Leaflet: information for the user

Ibandronic Acid ratiopharm 150 mg film-coated tablets

Read the entire leaflet carefully before starting to take the medicine

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to 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 additional information

Ibandronic acid belongs to a group of medications known asbisphosphonates.

It contains the active ingredient ibandronic acid.

Ibandronic acid may 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 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 have a high risk of suffering fractures.Osteoporosis is a condition characterized by thinning and weakening of the bones, a common occurrence 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 greater 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,

- lack of weight-bearing exercise,

- family history of osteoporosis

A healthy lifestyle also facilitates the favorable effects of treatment. These include:

• a balanced diet rich in calcium and vitamin D
• weight-bearing exercise
• not smoking and moderate alcohol consumption.

Do not take Ibandronic Acidratiopharm:

• if you areallergic to ibandronic acid or any of the other ingredientsof this medicine (listed in section 6).
• if you have certain problems with your throat/food pipe (esophagus) 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 levels of calcium in your blood. Please consult your doctor.

Warnings and precautions

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 ibandronic acid for osteoporosis. ONJ may also appear after stopping treatment.

It is essential to prevent the development of ONJ as 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 or pharmacist if:

• you have problems in your mouth or teeth, such as poor dental health, gum disease, or a planned tooth extraction.
• if you do not receive regular dental care or if you have not had a dental check-up for a long time.
• if you are a smoker (as this may 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 corticosteroid medications (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.

While on treatment, you should maintain good oral hygiene (including regular brushing of your teeth) and undergo regular 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 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 in 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.

It may cause irritation, inflammation, or ulceration of the throat/food pipe (esophagus), often with symptoms of 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 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 old.

Use of Ibandronic Acid ratiopharm with other medicines

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

• Calcium, magnesium, iron, or aluminum supplements,as they may possibly influence the effects of ibandronic acid.

• Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) that may irritate the stomach and intestines; like ibandronic acid). Be careful when takinganalgesics or anti-inflammatoryat 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 its effectiveness if taken with food.

You may drink water but not 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 they should not take it if they are fertile.

Do not takeIbandronic Acidratiopharm if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machines

You may drive and operate machines as it is expected that ibandronic acid will have no effect or a negligible effect on your ability to drive and operate machines.

Ibandronic Acid ratiopharm contains lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult him before taking this medicine.

Ibandronic Acid ratiopharm contains sodium

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

Follow the exact administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The normal dose of ibandronate 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 ibandronate acid reaches the stomach quickly and causes less irritation.

• Take one tablet ofIbandronate Acidratiopharm once a month..
• Choose the day of the monththat is easiest for you to remember.You can 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 what best suits your routine.
• Take the ibandronate acid tabletafter a minimum of 6 hours from the last meal or drinkexcept water.

• Take the ibandronate acid tablet:
• nothing more than upon waking, and
• before breakfast or ingesting liquids(with an empty stomach)

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

Do nottake the tablet with water high in calcium, fruit juice, or other beverages. If there is concern about high levels of calcium 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 hour following (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 water, if needed)
• do not take any other medication

• After waiting 1 hour, you can take breakfast and the first drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medications you need.

Continuation of treatment withIbandronate Acidratiopharm

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

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

If you take moreIbandronate Acidratiopharm than you should

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

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

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

If you forget to takeIbandronate Acidratiopharm

• 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.

• Ifyou forgot to take the tablet on your chosen day andyour next dose is within1 to7 days...

Never take two ibandronate acid tablets within the same week. Wait until it is time to take the next dose and take it as usual, then go back to taking one tablet a month according to the marked days on your calendar.

• Ifyou forgot to take the tablet on your chosen day andyour next dose is more than 7 days...

Take a tablet the morning after the day you remember forgetting the dose; then go back to taking one tablet a month according to the marked days on your calendar.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• Severe chest pain, intense pain when swallowing food or drink, intense nausea or vomiting, difficulty swallowing. You may have a severe inflammation of the throat/food pipe, possibly with ulcers or constriction of the throat/food pipe.

Uncommon(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 and indicative of a possible femur fracture.

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

• Pain or ulcer 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 may be symptoms of damage to the ear bones
• Potentially life-threatening severe allergic reaction
• Severe adverse reactions in the skin.

Other possible side effects:

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

• Headache
• Heartburn, discomfort when swallowing, stomach pain or cramps (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses)
• Muscle cramps, joint stiffness and extremities
• Symptoms similar to the flu, including fever, chills, and shivering, feeling unwell, bone and muscle pain, and joint pain. Consult your nurse or doctor if any effect becomes bothersome or lasts more than two days.
• Skin rash

Uncommon(may affect up to 1 in 100 people)

• Dizziness

• Flatulence (gas, feeling bloated)
• 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 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
• Urticaria

Reporting of side effects:

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

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

Do not use this medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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 (core of the tablet); polyvinyl alcohol, macrogol/PEG 3350, talc (E-553b) and titanium dioxide (E-171) (coating).

Appearance of the product and contents of the package

Coated tablets, white or off-white in color, oblong in shape, marked with the inscription “I9BE” on one face and “150”on the other.

They are presented in packages of 1, 3, 7 or 14 tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva Pharma, S.L.U.

c/ Anabel Segura 11, Edificio Albatros B 1st floor

28108 Alcobendas Madrid

Responsible for manufacturing

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-Stra?e 3,

89143 Blaubeuren (Germany)

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Ibandronsäure ratiopharm 150 mg Filmtabletten

Austria:Ibandronsäure ratiopharm 150 mg Filmtabletten

Spain:Ibandronic Acid ratiopharm 150 mg coated tablets EFG

Finland:Ibandronic acid ratiopharm 150 mg

Luxembourg:Ibandronic acid ratiopharm 150 mg

Netherlands:Ibandroninezuur ratiopharm 150 mg, tablets

Portugal:Ibandronic Acid ratiopharm 150 mg tablets

Last review date of this leaflet:October 2022

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