BONVIVA 150 mg Фильм-Coated Таблетки

Содержание инструкции

1. Bonviva
   1. What is Bonviva and what it is used for
   2. What you need to know before taking Bonviva
   3. How to take Bonviva
2. Bonviva may choose a specific day of the month (e.g. the 1st of each month) or a
   1. Possible side effects
   2. How to store Bonviva
   3. Package Contents and Other Information
3. Bonviva 3 mg injectable solution
   1. What is Bonviva and what is it used for
   2. What you need to know before you are given Bonviva
   3. How Bonviva is administered
   4. Possible side effects
   5. How to store Bonviva
   6. Package Contents and Other Information

Bonviva

150 mg film-coated tablets
ibandronic acid

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Bonviva and what it is used for

Bonviva belongs to a group of medicines called bisphosphonates. It contains the active ingredient ibandronic acid.
Bonviva can reverse bone loss by blocking further bone loss and increasing bone mass in many women
who take it, even if they will not be able to see or feel a difference. Bonviva may help decrease the
likelihood of bone breaks (fractures). This reduction in fractures has been demonstrated for the spine but not
for the hip.

Bonviva has been prescribed to you to treat postmenopausal osteoporosis because you have a high
risk of fractures. Osteoporosis consists of a thinning and weakening of the bones, a common
phenomenon in women after menopause. At menopause, a woman's ovaries stop producing a female
hormone, estrogen, which promotes the maintenance of a healthy skeleton. The earlier a woman reaches
menopause, the greater the risk of fractures in osteoporosis. Other factors that can increase the risk of
fractures are:

• inadequate intake of calcium and vitamin D with food;
• smoking or the habit of drinking too much alcohol;
• insufficient physical activity (walking or performing other weight-bearing activities);
• family history of osteoporosis.

Also a healthy lifestylewill help you get the most benefit from treatment. This includes:

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

2. What you need to know before taking 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 throat/food pipe (oesophagus), such as narrowing or difficulty swallowing;
• if you are unable to stay fully upright standing or sitting for at least one hour (60 minutes) consecutively;
• if you have, or have had in the past, low blood calcium levels.In this case, contact your doctor.

Warnings and precautions
A side effect called osteonecrosis of the jaw/maxilla (severe degeneration of the bone tissue of the jaw and maxilla) has been reported very rarely after marketing of Bonviva in patients treated for osteoporosis. Osteonecrosis of the jaw/maxilla can occur even after stopping treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/maxilla as it is a condition that can be painful and difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/maxilla, several precautions should be taken.
Atypical fractures of the long bones, such as the ulna and tibia, have also been reported in patients treated with ibandronate for a long time. These fractures occur after minimal or no trauma and some patients experience pain in the area of the fracture before developing a complete fracture.
Before starting treatment, tell your doctor or nurse (healthcare professional) if:

• you have any problems with your mouth or teeth such as poor dental hygiene, gum disease or if you are planning to have a tooth extracted
• you do not receive routine dental care or have not had a dental check-up for a long time
• you are a smoker (this can increase the risk of dental problems)
• you have previously been treated with bisphosphonates (used to treat or prevent bone problems)
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer.

Your doctor may ask you to have a dental check-up before starting treatment with Bonviva.
During treatment, you must maintain good oral hygiene (including regular teeth cleaning) and have routine dental check-ups. If you wear dentures, make sure they fit properly. If you are having dental treatment or are going to have dental surgery (e.g. tooth extractions), tell 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 tooth loss, pain or swelling, or sores that do not heal or discharge, as these could be signs of osteonecrosis of the jaw/maxilla.
Some people need to be particularly careful when taking Bonviva. Speak to your doctor before taking Bonviva:

• if you have any disturbance of mineral metabolism (such as vitamin D deficiency);
• if your kidneys do not function normally;
• if you have problems with swallowing or digestion.

Irritation, inflammation or ulceration of the throat/food pipe (oesophagus) can occur, often with symptoms of severe chest pain, severe pain after swallowing food and/or drink, severe nausea, or vomiting, especially if you do not drink a full glass of water and/or lie down within one hour of taking Bonviva. If you develop these symptoms, stop taking Bonviva and tell 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 aluminium, as they may affect the effects of Bonviva.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) which can irritate the stomach and intestine. Bonviva may have the same effect. Be particularly careful if you take painkillers or anti-inflammatory drugs at the same time as Bonviva.

After you have swallowed the monthly Bonviva tablet, wait 1 hour beforetaking any other medicine, including indigestion tablets, calcium supplements or vitamins.

Bonviva with food and drink
Do not take Bonviva with food.Bonviva is less effective if taken with food.

You can drink water but not other beverages.
After taking Bonviva, wait 1 hour before eating food and other beverages (see section 3 “How to take Bonviva”).

Pregnancy and breastfeeding
Bonviva can only be used by postmenopausal women and must not be taken by women who are still able to have children.
Do not take Bonviva if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.

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

Bonviva contains lactose
If your doctor has told you that you have an intolerance to some sugars (e.g. lactose deficiency), contact your doctor before taking this medicine.

3. How to take Bonviva

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your
doctor or pharmacist.

The usual dose of Bonviva is one tablet a month.
Taking your monthly tablet
It is important to follow the following instructions carefully. They are designed to help the tablet of
Bonviva reach the stomach quickly, so that there is less likelihood of it causing
irritation.

Take one 150 mg Bonviva tablet once a month.

• Choose a day of the monththat is easy to remember. For taking the tablet of

Bonviva may choose a specific day of the month (e.g. the 1st of each month) or a

day of the week (e.g. the first Sunday of each month), depending on what
best suits your habits.

• Take Bonviva tablets at least 6 hours after eating or drinking anythingother than water.
• Take Bonviva tablets
• immediately upon getting out of bedand
• before taking food or drinks(on an empty stomach).
• Swallow the tablet with a full glass of natural water(at least 180 mL).

Do nottake the tablet with water with a high calcium concentration, fruit juice or any
other beverage. It is recommended to use bottled water with a low mineral content if you are concerned
that tap water may have potentially high levels of calcium (hard water).

• Swallow the tablet whole, do not chew, crush, or allow it to dissolve in your mouth.
• For one hour (60 minutes)after taking the tablet
• do not lie down; if you do not remain upright (standing or sitting), some of the medicine may flow back into the esophagus

• do not eat anything

• do not drink anything(except water if you need it)
• do not take any other medicines.
• After waiting for one hour, you may eat food and drinks for your morning meal. After eating, you may also lie down if you wish, and take other medicines if necessary.

Continuing to take Bonviva
It is important to continue taking Bonviva every month, as long as your doctor prescribes it. After
taking Bonviva for 5 years, consult your doctor to find out if you should continue taking the medication.

If you take more Bonviva than you should
If you have taken more than one tablet by mistake, drink a full glass of milk and contact your
doctor immediately.

Do not induce vomiting and do not lie down– this could cause Bonviva to irritate your esophagus.

If you forget to take Bonviva

• If you forget to take the tablet on the morning of the scheduled day, do not take it later in theday. Instead, consult your calendar and check when the next dose is due.
• If you have forgotten to take the tablet on the chosen day and only 1 to 7days remain until the next scheduled dose…

Never take two Bonviva tablets in the same week.You must wait until the day
of the next scheduled dose and take the tablet as usual; then
continue to take one tablet once a month on the scheduled days marked on
your calendar.

• If you have forgotten to take the tablet on the chosen day and more than 7 daysremain until the next scheduled dose…You should take one tablet the morning after you remember; then continue to take one tablet once a month on the scheduled days marked on your calendar.

4. Possible side effects

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

Seek immediate medical attention from a nurse or doctor if you notice any of the
following serious side effects - urgent medical treatment may be needed:
Uncommon(may affect up to 1 in 100 people):

• severe chest pain, intense pain after swallowing food or drinks, severe nausea or vomiting, difficulty swallowing. A serious inflammation of the throat/food pipe may occur, sometimes with sores or constriction of the throat/food pipe.

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 a possible atypical femur fracture.

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

• pain or sore in the mouth or jaw. These could be signs of serious problems in the jaw (necrosis, i.e. severe degeneration and death of the jaw bone)
• see a doctor if you experience ear pain, ear discharge and/or ear infection. These episodes could be signs of bone damage in the ear;
• severe allergic reaction, potentially life-threatening.
• serious skin reactions.

Other possible side effects
Common(may affect up to 1 in 10 people):

• headache;
• heartburn, difficulty swallowing, stomach or abdominal pain (may be due to inflammation of the stomach), indigestion, nausea, diarrhoea;
• muscle cramps, stiffness of joints and limbs;
• flu-like symptoms, including fever, chills, feeling unwell, bone and muscle pain and aching joints. Talk to a nurse or doctor if any effect becomes troublesome or lasts for more than a couple of days.
• rash.

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

• dizziness;
• flatulence (intestinal gas, feeling of bloating);
• back pain;
• feeling tired and exhausted;
• asthma attacks
• symptoms of low blood calcium levels (hypocalcemia) including muscle cramps or spasms and/or tingling in the fingers or around the mouth.

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

• inflammation of the duodenum (first part of the intestine) causing stomach pain;
• urticaria.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton after “Scad.”. The expiry
date refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Bonviva contains

• The active ingredient is ibandronic acid. One 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 (E171), talc, macrogol 6000.

Description of Bonviva and package contents
Bonviva tablets are white to off-white in color, elongated in shape, 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:
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

This leaflet was last updated on
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/ .

PLANNING YOUR BONVIVA DOSING
The dose of Bonviva is one tablet once a month. Choose a day of the month that is easy
to remember:

• always the same day of the month (e.g. the 1st of each month)
• or the same day of the week (e.g. the first Sunday of each month).

It is important to continue taking Bonviva every month.

Bonviva 3 mg injectable solution

ibandronic acid

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Bonviva is and what it is used for
• 2. What you need to know before you are given Bonviva
• 3. How Bonviva is administered
• 4. Possible side effects
• 5. How to store 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 ingredient ibandronic acid.
Bonviva can reverse bone loss by blocking further bone loss and increasing bone mass in many women who take it, even if they will not be able to see or feel a
difference. Bonviva may help to decrease the possibility of bone breaks (fractures).
This reduction in fractures has been demonstrated for the spine but not for the hip.

Bonviva has been prescribed to you to treat post-menopausal osteoporosis because you have a high
risk of fractures. Osteoporosis consists of a thinning and weakening of the bones,
a common phenomenon in women after menopause. At menopause, a woman's ovaries stop
producing a female hormone, estrogen, which promotes the maintenance of a healthy skeleton.
The earlier a woman reaches menopause, the greater the risk of fractures in osteoporosis.
Other factors that can increase the risk of fractures are:

• inadequate intake of calcium and vitamin D with food;
• smoking cigarettes or drinking too much alcohol;
• insufficient physical activity (walking or performing other weight-bearing activity);
• family history of osteoporosis.

A healthy lifestylehelps you get the most benefit from your treatment. This
includes:

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

2. What you need to know before you are given Bonviva

Do not be given Bonviva:

• if you have, or have had in the past, a low level of calcium in your blood. 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/maxilla (severe degeneration of the bone tissue of the jaw and maxilla) has been reported very rarely after marketing authorization in patients taking Bonviva for osteoporosis. Osteonecrosis of the jaw/maxilla can also occur after stopping treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/maxilla as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/maxilla, several precautions should be taken.
Atypical fractures of the long bones, such as the ulna and tibia, have also been reported in patients treated long-term with ibandronate. These fractures occur after minimal or no trauma and some patients experience pain in the fracture area before developing a complete fracture.
Before receiving treatment, tell your doctor or nurse (healthcare professional) if:

• you have any problems with your mouth or teeth such as poor dental health, gum disease or if you are planning to have a 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 (this may increase the risk of dental problems)
• you have been previously treated with bisphosphonates (used to treat or prevent bone problems)
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• you have cancer.

Your doctor may ask you to have a dental check-up before starting treatment with Bonviva.
During treatment, you should maintain good oral hygiene (including regular teeth cleaning) and have routine dental check-ups. If you wear dentures, make sure they fit properly. If you are undergoing dental treatments or if you are to have 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 tooth loss, pain or swelling, or sores that do not heal or discharge, as these could be signs of osteonecrosis of the jaw/maxilla
Some patients must take special care when using Bonviva. Consult your doctor before you are given Bonviva:

• if you have, or have had, kidney problems, kidney failure or have needed dialysis, or if you have other diseases that can affect the kidneys;
• if you have any disorder of mineral metabolism (such as vitamin D deficiency);
• during treatment with Bonviva you must take calcium and vitamin D supplements. If you are unable to do so, inform your doctor;
• if you have heart problems and your doctor advises you to limit your daily fluid intake.

Cases of severe allergic reaction, sometimes fatal, have been reported in patients treated with ibandronic acid intravenously. If you experience any of the following symptoms, such as shortness of breath/difficulty breathing, feeling of tightness in the throat, swelling of the tongue, dizziness, feeling of fainting, redness or swelling of the face, rash, nausea and vomiting, you should immediately inform your doctor or nurse (see section 4).

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

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 breastfeeding
Bonviva can only be used by postmenopausal women and should not be taken by women who are still able to have children.
Do not take Bonviva if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
You can drive and use machines as Bonviva is not expected to have any significant effect on the ability to drive and operate machines.

Bonviva contains less than 1 mmol of sodium (23 mg) per dose (3 mL), i.e. it is practically “sodium-free”.

3. How Bonviva is administered

The recommended dose for the intravenous injection of Bonviva is 3 mg (1 pre-filled syringe) every 3
months.
The injection must be administered into a vein by a doctor or a qualified/trained healthcare
professional. Do not self-administer the injection.
The injectable solution must be administered only into a vein and nowhere else in the body.

Continuing Bonviva administration
To gain the greatest benefit from treatment, it is important to continue receiving injections every
3 months, as long as your doctor prescribes them. Bonviva can only treat osteoporosis as long
as treatment continues, even if you do not notice or feel a difference. After receiving
Bonviva for 5 years, consult your doctor to find out whether to continue receiving Bonviva.
You should also take calcium and vitamin D supplements, as directed by your doctor.

If you are given more Bonviva than you should
The levels of calcium, phosphorus, or magnesium in your blood may decrease. Your doctor can take
measures to correct these changes and may prescribe you an injection containing these
minerals.

If you miss a dose of Bonviva
Make an appointment to receive your next injection as soon as possible. Then, resume
receiving injections every 3 months from the date of the last injection.

4. Possible side effects

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

Seek immediate medical attention from a nurse or a doctor if you notice any of the following serious side effects - urgent medical treatment may be needed:
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 (if prolonged);
• new pain, weakness or discomfort in the thigh, hip or groin. These could be early signs of a possible atypical femur fracture.

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

• pain or sore mouth or jaw/jawbone. These could be early signs of serious jaw/jawbone problems (necrosis, that is, degeneration and death of the jaw/jawbone tissue);
• see a doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear;
• severe allergic reaction, potentially life-threatening (see section 2);
• serious skin reactions.

Other possible side effects
Common(may affect up to 1 in 10 people):

• headache;
• stomach discomfort (such as gastritis) or abdominal pain, indigestion, nausea, diarrhoea or constipation;
• muscle, joint, or back pain;
• feeling tired and exhausted;
• flu-like symptoms, including fever, chills and shivering, feeling unwell, bone pain and aching muscles and joints. Talk to a nurse or doctor if any effect becomes bothersome or lasts 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 of weakness;
• asthma attacks
• symptoms of low calcium levels in the blood (hypocalcemia) including muscle cramps or spasms and/or tingling in the fingers or around the mouth.

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

• urticaria.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex 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 medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the carton and the syringe after
“Scad.” or “EXP”. The expiry date refers to the last day of the month.
The person administering the injection must dispose of any unused solution and place
the used syringe and injection needle in a suitable waste container.

6. Package Contents and Other Information

What Bonviva contains

• The active ingredient is ibandronic acid. A pre-filled syringe contains 3 mg of ibandronic acid in 3 mL of solution (as a monohydrate sodium salt).
• The other ingredients are sodium chloride, acetic acid, trisodium citrate dihydrate and water for injections.

Description of Bonviva and package contents
Bonviva 3 mg injectable solution in a pre-filled syringe is a clear and 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 Netherlands B.V.
Copenhagen Towers,
Ørestads Boulevard 108, 5.tv
DK-2300 København S
Denmark

Manufacturer
Atnahs Pharma Denmark ApS,
Copenhagen Towers,
Ørestads Boulevard 108, 5.tv
DK-2300 København S
Denmark

This leaflet was last updated on
More detailed information on this medicine is available on the European Medicines Agency’s website: http://www.ema.europa.eu/ .
-----------------------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals:

INFORMATION FOR HEALTHCARE PROFESSIONALS
For further information, see the summary of product characteristics.
Administration of Bonviva 3 mg injectable solution in a pre-filled syringe:
Bonviva 3 mg injectable solution in a pre-filled syringe must be injected intravenously
over 15-30 seconds.
The solution is irritating, therefore it is important to strictly adhere to the intravenous route of administration. If inadvertently injected into the tissue surrounding the vein, patients may
experience local irritation, pain and inflammation at the injection site.
Bonviva 3 mg injectable solution in a pre-filled syringe must notbe mixed with solutions
containing calcium (such as Ringer’s lactate solution or calcium heparinate) or with other medicines
administered intravenously. If Bonviva is administered into a pre-existing intravenous infusion line, use only isotonic saline solution or 50 mg/mL (5%) glucose solution.

Missed dose:
If a dose is missed, administer the injection as soon as possible.
Subsequently, schedule injections at intervals of 3 months from the date of the last injection.

Overdose:
There is no specific information available on the treatment of an overdose with Bonviva.
Based on knowledge of this class of compounds, intravenous overdose may
result in hypocalcaemia, hypophosphataemia and hypomagnesaemia, with possible paraesthesia as a consequence. In
severe cases, it may be necessary to infuse adequate doses of calcium gluconate,
potassium phosphate or sodium phosphate and magnesium sulphate intravenously.

General advice:
Bonviva 3 mg injectable solution in a pre-filled syringe, like other bisphosphonates administered intravenously,
may cause a transient reduction in serum calcium levels.
Before starting treatment with injectable Bonviva, hypocalcaemia and other disorders of bone and mineral metabolism must be evaluated and effectively treated. Adequate intake of calcium and vitamin D is important in all patients. All patients should take calcium and vitamin D supplements.
Patients with concomitant diseases or who are using medicines that can cause adverse effects
on the kidneys should be monitored periodically during treatment, in accordance with good clinical practice.
Unused injectable solution, syringes and injection needles should be disposed of in
accordance with local legal requirements.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
Taking into account the assessment of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for Bondronat (ibandronic acid), the scientific conclusions of the Committee for Medicinal Products for Human Use (CHMP) are as follows:
In light of the available data on hypocalcaemia from spontaneous reports, including in some
cases a strong temporal association, a positive de-challenge and the fact that hypocalcaemia is an identified risk for ibandronic acid, the PRAC considers a causal relationship between ibandronic acid and
hypocalcaemia to be established. The PRAC concluded that the product information for products containing
ibandronic acid (osteoporosis indication (Bonviva)) should be amended accordingly.
Update of section 4.8 of the SmPC to add hypocalcaemia ADR with a frequency of not
The CHMP agrees with the scientific conclusions of the PRAC.

Justification for variation of the terms of the marketing authorisation
Based on the scientific conclusions on ibandronic acid, the CHMP considers that the benefit/risk
ratio of the medicine containing ibandronic acid remains unchanged, subject to the proposed changes
to the medicine information.
The CHMP recommends the variation of the terms of the marketing authorisation.