Ibandronic acid Kern Pharma 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibandronic Acid Kern Pharma 150 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this 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 consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Ibandronic Acid Kern Pharma is and what it is used for
2. Before you take Ibandronic Acid Kern Pharma
3. How to take Ibandronic Acid Kern Pharma
4. Possible side effects
5. How to store 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 and contains ibandronic acid. It does not contain hormones.

Ibandronic acid 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 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 to treat your 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—that helps maintain skeletal health.

The earlier a woman enters menopause, the greater her risk of osteoporotic fractures. Other factors that increase the risk of fractures include:

• inadequate 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 have no 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 prevents bone loss caused by osteoporosis and helps rebuild bone. Therefore, Ibandronic Acid Kern Pharma reduces the likelihood 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. Before taking Ibandronic Acid Kern Pharma

Do not take Ibandronic Acid Kern Pharma:

• If you are allergic (hypersensitive) to ibandronic acid or to any of the other components of Ibandronic Acid Kern Pharma.
• 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.

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

Take special care with Ibandronic Acid Kern Pharma

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

• If you have a mineral metabolism disorder (e.g. 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.

Irritation, inflammation, or ulceration of the oesophagus (the tube connecting your mouth to your stomach) may occur, often accompanied by symptoms such as 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.

Very rarely, an adverse reaction known as 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 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 starting 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 have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
• You are taking medicines 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 Kern Pharma.

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 Kern Pharma.

Contact your doctor and dentist immediately if you experience any mouth or dental problems, such as tooth loss, pain or swelling, or difficulty healing of 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 informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains sodium as an active ingredient.

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

Use of other medicines

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

- Supplements containing calcium, magnesium, iron, or aluminium, as they may interfere with the effects of ibandronic acid.

- 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 (such as ibandronic acid). Therefore, exercise caution when taking analgesics or anti-inflammatory drugs 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 becomes less effective if taken with food.

You may drink tap water but no 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 discontinue it to take ibandronic acid.

Driving and using machines

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

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

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

3. How to take Ibandronic Acid Kern Pharma

Follow exactly the dosing instructions for ibandronic acid given to you by your doctor. If you have any doubts, consult your doctor or pharmacist.

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

- Take one tablet of Ibandronic Acid Kern Pharma 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 the same day of the week (such as the first Sunday of each month). Choose whichever best fits your routine.

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

• Take the ibandronic acid tablet

- immediately after 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 the tablet in your mouth.

• During the following hour (60 minutes) after taking the tablet:

- Do not lie down; if you do not remain upright (sitting or standing), part of the medication could flow back into the esophagus.

- Do not eat anything.

- Do not drink anything (except tap water, if needed).

- Do not take any other medication.

• After waiting one hour, you may eat your breakfast and drink your first beverage of the day. Once you have eaten, you may lie down if desired and take any other medications you need.

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

Continuation of treatment with Ibandronic Acid Kern Pharma

It is important that you take ibandronic acid every month, as directed by your doctor.

Ibandronic Acid Kern Pharma helps treat osteoporosis only as long as you continue taking the medication.

If you take more Ibandronic Acid Kern Pharma than you should

If you have accidentally taken an extra tablet, drink a full glass of milk and contact your doctor immediately.

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

In case of overdose or accidental ingestion, call the Toxicology Information Service at telephone: 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 on the morning of your chosen day, do not take the tablet later in the day. 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 your 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 on the morning after the day 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 tablets within the same week.

4. Possible adverse effects

Like all medicines, Ibandronic Acid Kern Pharma may produce adverse effects, although not everyone experiences them.

These side effects may occur with certain frequencies, defined as follows:

• very common: affects more than 1 in 10 people
• common: affects between 1 and 10 in every 100 people
• uncommon: affects between 1 and 10 in every 1,000 people
• rare: affects between 1 and 10 in every 10,000 people
• very rare: affects fewer than 1 in every 10,000 people
• not known: frequency cannot be estimated from available data

Common side effects include heartburn (a burning sensation rising from the stomach to the mouth), indigestion, diarrhoea, stomach pain, and nausea.

Ibandronic acid may also irritate the oesophagus, although this reaction can usually be avoided if the dose is taken as directed in the leaflet. 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 are rash, muscle cramps, muscle and joint pain, and headache.

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

Uncommon side effects include dizziness, back pain, flatulence, and symptoms of low blood calcium levels (hypocalcaemia), including muscle cramps or spasms and/or tingling sensations in the fingers or around the mouth.

Rare side effects may include swelling and itching of the face, lips, and mouth.

Atypical femoral fractures (thigh bone fractures) may occur rarely, particularly in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early warning signs indicating a possible femur fracture.

Very rare adverse effects: Consult your doctor if you experience ear pain, ear discharge, or ear infection. These could be symptoms of damage to the bones of the ear.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid Kern Pharma

Keep out of the sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Ibandronic Acid Kern Pharma

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

Appearance of the product and contents of the pack:

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

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

Only certain 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 the most recent revision of this leaflet: June 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/