Ibandronic acid Accord

Package leaflet: Information for the patient

Ibandronic Acid Accord 2 mg concentrate for solution for infusion, 6 mg concentrate for solution for infusion

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, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Ibandronic Acid Accord is and what it is used for
2. What you need to know before being given Ibandronic Acid Accord
3. How Ibandronic Acid Accord is administered
4. Possible side effects
5. How to store Ibandronic Acid Accord
6. Contents of the pack and other information

1. What Acido Ibandronico Accord is and what it is used for

Acido Ibandronico Accord contains the active substance ibandronic acid. This belongs to a
group of medicines known as bisphosphonates.
Acido Ibandronico Accord is used in adults and is prescribed if you have breast cancer
that has spread to the bones (bone metastases).

• It helps prevent bone fractures.
• It helps prevent other bone complications that might require surgery or radiotherapy.

Acido Ibandronico Accord may also be prescribed if you have high levels of calcium in the blood due to
cancer.
Acido Ibandronico Accord works by reducing the loss of calcium from the bones. This helps prevent bone weakening.

2. What you need to know before you are given Acido Ibandronico Accord

Acido Ibandronico Accord must not be given to you:

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

This medicine must not be administered to you if any of these conditions apply. If you are unsure,
consult your doctor or pharmacist before being given Acido Ibandronico Accord.
Warnings and precautions
An adverse reaction known as osteonecrosis of the jaw/mandible (ONJ) (degeneration of the jaw/mandible
bone tissue) has been reported very rarely after marketing in patients receiving ibandronic acid for
tumour-related conditions.
Osteonecrosis of the jaw/mandible may also occur after discontinuation of treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/mandible, as it is a painful
condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/mandible,
you should take certain precautions.
Before receiving treatment, inform your doctor/nurse (healthcare professional)

• if you have any mouth or dental problems, such as poor dental health, gum disease, or if you have a dental extraction scheduled
• if you do not receive regular dental care or have not had a dental check-up for a long time
• if you smoke (since smoking may increase the risk of dental problems)
• if you have previously received treatment with bisphosphonates (used to treat or prevent bone diseases)
• if you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• if you have a tumour.

Your doctor may ask you to have a dental examination before starting treatment with ibandronic acid.
During treatment, it is necessary to maintain good oral hygiene (including regular tooth cleaning) and
to have periodic dental check-ups. If you wear dentures, ensure they fit properly.
If you are undergoing dental treatment or are planning to have dental surgery (e.g. tooth extractions),
inform your doctor about the dental treatment and inform your dentist that you are being treated with
ibandronic acid.
Contact your doctor and dentist immediately if you notice any mouth or dental problems, such as loose
teeth, pain or swelling, or failure of mouth sores to heal, or discharge, as these could be signs of
osteonecrosis of the jaw/mandible.
Atypical fractures of long bones, such as the ulna and tibia, have also been reported in patients on long-term
ibandronate treatment. These fractures occur after minimal or no trauma, and some patients experience
pain in the fracture area before a complete fracture occurs.
Consult your doctor or pharmacist before being given Acido Ibandronico Accord

• if you are allergic to any other bisphosphonate
• if you have high or low levels of vitamin D, calcium in the blood, or any other mineral
• if you have kidney problems
• if you have heart problems and your doctor has advised you to limit your daily fluid intake.

Cases of 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 and vomiting, you must inform your doctor or nurse immediately (see section 4).
Children and adolescents
Acido Ibandronico Accord must not be used in children and adolescents under 18 years of age.
Other medicines and Acido Ibandronico Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This is because Acido Ibandronico Accord may affect the action of other medicines. In
addition, other medicines may affect the action of Acido Ibandronico Accord.
Specifically, inform your doctor or pharmacist if you are taking a type of injectable antibiotic called
“aminoglycoside”, such as gentamicin, since aminoglycosides and Acido Ibandronico Accord can both
reduce the amount of calcium in the blood.
Pregnancy and breastfeeding
Acido Ibandronico Accord must not be administered if you are pregnant, planning a pregnancy, or
breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may drive and use machines, as Acido Ibandronico Accord is expected to have no effect or a negligible
effect on the ability to drive and operate machinery.
Consult your doctor before driving, using machines or equipment.
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. it is practically ‘sodium-free’.

3. How Acido Ibandronico Accord is administered

Administration of this medicine

• Acido Ibandronico Accord is normally administered by a doctor or medical staff experienced in the treatment of cancer.
• Acido Ibandronico Accord is given as an intravenous infusion.

Your doctor may carry out periodic blood tests during treatment with Acido Ibandronico Accord to ensure that you are receiving the correct dose of this medicine.
How much medicine you will be given
Your doctor will determine the amount of Acido Ibandronico Accord you will receive depending on your condition.
If you have breast cancer that has spread to the bones, the recommended dose is 3 vials (6 mg) every 3–4 weeks, administered as an intravenous infusion lasting at least 15 minutes.
If you have high levels of calcium in the blood due to tumour, the recommended dose is a single administration of 2 mg or 4 mg depending on the severity of the disease.
The medicine must be administered as a two-hour intravenous infusion. Repeating the dose may be considered if the response is inadequate or if the disease recurs.
Your doctor may adjust the dose or the duration of the intravenous infusion if you have kidney problems.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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):

• 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):

• mouth soreness or pain in the jaw/mandible. These may be early signs of serious jaw problems (osteonecrosis (bone tissue death) of the mandible)
• inform your doctor if you have ear pain, ear discharge, and/or an ear infection. These could be signs of bone tissue degeneration inside the ear.
• itching, swelling of the face, lips, tongue, and throat, with breathing difficulties. You may be experiencing a severe allergic reaction that could be life-threatening (see section 2).
• severe skin reactions

Not known (frequency cannot be estimated from available data)

• asthma attack

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

• flu-like symptoms, including fever, shaking, chills, feeling unwell, fatigue, bone pain, and painful muscles and joints. These symptoms usually disappear within a few hours or days. Talk to a nurse or doctor if any symptom becomes bothersome or lasts longer than a few days
• increased body temperature
• stomach and abdominal pain, indigestion, malaise, vomiting, or diarrhoea
• low levels of calcium or phosphate in the blood
• changes in blood test results such as Gamma GT or creatinine
• a heart rhythm problem called "bundle branch block"
• bone or muscle pain
• headache, dizziness, or feeling weak
• feeling thirsty, sore throat, altered taste
• swelling of the legs or feet
• joint pain, arthritis, or other joint problems
• problems with the parathyroid gland
• bruising
• infections
• an eye condition called cataract
• skin problems
• dental problems.

Uncommon (affects less than 1 in 100 people)

• tremor or chills
• excessive drop in body temperature (hypothermia)
• a condition affecting blood vessels in the brain known as "cerebrovascular disorder"
• heart problems and circulatory problems (including palpitations, heart attack, hypertension (high blood pressure), and varicose veins)
• changes in blood cells (anaemia)
• elevated levels of alkaline phosphatase in the blood
• fluid accumulation and swelling (lymphoedema)
• fluid in the lungs
• stomach problems such as "gastroenteritis" or "gastritis"
• stones (calculi)
• inability to urinate (urination problems), cystitis (bladder inflammation)
• migraine
• nerve ending pain or damage
• deafness
• increased sensitivity of hearing, taste, or touch, or altered sense of smell
• difficulty swallowing
• mouth ulcers, lip swelling ("cheilitis"), oral thrush
• itching or numbness of the skin around the mouth
• pelvic pain, discharge, itching, or pain in the vagina
• a skin growth called "benign cutaneous neoplasia"
• memory loss
• sleep disorders, feeling anxious, emotional instability, or mood changes
• skin rash
• hair loss
• injury or pain at the injection site
• weight loss
• kidney cysts (fluid-filled sac in the kidney).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse.
You can also report side effects directly via 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 Ibandronic Acid Accord

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

• Do not use this medicine after the expiry date stated on the carton and label after 'Exp.'. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.

After dilution:
Chemical and physical in-use stability after dilution in 0.9% sodium chloride solution or 5% glucose solution has been demonstrated for 36 hours at 25°C and from 2°C to 8°C.
From a microbiological standpoint, the infusion solution should be used immediately. If it is not used immediately, the period and conditions of in-use storage are the responsibility of the user and should normally not exceed 24 hours at a temperature between 2°C and 8°C, unless the dilution was carried out under controlled and validated aseptic conditions.
Do not use this medicine if you notice that the solution is not clear or contains particles.

6. Package contents and other information

What Acido Ibandronico Accord contains

• The active substance is ibandronic acid.
  Acido Ibandronico Accord 2 mg concentrate for solution for infusion
  One vial containing 2 ml of concentrate for infusion solution contains 2 mg of ibandronic acid (equivalent to 2.25 mg of ibandronate sodium monohydrate).
  Acido Ibandronico Accord 6 mg concentrate for solution for infusion
  One vial containing 6 ml of concentrate for infusion solution contains 6 mg of ibandronic acid (equivalent to 6.75 mg of ibandronate sodium monohydrate).

• The other components are sodium chloride, sodium acetate trihydrate, glacial acetic acid and water for injections.

Description of the appearance of Acido Ibandronico Accord and contents of the pack
Acido Ibandronico Accord is a sterile concentrate for infusion solution. A clear, colourless solution.
It is supplied in glass vials (type I) with rubber stoppers and aluminium seals with removable caps.
Acido Ibandronico Accord 2 mg concentrate for solution for infusion
Each vial contains 2 ml of concentrate. Each pack contains 1 vial.
Acido Ibandronico Accord 6 mg concentrate for solution for infusion
Each vial contains 6 ml of concentrate and is available in packs containing 1, 5 or 10 vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.

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The following information is intended for healthcare professionals only:

Dosage: prevention of skeletal events in patients with breast cancer and bone metastases
The recommended dose for the prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg administered intravenously every 3–4 weeks. The dose should be infused over at least 15 minutes.

Patients with renal impairment
In patients with mild renal impairment (creatinine clearance CLcr ≥50 and <80 ml/min), no dose adjustment is required. In patients with moderate renal impairment (CLcr ≥30 and <50 ml/min) or severe renal impairment (CLcr <30 ml/min) being treated for the prevention of skeletal events related to breast cancer and metastatic bone disease, the following dosage recommendations should be followed:

| Creatinine clearance (ml/min) | Dosage | Infusion volume and duration | |-------------------------------|--------|------------------------------| | ≥ 50 to < 80 | 6 mg (6 ml concentrate diluted in 100 ml) | Over 15 minutes | | ≥ 30 to < 50 | 4 mg (4 ml concentrate diluted in 500 ml) | Over 1 hour | | < 30 | 2 mg (2 ml concentrate diluted in 500 ml) | Over 1 hour |

Diluent: 0.9% sodium chloride solution or 5% glucose solution
Administration: every 3–4 weeks

The 15-minute infusion time has not been studied in patients with malignancies and creatinine clearance below 50 ml/min.

Dosage: treatment of tumour-induced hypercalcaemia
Acido Ibandronico Accord is generally administered in a hospital setting. The dosage will be determined by the physician, taking into account the following factors.

Prior to treatment with Acido Ibandronico Accord, the patient should be adequately rehydrated with 9 mg/ml (0.9%) sodium chloride. The severity of hypercalcaemia and the type of tumour should be considered. In most patients with severe hypercalcaemia (albumin-corrected serum calcium* ≥ 3 mmol/l or ≥ 12 mg/dl), 4 mg as a single dose is adequate. In patients with moderate hypercalcaemia (albumin-corrected serum calcium <3 mmol/l or <12 mg/dl), 2 mg is an effective dosage. The highest dose used in clinical studies was 6 mg, but this dose does not provide additional efficacy benefit.

* Note that albumin-corrected plasma calcium concentrations are calculated as follows:

Corrected calcium [mmol/l] = serum calcium [mmol/l] - [0.02 × albumin value (g/l)] + 0.8
OR
Corrected calcium [mg/dl] = serum calcium [mg/dl] + 0.8 × [4 - albumin value (g/dl)]

To convert albumin-corrected calcium values from mmol/l to mg/dl, multiply by 4.

In most cases, elevated serum calcium levels can be normalized within 7 days. The median time to relapse (recurrence of albumin-corrected serum calcium > 3 mmol/l) was 18–19 days for the 2 mg and 4 mg doses. For the 6 mg dose, the median time to relapse was 26 days.

Method and route of administration
Acido Ibandronico Accord concentrate for solution for infusion must be administered as an intravenous infusion.

The vial contents should be used as follows:

• Prevention of skeletal events in patients with breast cancer and bone metastases
  Diluted in 100 ml of 0.9% sodium chloride solution or 100 ml of 5% glucose solution and infused over at least 15 minutes. See also the dosage section above for patients with renal impairment.

• Treatment of tumour-induced hypercalcaemia
  Diluted in 500 ml of 0.9% sodium chloride solution or 500 ml of 5% dextrose solution and infused over 2 hours.

Note:
To avoid potential incompatibilities, Acido Ibandronico Accord concentrate for solution for infusion must be diluted only with 0.9% sodium chloride solution or 5% dextrose solution. Solutions containing calcium must not be mixed with Acido Ibandronico Accord concentrate for solution for infusion.

Diluted solutions are for single use only. Solutions should be used only if they are clear and free from particles.

It is recommended to use the product immediately after dilution (see section 5 of this leaflet, “How to store Acido Ibandronico Accord”).

Acido Ibandronico Accord concentrate for solution for infusion must be administered by intravenous infusion. Care must be taken to avoid intra-arterial or paravenous administration, as this may result in tissue damage.

Frequency of administration
For the treatment of tumour-induced hypercalcaemia, Acido Ibandronico Accord concentrate for solution for infusion is generally administered as a single infusion.

For the prevention of skeletal events in patients with breast cancer and bone metastases, Acido Ibandronico Accord infusion should be repeated every 3–4 weeks.

Duration of treatment
A limited number of patients (50 patients) received a second infusion for hypercalcaemia. Repeated treatments may be considered in cases of recurrent hypercalcaemia or inadequate response.

In patients with breast cancer and bone metastases, Acido Ibandronico Accord infusion should be administered every 3–4 weeks. In clinical studies, treatment was continued for up to 96 weeks.

Overdose
There have been no reports of acute intoxication with Acido Ibandronico Accord concentrate for solution for infusion to date. Since in preclinical studies both the kidneys and the liver were identified as target organs of toxicity at high doses, renal and hepatic function should be monitored.

Clinically significant hypocalcaemia (very low serum calcium levels) should be corrected by intravenous administration of calcium gluconate.

Patient Information Leaflet

Ibandronic Acid Accord 3 mg solution for injection in pre-filled syringe

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 get any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Ibandronic Acid Accord is and what it is used for
2. What you need to know before you are given Ibandronic Acid Accord
3. How to use Ibandronic Acid Accord
4. Possible side effects
5. How to store Ibandronic Acid Accord
6. Contents of the pack and other information

1. What Acido Ibandronico Accord is and what it is used for

Acido Ibandronico Accord belongs to a group of medicines called bisphosphonates. It contains the
active substance ibandronic acid.
Acido Ibandronico Accord can reverse bone loss by preventing further bone loss and increasing bone mass in many women who take it, even though they may not see or feel a difference. Acido Ibandronico Accord can help reduce the likelihood of bone breaks (fractures). This reduction in fractures has been demonstrated for the spine, but not for the hip.
Acido Ibandronico Accord has been prescribed to treat your postmenopausal osteoporosis
because you have a high risk of fractures. Osteoporosis involves thinning and weakening of the bones, a condition common in women after the menopause. At menopause, a woman's ovaries stop producing the female hormone oestrogen, 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 cigarettes or drinking excessive amounts of alcohol;
• lack of regular weight-bearing physical activity such as walking;
• 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 Acido Ibandronico Accord

Do not use Acido Ibandronico Accord:

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

Warnings and precautions
An adverse effect called osteonecrosis of the jaw (ONJ) (degeneration of the jawbone tissue) has been reported very rarely after marketing authorization in patients receiving ibandronic acid for the treatment of osteoporosis.
Osteonecrosis of the jaw may also occur after discontinuation of treatment.
It is important to try to prevent the development of osteonecrosis of the jaw, as it is a painful condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, you should take certain precautions.
Before receiving treatment, inform your doctor/nurse (healthcare professional)

• if you have any mouth or dental problems, such as poor dental health, gum disease, or if you have a dental extraction scheduled
• if you do not receive regular dental care or have not had a dental check-up for a long time
• if you smoke (since smoking may increase the risk of dental problems)
• if you have previously been treated with bisphosphonates (used to treat or prevent bone diseases)
• if you are taking medicines called corticosteroids (such as prednisolone or dexamethasone)
• if you have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with ibandronic acid.
During treatment, it is necessary to maintain good oral hygiene (including regular tooth cleaning) and to have periodic dental check-ups. If you wear dentures, ensure they fit properly. If you are undergoing dental treatment or are scheduled to undergo dental surgery (e.g. tooth extractions), inform your doctor about the dental treatment and inform your dentist that you are being treated with ibandronic acid.
Contact your doctor and dentist immediately if you notice any mouth or dental problems, such as loose teeth, pain or swelling, or failure of mouth sores to heal, or presence of discharge, as these could be signs of osteonecrosis of the jaw.
Atypical fractures of long bones, such as the ulna and tibia, have also been reported in patients on long-term ibandronate treatment. These fractures occur after minimal or no trauma, and some patients experience pain in the area of the fracture before a complete fracture occurs.

Some patients need to take special care when using Acido Ibandronico Accord. Consult your doctor before being given Acido Ibandronico Accord:

• if you have, or have previously had, kidney problems, kidney 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 Acido Ibandronico Accord, 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 limiting your daily fluid intake.

Cases of 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, throat tightness, tongue swelling, dizziness, feeling faint, facial redness or swelling, rash, nausea and vomiting, you must inform your doctor or nurse immediately (see section 4).
Children and adolescents
Do not administer Acido Ibandronico Accord to children or adolescents under 18 years of age.
Other medicines and Acido Ibandronico Accord
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
Acido Ibandronico Accord may only be used by post-menopausal women and must not be taken by women who are still able to have children.
Do not take Acido Ibandronico Accord 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 Acido Ibandronico Accord is expected to have no or negligible effect on the ability to drive and operate machinery.
Acido Ibandronico Accord contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose (3 ml), i.e. it is practically
“sodium-free”.

3. How to use Ibandronic Acid Accord

The recommended dose for intravenous injection of Ibandronic Acid Accord is 3 mg (1 pre-filled syringe) every 3 months.
The injection must be administered intravenously by a doctor or qualified/trained healthcare professional. Do not self-administer the injection.
The injectable solution must be given only into a vein and nowhere else in the body.
Continuation of Ibandronic Acid Accord administration
To obtain the maximum benefit from treatment, it is important to continue receiving injections every 3 months, for as long as prescribed by your doctor. Ibandronic Acid Accord treats osteoporosis only while you continue treatment, even though you may not see or feel any difference. After receiving Ibandronic Acid Accord for 5 years, consult your doctor to determine whether you should continue receiving Ibandronic Acid Accord.
You should also take calcium and vitamin D supplements as advised by your doctor.
If you use more Ibandronic Acid Accord than you should
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 forget to use Ibandronic Acid Accord
Make an appointment to receive the next injection as soon as possible. Then resume receiving injections every 3 months, counting from the date of your last injection.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact a nurse or doctor immediately if you notice any of the following serious side effects – you may
require 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 pain in the jaw; these may be early signs of serious jaw problems (necrosis, i.e. death of bone tissue, of the jaw);
  • inform your doctor if you have ear pain, ear discharge and/or an ear infection. These could be signs of bone tissue degeneration within 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 symptom becomes bothersome or lasts more than a few days
• skin rash.

Uncommon (affects up to 1 in 100 people):

• inflammation of a vein
• pain or injury at the injection site
• bone pain
• feeling weak
• 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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the syringe after
"Exp" or "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The person administering the injection must discard any unused solution and dispose of the used syringe and injection needle in an appropriate waste container.

6. Contents of the pack and other information

What Acido Ibandronico Accord contains

• A 3 ml pre-filled syringe of solution contains 3 mg of ibandronic acid (as monosodium monohydrate). Each ml of solution contains 1 mg of ibandronic acid.
• The other components are sodium chloride, acetic acid, sodium acetate trihydrate and water for injections.

Description of the appearance of Acido Ibandronico Accord and contents of the pack
Acido Ibandronico Accord 3 mg solution for injection in pre-filled syringe is a clear, colourless solution. Each pre-filled syringe contains 3 ml of solution. Acido Ibandronico Accord is available in packs containing 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
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50, 95-200 Pabianice, Poland

Other sources of information
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:

For further information, refer to the summary of product characteristics.
Administration of Acido Ibandronico Accord 3 mg solution for injection in pre-filled syringe:
Acido Ibandronico Accord 3 mg solution for injection in pre-filled syringe must be administered
intravenously over 15 to 30 seconds.
The solution is irritating; therefore, strict adherence to intravenous administration is essential.
If accidentally injected into the tissue surrounding the vein, patients may experience local irritation,
pain, and inflammation at the injection site.
Acido Ibandronico Accord 3 mg solution for injection 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. When Acido Ibandronico Accord is administered via
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 regarding the treatment of overdose with Acido Ibandronico Accord 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 administration of adequate doses of calcium gluconate, potassium or sodium phosphate,
and magnesium sulfate may be required.
General advice:
Acido Ibandronico Accord 3 mg solution for injection in pre-filled syringe, like other intravenous
bisphosphonates, may cause a transient reduction in serum calcium levels.
Before initiating treatment with Acido Ibandronico Accord solution for injection, hypocalcemia and
other disturbances of bone and mineral metabolism should be assessed and effectively treated.
An 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 taking medicinal products that may cause renal adverse
effects should be monitored periodically during treatment, in accordance with good clinical practice.
Unused solution, syringes, and injection needles must be disposed of in accordance with local legal
requirements.