Bonviva

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  • Bonviva
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Staðsetning

  • Fáanlegt í:
  • Bonviva
    Evrópusambandið
  • Tungumál:
  • enska

Meðferðarupplýsingar

  • Meðferðarhópur:
  • DRUGS FOR TREATMENT OF BONE DISEASES
  • Lækningarsvæði:
  • Osteoporosis, Postmenopausal
  • Ábendingar:
  • Treatment of osteoporosis in postmenopausal women at increased risk of fracture.A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
  • Vörulýsing:
  • Revision: 24

Staða

  • Heimild:
  • EMA - European Medicines Agency
  • Leyfisstaða:
  • Authorised
  • Leyfisnúmer:
  • EMEA/H/C/000501
  • Leyfisdagur:
  • 22-02-2004
  • EMEA númer:
  • EMEA/H/C/000501
  • Síðasta uppfærsla:
  • 28-03-2019

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Send a question via our website

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© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

EMA/323898/2016

EMEA/H/C/000502

EPAR summary for the public

Bonviva

ibandronic acid

This is a summary of the European public assessment report (EPAR) for Bonviva. It explains how the

Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in

favour of granting a marketing authorisation and its recommendations on the conditions of use for

Bonviva.

What is Bonviva?

Bonviva is a medicine that contains the active substance ibandronic acid. It is available as tablets (150

mg) and as a solution for injection in a prefilled syringe (3 mg).

What is Bonviva used for?

Bonviva is used to treat osteoporosis (a disease that makes bones fragile) in women who have been

through the menopause and are at risk of developing bone fractures (breaks). Its effect in reducing the

risk of spine fractures has been shown in studies, but its effect on the risk of fractures of the neck of

the femur (the top of the thighbone) has not been established.

The medicine can only be obtained with a prescription.

How is Bonviva used?

Bonviva can be given either as a tablet or as an injection into a vein. If the tablet is used, the dose is

one tablet every month, preferably on the same date each month. The tablet should be taken after an

overnight fast, one hour before any food or drink except for water, and with a full glass of plain water.

(In areas with hard water, where tap water contains a lot of dissolved calcium, bottled water with a low

mineral content may be used.) The patient should not lie down for one hour after taking the tablet. The

dose by injection is 3 mg once every three months. Patients taking Bonviva should also take vitamin D

and calcium supplements if they do not get enough from their diet.

Bonviva

EMA/323898/2016

Page 2/3

How does Bonviva work?

Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken

down. Gradually, the bones become thin and fragile, and more likely to break. Osteoporosis is more

common in women after the menopause, when the levels of the female hormone oestrogen fall, since

oestrogen helps to keep bones healthy.

The active substance in Bonviva, ibandronic acid, is a bisphosphonate. It stops the action of the

osteoclasts, the cells that are involved in breaking down the bone tissue. Blocking the action of these

cells leads to less bone loss.

How has Bonviva been studied?

Bonviva has been studied in three main studies involving women with osteoporosis. The first study

compared Bonviva 2.5-mg tablets taken once a day with placebo (a dummy treatment) in almost

3,000 women and looked at how many new spine fractures were seen in the patients over three years.

The other two studies compared the 150-mg monthly tablets (1,609 patients) and the injections

(1,395 patients) with the 2.5-mg once-daily tablets. The studies looked at the change in the density of

the bones in the spine and the hip over two years.

The 2.5-mg once-daily tablets used in the studies are no longer authorised.

What benefit has Bonviva shown during the studies?

In the first study, daily treatment with Bonviva 2.5-mg tablets reduced the risk of new spine fractures

by 62% in comparison with placebo. The other two studies showed that the 150-mg monthly tablets

and the injections were more effective than the 2.5-mg once-daily tablets at increasing bone density in

the spine and the hip. Over two years, bone density in the spine increased by 7% with the monthly

tablets and by 6% with the injections, compared with 5% with the daily tablets. In the hip, bone

density increased by 4% with the monthly tablets and by 3% with the injections, compared with 2%

with the daily tablets.

What is the risk associated with Bonviva?

The most common side effects with Bonviva (seen in between 1 and 10 patients in 100) are arthralgia

(joint pain) and influenza (flu)-like symptoms. The most serious side effects with Bonviva are

anaphylactic reaction (severe allergic reaction), atypical fractures of the femur (an unusual type of

fracture of the bone of the upper leg), osteonecrosis of the jaw (damage to the bones of the jaw, which

could lead to pain, sores in the mouth or loosening of teeth), gastrointestinal (stomach and gut)

irritation and eye inflammation. For the full list of all side effects reported with Bonviva, see the

package leaflet.

Bonviva must not be used in patients who have hypocalcaemia (low blood calcium levels). The tablets

must not be used in patients who have abnormalities of the oesophagus or who cannot stand or sit

upright for at least an hour. For the full list of restrictions with Bonviva, see the package leaflet.

Why has Bonviva been approved?

The CHMP decided that Bonviva’s benefits are greater than its risks and recommended that it be given

marketing authorisation.

Bonviva

EMA/323898/2016

Page 3/3

What measures are being taken to ensure the safe and effective use of

Bonviva?

A risk management plan has been developed to ensure that Bonviva is used as safely as possible.

Based on this plan, safety information has been included in the summary of product characteristics and

the package leaflet for Bonviva, including the appropriate precautions to be followed by healthcare

professionals and patients.

In addition, the company that markets Bonviva will provide a card to inform patients receiving Bonviva

infusion about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they

experience symptoms.

Other information about Bonviva

The European Commission granted a marketing authorisation valid throughout the European Union for

Bonviva on 23 February 2004.

The full EPAR for Bonviva can be found on the Agency’s website: ema.europa.eu/Find medicine/Human

medicines/European public assessment reports. For more information about treatment with Bonviva,

read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2016.

Upplýsingar um fylgiseðil sjúklinga: samsetning, vísbendingar, aukaverkanir, skammtar, milliverkanir, aukaverkanir, meðgöngu, brjóstagjöf

B. PACKAGE LEAFLET

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.

What is in this leaflet

Planning when to take Bonviva

with peel-off stickers for your personal calendar

What Bonviva is and what it is used for

What you need to know before you take Bonviva

How to take Bonviva

Possible side effects

How to store Bonviva

Content 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 may reverse bone loss by stopping more loss of bone and increasing bone

mass in most women who take it, even though they won’t be able to see or feel a difference. Bonviva

may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for

the spine but not for the hip.

Bonviva is prescribed to you to treat postmenopausal osteoporosis because you have an

increased risk of fractures

. Osteoporosis is a thinning and weakening of the bones, which is common

in women after the menopause. At the menopause, a woman’s ovaries stop producing the female

hormone, oestrogen, which helps to keep her skeleton healthy.

The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis.

Other things that can increase the risk of fractures include:

not enough calcium and vitamin D in the diet

smoking, or drinking too much alcohol

not enough walking or other weight-bearing exercise

a family history of osteoporosis

A healthy lifestyle

will also help you to get the most benefit from your treatment. This includes:

eating a balanced diet rich in calcium and vitamin D

walking or any 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/food pipe (oesophagus) such as narrowing or

difficulty swallowing.

If you can’t stand or sit upright for at least one hour (60 minutes) at a time.

If you have, or had in the past low blood calcium

. Please consult your doctor.

Warnings and precautions

A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very

rarely in the post marketing setting in patients receiving Bonviva for osteoporosis. ONJ can also occur

after stopping treatment.

It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to

treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions

you should take.

Before receiving treatment, tell your doctor/nurse (health care professional) if:

you have any problems with your mouth or teeth such as poor dental health, gum disease, or a

planned tooth extraction

you don’t 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 undergo a dental examination before starting treatment with Bonviva.

While being treated, you should maintain good oral hygiene (including regular teeth brushing) and

receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you

are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor

about your dental treatment and tell 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 loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of

osteonecrosis of the jaw.

Some people need to be especially careful while they’re taking Bonviva. Talk to your doctor before

taking Bonviva:

If you have any disturbances of mineral metabolism (such as vitamin D deficiency).

If your kidneys are not functioning normally.

If you have any swallowing or digestive problems.

Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) often with symptoms of

severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting

may occur, especially if you do not drink a full glass of water and/or if you lie down within an hour of

taking Bonviva. If you develop these symptoms, stop taking Bonviva and tell your doctor straight

away (see section 3).

Children and adolescents

Do not give Bonviva to children or adolescents below 18 years.

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 aluminium

, as they could possibly

influence the effects of Bonviva.

Acetylsalicylic acid and other non-steroidal anti-inflammatory medicines (NSAIDs) (including

ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine. Bonviva

may also do so. So be especially careful if you take painkillers or anti-inflammatories while

you’re taking Bonviva.

After swallowing your monthly Bonviva tablet,

wait for 1 hour before taking any other medication

including indigestion tablets, calcium supplements, or vitamins.

Bonviva with food and drink:

Do not take Bonviva with food.

Bonviva is less effective if it’s taken with food.

You can drink water but no other drinks

After you have taken Bonviva, please wait for 1 hour before you can have your first food and further

drinks. (see 3. How to take Bonviva).

Pregnancy and breast feeding

Bonviva is for use only by postmenopausal women and must not be taken by women who could still

have a baby.

Do not take Bonviva if you are pregnant or breast feeding.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as it’s expected that Bonviva has no or negligible effect on your

ability to drive and use machines.

Bonviva contains lactose.

If you have been told by your doctor that you cannot tolerate or digest some sugars (e.g. if you have a

galactose intolerance, the Lapp lactase deficiency or have problems with glucose-galactose

absorption), talk to your doctor before taking this medicine.

3.

How to take Bonviva

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist

if you are not sure.

The usual dose of Bonviva is one tablet once a month

Taking your monthly tablet

It’s important to follow these instructions carefully. They are designed to help your Bonviva tablet

reach your stomach quickly, so it’s less likely to cause irritation.

Take one Bonviva 150 mg tablet once a month

Choose one day of the month

that will be easy to remember. You can choose either the same

date (such as the 1

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

take your Bonviva tablet. Choose the date that best fits your routine.

Take your Bonviva tablet

at least 6 hours after you last had anything

to eat or drink except

water.

Take your Bonviva tablet

after you first get up for the day

, and

before you have anything to eat or drink

(on an empty stomach)

Swallow your tablet with a full glass of water

(at least 180 ml).

Do not

take your tablet with water with a high concentration of calcium, fruit juice or any other

drinks. If there is a concern regarding potentially high levels of calcium in the tap water (hard water),

it is advised to use bottled water with a low mineral content.

Swallow your tablet whole

, do not chew it, crush it or let it dissolve in your mouth.

For the next hour (60 minutes)

after you’ve taken your tablet

do not lie down

; if you do not stay upright (standing or sitting), some of the medicine

could leak back into your oesophagus

do not eat anything

do not drink anything

(except water if you need it)

do not take any other medicines

After you’ve waited for an hour, you can have your first food and drink of the day. Once you’ve

eaten, it’s OK to lie down if you wish, and to take any other medication you need.

Continuing to take Bonviva

It’s important to keep taking Bonviva every month, as long as your doctor prescribes it for you. After

5 years of using Bonviva, please consult with your doctor whether you should continue to take

Bonviva.

If you take more Bonviva than you should

If you’ve taken more than one tablet by mistake,

drink a full glass of milk and talk to your doctor

straight away

Do not make yourself vomit, and do not lie down

— this could cause Bonviva to irritate your

oesophagus.

If you forget to take Bonviva

If you forget to take your tablet on the morning of your chosen day,

do not take a tablet later

in the day

Instead, consult your calendar and find out when your next scheduled dose is.

If you forgot to take your tablet on your chosen day and your next scheduled dose is only 1

to 7 days away…

Never take two Bonviva tablets within the same week

. You should wait until the next

scheduled dose is due and take it as normal; then, continue taking one tablet once a month on

the scheduled days you’ve marked on your calendar.

If you forgot to take your tablet on your chosen day and your next scheduled dose is more

than 7 days away…

You should take one tablet the next morning after the day you remember;

then, continue taking

one tablet once a month on the scheduled days you’ve marked on your calendar.

4.

Possible side effects

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects -

you may need urgent medical treatment

Uncommon

(may affect up to 1 in 100 people):

severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting,

difficulty in swallowing. You may have a severe inflammation of your gullet/food pipe,

possibly with sores or constriction of the gullet/food pipe

Rare (

may affect up to 1 in 1000 people):

itching, swelling of your face, lips, tongue and throat, with difficulty breathing.

persistent eye pain and inflammation

new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a

possible unusual fracture of the thigh bone

Very rare (

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

pain or sore in your mouth or jaw. You may have early signs of severe jaw problems (necrosis

(dead bone tissue) in the jaw bone)

Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These

could be signs of bone damage in the ear.

serious, potentially life-threatening allergic reaction

severe adverse skin reactions

Other possible side effects

Common

(may affect up to 1 in 10 people):

headache

heartburn, discomfort in swallowing, stomach or tummy pain (may be due to an inflammation of

the stomach), indigestion, nausea, having diarrhoea (loose bowels)

muscle cramps, stiffness of your joints and limbs

flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and

aching muscles and joints. Talk to a nurse or doctor if any effects become troublesome or last

more than a couple of days

rash

Uncommon

(may affect up to 1 in 100 people):

dizziness

flatulence (farting, feeling bloated)

back pain

feeling tired and exhausted

asthma attacks

Rare

(may affect up to 1 in 1000 people):

inflammation of the duodenum (first section of the bowel) causing stomach pain

hives

Reporting of side effects

If you get 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.

How to store Bonviva

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

There are no special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry

date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Bonviva contains

The active substance is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as

sodium monohydrate).

The other ingredients are:

tablet core

: lactose monohydrate, povidone, cellulose microcrystalline, crospovidone, stearic acid

purified, silica colloidal anhydrous

tablet coat

: hypromellose, titanium dioxide (E 171), talc, macrogol 6000

What Bonviva looks like and contents of the pack

Bonviva tablets are white to off white, of oblong shape and marked “BNVA” on one side, and “150”

on the other side. The tablets are supplied in blisters containing 1 or 3 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Atnahs Pharma UK Limited

Sovereign House

Miles Gray Road

Basildon

Essex

SS14 3FR

United Kingdom

Manufacturer

Waymade PLC

Sovereign House,

Miles Gray Road,

Basildon, Essex, SS14 3FR

United Kingdom

Waymade PLC

Josselin Road

Burnt Mills Industrial Estate

Basildon

SS13 1QF

United Kingdom

IL CSM Clinical Supplies Management GmbH

Marie-Curie-Strasse 8

Lörrach

Baden-Württemberg

79539, Germany

This leaflet was last revised in .

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

REMINDER STICKERS TEXT

PLANNING WHEN TO TAKE BONVIVA

The dose of Bonviva is one tablet once a month. Choose one day of the month that will be easy to

remember:

either the same date (such as the 1

of each month)

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

Use the peel-off stickers below to mark the dates on your calendar.

Once you’ve taken your tablet, put a tick in the box on the sticker.

PEEL-OFF STICKERS

FOR YOUR PERSONAL CALENDAR

Monthly tablet

Monthly tablet

Monthly tablet

Bonviva

Bonviva

Bonviva

It’s important to keep taking Bonviva every month.

Package leaflet: Information for the user

Bonviva 3 mg solution for injection

ibandronic acid

Read all of this leaflet carefully before you start using 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, pharmacist or nurse.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Bonviva is and what it is used for

What you need to know before you receive Bonviva

How to receive Bonviva

Possible side effects

How to store Bonviva

Content 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 may reverse bone loss by stopping more loss of bone and increasing bone mass in most

women who take it, even though they won’t be able to see or feel a difference. Bonviva may help

lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine

but not for the hip.

Bonviva is prescribed to you to treat postmenopausal osteoporosis because you have an

increased risk of fractures

. Osteoporosis is a thinning and weakening of the bones, which is common

in women after the menopause. At the menopause, a woman’s ovaries stop producing the female

hormone, oestrogen, which helps to keep her skeleton healthy. The earlier a woman reaches the

menopause, the greater her risk of fractures in osteoporosis.

Other things that can increase the risk of fractures include:

not enough calcium and vitamin D in the diet

smoking cigarettes, or drinking too much alcohol

not enough walking or other weight-bearing exercise

a family history of osteoporosis

A healthy lifestyle

will also help you to get the most benefit from your treatment. This includes:

eating 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 receive Bonviva

Do not receive Bonviva

if you have, or had in the past, low blood calcium

. Please consult your doctor

if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in

section 6)

Warnings and precautions

A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very

rarely in the post marketing setting in patients receiving Bonviva for osteoporosis. ONJ can also occur

after stopping treatment.

It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to

treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions

you should take.

Before receiving treatment, tell your doctor/nurse (health care professional) if:

you have any problems with your mouth or teeth such as poor dental health, gum disease, or a

planned tooth extraction

you don’t 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 undergo a dental examination before starting treatment with Bonviva.

While being treated, you should maintain good oral hygiene (including regular teeth brushing) and

receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you

are under dental treatment or will undergo dental surgery (e.g. tooth extractions), inform your doctor

about your dental treatment and tell 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 loose teeth, pain or swelling, or non-healing of sores or discharge, as these could be signs of

osteonecrosis of the jaw.

Some patients need to be especially careful when using Bonviva. Talk to your doctor before receiving

Bonviva:

If you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you

have any other disease that may affect your kidneys

If you have any disturbance of mineral metabolism (such as vitamin D deficiency)

You should take calcium and vitamin-D supplements while receiving Bonviva. If you are

unable to do so, you should inform your doctor

If you have heart problems and the doctor recommended to limit your daily fluid intake.

Cases of serious, sometimes fatal allergic reaction have been reported in patients treated with

intravenous ibandronic acid. If you experience one of the following symptoms, such as shortness of

breath/difficulty breathing, tight feeling in throat, swelling of tongue, dizziness, feeling of loss of

consciousness, redness or swelling of face, body rash, nausea and vomiting, you should immediately

alert your doctor or nurse (see section 4).

Children and adolescents

Bonviva must not be used in children or adolescents below 18 years.

Other medicines and Bonviva

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other

medicines.

Pregnancy and breast-feeding

Bonviva is for use only by postmenopausal women and must not be taken by women who could still

have a baby.

Do not take Bonviva if you are pregnant or breast-feeding.

Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

You can drive and use machines as it’s expected that Bonviva has no or negligible effect on your

ability to drive and use machines.

Bonviva contains less than 1 mmol sodium (23 mg) per dose (3 ml), i.e. essentially “sodium-free”.

3.

How to receive Bonviva

The recommended dose of Bonviva for the intravenous injection is 3 mg (1 pre-filled syringe) once

every 3 months.

The injection should be given into the vein by a physician or qualified/trained health care worker. Do

not administer the injection to yourself.

The solution for injection must be administered into a vein only, and not anywhere else in the body.

Continuing to receive Bonviva

To get the most benefit from the treatment it is important to continue receiving the injections every 3

months for as long as your doctor prescribes it for you. Bonviva can treat osteoporosis only for as long

as you keep receiving the treatment, even though you will not be able to see or feel a difference. After

5 years of receiving Bonviva, please consult with your doctor whether you should continue to receive

Bonviva.

You should also take calcium and vitamin-D supplements, as recommended by your doctor.

If too much Bonviva is given

You may develop low levels of calcium, phosphorus or magnesium in the blood. Your doctor may

take steps to correct such changes and may give you an injection containing these minerals.

If a dose of Bonviva is missed

You should arrange an appointment to get the next injection as soon as possible. After that, go back to

getting the injections every 3 months from the date of the most recent injection.

4.

Possible side effects

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects -

you may need urgent medical treatment:

Rare (

may affect up to 1 in 1000 people):

itching, swelling of your face, lips, tongue and throat, with difficulty breathing.

persistent eye pain and inflammation (if prolonged)

new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a

possible unusual fracture of the thigh bone.

Very rare (

may affect up to 1 in 10000 people):

pain or sore in your mouth or jaw .You may have early signs of severe jaw problems ( necrosis

(dead bone tissue) in the jaw bone).

Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These

could be signs of bone damage in the ear.

serious, potentially life-threatening allergic reaction (see section 2).

severe adverse skin reactions

Other possible side effects

Common

(may affect up to 1 in 10 people):

headache

stomach pain (such as gastritis) or tummy pain, indigestion, nausea, having diarrhoea (loose

bowels) or constipation

pain in your muscles, joints, or back

feeling tired and exhausted

flu-like symptoms, including fever, shaking and shivering, feeling of discomfort, bone pain and

aching muscles and joints. Talk to a nurse or doctor if any effects become troublesome or last

more than a couple of days

rash

Uncommon

(may affect up to 1 in 100 people)

inflammation of a vein

pain or injury at the injection site

bone pain

feeling weak

asthma attacks

Rare

(may affect up to 1 in 1000 people):

hives

Reporting of side effects

If you get 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.

How to store Bonviva

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

This medicinal product does not require any special storage conditions.

Do not use Bonviva this medicine after the expiry date which is stated on the carton and on the syringe

after “EXP”. The expiry date refers to the last day of that month.

The person giving the injection should throw away any unused solution and put the used syringe and

injection needle into an appropriate disposal container.

6.

Content of the pack and other information

What Bonviva contains

The active substance is ibandronic acid. One pre-filled syringe contains 3 mg of ibandronic acid

in 3 ml of solution (as sodium monohydrate).

The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate and water for

injections.

What Bonviva looks like and contents of the pack

Bonviva 3 mg solution for injection in pre-filled syringes is a clear colourless solution. Each pre-filled

syringe contains 3 ml of solution. Bonviva is available in packs of 1 pre-filled syringe and 1 injection

needle or 4 pre-filled syringes and 4 injection needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Atnahs Pharma UK Limited

Sovereign House

Miles Gray Road

Basildon

Essex

SS14 3FR

United Kingdom

Manufacturer

Waymade PLC

Sovereign House,

Miles Gray Road,

Basildon, Essex, SS14 3FR

United Kingdom

Waymade PLC

Josselin Road

Burnt Mills Industrial Estate

Basildon

SS13 1QF

United Kingdom

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

INFORMATION FOR THE HEALTHCARE PROFESSIONALS

Please see the Summary of Product Characteristics for more information.

Administration of Bonviva 3 mg solution for injection in pre-filled syringe:

Bonviva 3 mg solution for injection in pre-filled syringe should be injected intravenously over a

period of 15 - 30 seconds.

The solution is irritant, therefore strict adherence to the intravenous route of administration is

important. If you inadvertently inject into the tissues around the vein, patients may experience local

irritation, pain and inflammation at the injection site.

Bonviva 3 mg solution for injection in pre-filled syringe

must not

be mixed with calcium-containing

solutions (such as Ringer-Lactate solution, calcium heparin) or other intravenously administered

medicinal products. Where Bonviva is administered via an existing intravenous infusion line, the

intravenous infusate should be restricted to either isotonic saline or 50 mg/ml (5 %) glucose solution.

Missed dose:

If a dose is missed, the injection should be administered as soon as convenient. Thereafter, injections

should be scheduled every 3 months from the date of the last injection.

Overdose:

No specific information is available on the treatment of overdosage with Bonviva.

Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia,

hypophosphataemia, and hypomagnesaemia, which can cause paraesthesia. In severe cases

intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and

magnesium sulfate, may be needed.

General advice:

Bonviva 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered

intravenously, may cause a transient decrease in serum calcium values.

Hypocalcaemia and other disturbances of bone and mineral metabolism should be assessed and

effectively treated before starting Bonviva injection therapy. Adequate intake of calcium and

vitamin D is important in all patients. All patients must receive supplemental calcium and vitamin D.

Patients with concomitant diseases, or who use medicinal products which have a potential for

undesirable effects on the kidney, should be reviewed regularly in line with good medical practice

during treatment.

Any unused solution for injection, syringe and injection needle should be disposed of in accordance

with local requirements.