BONVIVA 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Bonviva

150 mg film-coated tablets Ibandronic acid

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Bonviva and what is it 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 cannot see or feel the difference. Bonviva may help reduce the likelihood of bone fractures. This reduction has been shown in spinal fractures but not in hip fractures.

You have been prescribed Bonviva to treat your postmenopausal osteoporosis because you are at high risk of fractures. Osteoporosis is a condition where bones become thinner and weaker, which is common in women after the menopause. During the menopause, the ovaries stop producing the female hormone oestrogen, which helps to keep bones healthy.

The earlier a woman reaches the menopause, the higher her risk of fractures due to osteoporosis. Other factors that increase the risk of fractures are:

• inadequate intake of calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• little weight-bearing exercise, such as walking
• family history of osteoporosis.

Healthy lifestyle habitsalso help the beneficial effects of treatment. These include:

• a balanced diet rich in calcium and vitamin D
• walking or other weight-bearing exercise
• not smoking and not drinking too much alcohol.

2. What you need to know before you take Bonviva

Do not take Bonviva:

• if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6)
• if you have certain problems with your gullet (oesophagus), such as narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least one hour (60 minutes)
• if you have or have had low blood calcium levels. Please consult your doctor.

Warnings and precautions

A very rare side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in patients treated with Bonviva for osteoporosis. ONJ can also occur after stopping treatment.

It is important to try 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.

Atypical fractures of long bones, such as the forearm (cubitus) and shinbone (tibia), have also been reported in patients receiving long-term treatment with ibandronate. 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 treatment, inform your doctor/nurse (healthcare professional) if:

• you have dental problems or are about to undergo dental surgery
• you do not receive regular dental check-ups 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 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 you are being treated, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups. If you wear dentures, you should ensure they fit properly. 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 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 need special care when taking Bonviva. Consult your doctor before taking Bonviva:

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

Irritation, inflammation or ulceration of the gullet (oesophagus) may occur, often with symptoms of severe chest pain, severe pain after swallowing food or drink, severe nausea or vomiting, especially if patients do not drink a full glass of water and/or if they lie down less than 60 minutes after taking Bonviva. If you develop these symptoms, stop taking Bonviva and inform your doctor immediately (see section 3).

Children and adolescents

Do not give Bonviva to children or adolescents under 18 years of age.

Other medicines and Bonviva

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:

• supplements containing calcium, magnesium, iron or aluminiumas they may affect the action of Bonviva.

• aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium and naproxen) which may irritate the stomach and intestines, as does Bonviva. Therefore, be careful 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 or vitamin supplements.

Bonviva with food and drinks:

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

You can drink water but not other liquids.

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

Pregnancy and breast-feeding

Bonviva is 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 breast-feeding.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

You can drive and use machines as Bonviva is not expected to affect your ability to drive or use machines.

Bonviva contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Bonviva

Follow exactly the instructions for administration of this medicine as given by your doctor. If you are not sure, consult your doctor or pharmacist.

The usual dose of Bonviva is one tablet once a 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 and cause less irritation.

• Take one Bonviva 150 mg tablet once a month
• Choose a day of the monththat you can easily remember. You can choose the same date (e.g. the first day of each month) or always the same day (e.g. the first Sunday of each month) to take your Bonviva tablet. Choose what best fits your routine
• Take the Bonviva tablet after an interval of at least 6 hours after the last food or drink, except for water

• Take the Bonviva tablet
• immediately after waking up
• 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 with a high concentration of calcium, fruit juice or other drinks. If you are unsure about the 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 let it dissolve in your mouth.

• During the next hour (60 minutes) after taking the tablet
• do not lie down; if you do not stay upright (standing or sitting), part of the medicine could come back up into the oesophagus

• After waiting 1 hour, you can have your breakfast and your first drink of the day. Once you have eaten, you can, if you wish, lie down and take any other medicines 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 see if you should continue taking Bonviva.

If you take more Bonviva than you should

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

Do not induce vomiting or lie downbecause this could irritate the oesophagus.

If you forget to take Bonviva

If you forget to take the tablet on the morning of the day you have chosen, do not take it later

Instead, consult your calendar to see when your next dose is due

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Never take two Bonviva tablets within the same week. Wait until your next dose is due and take it as usual, then take one tablet per month according to the days marked on your calendar.

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Take one tablet the next morning after the day you remember you forgot the dose, then take one tablet per month according to the days marked on your calendar

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you notice any of the following serious side effects, as you may need 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 a feeling of pain or constriction, in the gullet (oesophagus)

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 can be early symptoms of a possible unusual fracture of the thigh bone

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

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

Other possible side effects

Common(may affect up to 1 in 10 people)

• Headache
• Heartburn, discomfort when swallowing, stomach pain or abdominal pain (due to stomach inflammation), indigestion, nausea, diarrhoea (loose stools)
• Muscle cramps, stiffness of joints and limbs
• 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 troublesome or lasts more than a couple of days
• Rash

Uncommon(may affect up to 1 in 100 people)

• Dizziness
• Wind (flatulence, feeling bloated)
• Back pain
• Feeling tired and exhausted
• Asthma attack
• Symptoms of low blood calcium levels (hypocalcaemia) 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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, 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 which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Bonviva contains:

• The active substance is ibandronic acid. Each tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
• The other ingredients 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 and packaging

Bonviva tablets are white or almost white, oblong and have the inscription “BNVA” on one side and “150” on the other side. They can be supplied in packs of 1 or 3 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Atnahs Pharma Netherlands B.V.

Copenhagen Towers,

Ørestads Boulevard 108, 5.tv

DK-2300 København S

Denmark

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

Date of last revision of this leaflet

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

PLANNING THE INTAKE OF BONVIVA

The dose of Bonviva is one tablet per month. Choose a day of the month that you can easily remember: either the same date (e.g. the first day of each month)

or always the same day (e.g. the first Sunday of each month).

It is important to take Bonviva every month.