Ibandronic acid Aurovitas 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibandronic acid Aurovitas 150 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ibandronic acid Aurovitas is and what it is used for
2. What you need to know before taking Ibandronic acid Aurovitas
3. How to take Ibandronic acid Aurovitas
4. Possible adverse effects
5. How to store Ibandronic acid Aurovitas
6. Contents of the pack 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 bone loss because it prevents further bone loss and increases bone mass in most women who take it, even if they are unable to see or notice the difference. Ibandronic Acid Aurovitas can help reduce the likelihood of bone breaks (fractures). This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

You have been prescribed ibandronic acid to treat your postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which is common among women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain skeletal health.

The earlier a woman reaches menopause, the greater her risk of fractures due to osteoporosis. Other factors that 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 exercises,
• family history of osteoporosis.

Healthy lifestyle habits also support the beneficial effects of treatment. These include:

• a balanced diet rich in calcium and vitamin D,
• walking or any other weight-bearing exercise,
• not smoking and avoiding excessive alcohol consumption.

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

Do not take Ibandronic Acid Aurovitas:

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

Warnings and precautions

Very rarely, a serious adverse reaction 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 may also occur after discontinuation of treatment.

It is important to try to prevent the development of ONJ, as it is a painful condition that may 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 bone (ulna) and shin bone (tibia), have also been reported in patients receiving long-term treatment with ibandronate. These fractures occur following minimal or no trauma, and some patients experience pain in the affected area before a complete fracture occurs.

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

• You have mouth or dental problems, such as poor dental health, gum disease, or planned tooth extraction.
• You do not receive routine dental care 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 previously been 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 examination before starting treatment with ibandronic acid.

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or are scheduled for 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 mouth or dental problems, 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 require special care during treatment with ibandronic acid. Consult your doctor before starting ibandronic acid:

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

Irritation, inflammation, or ulceration of the throat/food pipe (oesophagus) may occur, often with symptoms such as 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 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.

Taking Ibandronic Acid Aurovitas with other medicines

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

• Supplements containing calcium, magnesium, iron, or aluminium, as they may interfere with the effects of ibandronic acid.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen), which can irritate the stomach and intestines, just like Ibandronic Acid Aurovitas. Therefore, take special care when taking painkillers or anti-inflammatory drugs at the same time as ibandronic acid.

After taking the monthly ibandronic acid tablet, wait 1 hour before taking any other medicine, including antacid tablets, 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 may drink water but no other liquids.

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

Pregnancy, breastfeeding, and fertility

Ibandronic acid is intended for use only in postmenopausal women and should not be taken by women of childbearing potential. 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may drive and operate machinery, as ibandronic acid is not expected to affect, or has a negligible effect on, your ability to drive and use machines.

Ibandronic Acid Aurovitas contains sodium

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

3. How to take Ibandronic Acid Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet per month.

How to take the monthly tablet

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

• Take one tablet of Ibandronic Acid Aurovitas 150 mg once a month.

• Choose a day of the month that is easiest for you to remember. You may choose the same date (e.g., the first day of each month) or the same day of the week (e.g., the first Sunday of each month) to take your ibandronic acid tablet. Choose the day that best fits your routine.

• Take the ibandronic acid tablet after at least 6 hours without food or drink, except water.

• Take the ibandronic acid tablet:

• immediately upon waking up, and

• before breakfast or drinking any liquids (on an empty stomach).

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

Do not take the tablet with water that has a high calcium content, fruit juice, or other beverages. If you are unsure 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 allow it to dissolve in your mouth.

• During the following hour (60 minutes) after taking the tablet:

• Do not lie down; if you do not remain upright (standing or sitting), part 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 medicine.

• After waiting for 1 hour, you may eat breakfast and drink your first beverage of the day. Once you have eaten, you may lie down and take any other medicines you require.

Continuation of treatment with Ibandronic 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 determine whether you should continue treatment with Ibandronic Acid Aurovitas.

If you take more Ibandronic Acid Aurovitas than you should

If you have taken an extra tablet by mistake, drink a full glass of milk and contact your doctor immediately.

Do not induce vomiting or lie down, as this could irritate the oesophagus.

If you forget to take Ibandronic Acid Aurovitas

• If you forget to take the tablet on the morning of your chosen day, do not take the tablet later in the day.

Instead, check your calendar to determine when your next dose is due.

• If you forgot to take the tablet on your chosen day and your next dose is due in 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 according to your calendar.

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

Take one tablet the morning after you remember missing the dose, then resume taking one tablet per month according to your scheduled calendar dates.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• Severe chest pain, severe pain when swallowing food or drink, severe nausea or vomiting, difficulty swallowing. You may have severe inflammation in the throat/food pipe, possibly with a sensation of pain or tightness.

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 signs of an unusual femur (thigh bone) fracture.

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

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

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

• Unusual fractures in 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 (due to stomach inflammation), indigestion, nausea, diarrhea (loose stools).
• Muscle cramps, stiffness in joints and limbs.
• Flu-like symptoms, including fever, chills, shivering, feeling unwell, bone, muscle and joint pain. Consult your nurse or doctor if any of these effects become bothersome or last more than a few days.
• Skin rash.

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

• Dizziness.
• Flatulence (gas, bloating).
• Back pain.
• Feeling of fatigue and exhaustion.
• 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) causing stomach pain.
• Hives.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibandronic Acid Aurovitas

• The active substance 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), colloidal anhydrous silica, crospovidone (Type-B), sodium stearyl fumarate.

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

Appearance of the product and contents of the container

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

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

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

Only certain pack 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 European Economic Area member states 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 most recent revision of this leaflet: August 2024

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