IBANDRONIC ACID QUALIGEN 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibandronic Acid Qualigen 150 mgfilm-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.

Contents of the pack and other information:

1. What is Ibandronic Acid Qualigen and what is it used for
2. What you need to know before you take Ibandronic Acid Qualigen
3. How to take Ibandronic Acid Qualigen
4. Possible side effects
5. Storing Ibandronic Acid Qualigen
6. Contents of the pack and other information

1. What is Ibandronic Acid Qualigen and what is it used for

Ibandronic Acid Qualigen belongs to a group of medicines called bisphosphonates, which contains ibandronic acid. It does not contain hormones.

Ibandronic Acid Qualigen can reverse bone loss because it prevents further bone loss and increases bone mass in most women who take it, even if they cannot see or appreciate the difference. Ibandronic Acid Qualigen may help reduce the number of bone fractures (fractures). This reduction has been shown in vertebral fractures but not in hip fractures.

You have been prescribed Ibandronic Acid Qualigen to treat your postmenopausal osteoporosis because you are at high risk of suffering fractures. Osteoporosis is a 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 bone health.

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

• inadequate intake of calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• little walking or other weight-bearing exercises
• family history of osteoporosis

Many people with osteoporosis do not suffer symptoms. If you do not have symptoms, it may be difficult for you to know if you have the disorder. However, osteoporosis increases the likelihood of bone fracture in cases of falls or injuries. Any bone fracture that appears after the age of 50 may be a sign of osteoporosis. Osteoporosis can also cause back pain, loss of height, and hunchback.

Ibandronic Acid Qualigen prevents bone loss due to osteoporosis and helps rebuild bone. Therefore, Ibandronic Acid Qualigen reduces the likelihood of fractures.

Healthy lifestyle habits also facilitate 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 not excessive alcohol consumption

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

Do not take Ibandronic Acid Qualigen

• If you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have certain esophageal problems (the esophagus is the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing.
• If you cannot stay upright, either standing or sitting, 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

Some people require special care during treatment with Ibandronic Acid Qualigen. Consult your doctor or pharmacist before starting treatment with Ibandronic Acid Qualigen, especially:

• If you have any mineral metabolism disorder (e.g., vitamin D deficiency).
• If you have any kidney problems.
• If you have any swallowing or digestive problems.
• If you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are being treated with Ibandronic Acid Qualigen.

Irritation, inflammation, or ulceration of the esophagus (the esophagus is the tube that connects your mouth to your stomach) 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 Qualigen. If you develop these symptoms, stop taking Ibandronic Acid Qualigen and inform your doctor immediately.

A rare 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 Qualigen 150 mg for osteoporosis. ONJ may also appear after discontinuing treatment.

It is essential 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 must be taken.

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

• You have mouth or tooth problems, such as poor dental health, gum disease, or a planned tooth extraction.
• If you do not receive routine dental care or if you have not had a dental check-up for a long time.
• If you are a smoker (as this can increase the risk of dental problems).
• If you are taking medications called corticosteroids (such as prednisolone or dexamethasone)
• If you have cancer

Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronic Acid Qualigen 150 mg.

While you are being treated, you must maintain good oral hygiene (including regular brushing of teeth) and undergo routine dental check-ups. If you wear dentures, you must ensure they fit properly. 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 Qualigen 150 mg.

Contact your doctor and dentist immediately if you experience any mouth or tooth problems, such as tooth loss, pain, or swelling, or difficulty healing ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Children and adolescents

Do not give Ibandronic Acid Qualigen to children or adolescents.

Interaction of Ibandronic Acid Qualigen with other medicines

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medicines, especially:

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the effects of Ibandronic Acid Qualigen.
• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen) that can irritate the stomach and intestines; as well as bisphosphonates (such as Ibandronic Acid Qualigen). Therefore, be very careful when taking painkillers or anti-inflammatory drugs at the same time as Ibandronic Acid Qualigen.

After taking the monthly tablet of Ibandronic Acid Qualigen, wait 1 hour before taking any other medicine, including antacids, calcium supplements, and vitamins.

Ibandronic Acid Qualigen with food and drink

Do not take Ibandronic Acid Qualigen with food. Ibandronic Acid Qualigen loses its effectiveness if taken with food.

You can drink tap water, but not other liquids (see section 3 How to take Ibandronic Acid Qualigen).

Pregnancy and breastfeeding

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

Driving and using machines

Ibandronic Acid Qualigen is unlikely to affect your ability to drive or use machines.

Ibandronic Acid Qualigen contains lactose.If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Ibandronic Acid Qualigen

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. The usual dose of Ibandronic Acid Qualigen is one tablet per month.

How to take the monthly tablet

It is essential that you follow these instructions carefully. They are designed to ensure that Ibandronic Acid Qualigen reaches the stomach quickly and causes less irritation.

• Take one Ibandronic Acid Qualigen 150 mg tablet once a month.
• Choose a day of the month that is easy for you to 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). Choose what best fits your routine.
• Take the Ibandronic Acid Qualigen tablet after a minimum of 6 hours of your last meal or drink (except water). You can only drink water during this period.
• Take the Ibandronic Acid Qualigen tablet:

• as soon as you get up, and
• before breakfast or drinking liquids (on an empty stomach)
  • Swallow the tablet with a glass of tap water (at least 180 ml). Do not take the tablet with mineral water, fruit juice, or other drinks.
  • Swallow the tablet whole, do not chew, crush, or dissolve it 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 may return to the esophagus.
• do not eat anything
• do not drink anything (except tap water, if needed)
• do not take any other medicine
  • After waiting 1 hour, you can have 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.

Do not take this medicine at bedtime or before getting up.

Continuation of treatment with Ibandronic Acid Qualigen

It is essential that you take Ibandronic Acid Qualigen every month, until your doctor tells you to stop.

Ibandronic Acid Qualigen is effective in treating osteoporosis only while you are taking this medicine.

If you take more Ibandronic Acid Qualigen than 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 down, as this may irritate the esophagus.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ibandronic Acid Qualigen

If you forget to take the tablet on the morning of the day you have chosen, do not take the tablet later. Instead, consult your calendar to see when your next dose is due:

• If your next dose is within 1 to 7 days:

Wait until your next scheduled dose and take it as usual, then continue taking one tablet per month according to the days marked on your calendar.

• If your next dose is more than 7 days away:

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

Never take two Ibandronic Acid Qualigen tablets within the same week.

4. Possible side effects

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

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

• rash, itching, swelling of the face, lips, tongue, and throat with difficulty breathing. You may be having an allergic reaction to the medicine.
• severe chest pain, severe pain when swallowing food or drink, severe nausea or vomiting.
• flu-like symptoms (if any effect starts to be bothersome or lasts more than a couple of days).
• pain or sensation of pain in the mouth or jaw.
• eye pain and inflammation (if prolonged)

Other possible side effects

Common(affects less than 1 in 10 people)

• headache
• heartburn, stomach pain (like "gastroenteritis" or "gastritis"), indigestion, nausea, diarrhea, or constipation
• skin rash
• pain or stiffness in the muscles, joints, or back
• flu-like symptoms (including fever, chills, and shivering, feeling unwell, fatigue, pain in bones and muscles and joints)
• fatigue

Uncommon(affects less than 1 in 100 people)

• bone pain
• feeling of weakness
• dizziness
• flatulence
• 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(affects less than 1 in 1,000 people)

• allergic reactions, swelling of the face, lips, and mouth (see allergy)
• itching
• eye pain or inflammation
• atypical fractures of the femur (thigh bone) that can occur rarely, especially in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms of a possible femur fracture.

Very rare(affects less than 1 in 10,000 people)

• a disease in which the bone in the mouth is exposed, called "osteonecrosis of the jaw"
• Talk to your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones in the ear.

If you experience side effects, consult your doctor or pharmacist, even if it is not listed in this leaflet.

5. Storing Ibandronic Acid Qualigen

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

No special storage conditions are required.

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. Contents of the pack and other information

Composition of Ibandronic Acid Qualigen

• The active substance is ibandronic acid. Each tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).
• The other ingredients are:

tablet core: povidone (E1201), microcrystalline cellulose (E460), corn starch, crospovidone (E1202), colloidal anhydrous silica, and dibehenate.

coating: opadry OY-LS-28908 (white II) consisting of titanium dioxide E171, lactose monohydrate, hypromellose (E464), and macrogol.

Appearance of the product and pack contents

Ibandronic Acid Qualigen film-coated tablets are white or almost white, round, and biconvex. They can be supplied in packs of 1 or 3 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970- Sant Joan Despí

Barcelona- Spain

Manufacturer

Pharmathen, S.A.

Dervenakion 6

15351 Pallini, Attikis

Greece

This leaflet was last revised in May 2022.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/