ACIDO 5 mg /100 Ml Infusion Solution

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1. ACIDO ZOLEDRONICO SEACROSS 5 mg/100 mL solution for infusion
   1. What is ACIDO ZOLEDRONICO SEACROSS and what is it used for
   2. What you need to know before you use ACIDO ZOLEDRONICO SEACROSS
   3. How to use ACIDO ZOLEDRONICO SEACROSS
2. ZOLEDRONIC ACID SEACROSS as directed by your doctor. This will help to prevent
   1. Possible side effects
   2. How to store ACIDO ZOLEDRONICO SEACROSS
   3. Package contents and other information

ACIDO ZOLEDRONICO SEACROSS 5 mg/100 mL solution for infusion

acido zoledronico
Equivalent medicinal product

Read this leaflet carefully before using 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 any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

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

1. What is ACIDO ZOLEDRONICO SEACROSS and what is it used for

ACIDO ZOLEDRONICO SEACROSS contains the active ingredient zoledronic acid. It belongs
to a group of medicines called bisphosphonates and is used for the treatment of post-
menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with corticosteroids
used to treat inflammation, and Paget's disease of bone in adults.

Osteoporosis
Osteoporosis is a disease that causes thinning and weakening of the bones and is common in
women after menopause but can also occur in men. At menopause, the ovaries
stop producing the female hormone estrogen, which helps to maintain bone health. After menopause, bone loss occurs, bones become weaker and break more
easily. Osteoporosis can also occur in men and women due to long-term use of
steroids, which can affect bone strength. Many patients with osteoporosis have no symptoms,
but are still at risk of bone fracture as osteoporosis has made their bones more fragile. The
reduction in the levels of circulating sex hormones, mainly estrogens converted from androgens,
also plays a role in the more gradual bone loss observed in men. In both women and
men, ACIDO ZOLEDRONICO SEACROSS strengthens bones and makes the risk
of fracture less likely.
ACIDO ZOLEDRONICO SEACROSS is also used in patients who have recently had a hip fracture due to minor trauma such as a fall and are therefore at risk of bone fractures.

Paget's disease of bone
It is normal for aged bone to be removed and replaced with new bone tissue. This process
is called bone remodeling. In Paget's disease, bone remodeling is too rapid and the
new bone is formed in a disorganized manner, which makes it weaker than normal. If the disease is not
treated, bones can become deformed and painful, and can break. ACIDO
ZOLEDRONICO SEACROSS works by restoring normal bone remodeling
process, ensuring normal bone formation, thus restoring bone strength.

2. What you need to know before you use ACIDO ZOLEDRONICO SEACROSS

Follow all the instructions given to you by your doctor, pharmacist or nurse before you are
administered ACIDO ZOLEDRONICO SEACROSS.

ACIDO ZOLEDRONICO SEACROSS must not be administered to you

• if you are allergic to zoledronic acid, other bisphosphonates or any of the excipients of this medicine (listed in section 6).
• if you have hypocalcemia (i.e. if the levels of calcium in your blood are too low).
• if you have severe kidney problems.
• if you are pregnant.
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor before you are administered ACIDO ZOLEDRONICO SEACROSS:

• if you are being treated with any medicine containing zoledronic acid, which is also the active substance of ACIDO ZOLEDRONICO SEACROSS (zoledronic acid is used in adult patients with some types of cancer to prevent bone complications or to reduce the amount of calcium).
• if you have kidney problems, or have had them.
• if you cannot take a daily calcium supplement.
• if you have had part or all of your parathyroid glands in your neck surgically removed.
• if you have had sections of your intestine removed.

An undesirable effect called osteonecrosis of the jaw/maxilla (bone damage of the
jaw/maxilla) has been reported in post-marketing experience in patients treated with zoledronic acid
for the treatment of osteoporosis. Osteonecrosis of the jaw/maxilla can also occur
even after stopping treatment.
It is important to try to prevent the onset of osteonecrosis of the jaw/maxilla as it is a
painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis
of the jaw/maxilla there are some precautions you must take.
Before receiving treatment with ACIDO ZOLEDRONICO SEACROSS, talk to your doctor, your
pharmacist or nurse if:

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

Your doctor may ask you to have a dental examination before starting treatment with ACIDO
ZOLEDRONICO SEACROSS.
During treatment with ACIDO ZOLEDRONICO SEACROSS, you must maintain good oral hygiene
(including regular teeth cleaning) and you must receive routine dental check-ups. If you wear a
denture, you should make sure it fits properly. If you are having dental treatment or need to undergo
dental surgery (e.g. tooth extractions), tell your doctor and tell your dentist
that you are being treated with ACIDO ZOLEDRONICO SEACROSS. Immediately inform your doctor
and dentist if you experience any problems with your mouth or teeth such as tooth loss, pain, swelling
or failure of sores to heal or discharge, as these may be signs of
osteonecrosis of the jaw/maxilla.

Monitoring tests
Your doctor must take a blood sample to check your kidney function (creatinine levels)
before each infusion of ACIDO ZOLEDRONICO SEACROSS. It is important that you drink at least
two glasses of liquid (e.g. water) within a few hours before treatment with ACIDO
ZOLEDRONICO SEACROSS, as instructed by those caring for you.

Children and adolescents
ACIDO ZOLEDRONICO SEACROSS is not recommended in children and adolescents under the age of 18 years.

Other medicines and ACIDO ZOLEDRONICO SEACROSS
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might
take any other medicines.
It is important for your doctor to know all the medicines you are taking, especially if you are already
taking other medicines potentially harmful to the kidneys (e.g. aminoglycosides) or diuretics
(“water tablets”) that can cause dehydration.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
with breast milk, you must not be administered ACIDO ZOLEDRONICO SEACROSS.
Ask your doctor, pharmacist or nurse for advice before taking this medicine.

Driving and operating machinery
If you feel dizzy while taking ACIDO ZOLEDRONICO SEACROSS, do not drive or
use machinery until you feel better.

ACIDO ZOLEDRONICO SEACROSS contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 100 mL vial of ACIDO
ZOLEDRONICO SEACROSS, that is to say essentially “sodium-free”.

3. How to use ACIDO ZOLEDRONICO SEACROSS

Follow all instructions provided by your doctor or nurse carefully. If you have any doubts, consult your
doctor or nurse.

Osteoporosis
The usual dose is 5 mg, administered by the doctor or nurse in a single intravenous infusion
per year. The infusion will last at least 15 minutes.
In the case of a recent hip fracture, it is recommended to administer ACIDO ZOLEDRONICO
SEACROSS two or more weeks after the surgical repair of the hip fracture.
It is important to take calcium and vitamin D supplements (e.g. in tablet form) as instructed by your
doctor.
For osteoporosis, ACIDO ZOLEDRONICO SEACROSS works for one year. Your doctor will let you know
when to return for the next dose.

Paget's Disease
For the treatment of Paget's disease, ACIDO ZOLEDRONICO SEACROSS should only be prescribed by
doctors experienced in the treatment of bone Paget's disease.
The usual dose is 5 mg, administered by the doctor or nurse in an initial intravenous infusion.
The infusion will last at least 15 minutes. ACIDO ZOLEDRONICO SEACROSS can work for more than
one year and your doctor will let you know if you need further treatment.
Your doctor may advise you to take calcium and vitamin D supplements (e.g. in tablet form) for
at least the first ten days after the administration of ACIDO ZOLEDRONICO SEACROSS.
It is important that you carefully follow this advice so that the calcium level in your blood does not
become too low in the period following the infusion. Your doctor will inform you about the possible symptoms
associated with hypocalcemia.

ACIDO ZOLEDRONICO SEACROSS with food and drinks
Make sure you drink enough fluids (at least one or two glasses) before and after treatment with

ZOLEDRONIC ACID SEACROSS as directed by your doctor. This will help to prevent

dehydration. On the day of treatment with ZOLEDRONIC ACID SEACROSS you can eat
normally. This is particularly important in patients who are taking diuretics (water pills) and in elderly patients (65 years of age or older).

If you forget a dose of ZOLEDRONIC ACID SEACROSS
Contact your doctor or hospital as soon as possible to schedule a new appointment.

Before stopping treatment with ZOLEDRONIC ACID SEACROSS
If you are thinking of stopping treatment with ZOLEDRONIC ACID SEACROSS, attend
your next appointment and discuss it with your doctor. The doctor will be able to advise you and decide how long
to continue treatment.
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.
Side effects related to the first infusion are very common (they occur in more than 30% of
patients) but are less common following subsequent infusions. Most of the side
effects such as fever and chills, muscle or joint pain and headache occur
within the first three days after the administration of zoledronic acid. The symptoms are usually mild
to moderate and disappear within three days. Your doctor may recommend a mild pain reliever
such as ibuprofen or paracetamol to reduce these side effects. The possibility of experiencing side
effects decreases with subsequent doses of ACIDO ZOLEDRONICO SEACROSS.

Some side effects can be serious
Common (may affect up to 1 in 10 people)
In patients treated with zoledronic acid for post-menopausal osteoporosis, irregular heartbeat (atrial
fibrillation) has been observed. It is currently unclear whether zoledronic acid is
the cause of this irregular heartbeat, but you should tell your doctor if you experience such symptoms
after being given zoledronic acid.
Uncommon (may affect up to 1 in 100 people)
Swelling, redness, pain and itching of the eyes or sensitivity to light.
Very rare (may affect up to 1 in 10,000 people)
Contact your doctor if you experience ear pain, ear discharge and/or ear infection.
These episodes may be signs of bone damage to the ear.
Not known (frequency cannot be estimated based on available data)
Pain in the mouth and/or jaw, swelling or sores in the mouth or jaw that do not
heal, discharge, numbness or feeling of heaviness in the jaw or tooth loss;
these may be signs of severe decay of the jaw bone/maxilla (osteonecrosis). Immediately inform your
doctor and dentist if you experience such symptoms while
being treated with zoledronic acid or after stopping treatment.
Kidney problems may occur (e.g. decreased urine output). The doctor will need to
perform a blood test to check your kidney function before each infusion of
zoledronic acid. It is important that you drink at least one or two glasses of fluids (e.g. water) within
a few hours before treatment with zoledronic acid, as directed by your healthcare provider.
If you experience any of these side effects, tell your doctor immediately.

Zoledronic acid can also cause other side effects
Very common (may affect more than 1 in 10 people)
Fever
Common (may affect up to 1 in 10 people)
Headache, dizziness, unwellness, vomiting, diarrhea, muscle pain, bone and/or joint pain,
back, arm or leg pain, flu-like symptoms (e.g. fatigue, chills, joint and muscle pain), chills, feeling
tired and lacking interest, weakness, pain,
feeling unwell, swelling and/or pain at the infusion site.
In patients with Paget's disease, symptoms due to low blood calcium levels have been reported,
such as muscle spasms, or numbness or tingling especially in the area around the mouth.
Uncommon (may affect up to 1 in 100 people)
Flu, upper respiratory tract infections, decreased red blood cell count, loss of
appetite, insomnia, drowsiness which may include reduced state of alertness and consciousness,
feeling of tingling or numbness, extreme fatigue, tremor, temporary loss of
consciousness, eye infection or irritation or inflammation with pain and redness, feeling of
dizziness, increased blood pressure, hot flushes, cough, shortness of breath, stomach pain,
abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching,
skin redness, neck pain, muscle stiffness, bone and/or joint stiffness, joint swelling,
muscle spasms, shoulder pain, pain in the chest and chest muscles,
joint inflammation, muscle weakness, abnormal kidney test results, frequent
abnormal need to urinate, swelling of the hands, ankles or feet, thirst, toothache, altered
taste.
Rare (may affect up to 1 in 1,000 people)
Rarely, particularly in patients treated for osteoporosis for a long time, an unusual fracture of the
femur may occur. Contact your doctor if you experience pain, weakness or discomfort in the thigh,
hip or groin as this may be an early indication of a possible femur fracture. Low levels of phosphate
in the blood.
Not known (frequency cannot be estimated based on available data)
Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and
throat, decreased blood pressure, dehydration secondary to acute phase reactions
(symptoms following infusion such as fever, vomiting and diarrhea).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly
through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-
reazioni-avverse . By reporting side effects you can help provide more information
about the safety of this medicine.

5. How to store ACIDO ZOLEDRONICO SEACROSS

The doctor, pharmacist or nurse are informed on how to store ACIDO
ZOLEDRONICO SEACROSS appropriately.

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is reported on the package and vial after Exp.
• The unopened vial does not require any particular storage conditions.
• After opening: Chemical and physical stability in use has been demonstrated for 24 hours at 2 - 8°C or below 25°C.
• After opening the vial, the product must be used immediately to avoid microbial contamination. If not used immediately, the storage times and conditions before use are the responsibility of the user and should normally not exceed 24 hours at 2°C - 8°C. Allow the solution taken from the refrigerator to reach room temperature before use.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ACIDO ZOLEDRONICO SEACROSS contains

• The active ingredient is zoledronic acid. Each 100 mL vial of solution contains 5 mg of zoledronic acid (as monohydrate).
• 1 mL of solution contains 0.05 mg of zoledronic acid (as monohydrate).
• The other ingredients are mannitol (E421), sodium citrate (E331) and water for injections.

Description of the appearance of ACIDO ZOLEDRONICO SEACROSS and contents of the pack
ACIDO ZOLEDRONICO SEACROSS is a clear and colorless solution. The 100 mL solution is
packaged in transparent type II soda-lime glass vials, closed with type I chlorobutyl rubber stoppers and sealed with aluminum polypropylene flip-off caps.
ACIDO ZOLEDRONICO SEACROSS 5 mg/100 mL solution for infusion is supplied in:
1 vial

Marketing authorization holder and manufacturer
Seacross Pharma (Europe) Limited
POD 13, The Old Station House
15A Main Street, Blackrock
Dublin, A94 T8P8
Ireland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:

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INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended for healthcare professionals only (see section 3):

How to prepare and administer ACIDO ZOLEDRONICO SEACROSS

• ACIDO ZOLEDRONICO SEACROSS 5 mg/100 mL solution for infusion is ready for use.

For single use only. Any unused solution should be discarded. The solution must
only be used if it is clear, free from particles and discoloration. ACIDO
ZOLEDRONICO SEACROSS must not be mixed or administered intravenously with other
medicines and must be administered through a separate infusion line with a ventilation membrane at a constant infusion rate. The infusion time should not be less than 15 minutes.
ACIDO ZOLEDRONICO SEACROSS must not come into contact with solutions containing calcium. If
stored in a refrigerator, allow the solution to reach room temperature before
administration. Aseptic techniques must be followed during preparation of the infusion.
The infusion must be carried out in accordance with standard medical practice.

How to store ACIDO ZOLEDRONICO SEACROSS

• Keep ACIDO ZOLEDRONICO SEACROSS out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package and the vial after Exp.
• The unopened vial does not require any special storage conditions.
• After opening the vial, the product must be used immediately to avoid microbial contamination. If not used immediately, the in-use storage times and storage conditions are the responsibility of the user and should generally not exceed 24 hours at 2°C - 8°C. Allow the solution stored in a refrigerator to reach room temperature before administration.