Label: Information for the User

Zoledronic Acid Seacross 5 mg/100 ml Infusion Solution EFG

Read this label carefully before this medicine is administered to you, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Zoledronic Acid Seacross contains zoledronic acid as the active substance. It belongs to a group of medications called bisphosphonates and is used to treat postmenopausal women and adult men with osteoporosis, osteoporosis caused by corticosteroid treatment used for the treatment of inflammation, and Paget's bone disease in adults.

Osteoporosis

Osteoporosis is a disease that consists of a thinning and weakening of the bones and is common in women after menopause, but men can also present it. During menopause, a woman's ovaries stop producing estrogens (female hormones) that help maintain bone health. After menopause, there is a loss of bone mass, bones become weaker and more fragile. Osteoporosis can also be presented by men and women due to the use of steroids for a long period of time, which can affect bone resistance. Many patients with osteoporosis do not present any symptoms but have a risk of suffering bone fractures, weakened by osteoporosis. Decreased circulating levels of sex hormones, mainly estrogens formed from androgens, also participate in the gradual loss of bone mass observed in men. Zoledronic acid strengthens bones in women and men, making it less likely to break.

Zoledronic acid is also used in patients who have recently fractured their hip in a low-impact trauma such as a fall and therefore have a risk of suffering new bone fractures.

Paget's Bone Disease

It is normal for old bone to be eliminated and replaced by new bone material. This process is called bone remodeling. In Paget's disease, the bone remodeling process is too fast and the new bone is formed in a disordered way, making it more fragile than normal. If not treated, bones can deform, cause pain, and break. Zoledronic acid normalizes the bone remodeling process, ensuring the formation of normal bone and thereby restoring bone resistance.

Follow carefully all instructions from your doctor, pharmacist, or nurse before receiving zoledronic acid.

Do not use Zoledronic Acid Seacross

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

Warnings and precautions

Consult your doctor before starting treatment with zoledronic acid:

• if you are being treated with any medication that contains zoledronic acid, which is also the active ingredient in this medication (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce calcium levels).
• if you have or have had kidney problems.
• if you cannot take daily calcium supplements.
• if you have had partial or total surgical removal of the parathyroid glands in your neck.
• if you have had a segment of your intestine removed.

A rare but serious side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in patients treated with zoledronic acid for osteoporosis during post-marketing experience. ONJ can also appear after stopping treatment.

It is essential to prevent the development of ONJ as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw, certain precautions should be taken.

Before receiving treatment with zoledronic acid, inform your doctor, pharmacist, or nurse:

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

Your doctor may ask you to undergo a dental examination before starting treatment with zoledronic acid.

While being treated with zoledronic acid, you should maintain good oral hygiene (including regular brushing of your teeth) and undergo routine dental check-ups. If you wear dentures, ensure they are properly secured. If you are undergoing dental treatment or are about to undergo dental surgery (e.g., tooth extraction), inform your doctor about your dental treatment and inform your dentist that you are being treated with zoledronic acid. Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling, or difficulty in healing ulcers or discharge, as these may be signs of osteonecrosis of the jaw.

Control tests

Your doctor will need to perform a blood test to check your kidney function (creatinine levels) before each dose of zoledronic acid. It is essential to drink at least two glasses of liquid (such as water), a few hours before receiving zoledronic acid, as instructed by your doctor.

Children and adolescents

Zoledronic acid is not recommended for use in individuals under 18 years of age.

Other medications and Zoledronic Acid Seacross

Inform your doctor, pharmacist, or nurse if you are taking, have taken recently, or may need to take any other medication.

It is essential for your doctor to know all the medications you are taking, especially if you are taking any medication that may affect your kidneys (e.g., aminoglycosides) or diuretics that can cause dehydration.

Pregnancy and breastfeeding

Zoledronic acid should not be administered if you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant.

Consult your doctor, pharmacist, or nurse before using this medication.

Driving and operating machinery

If you feel dizzy while receiving zoledronic acid, do not drive or operate machinery until you feel better.

Zoledronic Acid Seacross contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 100 ml of zoledronic acid; it is essentially«sodium-free».

Follow exactly all the instructions indicated by your doctor or nurse. In case of doubt, consult your doctor or nurse again.

Osteoporosis

The normal dose is 5 mg per year administered as an intravenous infusion by your doctor or nurse. The infusion lasts at least 15 minutes.

If you have recently fractured your hip, it is recommended to administer zoledronic acid two or more weeks after surgical repair.

It is essential to take calcium and vitamin D supplements (for example, tablets) as your doctor indicates.

For osteoporosis, zoledronic acid acts for one year. Your doctor will inform you when you need to return for your next dose.

Paget's Disease

For the treatment of Paget's disease, zoledronic acid should only be prescribed by doctors with experience in the treatment of Paget's bone disease.

The normal dose is 5 mg, which is administered as an initial intravenous infusion by your doctor or nurse. The infusion lasts at least 15 minutes. Zoledronic acid may act for more than one year, and your doctor will inform you if you need to be treated again.

Your doctor may advise you to take calcium and vitamin D supplements (e.g., tablets) for at least the first ten days after administration of zoledronic acid. It is essential to follow this recommendation strictly to prevent a decrease in blood calcium levels (hypocalcemia) in the period after the infusion. Your doctor will inform you about the symptoms associated with hypocalcemia.

Use of Seacross Zoledronic Acid with Food and Beverages

Make sure to drink enough liquids (at least one or two glasses) before and after treatment with zoledronic acid, as your doctor indicated. This will help you prevent dehydration. On the day you receive zoledronic acid, you can eat normally. This is especially important for patients taking diuretics and elderly patients (over 65 years old).

If you forgot a dose of Seacross Zoledronic Acid

Contact your doctor or hospital as soon as possible to agree on another day for your visit.

If you interrupt treatment with Seacross Zoledronic Acid

If you are considering interrupting treatment with zoledronic acid, attend your next visit and consult with your doctor. Your doctor will inform you and decide for how long you should receive treatment with zoledronic acid.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects related to the first infusion are very frequent (occur in more than 30% of patients) but are less frequent after subsequent infusions. Most of these side effects, such as fever and cold, muscle or joint pain, and headache, appear in the first three days after administration ofzoledronic acid. The symptoms are normally mild to moderate and disappear within three days. Your doctor may recommend a weak analgesic, such as ibuprofen or paracetamol, to reduce these side effects. The possibility of these side effects appearing decreases with subsequent doses of zoledronic acid.

Some side effects can be serious

Frequent (can affect up to 1 in 10 people)

In patients receiving zoledronic acid for the treatment of postmenopausal osteoporosis, irregular heart rhythm (atrial fibrillation) has been observed. It is not yet clear whether zoledronic acid causes irregular heart rhythm, but if you experience these symptoms after having been administered zoledronic acid, you should inform your doctor.

Rare (can affect up to 1 in 100 patients)

Swelling, redness, pain, and itching or sensitivity of the eyes to light.

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

Consult your doctor if you have ear pain, the ear is discharging, or you have an ear infection.These could be symptoms of damage to the bones of the ear.

Frequency unknown (cannot be estimated from available data)

Pain in the mouth and/or jaw, swelling or difficulty in healing of ulcers in the mouth or jaw, secretion, numbness or heaviness in the jaw or loss of a tooth; these may be signs of bone damage in the jaw (osteonecrosis). If you experience these symptoms while being treated withzoledronic acid or after stopping treatment, inform your doctor and dentist immediately.

You may experience kidney damage (e.g. decreased urine output). Your doctor will need to do a blood test to check your kidney function before each dose ofzoledronic acid. It is essential that you drink at least 2 glasses of liquid (such as water), a few hours before receiving zoledronic acid, as instructed by the healthcare professional.

If you experience any of the above symptoms, you must contact your doctor immediately.

Zoledronic acid Seacross may cause other side effects

Very frequent (can affect more than 1 in 10 people)

Fever

Frequent (can affect up to 1 in 10 people)

Headache, dizziness, feeling of dizziness, vomiting, diarrhea, muscle pain, bone and/or joint pain, back, arm, or leg pain, flu-like symptoms (e.g. fatigue, cold, muscle and joint pain) chills, feeling of fatigue and loss of interest, weakness, pain, discomfort, swelling, and/or pain at the injection site.

In patients with Paget's disease, symptoms due to low blood calcium levels, such as muscle spasms or numbness, or a feeling of tingling, especially around the mouth, have been reported.

Rare (can affect up to 1 in 100 people)

Flu, upper respiratory tract infections, decreased red blood cell count, loss of appetite, insomnia, somnolence that can cause reduced alertness and consciousness, feeling of tingling or numbness, extreme fatigue, tremor, temporary loss of consciousness, eye infection or irritation with pain and redness, feeling of dizziness in which everything spins around, increased blood pressure, flushing, cough, shortness of breath (dyspnea), stomach discomfort, abdominal pain, constipation, dry mouth, acid reflux, skin rash, excessive sweating, itching, redness of the skin, neck pain, muscle stiffness, joint pain, swelling of the joints, muscle spasms, shoulder pain, chest muscle or ribcage pain, joint inflammation, muscle weakness, altered renal function test results, altered frequency of the need to urinate, swelling of the hands, ankles, or feet, thirst, toothache, altered taste.

Rare (can affect up to 1 in 1,000 people)

Atypical femoral fractures that may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms and indicative of a possible femoral fracture. Low blood phosphate levels.

Unknown frequency (cannot be estimated from available data)

Severe allergic reactions, including vertigo and difficulty breathing, swelling mainly of the face and throat, decreased blood pressure, secondary dehydration due to acute phase reactions (post-administration symptoms such as fever, vomiting, and diarrhea).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you cancontribute to providing more information on the safety of this medicine.

Your doctor, pharmacist, or nurse knows how to properly conserve zoledronic acid.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the box and vial after CAD.
• The unopened vial does not require special storage conditions.
• After opening: Chemical and physical stability has been demonstrated for use within 24 hours between 2°C - 8°C or below 25°C.
• After opening the vial, the product must be used immediately to prevent microbial contamination. If not used immediately, the time and storage conditions before use are the responsibility of the user and should not exceed 24 hours at 2°C - 8°C. Allow the refrigerated solution to reach room temperature before administration.

Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Zoledronic Acid Seacross

• The active ingredient is zoledronic acid. Each vial of 100 ml solution contains 5 mg of zoledronic acid (as monohydrate).
• One ml of solution contains 0.05 mg of zoledronic acid (as monohydrate).

• The other components are mannitol, sodium citrate, and water for injection preparations.

Appearance of the product and contents of the package

Zoledronic acid Seacross is a transparent and colorless solution. It is presented in type II glass vials of soda-lime silica, sealed with type I rubber stoppers and closed with flip-off type polypropylene and aluminum seals, containing 100 ml of solution.

The packaging of Zoledronic acid Seacross 5 mg/100 ml solution for infusion contains1 vial

Holder of the marketing authorization and responsible manufacturer

Seacross Pharma (Europe) Limited

POD 13, The Old Station House

15A Main Street, Blackrock

Dublin, A94 T8P8

Ireland

Local Representative

Pharmavic Ibérica, S.L.

C/ Compositor Lehmberg Ruiz

6 Edificio Ibiza, Office 7

29007 Málaga, (Spain)

Tel: 676295501

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leafletMay2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

-----------------------------------------------------------------------------------------------------------------

INFORMATION FOR THE HEALTHCARE PROFESSIONAL

This information is intended solely for healthcare professionals (see section 3):

How to prepare and administer Zoledronic acid Seacross

• Zoledronic acid Seacross 5 mg/100 ml solution for infusion EFG is ready to use.

For single use. Any unused portion of the solution should be discarded. Only the transparent and particle-free and colorless solution should be used. Zoledronic acid should not be mixed or administered intravenously with any other medication and should be administered through a separate infusion line with air vent at a constant infusion rate. The infusion time should not be less than 15 minutes. Zoledronic acid should not come into contact with any solution containing calcium. If refrigerated, allow the refrigerated solution to reach room temperature before administration. During the preparation of the infusion, aseptic techniques should be followed. The infusion should be performed according to standard clinical practice.

How to store Zoledronic acid Seacross

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiration date appearing on the package after CAD.
• The unopened vial does not require any special storage conditions.

After opening the vial, the product should be used immediately to avoid microbial contamination. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should not normally exceed 24 hours at 2°C - 8°C. The solution, if refrigerated, should reach room temperature before administration..