ACIDO 2 mg Концентрат Для Инфузионного Раствора

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1. Acido Ibandronico Accord 2 mg concentrate for solution for infusion, 6 mg concentrate for solution for infusion
   1. What is Acido Ibandronico Accord and what it is used for
   2. What you need to know before you are given Acido Ibandronico Accord
   3. How Acido Ibandronico Accord is administered
   4. Possible side effects
   5. How to store Acido Ibandronico Accord
   6. Contents of the pack and other information
2. Ibandronic Acid Accord 3 mg injectable solution in pre-filled syringe
   1. What is Acido Ibandronico Accord and what it is used for
   2. What you need to know before you are given Acido Ibandronico Accord
   3. How to use Acido Ibandronico Accord
   4. Possible side effects
   5. How to store Acido Ibandronico Accord
   6. Package Contents and Other Information

Acido Ibandronico Accord 2 mg concentrate for solution for infusion, 6 mg concentrate for solution for infusion

ibandronic acid

Read this leaflet carefully before you start using this medicine because it contains important
information for you.

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

Contents of this leaflet:

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

1. What is Acido Ibandronico Accord 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 to you if you have breast cancer
that has spread to the bones (bone metastases).

• It helps to prevent bone fractures.
• It helps to prevent other bone problems that may require surgery or radiotherapy.

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

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

You must not be given Acido Ibandronico Accord:

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

You must not be given this medicine if any of these conditions apply to you. If you are not sure, ask your doctor or pharmacist before you are given Acido Ibandronico Accord.

Warnings and precautions
An undesirable effect called osteonecrosis of the jaw/maxilla (ONJ) (degeneration of the bone tissue of the jaw/maxilla) has been reported very rarely following post-marketing surveillance in patients receiving ibandronic acid for conditions related to cancer.
Osteonecrosis of the jaw/maxilla can also occur after discontinuation of 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. In order to reduce the risk of developing osteonecrosis of the jaw/maxilla you should take some precautions.
Before receiving treatment, tell your doctor/nurse (healthcare professional)

• if you have mouth or dental problems, such as poor dental health, gum disease, or if you are planning to have a tooth extraction
• if you do not receive regular dental care or have not had a dental check-up for a long time
• if you smoke (as smoking can increase the risk of dental problems)
• if you have previously had 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 cancer.

Your doctor may ask you to have a dental check-up before starting treatment with ibandronic acid.
During treatment it is necessary to maintain good oral hygiene (including regular teeth cleaning) and to have periodic dental check-ups. If you wear dentures, you should make sure they fit properly.
If you are undergoing dental treatment or are planning to have dental surgery (e.g. tooth extractions), tell your doctor about the dental treatment and tell your dentist that you are being treated with ibandronic acid.
Contact your doctor and dentist immediately if you notice the appearance of problems with your mouth or teeth, such as loosening of teeth, pain or swelling, or failure of mouth sores to heal or the presence of discharge, as these could be signs of osteonecrosis of the jaw/maxilla.
Ask your doctor or pharmacist before you are 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 suffer from kidney problems
• if you suffer from heart problems and your doctor has recommended that you 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, a feeling of tightness in the throat, swelling of the tongue, dizziness, feeling of loss of consciousness, redness or swelling of the face, rash, nausea and vomiting, you should immediately inform your doctor or nurse (see section 4).

Children and adolescents
Acido Ibandronico Accord should not be used in children and adolescents under 18 years of age.

Other medicines and Acido Ibandronico Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Acido Ibandronico Accord can affect the action of other medicines. Also, other medicines can have effects on the action of Acido Ibandronico Accord.

In particular tell your doctor or pharmacistif you are taking a type of antibiotic given by injection called “aminoglycoside”, such as gentamicin, as aminoglycosides and Acido Ibandronico Accord can both reduce the amount of calcium in the blood.

Pregnancy and breastfeeding
You must not be given Acido Ibandronico Accord if you are pregnant, if you are planning a pregnancy or if you are breastfeeding with breast milk.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
You can drive vehicles and use machines as it is not expected that Acido Ibandronico Accord will have any effect or have a negligible effect on the ability to drive vehicles and operate machines.
Consult your doctor before driving vehicles, 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 usually administered by a doctor or medical personnel who have experience with the treatment of tumors.
• Acido Ibandronico Accord is administered via intravenous infusion.

The doctor may perform periodic blood tests during treatment with Acido Ibandronico Accord to verify that you are being administered the correct dose of this medicine.

How much medicine will be administered to you
The doctor will determine how much Acido Ibandronico Accord will be administered to you depending on the
disease.
If you have breast cancer that has spread to the bones, the recommended dose is 3 vials
(6 mg) every 3-4 weeks, as an intravenous infusion of at least 15 minutes.
If you have high levels of calcium in the blood due to cancer, 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 an intravenous infusion of two hours. Repeating the dose may be considered
if the response is not adequate or if the disease recurs.
The doctor may modify the dose or the duration of the intravenous infusion if you have kidney problems.
If you have any doubts about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

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

Seek immediate help from a nurse or doctor if you notice any of the following serious side effects - urgent medical treatment may be needed:
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 a possible atypical femur fracture.

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

• pain or sore mouth or jaw pain/mandible pain. These could be early signs of serious jaw/mandible problems (necrosis (death of bone tissue) of the jaw/mandible)
• tell 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 difficulty breathing. You may be having a severe allergic reaction that is potentially life-threatening (see section 2).
• serious 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, shivering and chills, feeling unwell, fatigue, bone and muscle pain and painful joints. These symptoms usually disappear within a few hours or days. Talk to a nurse or doctor if any effect becomes bothersome or lasts more than a few days
• increased body temperature
• stomach and abdominal pain, indigestion, feeling sick, 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 cataracts
• skin problems
• dental problems.

Uncommon(affects less than 1 in 100 people)

• tremor or shivering
• excessive lowering of body temperature (hypothermia)
• a condition affecting blood vessels in the brain known as “cerebrovascular disease”
• heart problems and circulation problems (including palpitations, heart attack, high blood pressure and varicose veins)
• changes in blood cells (anaemia)
• elevated levels of alkaline phosphatase in the blood
• fluid build-up and swelling (lymphoedema)
• fluid in the lungs
• stomach problems such as “gastroenteritis” or “gastritis”
• stones
• inability to urinate, cystitis (bladder inflammation)
• migraine
• pain and injury to the nerve endings
• hearing loss
• increased sensitivity of hearing, taste or touch or altered sense of smell.
• difficulty swallowing
• mouth ulcers, swelling of the lips (“cheilitis”), thrush
• itching or numbness of the skin around the mouth
• pelvic pain, discharge, itching or vaginal pain
• skin growth called “benign skin neoplasm”
• 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 get any side effects, even those not listed in this leaflet, tell your
doctor, or pharmacist or nurse. 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 Acido Ibandronico Accord

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

• Do not use this medicine after the expiry date which is stated on the pack and on the label after ‘Exp.’. The expiry date refers to the last day of that month. This medicine does not require any particular storage conditions.

After dilution:
The chemical and physical stability during use 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 point of view, the infusion solution must be used immediately. If
not used immediately, the period and conditions of storage during use are under
the responsibility of the user and should not normally exceed 24 hours at a temperature
between 2°C and 8°C, unless the dilution has taken place under controlled and
validated aseptic conditions.
Do not use this medicine if you notice that the solution is not clear or contains particles.

6. Contents of the pack and other information

What Acido Ibandronico Accord contains

• The active ingredient is ibandronic acid. Acido Ibandronico Accord 2 mg concentrate for solution for infusionOne vial with 2 ml of concentrate for solution for infusion contains 2 mg of ibandronic acid (equivalent to 2.25 mg of ibandronic acid sodium monohydrate). Acido Ibandronico Accord 6 mg concentrate for solution for infusion

One vial with 6 ml of concentrate for solution for infusion contains 6 mg of acid
ibandronic (equivalent to 6.75 mg of ibandronic acid sodium monohydrate).

• The other ingredients 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 concentrate for solution for infusion (sterile concentrate). A
colourless and clear solution.
It is supplied in glass vials (type I) with a rubber stopper and aluminium seals with a removable
cap.

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
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.
----------------------------------------------------------------------------------------------------------------
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 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 (CLcr ≥50 and <80 ml/min) no dose
adjustment is necessary. In patients with moderate renal impairment (CLcr ≥30 and
<50 ml/min) or severe renal impairment (CLcr <30 ml/min) who are being treated for the
prevention of skeletal events resulting from breast cancer and metastatic bone disease,
the following dosage recommendations should be followed:
Creatinine clearance Dosage Infusion volume and time
(ml/min)
≥ 50 CLcr < 80 6 mg (6 ml of concentrate for
solution for infusion)
100 ml over 15 minutes
≥ 30 CLcr < 50 4 mg (4 ml of concentrate for
solution for infusion)
500 ml over 1 hour
< 30 2 mg (2 ml of concentrate for
solution for infusion)
500 ml over 1 hour
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 a creatinine
clearance of less than 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 doctor considering the following factors.
Before treatment with Acido Ibandronico Accord the patient must be adequately rehydrated
with 9 mg/ml (0.9%) sodium chloride. The severity
of the hypercalcaemia and the type of tumour must be taken into consideration. In most patients with severe hypercalcaemia
(calcium corrected for albumin*  3 mmol/l or  12 mg/dl), 4 mg constitutes an adequate dose, as a single administration. In patients with moderate hypercalcaemia (calcium corrected
for albumin <3 mmol/l or <12 mg/dl), 2 mg constitutes an effective dosage. The highest dose
used in clinical studies was 6 mg, but this dosage does not determine any further
benefit in terms of efficacy.
* Note that plasma calcium concentrations corrected for albumin are calculated
as follows:
Calcium [mmol/l] corrected
for albumin
= calcium [mmol/l] - [0.02 × albumin values
(g/l)] + 0.8

Or
Calcium [mg/dl] corrected
for albumin
= calcium [mg/dl] + 0.8 x [4 - albumin values
(g/dl)]
To convert corrected calcium values for albumin from mmol/l to mg/dl,
multiply by 4.
In most cases, increased calcium can be brought back to normal within 7
days. The median time to relapse (re-increase in serum calcium corrected for albumin values greater than 3 mmol/l) was 18-19 days for doses of 2 mg and 4 mg. For the 6 mg dose, the
median time to relapse was 26 days.

Route of administration and method of administration
Acido Ibandronico Accord concentrate for solution for infusion must be administered as
an intravenous infusion.
To this end, the contents of the vial must be used as follows:

• - Prevention of skeletal events in patients with breast cancer and bone metastases
• added to 100 ml of sodium chloride 0.9% solution or 100 ml of a 5% glucose solution and infused over at least 15 minutes. See also the dosage paragraph above for patients with renal impairment.
• Treatment of tumour-induced hypercalcaemia - added to 500 ml of isotonic sodium chloride solution or 500 ml of a 5% dextrose solution and infused over 2 hours.

Note:
To avoid any incompatibilities, Acido Ibandronico Accord concentrate for solution for
infusion must only be diluted with an isotonic sodium chloride solution or a
5% dextrose solution. Solutions containing calcium must not be mixed with Acido Ibandronico
Accord concentrate for solution for infusion.
The diluted solutions are for single dose. The solutions must only be used if they appear
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. It is important to ensure that Acido Ibandronico Accord
concentrate for solution for infusion is not administered via intra-arterial or paravenous route, as this could lead to 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, the infusion of Acido Ibandronico Accord is repeated every 3-4 weeks.

Duration of treatment
A limited number of patients (50 patients) received a second infusion for hypercalcaemia. Are
possible repeated treatments in case of recurrent hypercalcaemia or insufficient efficacy.
For patients with breast cancer and bone metastases, the infusion of Acido Ibandronico
Accord should be administered every 3-4 weeks. During clinical trials, therapy was
continued for up to 96 weeks.

Overdose
To date, no cases of acute intoxication with Acido Ibandronico Accord
concentrate for solution for infusion have been reported. Since, during preclinical studies, both the kidneys and the liver have been found to be target organs for toxicity, both renal and hepatic function must be
monitored.
Clinically relevant hypocalcaemias (very low serum calcium levels) must be
corrected by intravenous administration of calcium gluconate.

Ibandronic Acid Accord 3 mg injectable solution in pre-filled syringe

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, see section 4, and speak to your doctor, pharmacist or nurse.

Contents of this leaflet:

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

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

Acido Ibandronico Accord belongs to a group of medicines called bisphosphonates. It contains the
active ingredient ibandronic acid.
Acido Ibandronico Accord 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. Acido Ibandronico Accord can help to decrease the possibility 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 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, the
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 habit of walking or other weight-bearing physical activity;
• family history of osteoporosis.

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

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

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

Do not use Acido Ibandronico Accord:

• if you have, or have had in the past, a low level of calcium in the 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
An undesirable effect called osteonecrosis of the jaw/maxilla (ONJ) (degeneration of the
bone tissue of the jaw/maxilla) has been reported very rarely following marketing authorisation in
patients receiving ibandronic acid for the treatment of osteoporosis.
Osteonecrosis of the jaw/maxilla can occur even after discontinuation of treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/maxilla in
as it is a painful condition that can be difficult to treat. In order to reduce the risk of
developing osteonecrosis of the jaw/maxilla you should take some precautions. Before receiving
treatment, tell your doctor/nurse (healthcare professional)

• if you have mouth or dental problems, such as poor dental health, gum disease, or if you are planning to have a tooth extraction
• if you do not receive regular dental care or have not had a dental check-up for a long time
• if you smoke (as smoking can increase the risk of dental problems)
• if you have previously had 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 cancer.

Your doctor may ask you to have a dental check-up before starting treatment with
ibandronic acid.
During treatment you should maintain good oral hygiene (including regular teeth cleaning) and have periodic
dental check-ups. If you wear dentures, you should make sure that
they fit properly. If you are undergoing dental treatment or are planning to
have dental surgery (e.g. tooth extractions), tell your doctor about the dental treatment
and tell your dentist that you are in
treatment with ibandronic acid.
Contact your doctor and dentist immediately if you notice the appearance of problems with your mouth or teeth,
such as loosening of 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/maxilla .
Some patients need to take particular care when using Acido Ibandronico Accord. Consult
your doctor before you are given Acido Ibandronico Accord:

• 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 Acido Ibandronico Accord you must take a calcium and vitamin D supplement. If you are unable to do so, tell 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
loss of consciousness, redness or swelling of the face, rash, nausea and vomiting, you should immediately warn
your doctor or nurse (see section 4).

Children and adolescents
Do not give Acido Ibandronico Accord to children or adolescents under 18 years of age.

Other medicines and Acido Ibandronico Accord
Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might
take any other medicines.

Pregnancy and breastfeeding
Acido Ibandronico Accord can only be used by post-menopausal women and should 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 can drive and use machines as it is expected that Acido Ibandronico Accord will have no or
negligible effect on the ability to drive and operate machines.

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 Acido Ibandronico Accord

The recommended dose for the intravenous injection of Acido Ibandronico Accord 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 administered only intravenously and nowhere else in the body.

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

If you use more Acido Ibandronico Accord 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 forget to use Acido Ibandronico Accord
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.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or
nurse.

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:
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. You may have 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 pain/mandible. You could have early signs of serious jaw/mandible problems (necrosis, i.e. death of the jaw/mandible bone tissue);
• tell 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.
• 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, shivering and chills, feeling unwell, bone pain and sore muscles and joints. Talk to a nurse or doctor if any effect becomes bothersome or lasts more than a couple of days
• skin 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):

• hives.

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 Acido Ibandronico Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the syringe after
“Scad.” 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 place
the syringe and used injection needle in a suitable waste container.

6. Package Contents and Other Information

What Acido Ibandronico Accord Contains

• A pre-filled syringe of 3 ml of solution contains 3 mg of ibandronic acid (as sodium 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 package contents
Acido Ibandronico Accord 3 mg injectable solution in a pre-filled syringe is a clear and
colourless solution. Each pre-filled syringe contains 3 ml of solution. Acido Ibandronico Accord is available
in packs of 1 pre-filled syringe and 1 injection needle or 4 pre-filled syringes and 4 needles for
injection.
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
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
--------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for healthcare professionals:

For further information, see the summary of product characteristics.
Administration of Acido Ibandronico Accord 3 mg injectable solution in a pre-filled
syringe:
Acido Ibandronico Accord 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.
Acido Ibandronico Accord 3 mg injectable solution in a pre-filled syringe must notbe mixed
with solutions containing calcium (such as Ringer's lactate solution or calciparine) or with other
medicines administered intravenously. If Acido Ibandronico Accord 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 forgotten, administer the injection as soon as possible.
Subsequently, schedule injections at intervals of 3 months from the date of the last injection.

Overdose:
Specific information on the treatment of an overdose with Acido
Ibandronico Accord is not available.
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 and magnesium sulphate intravenously.

General advice:
Acido Ibandronico Accord 3 mg injectable solution in a pre-filled syringe, like other bisphosphonates
administered intravenously, may cause a transient decrease in serum calcium levels.
Before starting treatment with Acido Ibandronico Accord injectable solution, hypocalcaemia and other disorders of bone and mineral metabolism must be assessed and
effectively treated. Adequate calcium and vitamin D intake 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 must be disposed of in
accordance with local legal requirements.