Bonviva

Package Leaflet: Information for the User

Bonviva

150 mg film-coated tablets
ibandronic acid
Read this entire leaflet carefully before taking this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 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 by preventing further bone loss and increasing bone mass in many women who take it, although they may not see or feel any difference. Bonviva can help reduce 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 for you to treat postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis involves thinning and weakening of the bones, a condition common in women after menopause. At menopause, a woman's ovaries stop producing the female hormone estrogen, which helps maintain a healthy skeleton. The earlier a woman reaches menopause, the greater her risk of fractures due to osteoporosis.
Other factors that may increase the risk of fractures include:

• inadequate intake of calcium and vitamin D through diet;
• smoking or excessive alcohol consumption;
• lack of physical activity (such as walking or other weight-bearing exercise);
• family history of osteoporosis.

In addition, a healthy lifestyle will help you get the maximum benefit from your treatment. This includes:

• following a balanced diet rich in calcium and vitamin D;
• walking or engaging in other weight-bearing activities;
• 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 (oesophagus), such as narrowing or difficulty swallowing;
• if you are unable to remain in an upright position (sitting or standing) for at least one hour (60 minutes) continuously;
• if you have, or have had in the past, low levels of calcium in your blood. In this case, consult your doctor.

Warnings and precautions
A side effect called osteonecrosis of the jaw/mandible (a severe deterioration of the bone tissue of the jaw and mandible) has been reported very rarely after marketing authorization in patients taking Bonviva for osteoporosis. Osteonecrosis of the jaw/mandible may also occur after the end of treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/mandible, as this condition can be painful and difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/mandible, several precautions should be taken.
Atypical fractures of long bones, such as the ulna and 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 starting treatment, inform 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 scheduled for a dental 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 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 examination before starting treatment with Bonviva.
During treatment, you must maintain good oral hygiene (including regular tooth cleaning) and attend routine dental check-ups. If you wear dentures, ensure they fit properly in your mouth. If you are undergoing dental treatment or are scheduled for 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 non-healing lesions or discharge, as these could be signs of osteonecrosis of the jaw/mandible.
Some people need to take special care when taking Bonviva. Consult your doctor before taking Bonviva:

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

Irritation, inflammation or ulceration of the throat/food passage (oesophagus) may occur, often accompanied by symptoms such as severe chest pain, severe pain after eating or drinking, severe nausea, or vomiting, especially if you do not drink a full glass of water and/or if you lie down within one hour after taking Bonviva. If you develop these symptoms, stop taking Bonviva and inform your doctor immediately (see section 3).
Children and adolescents
Do not give 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 take any other medicines. Especially:

• Calcium, magnesium, iron or aluminium-containing supplements, as they may affect the effects of Bonviva.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac and naproxen), which can irritate the stomach and intestines. Bonviva may have a similar effect. Be particularly careful if you take painkillers or anti-inflammatory drugs together with Bonviva.

After swallowing the monthly Bonviva tablet, wait 1 hour before taking any other medicine, including antacids, calcium supplements or vitamins.
Bonviva with food and drink
Do not take Bonviva with food. Bonviva is less effective if taken with food.
You may drink water but no other beverages.
After taking Bonviva, wait 1 hour before eating food or drinking other beverages (see section 3 “How to take Bonviva”).
Pregnancy and breastfeeding
Bonviva may 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 may drive and use machines, as Bonviva is expected to have no or negligible effect on the ability to drive and operate machinery.
Bonviva contains lactose
If your doctor has informed you that you are intolerant or unable to digest certain sugars (e.g. galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption), contact your doctor before taking this medicine.

3. How to take Bonviva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The usual dose of Bonviva is one tablet per month.
Taking your monthly tablet
It is important to follow these instructions carefully. They are designed to help the Bonviva tablet reach your stomach quickly, reducing the chance that it may cause irritation.
Take one 150 mg Bonviva tablet once a month.

• Choose a day of the month that is easy to remember. For taking your Bonviva tablet, you may choose a specific date (e.g., the 1st of each month) or a particular day of the week (e.g., the first Sunday of each month), whichever best fits your routine.
• Take the Bonviva tablet at least 6 hours after eating or drinking anything other than water.
• Take the Bonviva tablet
• immediately after getting up and
• before eating or drinking anything (on an empty stomach).
• Swallow the tablet with a full glass of plain water (at least 180 mL).

Do not take the tablet with water that has a high calcium content, fruit juice, or any other beverage. It is recommended to use bottled water with low mineral content if you suspect that tap water may have high levels of calcium (hard water).

• Swallow the tablet whole – do not chew, crush, or let it dissolve in your mouth.
• During the hour (60 minutes) after taking the tablet
• do not lie down – if you do not remain upright (standing or sitting), part of the medicine could flow back into the oesophagus.

• do not eat anything

• do not drink anything (except water, if needed)
• do not take any other medicines.
• After waiting for one hour, you may eat and drink as part of your morning meal. After eating, you may lie down if you wish, and take other medicines if needed.

Continuing Bonviva treatment
It is important to continue taking Bonviva every month for as long as your doctor prescribes it. After you have taken Bonviva for 5 years, consult your doctor to determine whether you should continue taking the medicine.
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 oesophagus.
If you forget to take Bonviva

• If you forget to take the tablet in the morning on your chosen day, do not take it later during the day. Instead, check your calendar to see when your next scheduled dose is due.
• If you forgot to take the tablet on your chosen day and there are only 1 to 7 days until your next scheduled dose…

Never take two Bonviva tablets within the same week. Wait until your next scheduled dose and take the tablet as usual; then continue taking one tablet once a month on the dates marked on your calendar.

• If you forgot to take the tablet on your chosen day and there are more than 7 days until your next scheduled dose… Take one tablet on the morning after the day you remember; then continue taking one tablet once a month on the scheduled dates marked on your calendar.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Contact a nurse or doctor immediately if you notice any of the following serious side effects – you may
require urgent medical treatment:
Uncommon (affects up to 1 in 100 people):

• severe chest pain, intense pain after eating or drinking, severe nausea or vomiting, difficulty swallowing. There may be severe inflammation of the throat/food passage, sometimes with sores or narrowing of the throat/food passage.

Rare (affects up to 1 in 1,000 people):

• itching, swelling of the face, lips, tongue and throat, with breathing difficulties;
• persistent eye pain and inflammation;
• new pain, weakness or discomfort in the thigh, hip or groin. These may be early signs of an atypical femoral fracture.

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

• pain or sores in the mouth or jaw. These could be early signs of serious jaw problems (osteonecrosis, i.e. severe degeneration and death of jawbone tissue);
• contact your 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;
• severe skin reactions.

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

• headache;
• heartburn, difficulty swallowing, stomach or abdominal pain (possibly due to stomach inflammation), indigestion, nausea, diarrhoea;
• muscle cramps, joint and limb stiffness;
• flu-like symptoms, including fever, trembling and chills, feeling unwell, bone pain and muscle and joint pain. Talk to a nurse or doctor if any side effect becomes bothersome or lasts more than a few days;
• skin rash.

Uncommon (affects up to 1 in 100 people):

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

Rare (affects up to 1 in 1,000 people):

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects 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 stated on the carton after "Exp.". The expiry date refers to the last day of the month.
Do not dispose of medicines via 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 substance is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
• The other components are:

tablet core: monohydrate lactose, povidone, microcrystalline cellulose, crospovidone,
purified stearic acid, anhydrous colloidal silica;
tablet coating: hypromellose, titanium dioxide (E171), talc, macrogol 6000.
Description of the appearance of Bonviva and pack contents
Bonviva tablets are white to almost white, 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.
It is possible that not all pack sizes are marketed.
Marketing Authorization 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 medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/ .
PLANNING BONVIVA TREATMENT
The dosage of Bonviva is one tablet once a month. Choose a day of the month that is easy to remember:

• the same day of the month (e.g. the 1st day 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.

Package Leaflet: Information for the User

Bonviva 3 mg injectable solution

ibandronic acid
Please read this leaflet carefully before using this medicine because 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 experience any side effects, including those not listed in this leaflet, contact 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 Bonviva is administered to you
3. How Bonviva is administered
4. Possible side effects
5. How to store 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 acidum ibandronicum (ibandronic acid).
Bonviva can reverse bone loss by preventing further bone loss and increasing bone mass in many women who take it, although they may not see or feel any difference. Bonviva can help reduce the likelihood of bone fractures.
This reduction in fractures has been demonstrated for the spine, but not for the hip.
Bonviva has been prescribed to you for the treatment of postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis involves thinning and weakening of the bones, a condition common in women after menopause. At menopause, a woman's ovaries stop producing the female hormone estrogen, which helps maintain a healthy skeleton. The earlier a woman reaches menopause, the greater her risk of fractures due to osteoporosis.
Other factors that may increase the risk of fractures include:

• inadequate intake of calcium and vitamin D through diet;
• smoking or excessive alcohol consumption;
• insufficient physical activity (such as walking or other weight-bearing exercises);
• a family history of osteoporosis.

A healthy lifestyle will help you get the maximum benefit from your treatment. This includes:

• following a balanced diet rich in calcium and vitamin D;
• walking or engaging in weight-bearing physical activity;
• not smoking and avoiding excessive alcohol consumption.

2. What you should know before being given Bonviva

Bonviva must not be administered to you if:

• you have, or have previously had, low levels of calcium in your blood. Consult your doctor;
• you are allergic to ibandronic acid or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
A rare side effect called osteonecrosis of the jaw/mandible (severe deterioration of the bone tissue in the jaw and mandible) has been reported very rarely after marketing authorization in patients taking Bonviva for osteoporosis. Osteonecrosis of the jaw/mandible may also occur after treatment has ended.
It is important to try to prevent the development of osteonecrosis of the jaw/mandible, as this condition can be painful and difficult to treat. Several preventive measures should be taken to reduce the risk of developing osteonecrosis of the jaw/mandible.
Atypical fractures of long bones, such as the ulna and 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 starting treatment, inform 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 scheduled for 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 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 examination before starting treatment with Bonviva.
During treatment, you must maintain good oral hygiene (including regular tooth brushing) and attend routine dental check-ups. If you wear dentures, ensure they fit properly in your mouth. If you are undergoing or are scheduled for dental treatment or oral surgery (e.g., tooth extraction), 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 develop any problems with your mouth or teeth, such as tooth loss, pain or swelling, or non-healing sores or discharge, as these may be signs of osteonecrosis of the jaw/mandible.
Some patients need to take special care when using Bonviva. Consult your doctor before receiving Bonviva:

• if you have, or have had, kidney problems, renal failure, or have required dialysis, or if you have other diseases that may affect the kidneys;
• if you have any disorders 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 recommends limiting your daily fluid intake.

Severe allergic reactions, sometimes fatal, have been reported in patients treated with ibandronic acid intravenously. If any of the following symptoms occur—such as shortness of breath/difficulty breathing, tightness in the throat, swelling of the tongue, dizziness, feeling faint, facial redness or swelling, rash, nausea, or vomiting—inform your doctor or nurse immediately (see section 4).
Children and adolescents
Do not administer Bonviva to children or adolescents under 18 years of age.
Other medicines and Bonviva
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Bonviva may 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 may drive and operate machinery, as Bonviva is expected to have no or negligible effect on the ability to drive or operate machinery.
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 intravenous injection of Bonviva is 3 mg (1 pre-filled syringe) every 3 months.
The injection must be administered intravenously by a doctor or a qualified/trained healthcare professional. Do not self-administer the injection.
The injectable solution must be given only into a vein and not into any other part of the body.
Continuation of Bonviva administration
To get the maximum benefit from treatment, it is important to continue receiving injections every 3 months, for as long as your doctor prescribes them. Bonviva can treat osteoporosis only while you continue treatment, even though you may not see or feel a difference. After receiving Bonviva for 5 years, consult your doctor to determine whether you should 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 have
Levels of calcium, phosphorus, or magnesium in the blood may decrease. Your doctor may take measures to correct these changes and may prescribe an injection containing these minerals.
If you miss a dose of Bonviva
Make an appointment to receive the next injection as soon as possible. Then, resume receiving injections every 3 months, counting from the date of the last injection.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact a nurse or doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:
Rare (affects up to 1 in 1,000 people):

• itching, swelling of the face, lips, tongue and throat, with breathing difficulties;
• persistent pain and inflammation in the eyes (if prolonged);
• new pain, weakness or discomfort in the thigh, hip or groin. These may be early signs of an atypical femoral fracture.

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

• pain or sores in the mouth or jaw/mandible. These could be early signs of serious jaw/mandible problems (necrosis, i.e. deterioration and death of jaw/mandible bone tissue);
• consult your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes could indicate bone damage in the ear;
• severe allergic reaction, potentially life-threatening (see section 2);
• severe skin reactions.

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

• headache;
• stomach ache (such as gastritis) or abdominal pain, indigestion, nausea, diarrhoea or constipation;
• muscle, joint or back pain;
• feeling tired and weak;
• flu-like symptoms, including fever, shivering and chills, feeling unwell, bone pain and painful joints. Talk to a nurse or doctor if any side effect becomes bothersome or lasts more than a few days;
• rash.

Uncommon (affects 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 (hypocalcaemia), including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth.

Rare (affects up to 1 in 1,000 people):

• urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects 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 stated on the carton and the syringe after "Exp." or "EXP". The expiry date refers to the last day of the month.
The person administering the injection must discard any unused solution and dispose of the used syringe and injection needle in a suitable waste container.

6. Package contents 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 monohydrate sodium salt).
• The other components are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.

Description of the appearance of Bonviva and contents of the pack
Bonviva 3 mg solution for injection in pre-filled syringe is a clear, colourless solution. Each
pre-filled syringe contains 3 mL of solution. Bonviva is available in packs containing 1 pre-filled
syringe and 1 injection needle or 4 pre-filled syringes and 4 injection needles.
It is possible that not all pack sizes are marketed.

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 medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/ .

The following information is intended for healthcare professionals only:

INFORMATION FOR HEALTHCARE PROFESSIONALS
For further information, refer to the product characteristics summary.
Administration of Bonviva 3 mg injectable solution in pre-filled syringe:
Bonviva 3 mg injectable solution in pre-filled syringe must be administered intravenously over 15–30 seconds.
The solution is irritating; therefore, strict adherence to intravenous administration is essential. 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 pre-filled syringe must not be mixed with calcium-containing solutions (such as lactated Ringer's solution or calciparine) or with other medicinal products administered intravenously. If Bonviva is administered through an existing intravenous infusion line, only isotonic saline solution or glucose 50 mg/mL (5%) solution should be used.
Missed dose:
If a dose is missed, administer the injection as soon as possible. Subsequently, schedule injections at 3-month intervals from the date of the last injection.
Overdose:
Specific information on the treatment of Bonviva overdose is not available. Based on knowledge of this class of compounds, intravenous overdose may lead to hypocalcemia, hypophosphatemia, and hypomagnesemia, potentially resulting in paresthesia. In severe cases, intravenous infusion of adequate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate may be required.
General advice:
Bonviva 3 mg injectable solution in pre-filled syringe, like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium levels.
Before initiating treatment with injectable Bonviva, hypocalcemia and other disturbances in bone and mineral metabolism should be assessed and effectively treated. Adequate intake of calcium and vitamin D is important for all patients. All patients should take calcium and vitamin D supplements.
Patients with concomitant diseases or those using medicinal products that may cause renal adverse effects should be monitored periodically during treatment, in accordance with good clinical practice.
Unused injectable solution, syringes, and injection needles must be disposed of in accordance with local legal requirements.

ANNEX IV
SCIENTIFIC CONCLUSIONS AND REASONS FOR THE VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION

Scientific conclusions
Taking into account the evaluation by 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 Human Medicinal Products (CHMP) are as follows:
In light of the available data on hypocalcemia from spontaneous reports, including in some cases a close temporal relationship, a positive de-challenge, and the fact that hypocalcemia is an identified risk for ibandronic acid, the PRAC considers that a causal relationship between ibandronic acid and hypocalcemia is established. The PRAC concluded that the product information for medicinal products containing ibandronic acid (osteoporosis indication (Bonviva)) should be updated accordingly.
Update section 4.8 of the SmPC to include hypocalcemia as an adverse drug reaction (ADR) with "uncommon" frequency. The patient information leaflet will be updated accordingly.
The CHMP agrees with the scientific conclusions of the PRAC.

Reasons for the variation of the terms of the marketing authorisation
Based on the scientific conclusions regarding ibandronic acid, the CHMP considers that the benefit-risk balance of the medicinal product containing ibandronic acid remains favourable, subject to the proposed changes to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation.