Zoledronic Acid Seacross 5 mg/100 ml Solution for Infusion

Introduction

Package Leaflet: Information for the User

Zoledronic Acid Seacross 5 mg/100 ml Solution for Infusion EFG

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Zoledronic Acid Seacross and what is it used for

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

Osteoporosis

Osteoporosis is a disease that causes thinning and weakening of the bones and is common in women after menopause, but it can also occur in men. During menopause, the ovaries stop producing estrogen (female hormones), which help maintain bone health. After menopause, bone loss occurs, and the bones become weaker and more fragile. Osteoporosis can also occur in men and women due to long-term use of steroids, which can affect bone strength. Many patients with osteoporosis do not have any symptoms but are at risk of suffering bone fractures, weakened by osteoporosis. Decreased circulating levels of sex hormones, mainly estrogens formed from androgens, also contribute to the more gradual bone loss observed in men. Zoledronic acid strengthens bone in women and men and, therefore, is 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 Disease of the Bone

It is normal for old bone to be removed and replaced with 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 disorganized way, making it more fragile than normal. If the disease is not treated, the bones can deform, cause pain, and break. Zoledronic acid works by normalizing the bone remodeling process, ensuring the formation of normal bone, and thus restoring bone strength.

2. What you need to know before you are given Zoledronic Acid Seacross

Follow carefully all the instructions given by your doctor, pharmacist, or nurse before you are given zoledronic acid.

Do not use Zoledronic Acid Seacross

• if you are allergic to zoledronic acid, other bisphosphonates, or any of the other ingredients of this medicine (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

Talk to your doctor before starting treatment with zoledronic acid:

• if you are being treated with any medicine that contains zoledronic acid, which is also the active ingredient of this medicine (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 a kidney problem.
• if you cannot take daily calcium supplements.
• if you have had your parathyroid glands in your neck surgically removed, either partially or totally.
• if you have had a segment of your intestine surgically removed.

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

It is essential to try 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 must 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 routine dental care or if you 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 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 zoledronic acid.

While being treated with zoledronic acid, you must maintain good oral hygiene (including regular brushing of teeth) and undergo routine dental check-ups. If you wear dentures, you must ensure they fit properly. If you are undergoing dental treatment or are going 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 healing ulcers or discharge, as these can be signs of osteonecrosis of the jaw.

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 that you drink at least two glasses of liquid (such as water) a few hours before receiving zoledronic acid, as indicated by your doctor.

Children and Adolescents

The use of zoledronic acid is not recommended in children and adolescents under 18 years of age.

Other Medicines and Zoledronic Acid Seacross

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

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

Pregnancy and Breastfeeding

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

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

Driving and Using Machines

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

Zoledronic Acid Seacross contains Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 100 ml vial of zoledronic acid; this is essentially "sodium-free".

3. How to use Zoledronic Acid Seacross

Follow exactly all the instructions given by your doctor or nurse. If you are unsure, consult your doctor or nurse again.

Osteoporosis

The usual 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 (e.g., tablets) as indicated by your doctor.

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 of the Bone

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

The usual dose is 5 mg, administered as an initial intravenous infusion by your doctor or nurse. The infusion lasts at least 15 minutes. Zoledronic acid can 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 that you follow this recommendation strictly to prevent low calcium levels in the blood (hypocalcemia) in the period after infusion. Your doctor will inform you about the symptoms associated with hypocalcemia.

Using Zoledronic Acid Seacross with Food and Drinks

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

If you miss a dose of Zoledronic Acid Seacross

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

If you stop treatment with Zoledronic Acid Seacross

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

If you have any further 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 (occur in more than 30% of patients) but are less common after subsequent infusions. Most of these side effects, such as fever and chills, muscle or joint pain, and headache, occur within the first three days after 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 likelihood of these side effects decreases with subsequent doses of zoledronic acid.

Some side effects can be serious

Common (may affect up to 1 in 10 people)

In patients given zoledronic acid for the treatment of postmenopausal osteoporosis, an 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 receiving zoledronic acid, you should inform your doctor.

Uncommon (may affect up to 1 in 100 people)

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

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

Talk to your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of the ear.

Frequency not known (cannot be estimated from the available data)

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

You may experience kidney problems (e.g., decreased urine output). Your doctor will need to perform a blood test to check your kidney function before each dose of zoledronic acid. It is essential that you drink at least two glasses of liquid (such as water) a few hours before receiving zoledronic acid, as indicated by your doctor.

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

Zoledronic Acid Seacross can 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, feeling dizzy, vomiting, diarrhea, muscle pain, bone or joint pain, back, arm, or leg pain, flu-like symptoms (e.g., fatigue, chills, muscle and joint pain), chills, feeling tired, 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 calcium levels in the blood have been reported, such as muscle spasms or numbness, or a tingling sensation, especially 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 that can cause reduced alertness and consciousness, tingling or numbness, extreme fatigue, tremors, temporary loss of consciousness, eye infection or irritation, or inflammation with pain and redness, feeling dizzy, as if everything is spinning around, increased blood pressure, flushing, cough, shortness of breath (dyspnea), stomach upset, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, redness of the skin, neck pain, stiffness in the muscles, bones, and/or joints, swelling of the joints, muscle spasms, pain in the shoulder, pain in the chest or ribcage, joint inflammation, muscle weakness, altered kidney test results, altered frequency of urination, swelling of the hands, ankles, or feet, thirst, toothache, altered taste.

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

Atypical fractures of the thigh bone (femur) that can occur rarely, especially in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these can be early signs of a possible femur fracture. Low phosphate levels in the blood.

Frequency not known (cannot be estimated from the 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 (post-administration symptoms such as fever, vomiting, and diarrhea).

Reporting of Side Effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zoledronic Acid Seacross

Your doctor, pharmacist, or nurse knows how to store zoledronic acid correctly.

• 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 vial after EXP.
• The unopened vial does not require special storage conditions.
• After opening: Chemical and physical stability has been demonstrated for 24 hours between 2°C - 8°C or below 25°C.
• After opening the vial, the product should be used immediately to avoid microbial contamination. If not used immediately, the storage time and 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.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

Composition of Zoledronic Acid Seacross

• The active ingredient is zoledronic acid. Each 100 ml vial of 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 injectable preparations.

Appearance of the Product and Container Content

Zoledronic Acid Seacross is a clear and colorless solution. It is presented in transparent type II glass vials, sealed with type I chlorobutyl rubber stoppers and flip-off seals made of polypropylene and aluminum, containing 100 ml of solution.

The packaging of Zoledronic Acid Seacross 5 mg/100 ml solution for infusion contains 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

Local Representative

Pharmavic Ibérica, S.L.

C/ Compositor Lehmberg Ruiz

6 Edificio Ibiza, Oficina 7

29007 Málaga, (Spain)

Phone: 676295501

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this LeafletMay 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL

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

How to Prepare and Administer Zoledronic Acid Seacross

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

For single use. Any unused portion of the solution should be discarded. Only the clear and particle-free solution should be used. Zoledronic acid should not be mixed or administered intravenously with any other medicinal product and should be administered through a separate infusion line with an air intake 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. Aseptic techniques should be followed during the preparation of the infusion. The infusion should be performed according to usual clinical practice.

How to Store Zoledronic Acid Seacross

• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiration date stated on the packaging 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 in-use storage times and conditions 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.