Bondronat 50 mg comprimidos recubiertos con pelicula

Package Insert: Information for the Patient

Bondronat 50 mg Film-Coated Tablets

ibandronic acid

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

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

Table of Contents:

1. What is Bondronat and for what it is used
2. What you need to know before starting to take Bondronat
3. How to take Bondronat
4. Possible adverse effects
5. Storage of Bondronat
6. Contents of the package and additional information

Bondronat contains ibandronate as its active ingredient. This belongs to a group of medicines called bisphosphonates.

Bondronat is used in adults and has been prescribed if you have breast cancer that has spread to the bones (bone metastases).

• It helps prevent your bones from breaking (fractures)
• It helps prevent other bone problems that may require surgery or radiation therapy.

Bondronat works by reducing the amount of calcium lost from your bones. This helps slow down your bones becoming weaker.

Do not take Bondronat

• if you are allergic to ibandronate or any of the other components of this medication listed in section 6
• if you have problems with the tube where food passes through (esophagus), such as narrowing or difficulty swallowing
• if you cannot remain upright, both standing and sitting, for at least one hour in a row (60 minutes)
• if you have or have had low levels of calcium in your blood

Do not take this medication if something mentioned above happens to you. If you are unsure, consult your doctor or pharmacist before taking Bondronat.

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 Bondronat for cancer-related disorders. ONJ may also appear after stopping treatment.

It is essential to prevent the development of ONJ since 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/nurse (healthcare professional) if:

• You have problems in your mouth or teeth, such as poor dental health, gum disease, or planned tooth extraction
• You do not receive regular 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 corticosteroid medications (such as prednisolone or dexamethasone)
• You have cancer

Your doctor may ask you to undergo a dental examination before starting treatment with Bondronat.

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 fixed. 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 taking Bondronat.

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.

Atypical fractures of long bones, such as the forearm (radius) and shinbone (tibia), have been reported in patients receiving long-term treatment with ibandronate. These fractures occur after minor trauma or no trauma at all, and some patients experience pain in the area of the fracture before a complete fracture occurs.

Consult your doctor or pharmacist before taking Bondronat:

• if you are allergic to any other bisphosphonate
• if you have any swallowing problems or digestive issues
• if you have high or low levels of vitamin D or any other mineral
• if you have kidney problems

It may cause irritation, inflammation, or ulceration of the throat/tube where food passes through (esophagus), often with symptoms of intense chest pain, intense pain after swallowing food and/or drink, intense nausea, or vomiting, especially if you do not drink a full glass of water and/or if you lie down before an hour after taking Bondronat. If you develop these symptoms, stop taking Bondronat and inform your doctor immediately (see sections 3 and 4).

Children and adolescents

Bondronat should not be used in children and adolescents under 18 years old.

Use of Bondronat with other medications

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication. This is because Bondronat may affect how other medications work. Other medications may also affect how Bondronat works.

Specifically, inform your doctor or pharmacistif you are taking any of the following medications:

• supplements containing calcium, magnesium, iron, or aluminum
• acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (NSAIDs) called "AINEs," such as ibuprofen or naproxen. This is because both AINEs and Bondronat can irritate the stomach and intestines
• a type of injected antibiotic called "aminoglycoside" such as gentamicin. This is because both aminoglycosides and Bondronat can decrease the amount of calcium in the blood.

The use of medications that reduce stomach acidity, such as cimetidine and ranitidine, may slightly increase the effects of Bondronat.

Bondronat with food and drinks

Do not take Bondronat with food or other beverages except water, as Bondronat loses effectiveness if taken with food or beverages (see section 3).

Take Bondronat at least 6 hours after the last meal, drink, or any other medication or supplement (e.g., products containing calcium (milk), aluminum, iron, and magnesium) except water. And after taking the tablet, wait at least 30 minutes before taking the first food, drink, or taking any medication or supplement (see section 3).

Pregnancy and breastfeeding

Do not take Bondronat if you are pregnant, planning to become pregnant, or breastfeeding.

Consult your doctor or pharmacist before taking this medication

Driving and operating machinery

You may drive and use machines since it is expected that Bondronat will have no effect or a negligible effect on your ability to drive and use machines. Inform your doctor first if you want to drive, use machines, or tools.

Bondronat contains lactose.

If your doctor has told you that you cannot tolerate or digest some sugars (e.g., if you have galactose intolerance, lactase deficiency, or problems with glucose-galactose absorption), consult your doctor before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Take the tablet after a minimum of 6 hours after the last meal, drink or any other medication or supplement except water. Do not take with water with a high concentration of calcium. If you have doubts about the potentially high levels of calcium in tap water (hard water), it is recommended to use bottled water with low mineral content.

Your doctor may perform periodic blood tests while taking Bondronat. This is to check that you are receiving the correct amount of this medication.

Administration of this medication

It is essential to take Bondronat at the right time and in the right way. This is because it may cause irritation, inflammation, or ulcers in the tube through which food passes/gullet (esophagus).

You can help reduce this by doing the following:

• Take your tablet as soon as you get up that day before taking your first meal, drink, or any medication or supplement

• Take the tablet with a full glass of water (approx. 200 ml). Do not ingest the tablet with a drink that is not water

• Swallow the tablet whole. Do not chew, suck, or crush the tablet. Do not let the tablet dissolve in your mouth

• After taking the tablet, you will have to wait at least 30 minutes. After that, you can take your first meal and drink and take any other medication or supplement

• Remain upright (standing or sitting) when taking the tablet and during the next hour (60 minutes). If you do not do this, part of the medication may return to the tube through which food passes/gullet (esophagus).

Amount to be taken

The usual dose of Bondronat is one tablet a day. If you have moderate kidney problems, your doctor should reduce your dose to one tablet every two days. If you have severe kidney problems, your doctor should reduce your dose to one tablet a week.

If you take more Bondronat than you should

If you take too many tablets, inform your doctor or go to the hospital immediately. Drink a full glass of milk before going. Do not induce vomiting and do not lie down.

If you forget to take Bondronat:

Do not take a double dose to compensate for the missed doses. If you are taking one tablet a day, skip that dose. Then continue with the usual dose the next day. If you are taking one tablet every two days or one tablet a week, consult your doctor or pharmacist.

If you interrupt the treatment with Bondronat

Continue taking Bondronat until your doctor tells you to. The medication will only work if you take it during that time.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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:

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

• Sensation of dizziness, stomach burning, and discomfort when swallowing (inflammation of the tube through which food passes/ throat)

Infrequent(may affect up to 1 in 100 people)

• Severe stomach pain. It could be a sign of bleeding ulcers in the first section of the intestine (duodenum) or stomach inflammation (gastritis).

Rare(may affect up to 1 in 1,000 people)

• Persistent eye pain and inflammation
• New pain, weakness, or discomfort in the thigh, hip, or groin. They may be early symptoms of an unusual bone fracture in the thigh.

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

• Pain or sensation of pain in the mouth or jaw. They may be early symptoms of severe jaw problems [necrosis (death of bone tissue) of the jawbone]
• Consult your doctor if you have ear pain, discharge from the ear, or ear infection. These may be symptoms of damage to the ear bones
• Itching, swelling of the face, lips, tongue, and throat, with difficulty breathing. You may be having a severe allergic reaction that can be life-threatening
• Severe adverse reactions in the skin

Of unknown frequency (may be estimated with available data)

• Asthma attack

Other possible side effects

Frequent(may affect up to 1 in 10 people)

• Abdominal pain, indigestion
• Decreased calcium levels in the blood
• Weakness

Infrequent(may affect up to 1 in 100 people)

• Chest pain
• Itching or tingling sensation in the skin (paresthesia)
• Symptoms similar to the flu, usually with general discomfort or pain
• Dry mouth, bad taste in the mouth, or difficulty swallowing
• Anemia (low blood count)
• High levels of urea or parathyroid hormone in the blood

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theApéndice V. 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 medication after the expiration date that appears on the blister pack and on the outer packaging after CAD. The expiration date is the last day of the month indicated
• Store in the original packaging to protect it from moisture
• Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Bondronat

• The active ingredient is ibandronate acid. Each film-coated tablet contains 50 mg of ibandronate acid (as sodium monohydrate).

The other components are:

• tablet core: lactose monohydrate, povidone, microcrystalline cellulose, crospovidone, purified stearic acid, anhydrous colloidal silica
• tablet coating: hypromellose, titanium dioxide (E 171), talc, macrogol 6000.

Appearance of the product and content of the container

The film-coated tablets are oblong in shape, white to off-white in color, and have the following imprint: L2/IT. They are presented in containers of 28 and 84 tablets. It is possible that not all containers are marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Atnahs Pharma Netherlands B.V.

Copenhagen Towers,

Ørestads Boulevard 108, 5th floor

DK-2300 København S

Denmark

Responsible for manufacturing

IL CSM Clinical Supplies Management GmbH

Marie-Curie-Strasse 8

Lörrach

Baden-Württemberg

79539, Germany

Atnahs Pharma Denmark ApS

Copenhagen Towers,

Ørestads Boulevard 108, 5th floor

DK-2300 København S

Denmark

Last review date of this leaflet: MM/AAAA

The detailed information on this medicine is available on the website of the European Medicines Agencyhttp://www.ema.europa.eu.