Leaflet: information for the user

Bonviva

150 mg film-coated tablets Ibandronic acid

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have similar symptoms to yours, 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.

Contents of the leaflet:

1. What Bonviva is and what it is used for
2. What you need to know before you start taking Bonviva
3. How to take Bonviva
4. Possible side effects
5. Storage of Bonviva
6. Contents of the pack and additional information

Bonviva belongs to a group of medications known as bisphosphonates. It contains the active ingredient ibandronate acid.

Bonviva can 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. Bonviva can help reduce the likelihood of bone fractures. This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed Bonviva to treat your postmenopausal osteoporosis because you have a high risk of suffering fractures. Osteoporosis is characterized by a thinning and weakening of the bones, a common condition among women after menopause. During menopause, the ovaries stop producing the female hormoneestrogenthat 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:

• insufficient calcium and vitamin D intake in the diet
• smoking or excessive alcohol consumption
• limited walking or other weight-bearing exercises
• 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
• walking or any other weight-bearing exercise
• not smoking and not drinking too much alcohol

Do not take Bonviva:

• If you are allergic to ibandronate or any of the other components of this medication (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 Bonviva for osteoporosis. ONJ can 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.

Also, atypical fractures of long bones, such as the forearm bone (ulna) and shin bone (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 presenting a complete fracture.

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 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 can 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 medications called corticosteroids (such as prednisolone or dexamethasone)
• If you have cancer.

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

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

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 Bonviva. Consult your doctor before taking Bonviva:

• If you have any mineral metabolism disorder (e.g., vitamin D deficiency)
• If your kidneys do not function normally
• If you have any swallowing problems or digestive issues.

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 Bonviva. If you develop these symptoms, stop taking Bonviva and inform your doctor immediately (see section 3).

Children and adolescents

Do not administer Bonviva to children or adolescents under 18 years old.

Other medications and Bonviva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Especially:

• Supplements containing calcium, magnesium, iron, or aluminumas they may influence the effects of Bonviva.

• Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen) that may irritate the stomach and intestines; just like Bonviva. Therefore, be careful when taking painkillers or anti-inflammatory medications at the same time as Bonviva.

After taking the monthly Bonviva tablet,wait 1 hour to take any other medication,including antacids, calcium supplements, or vitamins.

Bonviva with food and drinks:

Do not take Bonviva with food.Bonviva loses its effectiveness if taken with food.

You may drink water but not other liquids.

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

Pregnancy and breastfeeding

Bonviva is only for use in postmenopausal women, and they should not take it. Do not take Bonviva if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using this medication.

Driving and operating machines

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

Bonviva contains lactose.

If your doctor has indicated 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 indicated by your doctor. In case of doubt, consult with your doctor or pharmacist.

The usual dose of Bonviva is one tablet per month. How to take the monthly tablet

It is essential that you follow these instructions carefully. They are designed to facilitate Bonviva's quick arrival in the stomach and cause less irritation.

Arrive in the stomach and cause less irritation.

• Take one Bonviva 150 mg tablet once a month
• Choose the day of the monththat is easiest for you to remember. You can choose the same date (either the first day of each month) or always the same day (such as the first Sunday of each month) to take your Bonviva tablet. Choose what best fits your routine
• Take the Bonviva tabletafter a minimum of 6 hours after the last meal or drink,except for water

• Take the Bonviva tablet
• As soon as you wake up
• Before taking any food or drink(with an empty stomach)

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

Do nottake the tablet with water with a high concentration of calcium, fruit juice, or other beverages. If you have any doubts about the potential high calcium levels of tap water (hard water), it is recommended to use bottled water with low mineral content.

• Swallow the tablet whole, do not chew, crush, or leave it to dissolve in the mouth.

• During the hour following (60 minutes) after ingesting the tablet
• do not lie down; if you do not remain upright (standing or sitting), part of the medication could return to the esophagus

• 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 Bonviva treatment

It is essential that you take Bonviva every month, for the time your doctor prescribes. After 5 years of taking Bonviva, consult with your doctor if you should continue taking Bonviva.

If you take more Bonviva than you should

If you have taken, by mistake, one or more tablets, drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie downbecause you could irritate the esophagus.

If you forget to take Bonviva

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

?If you forget to take the tablet on your chosen day and your next dose is within 1 to 7 days…

Never take two Bonviva 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.

?If you forget to take the tablet on your chosen day and your next dose is more than 7 days…

Take one 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):

• Intense chest pain, intense difficulty swallowing food or drink, intense nausea or vomiting, difficulty swallowing. You may have intense inflammation, possibly with pain or constriction, in 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
• New pain, weakness, or discomfort in the thigh, hip, or groin. These may be early signs of an unusual fracture of the thigh bone

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

• Pain or sensation of pain in the mouth or jaw. These may be early signs of serious jaw problems [jaw necrosis (death of bone tissue) of the jawbone]
• Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These may be signs of damage to the ear bones
• Severe allergic reaction that may be life-threatening
• Severe adverse reactions in the skin

Other possible side effects

Common(may affect up to 1 in 10 people)

• Headache
• Heartburn, difficulty swallowing, stomach pain or cramps (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses)
• Muscle cramps, joint stiffness and extremities
• Flu-like symptoms, 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

Rare(may affect up to 1 in 100 people)

• Dizziness
• Flatulence (gas, feeling bloated)
• Back pain
• Sensation of fatigue and exhaustion
• Asthma attack
• 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

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

• Inflammation of the duodenum (first section of the intestine) causing stomach pain
• Urticaria

Reporting 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 thesnational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children. No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Bonviva:

• The active ingredient is ibandronate acid. Each tablet contains 150 mg of ibandronate acid (in the form of 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 contents of the packaging

Bonviva tablets are white or off-white, have an oblong shape, and the inscription “BNVA” on one face and “150” on the other face. They may be supplied in packs of 1 or 3 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer Marketing Authorization Holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers,

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Responsible Manufacturer

IL CSM Clinical Supplies Management GmbH

Marie-Curie-Strasse 8

Lörrach

Baden-Württemberg

79539, Germany

Atnahs Pharma Denmark ApS,

Copenhagen Towers,

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Last review date of this leaflet

The detailed information on this medicine is available on the European Medicines Agency websitehttp://www.ema.europa.eu

PLANNING THE TAKING OF BONVIVA

The dose of Bonviva is one tablet per month. Choose a day of the month that is easy to remember: either the same date (such as the first day of each month)

or always the same day (such as the first Sunday of each month).

It is essential to take Bonviva every month.