IBANDRONIC ACID KERN PHARMA 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibandronic Acid Kern Pharma 150 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Ibandronic Acid Kern Pharma and what is it used for
2. Before taking Ibandronic Acid Kern Pharma
3. How to take Ibandronic Acid Kern Pharma
4. Possible side effects
5. Storing Ibandronic Acid Kern Pharma
6. Further information

1. What is Ibandronic Acid Kern Pharma and what is it used for

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

Ibandronic acid can 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 feel the difference. Ibandronic acid may help reduce the risk of bone fractures. This reduction has been shown in spinal fractures but not in hip fractures.

You have been prescribed ibandronic acid to treat your osteoporosis because you are at high risk of fractures.Osteoporosis is a condition where the bones become thinner and weaker, often in women after the menopause. During the 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 osteoporosis fractures. Other factors that increase the risk of fractures include:

• inadequate intake of calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• little walking or other weight-bearing exercise
• 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 risk of bone fractures in the event of a fall or injury. 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 stooping.

Ibandronic acid prevents bone loss due to osteoporosis and helps rebuild bone. Therefore, Ibandronic Acid Kern Pharma reduces the risk of fractures.

Healthy lifestyle habitsalso 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 moderate alcohol consumption.

2. Before taking Ibandronic Acid Kern Pharma

Do not take Ibandronic Acid Kern Pharma:

• If you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients of Ibandronic Acid 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 stay upright (standing or sitting) for at least one hour (60 minutes).
• If you have low calcium levels in your blood. Please consult your doctor.

Do not give Ibandronic Acid Kern Pharma to children or adolescents.

Be careful with Ibandronic Acid Kern Pharma

Some people require special care during treatment with ibandronic acid. Consult your doctor:

• If you have any mineral metabolism disorder (e.g., vitamin D deficiency).
• If you have kidney problems.
• If you have swallowing or digestive problems.
• If you are undergoing dental treatment or plan to have 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 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 lie down before one hour has passed after taking ibandronic acid. If you develop these symptoms, stop taking Ibandronic Acid Kern Pharma 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 Kern Pharma for osteoporosis. ONJ can also occur after stopping treatment.

It is essential to try to prevent the development of ONJ, as it is a painful condition that can be challenging 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 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 Ibandronic Acid Kern Pharma.

While being treated, you must maintain good oral hygiene (including regular toothbrushing) and undergo routine dental check-ups. If you wear dentures, ensure they fit properly. If you are undergoing dental treatment or plan to have 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 Kern Pharma.

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.

This medicine contains lactose as an excipient

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them 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".

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription. Especially:

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the effects of ibandronic acid.
• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen), which can irritate the stomach and intestines, as well as bisphosphonates (such as ibandronic acid). Therefore, be careful when taking pain relievers or anti-inflammatory medications at the same time as Ibandronic Acid Kern Pharma.

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

Taking Ibandronic Acid Kern Pharma with food and drinks:

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

You can drink tap water but not other liquids(see section 3. HOW TO TAKE IBANDRONIC ACID 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 breastfeeding to take ibandronic acid.

Driving and using machines

It is unlikely that ibandronic acid will affect your ability to drive or use machines.

Important information about some of the ingredients of Ibandronic Acid Kern Pharma

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

3. How to take Ibandronic Acid Kern Pharma

Follow the instructions for taking ibandronic acid that your doctor has given you. Ask your doctor or pharmacist if you have any questions.

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 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 tablet after a minimum of 6 hours of not eating or drinking (except water). You can only drink water during this period.

• Take the ibandronic acid tablet
• as soon as you get up, and
• before breakfast or drinking (on 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 drinks.

• Swallow the tablet whole.

Do notchew, 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 come back up into 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 lie down and take any other medicines you need.

Do nottake this medicine at bedtime or before getting up.

Continuing 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 only works to treat osteoporosis while you are taking this medicine.

If you take more Ibandronic Acid Kern Pharma than you should

If you have taken an extra tablet by mistake, drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie downas this may irritate the esophagus.

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

If you forget to take Ibandronic Acid Kern Pharma

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 due in1 to7 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 due in more than 7 days…

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 tablets within the same week.

4. Possible side effects

Like all medicines, Ibandronic Acid Kern Pharma can cause side effects, although not everyone gets them.

These side effects may occur with 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

Common side effectsinclude heartburn (burning sensation rising from the stomach to the mouth), indigestion, diarrhea, stomach pain, and nausea.

Ibandronic acid can also irritate the esophagus, although this reaction is usually avoided if the dose is taken according to the package leaflet.If you experience symptoms such as severe chest pain, severe pain after swallowing food or drink, 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 soon after taking the first dose. It is likely that you can tolerate them and continue treatment with ibandronic acid. However, talk to your doctor if the effects worsen or last a long time.

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 sensation in the fingers or around the mouth.

Rare side effects that may occur are swelling and itching of the face, lips, and mouth.

Atypical fractures of the femur (thigh bone) 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 side effects: Consult your doctor if you experience ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Ibandronic Acid Kern Pharma

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Further information

Composition of Ibandronic Acid Kern Pharma

• Each tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).
• The other ingredients are: cornstarch, microcrystalline cellulose (E-460i), crospovidone (E1202), glycerol 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 and packaging of the product:

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Pharmathen, S.A

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

Greece

Date of last revision of this package leaflet: June 2022

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