Leaflet: information for the user

Ibandronic Acid pens150 mg film-coated tablets EFG

Ibandronic Acid

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you experience is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

2. Before starting to take Ibandronic Acid Pensa

3. How to take Ibandronic Acid Pensa

4. Possible side effects

5. Storage of Ibandronic Acid Pensa

6. Additional information

Ibandronic Acid Pensabelongs to a group of medications calledbisphosphonates. It does not contain hormones.

Ibandronic Acid Pensa may reverse bone loss since 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 Pensa may help reduce the cases of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed Ibandronic Acid Pensa to treat your osteoporosis because you have a high risk of suffering fractures. Osteoporosis consists of a thinning and weakening of the bones, a common condition 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 greater her risk of suffering fractures due to osteoporosis. Other factors that increase the risk of fractures are:

- 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 humpback.

Ibandronic Acid Pensaprevents bone loss due to osteoporosis and helps rebuild bone. Therefore,Ibandronic Acid Pensareduces the likelihood of fractures.

Healthy lifestyle habitsalso facilitate 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 takeAcid Ibandronic Pensia

- If you are allergic (hypersensitive) to acid ibandronic or to any of the other components of Acid Ibandronic Pensia.

- 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 think you may have low calcium levels in your blood. Please consult your doctor.

Children and adolescents

Do not administer Acid Ibandronic Pensia to children or adolescents.

Be especially careful withAcid Ibandronic Pensia

Some people need special care during treatment with Acid Ibandronic Pensia. Consult your doctor:

- 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 Acid Ibandronic Pensia.

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 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 Acid Ibandronic Pensia. If you develop these symptoms, stop taking Acid Ibandronic Pensia 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 Acid Ibandronic Pensia for osteoporosis. ONJ may also appear after stopping 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 may increase the risk of dental problems).
• If you have been previously treated with a bisphosphonate (used to treat or prevent bone disorders).
• 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 Acid Ibandronic Pensia.

While you are being treated, you should maintain good oral hygiene (including regular brushing of your teeth) and undergo routine dental check-ups. If you wear dentures, make sure they are properly secured. If you are undergoing dental treatment or are about 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 Acid Ibandronic Pensia.

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.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription. Especially:

• Supplements containing calcium, magnesium, iron, or aluminumas they may affect the effects ofAcid IbandronicPensa.

• Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) thatmay irritate the stomach and intestines; like bisphosphonates (such as Acid IbandronicPensa). Be very careful when takinganalgesics or anti-inflammatoryat the same time as Acid IbandronicPensa.

After taking the monthly Acid IbandronicPensatablet, wait 1 hour before taking any other medication, including tablets or medications for indigestion, calcium supplements, or vitamins.

TakingAcid Ibandronic Pensiawith food and drinks

Do not take Acid IbandronicPensawith food.Acid IbandronicPensaloses effectiveness if taken with food.

You can drink tap water but not other liquids(see section 3. HOW TO TAKE Acid IbandronicPensa).

Pregnancy and breastfeeding

Do not take Acid Ibandronic Pensia if you are pregnant or breastfeeding.

If you are breastfeeding, you may need to stop it to take Acid IbandronicPensa.

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

It is very unlikely that Acid IbandronicPensawill affect your ability to drive and operate machines.

Important information about some of the components ofAcid Ibandronic Pensia

Acid IbandronicPensacontains lactose. If your doctor has told you that you have a certain sugar intolerance, contact him before taking this medication.

Follow the exact administration instructions for Ibandronic Acid exactly as your doctor has prescribed. Consult your doctor or pharmacist if you have any doubts.

The normal dose of Ibandronic Acidis one tablet per month.

How to take the monthly tablet

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

-Take one Ibandronic Acid tablet once a month..

-Choose a day of the month that 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 Ibandronic Acid tabletafter a minimum of 6 hours from the last meal or drink (except water). During this period, you can only drink water.

- Take the Ibandronic Acid tablet.

-As soon as you wake 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 not take the tablet with mineral water, fruit juice, or other beverages.

-Swallow the tablet whole-do not chew, crush, or dissolve it in your mouth.

-For the next hour (60 minutes)after taking the tablet

-do not lie down; if you do not remain upright (standing or sitting), part of the medication may 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 can take breakfast and the first drink of the day. Once you have eaten, you can, if you wish, lie down and take the other medications you need.

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

Continuation of treatment with Ibandronic Acid Pensa

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

Ibandronic Acid Pensa is used to treat osteoporosis only while you are taking this medication.

If you take moreIbandronic Acid Pensathan you should

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

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

If you forget to takeIbandronic Acid Pensa

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 within 1 to 7 days...

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

If your next dose is more than 7 days...

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

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

Like all medications, Ibandronic AcidPensamay cause side effects, although not everyone will experience them.

Inform your doctor or nurse 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 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
• Pain or stiffness of the muscles, joints, or back
• Flu-like symptoms (including fever, chills, and shivering, feeling unwell, fatigue, bone 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 femoral fractures 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 they may be early signs of a possible femoral fracture.

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

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

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not useIbandronic AcidPensad after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofIbandronic Acid Pens

- The active ingredient is ibandronic acid. Each tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate)

- The other components are:

tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica

tablet coating: hydroxypropylcellulose (HPC-L), titanium dioxide (E171), macrogol 6000

Appearance of the product and contents of the package

Ibandronic Acid Pens tablets are film-coated tablets, white in color, oblong in shape, and marked with the inscription “LC” on one face.

They may be supplied in packages of 1 or 3 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

This leaflet was approved in March 2022

The 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/