Bonviva 150 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bonviva

150 mg film-coated tablets Ibandronic acid

Read the entire leaflet carefully before you start taking this medicine, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents:

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

1. What Bonviva is and what it is used for

Bonviva belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.

Bonviva can reverse bone loss because it prevents further bone loss and increases bone mass in most women who take it, even if they are unable to see or feel the difference. Bonviva can help reduce the likelihood of bone fractures. This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

You have been prescribed Bonviva to treat your postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which is common in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain skeletal health.

The earlier a woman enters 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 any other weight-bearing exercise
• not smoking and avoiding excessive alcohol consumption.

2. What you need to know before taking Bonviva

Do not take Bonviva:

• 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 passage tube (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

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 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 ibandronate. These fractures occur following minimal or no trauma, and some patients experience pain in the area of the fracture before a complete fracture occurs.

Before starting treatment, inform your doctor/nurse (healthcare professional) if:

• you have mouth or dental problems, such as poor dental health, gum disease, or 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 Bonviva.

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

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 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 are not functioning normally
• If you have any difficulty swallowing or digestive problems.

Irritation, inflammation, or ulceration of the throat/food passage tube (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 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 of age.

Other medicines and Bonviva

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

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

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen), which can irritate the stomach and intestines, just like Bonviva. Therefore, be very cautious when taking painkillers or anti-inflammatory medicines at the same time as Bonviva.

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

Bonviva with food and drinks:

Do not take Bonviva with food. Bonviva becomes less effective if taken with food.

You may drink water, but no other liquids.

After taking Bonviva, wait 1 hour before eating your first meal or drinking other beverages (see section 3 How to take Bonviva).

Pregnancy and lactation

Bonviva is intended only for use in postmenopausal women and should not be taken by women of childbearing potential. Do not take Bonviva if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and use of machines

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

Bonviva contains lactose.

If your doctor has informed you that you cannot tolerate or digest certain sugars (e.g. if you have galactose intolerance, lactase deficiency, or glucose-galactose malabsorption), consult your doctor before taking this medicine.

3. How to take Bonviva

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist.

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

It is important that you follow these instructions carefully. They are designed to help Bonviva reach the stomach quickly and cause less irritation.

• Take one Bonviva 150 mg tablet once a month

• Choose the day of the month that is easiest for you to remember. You may choose the same date (e.g. the first day of each month) or the same day of the week (e.g. the first Sunday of each month) to take your Bonviva tablet. Choose whichever best fits your routine.

• Take the Bonviva tablet after at least 6 hours have passed since your last food or drink, except water.

• Take the Bonviva tablet

• First thing in the morning

• Before taking any food or drink (on an empty stomach)

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

Do not take the tablet with water that has a high calcium concentration, fruit juice, or other beverages. If you are unsure about potentially high calcium levels in your tap water (hard water), it is recommended to use bottled water with low mineral content.

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

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

• Do not lie down; if you do not remain upright (standing or sitting), part of the medicine may flow back into the esophagus.

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

Continuation of treatment with Bonviva

It is important that you take Bonviva every month for as long as your doctor prescribes it. After 5 years of taking Bonviva, consult your doctor to determine whether you should continue taking Bonviva.

If you take more Bonviva than you should

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

Do not induce vomiting or lie down, as this could irritate the esophagus.

If you forget to take Bonviva

If you forget to take the tablet on the morning of the day you chose, do not take the tablet later.

Instead, check your calendar to see when your next dose is due.

If I forget to take the tablet on my chosen day and my next dose is within 1 to 7 days...

Never take two Bonviva tablets within the same week. Wait until it is time to take your next dose, take it as usual, then continue taking one tablet per month on the dates marked on your calendar.

?If I forget to take the tablet on my chosen day and my next dose is more than 7 days away…

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

4. Possible adverse effects

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

Tell your doctor or nurse immediately if you notice any of the following serious adverse effects, as you may require 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, possibly with pain or tightness, in the throat or food passage

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
• New pain, weakness or discomfort in the thigh, hip or groin. These may be early signs of an unusual femur (thigh bone) fracture

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

• Pain or discomfort in the mouth or jaw. These may be early signs of serious jaw problems [necrosis (death of bone tissue) of the jaw bone]
• Consult your doctor if you have ear pain, discharge from the ear, or suffer an ear infection. These could be symptoms of damage to the ear bones
• Severe allergic reaction that may be life-threatening
• Serious skin 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 bowel movements)
• Muscle cramps, stiffness in joints and limbs
• Flu-like symptoms, including fever, chills and shivering, feeling unwell, bone, muscle and joint pain. Consult your nurse or doctor if any symptom becomes bothersome or lasts more than a few days
• Skin rash

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

• Dizziness
• Flatulence (wind, bloated feeling)
• Back pain
• Feeling 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

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

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

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it concerns possible adverse reactions not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Bonviva

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

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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bonviva:

• The active substance is ibandronic acid. Each tablet contains 150 mg of ibandronic 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 contents of the pack

Bonviva tablets are white or almost white, oblong in shape, with the inscription “BNVA” on one side and “150” on the other. They may be supplied in packs containing 1 or 3 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible

Marketing Authorization Holder

Atnahs Pharma Netherlands B.V.

Copenhagen Towers,

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

Manufacturer Responsible

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

Date of the most recent review of this leaflet

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu

BONVIVA DOSING SCHEDULE

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

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

It is important to take Bonviva every month.