help reduce the likelihood of bone fractures. This reduction has been shown in spinal fractures but not in hip fractures.

You have been prescribedibandronic acidto treat your postmenopausal osteoporosis because you are at high risk of fractures. Osteoporosis is a condition where bones become thinner and weaker, often occurring in women after the menopause. During the menopause, the ovaries stop producing the female hormone, estrogen, which helps maintain bone health.

The earlier a woman reaches the menopause, the greater her risk of fractures due to osteoporosis. Other factors that increase the risk of fractures include:

• inadequate intake of calcium and vitamin D in the diet,
• smoking or excessive alcohol consumption,
• little weight-bearing exercise, such as walking,
• family history of osteoporosis.

Healthy lifestyle habitsalso help the beneficial effects of treatment. These include:

• a balanced diet rich in calcium and vitamin D,
• walking or other weight-bearing exercises,
• not smoking and not drinking too much alcohol.

2. What you need to know before you take Ibandronic Acid Aurovitas

Do not takeIbandronic Acid Aurovitasif:

• You are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• You have certain problems with your throat/food pipe (esophagus), such as narrowing or difficulty swallowing.
• You cannot stand or sit up for at least one hour (60 minutes).
• If you have or have had low calcium levels in your blood. Please consult your doctor.

Warnings and precautions

A very rare side effect 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 occur after stopping treatment.

It is important to try 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, certain precautions should be taken.

Atypical fractures of long bones, such as the forearm (ulna) and lower leg (tibia), have also been reported in patients receiving long-term treatment with ibandronate. These fractures occur after minimal or no trauma and some patients experience pain in the fracture area before a complete fracture occurs.

Before receiving treatment, inform your doctor/nurse (healthcare professional) if:

• You have dental problems or are planning to undergo dental surgery.
• You do not receive regular dental check-ups or have not had a dental check-up for a long time.
• You are a smoker (as this may increase the risk of dental problems).
• You have been previously treated with a bisphosphonate (used to treat or prevent bone disorders).
• You are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
• You have cancer.

Your doctor may ask you to have a dental check-up before starting treatment with ibandronic acid.

While you are being treated, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups. If you wear dentures, ensure they fit properly. If you are undergoing dental treatment or are about to have 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 with your mouth or teeth, such as tooth loss, pain, or swelling, or difficulty healing of ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Some people need special care when taking ibandronic acid. Consult your doctor before starting treatment with ibandronic acid:

• If you have any mineral metabolism disorder (e.g. vitamin D deficiency).
• If your kidneys do not work normally.
• If you have any swallowing or digestive problems.

Irritation, inflammation, or ulceration of the throat/food pipe (esophagus) may occur, often with symptoms of severe chest pain, severe pain after swallowing food and/or drink, severe nausea, or vomiting, especially if patients do not drink a full glass of water and/or if they lie down before one 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 give ibandronic acid to children or adolescents under 18 years of age.

TakingIbandronic Acid Aurovitaswith other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Especially:

• Supplements containing calcium, magnesium, iron, or aluminumas they may affect the action of ibandronic acid.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen) which may irritate the stomach and intestines; as does Ibandronic Acid Aurovitas. Therefore, be careful when taking painkillers or anti-inflammatory medicines at the same time as ibandronic acid.

After taking the monthly ibandronic acid tablet, wait 1 hour before taking any other medicine, including antacids, calcium supplements, or vitamins.

Taking Ibandronic Acid Aurovitas with food, drinks, and alcohol

Do not take ibandronic acid with food. Ibandronic Acid Aurovitas is less effective if taken with food.

You can drink water but not other liquids.

After taking ibandronic acid, please wait 1 hour before taking your first meal and other drinks (see section 3. How to take Ibandronic Acid Aurovitas).

Pregnancy, breastfeeding, and fertility

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.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as ibandronic acid is not expected to affect your ability to drive or use machines, or this effect is negligible.

Ibandronic Acid Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Ibandronic Acid Aurovitas

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again.

The recommended doseis one tablet once a month.

How to take the monthly tablet

It is important that you follow these instructions carefully. They are designed to help ibandronic acid reach the stomach quickly and cause less irritation.

• Take one Ibandronic Acid Aurovitas 150 mg tablet once a month.
• Choose a day of the monththat you can easily remember. You can choose the same date (e.g. the first day of each month) or always the same day (e.g. the first Sunday of each month) to take your ibandronic acid tablet. Choose a date that fits your routine.
• Take the ibandronic acid tablet after a minimum of 6 hours after your last meal or drink, except for water.

• Take the ibandronic acid tablet:
• as soon as you get up, and
• before breakfast or drinking(on an empty stomach).

• Swallow the tablet with a full glass of water(at least 180 ml).

Do nottake the tablet with water with a high concentration of calcium, fruit juice, or other drinks. If you are unsure about the potentially high calcium levels in your 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.

• During the next hour (60 minutes)after taking the tablet:
• Do not lie down; if you do not stay upright (standing or sitting), part of the medicine could come back up into your esophagus.

• Do not eat anything.

• Do not drink anything(except water, if needed).
• Do not take any other medicine.

• After waiting 1 hour, you can have your breakfast and your first drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medicines you need.

Continuation of treatment withIbandronic Acid Aurovitas

It is important that you take ibandronic acid every month, for as long as your doctor prescribes it. After 3-5 years of taking ibandronic acid, please consult your doctor to see if you should continue taking Ibandronic Acid Aurovitas.

If you take moreIbandronic Acid Aurovitasthan you should

If you have taken more tablets than you should, drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie downas this could irritate your esophagus.

If you forget to takeIbandronic Acid Aurovitas

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

Never take two ibandronic acid tablets within the same week. Wait until your next scheduled dose and take it as usual, then continue taking one tablet per month on the days marked on your calendar.

• If you forget to take the tablet on your chosen day and your next dose is more than 7 days away...

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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. You may have severe inflammation of the throat/food pipe, possibly with a feeling of pain or constriction.

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. These may be early symptoms of a possible unusual fracture of the thigh bone.

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

• Pain or discomfort in the mouth or jaw. These may be early symptoms of serious jaw problems [necrosis (death of bone tissue) of the jawbone].
• Tell your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear.
• Severe allergic reaction that can be life-threatening.
• Severe skin reactions.

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

• Unusual fractures in long bones other than the thigh.

Other possible side effects

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

• Headache.
• Heartburn, difficulty swallowing, stomach pain or discomfort (due to stomach inflammation), indigestion, nausea, diarrhea (loose stools).
• Muscle cramps, stiffness of joints and limbs.
• Flu-like symptoms, including fever, chills, and sweating, feeling unwell, pain in bones, muscles, and joints. Consult your nurse or doctor if any effect becomes troublesome or lasts more than a couple of days.
• Rash.

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

• Dizziness.
• Flatulence (bloating, feeling bloated).
• Back pain.
• Feeling tired and weak.
• Asthma attacks.
• Symptoms of low calcium levels in the blood (hypocalcemia), 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):

• Inflammation of the duodenum (first section of the intestine) that causes stomach pain.
• Hives.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ibandronic Acid Aurovitas

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

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. Package Contents and Additional Information

Composition ofIbandronic Acid Aurovitas

• The active ingredient is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
• The other components (excipients) are:

Tablet core: microcrystalline cellulose, povidone (K-25), anhydrous colloidal silica, crospovidone (Type-B), sodium stearyl fumarate.

Tablet coating: hypromellose 2910, triacetin, talc, titanium dioxide (E171).

Appearance of the Product and Package Contents

Ibandronic Acid Aurovitas are film-coated tablets, white or almost white, oblong, biconvex, marked with "X" on one face of the tablet and "78" on the other.

The Ibandronic Acid Aurovitas tablets are available in PVC/PE/PVdC-aluminum foil blisters.

Package sizes: 1, 3, and 50 film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

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:

Spain: Ibandronic Acid Aurovitas 150 mg film-coated tablets EFG

Netherlands: Ibandroninezuur Aurobindo 150 mg, filmomhulde tabletten

Poland: Ibandronic Acid Aurovitas

Date of the last revision of this leaflet:August 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)