IBANDRONIC ACID RATIOPHARM 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibandronic Acid ratiopharm 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Ibandronic Acid ratiopharm and what is it used for
2. What you need to know before you take Ibandronic Acid ratiopharm
3. How to take Ibandronic Acid ratiopharm
4. Possible side effects
5. Storage of Ibandronic Acid ratiopharm
6. Contents of the pack and other information

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

Ibandronic acid belongs to a group of medicines known as bisphosphonates.

It contains the active substance ibandronic acid.

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 cannot see or appreciate the difference. Ibandronic acid may help reduce the number of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed ibandronic acid to treat your post-menopausal osteoporosis because you are at high risk of suffering fractures. Osteoporosis is a condition where bones become thinner and weaker, often occurring in women after menopause. During menopause, the ovaries stop producing the female hormone, estrogen, which helps maintain bone health.

The earlier a woman reaches menopause, the higher her risk of suffering fractures due to osteoporosis. 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 exercises,
• family history of osteoporosis

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. What you need to know before you take Ibandronic Acid ratiopharm

Do not take Ibandronic Acid ratiopharm:

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• if you have certain problems with your throat/esophagus, such as narrowing or difficulty swallowing.
• if you cannot stay upright, either standing or sitting, for at least one hour (60 minutes).
• if you have or have had low calcium levels in your blood. Please consult your doctor.

Warnings and precautions

A very rare 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 for osteoporosis. ONJ may 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.

Atypical fractures of long bones, such as the forearm (ulna) and shin (tibia), have also been reported in patients receiving long-term treatment with ibandronic acid. These fractures occur after minimal or no trauma, and some patients experience pain in the fracture area before presenting a complete fracture.

Before receiving treatment, inform your doctor or pharmacist 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 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 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 ibandronic acid.

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

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 ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

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

• if you have any mineral metabolism disorder (such as vitamin D deficiency).
• if you have any kidney problems.
• if you have any swallowing or digestive problems.

Irritation, inflammation, or ulceration of the throat/esophagus 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 and inform your doctor immediately (see section 3).

Children and adolescents

Do not give ibandronic acid to children or adolescents under 18 years of age.

Using Ibandronic Acid ratiopharm with other medicines

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. Especially:

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the effects of ibandronic acid.

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) that can irritate the stomach and intestine, like ibandronic acid. Therefore, be very careful when taking analgesics or anti-inflammatory drugsat the same time as ibandronic acid.

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

Taking Ibandronic Acid ratiopharm with food and drinks

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

You can drink water but no other liquids.

After taking Ibandronic Acid ratiopharm, wait 1 hour before taking your first meal and other drinks (see section 3. How to take Ibandronic Acid ratiopharm).

Pregnancy and breastfeeding

Ibandronic Acid ratiopharm is only for use in postmenopausal women and should not be taken by women of childbearing age.

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

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

You can drive and use machines as ibandronic acid is not expected to have a significant effect on your ability to drive and use machines.

Ibandronic Acid ratiopharm contains lactose

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

Ibandronic Acid ratiopharm contains sodium

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

3. How to take Ibandronic Acid ratiopharm

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again.

The usual dose of ibandronic acid 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 ratiopharm 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 your last meal or drink, except water.

• 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 water(at least 180 ml).

Do nottake the tablet with water with high calcium content, fruit juice, or other drinks. If there is concern about high calcium levels in tap water (hard water), it is recommended to use bottled water with low mineral content.

• Swallow the tablet whole-do not chew, 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 remain upright (standing or sitting), part of the medicine may return to the esophagus

• do not eat anything

• do not drink anything(except 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, if you wish, lie down and take any other medicines you need.

Continuation of treatment with Ibandronic Acid ratiopharm

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

After 3-5 years of taking ibandronic acid, consult your doctor to see if you should continue taking it.

If you take more Ibandronic Acid ratiopharm than you should

If you accidentally take too many tablets, drink a full glass of milk and contact your doctor immediately.

Do not induce vomiting and do not lie down-this may cause ibandronic acid to irritate your esophagus.

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

If you forget to take Ibandronic Acid ratiopharm

• 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 you forgot to take the tablet on your chosen day and your next dose is due in1 to7 days...

Never take two ibandronic acid tablets within the same week. 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 you forgot to take the tablet on your chosen day and your next dose is due in more than 7 days...

Take a tablet the next morning after the day you remember you missed the dose; then, continue taking one tablet per month according to the days marked on your calendar.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

Uncommon(may affect up to 1 in 100 people):

• severe chest pain, severe pain when swallowing food or drink, severe nausea, or vomiting, difficulty swallowing. You may have severe inflammation of the throat/esophagus, possibly with ulcers or narrowing of the throat/esophagus.
• 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(may affect up to 1 in 1,000 people):

• itching, swelling of the face, lips, tongue, and throat, with difficulty breathing
• persistent eye pain and inflammation
• pain, weakness, or discomfort in the thigh, hip, or groin. These may be early symptoms of a possible fracture of the femur

Very rare(may affect up to 1 in 10,000 people):

• pain or ulcers in the mouth or jaw. You may have the first symptoms of serious jaw problems, such as necrosis (dead bone tissue) in the jawbone
• 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
• potentially life-threatening allergic reaction
• severe skin reactions

Other possible side effects

Common(may affect up to 1 in 10 people):

• headache
• heartburn, discomfort when swallowing, stomach pain or abdominal pain (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses)
• pain in the muscles, bones, and joints, muscle cramps, joint stiffness, and limb discomfort
• flu-like symptoms, including fever, chills, and shivers, feeling unwell, bone, muscle, and joint pain. Consult your nurse or doctor if any effect becomes bothersome or lasts more than a couple of days
• skin rash

Uncommon(may affect up to 1 in 100 people)

• dizziness

• flatulence (bloating, feeling of bloating)
• back pain
• feeling tired and exhausted
• asthma attacks
• 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(may affect up to 1 in 1,000 people):

• inflammation of the duodenum (first section of the intestine) that causes stomach pain
• hives

Frequency not known(cannot be estimated from the available data):

• fractures of long bones (see section 2)

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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 required. This will help protect the environment.

6. Container Content and Additional Information

Composition ofIbandronic Acidratiopharm

The active ingredient is 150 mg of ibandronic acid.

The other components (excipients) are: lactose monohydrate, crospovidone (E-1202), microcrystalline cellulose (E-460), anhydrous colloidal silica (E-551), sodium stearyl fumarate (tablet core); polyvinyl alcohol, macrogol/PEG 3350, talc (E-553b), and titanium dioxide (E-171) (coating).

Appearance of the Product and Container Content

Film-coated tablets, white or almost white, oblong in shape, marked with the inscription “I9BE” on one side and “150” on the other.

They are available in packs of 1, 3, 7, or 14 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas Madrid

Manufacturer

Synthon BV

Microweg 22,

6545CM Nijmegen (Netherlands)

or

Synthon Hispania SL

Castelló 1, Polígono Las Salinas,

08830 Sant Boi de Llobregat (Spain)

or

Merckle GmbH

Ludwig-Merckle-Straße 3,

89143 Blaubeuren (Germany)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Ibandronsäure ratiopharm 150 mg Filmtabletten

Austria: Ibandronsäure ratiopharm 150 mg Filmtabletten

Spain: Ácido Ibandrónico ratiopharm 150 mg film-coated tablets EFG

Finland: Ibandronic acid ratiopharm 150 mg

Luxembourg: Ibandronic acid ratiopharm 150 mg

Netherlands: Ibandroninezuur ratiopharm 150 mg, tablets

Portugal: Ácido Ibandrónico ratiopharm 150 mg tablets

Date of the Last Revision of this Leaflet:January 2025

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