Leaflet: information for the user

Ibandronic Acid Qualigen 150 mgfilm-coated tablets

Read this leaflet carefully before you start 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 questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms of the disease, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

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

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

3. How to take Ibandronic Acid Qualigen

4. Possible side effects

5. Storage of Ibandronic Acid Qualigen

6. Contents of the pack and additional information

Ibandronic Acid Qualigen belongs to a group of medications calledbisphosphonateswhich contains ibandronic acid. It does not contain hormones.

Ibandronic Acid Qualigen may 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 appreciate the difference. Ibandronic Acid Qualigen may help reduce the cases of bone fractures.This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed Ibandronic Acid Qualigen to treat your postmenopausal osteoporosis because you have a high risk of suffering fractures. Osteoporosis is a condition characterized by the thinning and weakening of bones, a common occurrence among women after menopause. During menopause, the ovaries stop producing the female hormone -estrogens- that helps maintain bone health.

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

- Insufficient calcium and vitamin D intake in the diet

- Smoking or excessive alcohol consumption

- Limited walking or other weight-bearing exercises

- Family history of osteoporosis

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

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

A healthy lifestyle also facilitates the favorable effects of treatment. These include a balanced diet rich in calcium and vitamin D, walking or any other weight-bearing exercise; not smoking, and moderate alcohol consumption.

Do not take Ibandronic Acid Qualigen

- If you are allergic to ibandronic acid or any of the other components of this medication (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 remain upright, both standing and sitting, for at least one hour straight (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 to take Ibandronic Acid Qualigen, especially:

- If you have any mineral metabolism disorder (for example, vitamin D deficiency).

- If you have any kidney problems.

- If you have any swallowing or digestive problems.

- If you are undergoing dental treatment or have scheduled dental surgery, inform your dentist that you are being treated with Ibandronic Acid Qualigen.

It may cause irritation, inflammation, or ulceration of the esophagus (the esophagus is the tube that connects your mouth to your stomach), often with symptoms of intense chest pain, intense pain after swallowing food and/or drink, intense nausea, or vomiting, especially if patients do not drink a full glass of water and/or if they lie down before an hour has passed after taking Ibandronic Acid Qualigen. If you develop these symptoms, stop taking Ibandronic Acid Qualigen and inform your doctor immediately.

A very 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 can also appear after interrupting treatment.

It is essential to prevent the development of ONJ since 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.

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

• You have problems in your mouth or teeth, such as poor dental health, gum disease, or a planned tooth extraction.
• If you do not receive regular 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 corticosteroid medications (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 should maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, ensure they are properly secured. If you are undergoing dental treatment or are scheduled to undergo 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 problems in your mouth or teeth, such as tooth loss, pain, or swelling, or difficulty in healing ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Children and adolescents

Do not administer Ibandronic Acid Qualigen to children or adolescents.

Ibandronic Acid Qualigen interaction with other medications

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

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

After taking the monthly Ibandronic Acid Qualigen tablet, wait 1 hour before taking any other medication, 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 may drink tap water but not other liquids (see point 3 How to take Ibandronic Acid Qualigen).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication. If you are breastfeeding, you may need to stop it to take Ibandronic Acid Qualigen.

Driving and operating machinery

It is very unlikely that Ibandronic Acid Qualigen will affect your ability to drive and operate machinery.

Ibandronic Acid Qualigen contains lactose.If your doctor has told you that you have a certain sugar intolerance, contact them before taking this medication.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubts, ask your doctor or pharmacist.The usual dose of Ácido Ibandrónico 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 Ácido Ibandrónico Qualigen reaches your stomach quickly and causes less irritation.

• Take one Ácido Ibandrónico Qualigen 150 mg tablet once a month.
• Choose the day of the monththat is easiest for you to remember. You can choose the same date (either the first day of each month) or always the same day (such as the first Sunday of each month). Choose what best suits your routine.
• Take the Ácido Ibandrónico Qualigen tabletafter a minimum of 6 hours from the last meal or drink (except water). Youwill only be able to drink water during this period.
• Take the Ácido Ibandrónico Qualigen tablet:

-nothing more than waking up, and

-before breakfast or consuming liquids(with an empty stomach)

• Swallow the tablet with a glass of tap water(at least 180 ml).Do nottake the tablet with mineral water, fruit juice, or other beverages.
• Swallow the tablet whole,do not chew, crush, or dissolve it in your mouth.
• During the hour following (60 minutes)after taking the tablet:

-do not lie down; if you do not remain upright (standing or sitting), part of the medication could return to the esophagus.

-do not eat anything

-do not drink anything(except tap water, if you need it)

-do not take any other medication

• After waiting 1 hour, you will be able to take breakfast and the first drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medications you need.

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

Continuation of treatment with Ácido Ibandrónico Qualigen

It is essential that you take Ácido Ibandrónico Qualigen every month, until your doctor tells you otherwise.

Ácido Ibandrónico Qualigen is used to treat osteoporosis only while you are taking this medication.

If you take more Ácido Ibandrónico Qualigen than you should

If you have taken, by mistake, one or more tablets, drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie downbecause you could irritate your esophagus.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ácido Ibandrónico Qualigen

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 your next dose is within1 to7 days:

Wait until it is time to take your next dose and take it as usual, then go back to taking one tablet a month according to the days marked on your calendar.

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

Take a tablet the morning after the day you remember forgetting the dose, then go back to taking one tablet a month according to the days marked on your calendar.

Never take two Ácido Ibandrónico Qualigen tablets within the same week.

Like all medications, Ibandronic Acid Qualigen may cause side effects, although not everyone will experience them.

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

•eruption, itching, swelling of the face, lips, tongue, and throat with difficulty breathing. You may be having an allergic reaction to the medication.

•intense chest pain, intense pain when swallowing food or drink, intense nausea or vomiting.

•flu-like symptoms (if any effect begins 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

Frequent(affects less than 1 in 10 people)

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

Rare(affects less than 1 in 100 people)

• bone pain
• sensation of weakness
• dizziness
• flatulence
• symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or tingling in the fingers or around the mouth.

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

• hypersensitivity reactions, swelling of the face, lips, and mouth (see allergy)
• itching
• eye pain or inflammation
• atypical fractures of the femur (thigh bone) that may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early signs and indicative of a possible femur fracture.

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

• a disease in which the jawbone becomes exposed and is called "osteonecrosis of the jaw"
• Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These may be symptoms of damage to the bones of the ear.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Ibandronic Acid Qualigen

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

tablet core: povidone (E1201), microcrystalline cellulose (E460), cornstarch, crospovidone (E1202), anhydrous colloidal silica, and dibehenate of glycerol.

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

Appearance of the product and contents of the packaging

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970- Sant Joan Despí

Barcelona- Spain

Responsible for Manufacturing

Pharmathen, S.A.

Dervenakion 6

15351 Pallini, Attikis

Greece

This leaflet was revised in May 2022.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/