Ibandronate acid Ratiopharm 150 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibandronic Acid ratiopharm 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 only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ibandronic Acid ratiopharm is and what it is used for
2. What you need to know before taking Ibandronic Acid ratiopharm
3. How to take Ibandronic Acid ratiopharm
4. Possible side effects
5. How to store 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 by preventing further bone loss and increasing bone mass in most women who take it, even when they are unable to see or feel a difference. Ibandronic acid can help reduce the occurrence of bone fractures. This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

You have been prescribed ibandronic acid for the treatment of your postmenopausal osteoporosis because you are at high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, commonly occurring in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain skeletal health.

The earlier a woman reaches menopause, the greater her risk of fractures due to osteoporosis. 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.

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

Do not take Ibandronic Acid ratiopharm:

• if you are allergic to ibandronic acid or to any of the other ingredients of this medicine (listed in section 6).
• if you have certain problems with your throat/food pipe (oesophagus), such as narrowing or difficulty swallowing.
• if you cannot 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.

Warnings and precautions

Very rarely, an 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 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.

Atypical fractures of long bones, such as the forearm bone (ulna) and shin bone (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 area of the fracture before a complete fracture occurs.

Before receiving treatment, inform your doctor or pharmacist if:

• you have problems with your mouth or teeth, such as poor dental health, gum disease, or if you have 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 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.

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, make sure 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.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain or swelling, or difficulty healing of ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Some people may 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 difficulty swallowing or digestive problems.

Irritation, inflammation or ulceration of the throat/food pipe (oesophagus) may occur, often with 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 and inform your doctor immediately (see section 3).

Children and adolescents

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

Use of Ibandronic Acid ratiopharm with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. Especially:

• Calcium, magnesium, iron or aluminium-containing supplements, as they may possibly interfere with the effects of ibandronic acid.

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac and naproxen), which can irritate the stomach and intestine, just like ibandronic acid. Therefore, be very careful when taking analgesics or anti-inflammatory drugs at 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 becomes less effective if taken with food.

You may 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 intended for use only in postmenopausal women and must 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 may drive and use machines, as ibandronic acid is not expected to have any effect or its effect is negligible on your ability to drive and operate machinery.

Ibandronic Acid ratiopharm contains lactose

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.

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 exactly the instructions for use of this medicine as given by your doctor. If in doubt, 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 important that you follow these instructions carefully. They are designed to ensure that ibandronic acid reaches the stomach quickly and causes less irritation.

• Take one tablet of Ibandronic Acid ratiopharm 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 always the same day (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.

• Take the ibandronic acid tablet:

• first thing in the morning, and

• before breakfast or drinking anything (on an empty stomach)

• Swallow the tablet with a full glass of water (at least 180 ml).

Do not take the tablet with water high in calcium, fruit juice, or other beverages. 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 the mouth.

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

• do not lie down; if you do not remain upright (standing or sitting), part of the medicine could return to the oesophagus

• do not eat anything

• do not drink anything (except water, if needed)

• do not take any other medicine

• After waiting 1 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 medicines you need.

Continuing treatment with Ibandronic Acid ratiopharm

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

After 3–5 years of taking ibandronic acid, consult your doctor to determine whether you should continue treatment.

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 could cause ibandronic acid to irritate your oesophagus.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating 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 your chosen day, do not take it later in the day.

Instead, check 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 in 1 to 7 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 dates 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 one tablet the morning after you remember missing the dose; then continue taking one tablet per month according to the dates marked on your calendar.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• severe chest pain, intense pain when swallowing food or drink, severe nausea or vomiting, difficulty swallowing. You may have a serious inflammation of the throat/food passage, possibly with sores or narrowing of the throat/food passage.
• 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 indicating a possible femur fracture.

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

• pain or ulceration in the mouth or jaw. You may be experiencing early signs of serious jaw problems such as necrosis (dead bone tissue) in the jawbone.
• consult your doctor if you have ear pain, ear discharge or an ear infection. These could be symptoms of damage to the ear bones.
• severe, potentially life-threatening allergic reaction.
• serious skin adverse reactions.

Other possible adverse effects

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

• headache.
• heartburn, discomfort when swallowing, stomach or abdominal pain (due to stomach inflammation), indigestion, nausea, diarrhea (loose stools).
• muscle, bone and joint pain, muscle cramps, stiffness in joints and limbs.
• flu-like symptoms, including fever, shivering and chills, feeling unwell, bone, muscle and joint pain. Consult your nurse or doctor if any of these effects become bothersome or last more than a few days.
• skin rash.

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

• dizziness.
• flatulence (gas, bloating sensation).
• 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) causing stomach pain.
• urticaria (hives).

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

• fractures of long bones (see section 2).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you have any questions, please ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibandronic Acid ratiopharm

The active substance is 150 mg of ibandronic acid.

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

Appearance of the medicinal product and contents of the pack

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 containing 1, 3, 7 or 14 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio Albatros B, 1st floor
28108 Alcobendas, Madrid, Spain

Manufacturer

Synthon BV
Microweg 22,
6545 CM Nijmegen (The 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 European Economic Area member states under the following names:

Germany: Ibandronsäure ratiopharm 150 mg Filmtabletten
Austria: Ibandronsäure ratiopharm 150 mg Filmtabletten
Spain: Ácido Ibandrónico ratiopharm 150 mg comprimidos recubiertos con película EFG
Finland: Ibandronic acid ratiopharm 150 mg
Luxembourg: Ibandronic acid ratiopharm 150 mg
Netherlands: Ibandroninezuur ratiopharm 150 mg, tabletten
Portugal: Ácido Ibandrónico ratiopharm 150 mg comprimidos

Date of the most recent review of this leaflet: January 2025

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