Ibandronic acid Qualigen 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibandronic Acid Qualigen 150 mg film-coated tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

1. What Ibandronic Acid Qualigen is and what it is used for
2. What you need to know before taking Ibandronic Acid Qualigen
3. How to take Ibandronic Acid Qualigen
4. Possible adverse effects
5. How to store 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 and 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 are unable to see or feel the difference. Ibandronic Acid Qualigen can help reduce the occurrence of bone fractures. This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

Your doctor has prescribed Ibandronic Acid Qualigen to treat your postmenopausal osteoporosis because you are at 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 higher her risk of osteoporotic fractures. Other factors that 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
• family history of osteoporosis

Many people with osteoporosis do not experience symptoms. If you do not have symptoms, it may be difficult to know whether you have the condition. However, osteoporosis increases the likelihood of bone fractures following a fall or injury. Any bone fracture occurring after age 50 may be a sign of osteoporosis. Osteoporosis may also cause back pain, loss of height, and kyphosis (stooped posture).

Ibandronic Acid Qualigen prevents bone loss caused by osteoporosis and helps rebuild bone. Therefore, Ibandronic Acid Qualigen reduces the risk of fractures.

Healthy lifestyle habits also support 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 moderate alcohol consumption.

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

Do not take Ibandronic Acid Qualigen

• 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 oesophageal problems (the oesophagus is the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing.
• If you are unable to remain upright, either standing or sitting, for at least one continuous hour (60 minutes).
• If you have or have had low levels of calcium 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 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 dental surgery planned, inform your dentist that you are being treated with Ibandronic Acid Qualigen.

Irritation, inflammation, or ulceration of the oesophagus (the oesophagus is the tube connecting your mouth to your stomach) may occur, often with symptoms such as severe chest pain, severe pain after swallowing food and/or drink, severe nausea or vomiting, particularly if patients do not drink a full glass of water and/or 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.

Very rarely, an 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 occur after stopping 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.

Before receiving 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 are taking medications 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 Qualigen 150 mg.

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 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 healing of 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.

Interaction of Ibandronic Acid Qualigen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, especially:

• Supplements containing calcium, magnesium, iron, or aluminium, as they may interfere with the effects of Ibandronic Acid Qualigen.
• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen) which may irritate the stomach and intestine, similar to bisphosphonates (like Ibandronic Acid Qualigen). Therefore, take extra care when taking painkillers or anti-inflammatory medicines 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 indigestion tablets, calcium supplements, and vitamins.

Ibandronic Acid Qualigen with food and drink

Do not take Ibandronic Acid Qualigen with food. Ibandronic Acid Qualigen becomes less effective if taken with food.

You may drink tap water, but no other liquids (see section 3, How to take Ibandronic Acid Qualigen).

Pregnancy and breastfeeding

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

Driving and using machines

It is very unlikely that Ibandronic Acid Qualigen will affect your ability to drive or use machines.

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

3. How to take Ibandronic Acid Qualigen

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. The usual dose of Ibandronic Acid Qualigen is one tablet per month.

How to take the monthly tablet

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

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

• Choose the day of the month that is easiest for you to remember. You may choose the same date (such as the first day of each month) or always the same day (such as the first Sunday of each month). Choose whichever best fits your routine.

• Take the Ibandronic Acid Qualigen tablet after at least 6 hours without food or drink (except water). You may only drink water during this period.

• Take the Ibandronic Acid Qualigen tablet:

• immediately upon waking up, and

• before breakfast or drinking any 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 beverages.
  • Swallow the tablet whole; do not chew, crush, or dissolve it in the mouth.
  • During the hour following tablet ingestion (60 minutes):

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

• do not eat anything

• do not drink anything (except tap water, if needed)

• do not take any other medication

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

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

Continuation of treatment with Ibandronic Acid Qualigen

It is important that you take Ibandronic Acid Qualigen every month, as directed by your doctor.

Ibandronic Acid Qualigen helps treat osteoporosis only while you are taking this medicine.

If you take more Ibandronic Acid Qualigen than you should

If you have accidentally taken extra tablets, drink a full glass of milk and inform your doctor immediately.

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

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

If you forget to take Ibandronic Acid Qualigen

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

• If your next dose is due in 1 to 7 days:

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

• If your next dose is due in more than 7 days:

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

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

4. Possible adverse effects

Like all medicines, Ibandronic Acid Qualigen may cause adverse effects, although not everyone experiences them.

Immediately tell your doctor or nurse if you notice any of the following serious adverse 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 becomes bothersome or lasts more than a few days).
• pain or sensation of pain in the mouth or jaw.
• eye pain and inflammation (if prolonged).

Other possible adverse effects

Common (affects less than 1 in 10 people)

• headache
• heartburn, stomach pain (such as “gastroenteritis” or “gastritis”), indigestion, nausea, diarrhoea or constipation
• skin rash
• pain or stiffness in muscles, joints, or back
• flu-like symptoms (including fever, chills and shivering, feeling unwell, fatigue, bone pain, and muscle and joint pain)
• fatigue

Uncommon (affects less than 1 in 100 people)

• bone pain
• feeling of weakness
• dizziness
• flatulence
• symptoms of low calcium levels in the blood (hypocalcaemia), 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)

• hypersensitivity reactions, swelling of the face, lips and mouth (see allergy)
• itching
• eye pain or inflammation
• atypical femoral fractures (thigh bone fractures) which may occur rarely, particularly 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 indicating a possible femoral fracture.

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

• a condition in which the jaw bone becomes exposed, known as “osteonecrosis of the jaw”
• Consult 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.

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

5. Ibandronic Acid Qualigen Storage

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 stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 sodium ibandronate monohydrate).
• The other components are:

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

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 pack

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

Only certain 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 reviewed 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/