Leaflet: information for the user

Ibandronic Acid Kern Pharma 150 mg film-coated tablets

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you think you are having a serious side effect or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Ibandrónico Kern Pharma belongs to a group of medications called bisphosphonatesthat contains ibandronate. It does not contain hormones.

Ibandronate can 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. Ibandronate can 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 ibandronate to treat your osteoporosis because you have a high risk of suffering fractures. Osteoporosis is characterized by a thinning and weakening of the bones, a common condition among women after menopause. During menopause, the ovaries stop producing the female hormone - estrogen - 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 include:

- Insufficient calcium and vitamin D intake in the diet

- Smoking or excessive alcohol consumption

- Limited walks 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.

Ibandronate prevents bone loss due to osteoporosis and helps rebuild bone. Therefore, Ibandrónico Kern Pharma reduces the likelihood of fractures.

Healthy lifestyle habitsalso facilitate the favorable effects of treatment. These include a balanced diet rich in calcium and vitamin D, walks or any other weight-bearing exercise, not smoking, and moderate alcohol consumption.

Do not take Ácido Ibandrónico Kern Pharma:

- If you are allergic (hypersensitive) to ibandronic acid or to any of the other components of Ácido Ibandrónico Kern Pharma.

- 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.

Do not administer Ácido Ibandrónico Kern Pharmato children or adolescents.

Be especially careful with Ácido Ibandrónico Kern Pharma

Some people require special care during treatment with ibandronic acid. 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 ibandronic acid.

Irritation, inflammation, or ulceration of the esophagus (the esophagus is the tube that connects your mouth to your stomach) may occur, often with 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. If you develop these symptoms, stop taking Ácido Ibandrónico Kern Pharma 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 Ácido Ibandrónico Kern Pharma 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.
• You do not receive regular 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 been previously treated with a bisphosphonate (used to treat or prevent bone disorders).
• You are taking medications called corticosteroids (such as prednisolone or dexamethasone).
• You have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with Ácido Ibandrónico Kern Pharma.

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, ensure 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 Ácido Ibandrónico Kern Pharma.

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.

This medicine contains lactose as an excipient

This medicine contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains sodium as an active ingredient

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

Use of other medicines

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

-Supplements containing calcium, magnesium, iron, or aluminumas they may influence the effects of ibandronic acid.

-Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) that may irritate the stomach and intestines; like bisphosphonates (such as ibandronic acid). Be very careful when takinganalgesics or anti-inflammatoryat the same time as Ácido Ibandrónico Kern Pharma.

After taking the monthly ibandronic acid tablet, wait 1 hour before taking any other medication, including antacids, calcium supplements, and vitamins.

Taking Ácido Ibandrónico Kern Pharma with food and drinks:

Do not take ibandronic acid with food.Ibandronic acid loses its effectiveness if taken with food.

You may drink tap water but not other liquids(see point 3. HOW TO TAKE ÁCIDO IBANDRÓNICO KERN PHARMA).

Pregnancy and breastfeeding

Do not take ibandronic acid if you are pregnant or breastfeeding. If you are breastfeeding, you may need to stop it to take ibandronic acid.

Driving and operating machinery

It is very unlikely that ibandronic acid will affect your ability to drive and operate machinery.

Important information about some of the components of Ácido Ibandrónico Kern Pharma

This medicine contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions for ibandronic acid that your doctor has prescribed. Consult your doctor or pharmacist if you have any doubts.

The usual dose of Ibandronic Acid Kern Pharma is 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 the stomach quickly and causes less irritation.

-Take one Ibandronic Acid Kern Pharma 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 fits your routine.

-Take the ibandronic acid tabletafter a minimum of 6 hours from the last meal or drink (except water)you will only be able to drink water during this period.

-Take the ibandronic acid tablet

-nothing more than when you get up, and

-before breakfast or before 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 notcrush, chew, 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 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 the other medications you need.

Do nottake this medication at bedtime or before getting up.

Continuation of treatment with Ibandronic Acid Kern Pharma

It is essential to take ibandronic acid every month until your doctor tells you to stop.

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

If you take more Ibandronic Acid Kern Pharma 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, call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ibandronic Acid Kern Pharma

If you forget to take the tablet in 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 to 7 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 one tablet the next morning after the day you remember you forgot the dose, then go back to taking one tablet a month according to the days marked on your calendar.

Never take two ibandronic acid tablets within the same week.

Like all medicines, Ibandronic Acid Kern Pharma may cause side effects, although not everyone will experience them.

These side effects may occur at certain frequencies, which are defined below:

- very common: affects more than 1 in 10 people

- common: affects between 1 and 10 in 100 people

- uncommon: affects between 1 and 10 in 1,000 people

- rare: affects between 1 and 10 in 10,000 people

- very rare: affects less than 1 in 10,000 people

- unknown: the frequency cannot be estimated from the available data

The common side effectsinclude heartburn (a burning sensation that rises from the stomach to the mouth), indigestion, diarrhea, stomach pain, and nausea.

Ibandronic acid may also irritate the esophagus, although this reaction usually occurs if you take the dose according to the package insert. If you experience symptoms such as severe chest pain, severe pain when swallowing after eating or drinking, nausea, or vomiting, stop taking ibandronic acid and inform your doctor immediately.

Other common side effects include rash, muscle cramps, muscle and joint pain, and headache.

They also include flu-like symptoms (such as pain, feeling unwell, fatigue) that are usually mild, short-lived, and disappear shortly after taking the first dose. It is very likely that you can tolerate them and continue treatment with ibandronic acid. However, speak with your doctor if the side effects worsen or last a long time.

The uncommon side effects are dizziness, back pain, flatulence, and symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or tingling in the fingers or around the mouth.

The rare side effects that may appear are swelling and itching of the face, lips, and mouth.

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 symptoms and indicative of a possible femoral fracture.

Very rare side effects: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.

Reporting side effects

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

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use after the expiration date shown 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 medicines you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ibandronic Acid Kern Pharma

• Each tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).
• The other components are: cornstarch, microcrystalline cellulose (E-460i), crospovidone (E1202), glyceryl behenate, povidone (E1201) and colloidal silicon dioxide in the core of the tablet and titanium dioxide (E-171), hypromellose (E-464), lactose monohydrate and macrogol in the coating.

Appearance of the product and contents of the package:

Ibandronic Acid Kern Pharma tablets are white, round and biconvex.

Ibandronic Acid Kern Pharma is presented in blister packs of 1 and 3 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 – Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Pharmathen, S.A

6, Dervenakion Str - GR-16351 (Pallini Attikis)

Greece

Last review date of this leaflet: June 2022

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