ZOLEDRONIC ACID NORMON 4 mg/5 ml CONCENTRATE FOR INFUSION SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zoledronic Acid NORMON 4 mg/5 ml concentrate for solution for infusion EFG

Read all of 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 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 pack:

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

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

The active substance of Zoledronic Acid NORMON is zoledronic acid, which belongs to a group of substances called bisphosphonates. Zoledronic acid works by binding to bone and reducing the rate of bone turnover. It is used to:

• Prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from the original site to the bone).
• Reduce the amount of calcium in the blood in cases where it is too high due to the presence of a tumor. Tumors can accelerate normal bone turnover, resulting in increased release of calcium from the bone. This condition is known as tumor-induced hypercalcemia (TIH).

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

Follow carefully all instructions given by your doctor.

Your doctor will perform blood tests before you start treatment with Zoledronic Acid NORMON and will monitor your response to treatment at regular intervals.

Zoledronic Acid NORMON should not be given to you:

• if you are breast-feeding.
• if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic Acid NORMON belongs), or any of the other ingredients of Zoledronic Acid NORMON (see section 6).

Tell your doctor before you are given Zoledronic Acid NORMON

• if you have or have had a liver problem.
• if you have or have had a kidney problem.
• if you have or have had a heart problem.
• if you have or have had pain, swelling or numbness of the jaw, or a feeling of heaviness in the jaw or a tooth becomes loose. Your doctor may recommend that you undergo a dental examination before starting treatment with Zoledronic Acid NORMON.
• if you are receiving dental treatment or are going to undergo dental surgery, inform your dentist that you are being treated with Zoledronic Acid NORMON and inform your doctor about your dental treatment.

While being treated with Zoledronic Acid NORMON, you should maintain good oral hygiene (including regular brushing of teeth) and undergo routine dental check-ups.

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 of ulcers or discharge, as these may be signs of a condition called jaw osteonecrosis. Patients who are receiving chemotherapy and/or radiotherapy, who are taking corticosteroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who have received prior treatment with a bisphosphonate (used to treat or prevent bone disorders) may be at higher risk of developing jaw osteonecrosis.

Use of other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. It is especially important that you inform your doctor if you are also taking:

• Aminoglycosides (medicines used to treat serious infections), as the combination of these with bisphosphonates can significantly decrease blood calcium levels.
• Talidomide or any other medicine that may harm the kidneys.
• People who are receiving diuretic therapy should be adequately hydrated before administration of zoledronic acid.
• Medicines that also contain zoledronic acid and are used to treat osteoporosis and other non-cancerous bone diseases, or any other bisphosphonate, as the combined effects are unknown when administered together.

Patients 65 years and older

Zoledronic Acid NORMON can be given to people 65 years and older. These patients should be adequately hydrated before administration of zoledronic acid.

Use in children and adolescents

Zoledronic Acid NORMON is not recommended for use in adolescents and children under 18 years.

Pregnancy and breast-feeding

Zoledronic Acid NORMON should not be given to you if you are pregnant. Tell your doctor if you are or think you may be pregnant.

Zoledronic Acid NORMON should not be given to you if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.

Driving and using machines

In very rare cases, somnolence and drowsiness have been observed with the use of zoledronic acid. Therefore, you should be careful when driving, using machines, or performing other activities that require a lot of attention.

Important information about some of the ingredients of Zoledronic Acid NORMON

This medicine contains less than 23 mg (1 mmol) of sodium per vial, so it is essentially "sodium-free".

3. How Zoledronic Acid NORMON is given

• Zoledronic Acid NORMON should only be given by healthcare professionals experienced in the administration of intravenous bisphosphonates, i.e., administered in a vein.
• Your doctor will recommend that you drink a sufficient amount of water before each treatment to help prevent dehydration.
• Follow carefully all other instructions given by your doctor, nurse, or pharmacist.

How much Zoledronic Acid NORMON is given

• The usual single dose given is 4 mg.
• If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.

How often Zoledronic Acid NORMON is given

• If you are being treated to prevent bone complications due to bone metastases, you will be given an infusion of Zoledronic Acid NORMON every 3 or 4 weeks.
• If you are being treated to reduce the amount of calcium in the blood, you will usually only be given one infusion of Zoledronic Acid NORMON.

How Zoledronic Acid NORMON is given

• Zoledronic Acid NORMON is given as a drip (infusion) in a vein that should last at least 15 minutes and should be given as a single intravenous infusion in a separate infusion line.

Patient who do not have high levels of calcium in the blood will also be prescribed calcium and vitamin D supplements to take every day.

If you are given more Zoledronic Acid NORMON than you should

If you have received higher doses than recommended, you should be closely monitored by your doctor. This is because you may develop changes in the levels of certain substances in the blood (e.g., abnormal levels of calcium, phosphorus, and magnesium) and/or changes in kidney function, including severe kidney failure. If the level of calcium becomes too low, you may need to be given a calcium supplement by infusion.

4. Possible side effects

Like all medicines, Zoledronic Acid NORMON can cause side effects, although not everybody gets them. The most common ones are usually mild and will probably disappear after a short period of time.

Frequency not known:cannot be estimated from the available data.

Kidney inflammation (tubulointerstitial nephritis): signs and symptoms may include decreased urine output, blood in the urine, nausea, feeling of general discomfort.

Tell your doctor immediately if you experience any of the following side effects:

Common(affect 1 in 10 people):

• Severe kidney problems (usually determined by your doctor with a specific blood test).
• Low level of calcium in the blood.

Uncommon(affect 1 in 100 people):

• Pain in the mouth, teeth, and/or jaw, swelling or difficulty healing of ulcers within the mouth or jaw, discharge, numbness or feeling of heaviness in the jaw, or tooth loss. These may be signs of damage to the jawbone (osteonecrosis). Tell your doctor and dentist immediately if you experience these symptoms while being treated with Zoledronic Acid NORMON or after finishing treatment.
• An irregular heartbeat (atrial fibrillation) has been observed in patients treated with zoledronic acid for postmenopausal osteoporosis. It is not currently known whether zoledronic acid causes this irregular heartbeat, but you should tell your doctor if you experience these symptoms after receiving zoledronic acid.
• Severe allergic reaction: difficulty breathing, swelling, especially of the face and throat.

Tell your doctor as soon as possible about any of the following side effects:

Very common(affect more than 1 in 10 people):

• Low level of phosphates in the blood.

Common(affect 1 in 10 people):

• Headache and flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills, and pain in bones, joints, and/or muscles. In most cases, no specific treatment is required, and the symptoms disappear after a short period of time (a few hours or days).
• Gastrointestinal reactions such as nausea and vomiting, as well as loss of appetite.
• Conjunctivitis,
• Low level of red blood cells in the blood (anemia).

Uncommon(affect 1 in 100 people):

− Hypersensitivity reactions.

• Low blood pressure.
• Chest pain.
• Skin reactions (redness and swelling) at the infusion site, rash, itching.
• High blood pressure, difficulty breathing, dizziness, sleep disorders, tingling or numbness of the hands or feet, diarrhea.
• Decreased number of white blood cells and platelets.
• Low level of magnesium and potassium in the blood. Your doctor will monitor and take any necessary measures.
• Numbness.
• Tearing of the eyes, sensitivity of the eyes to light.
• Sudden cooling with fainting, weakness, or collapse.
• Difficulty breathing with wheezing or coughing.
• Hives.

Rare(affect 1 in 1,000 people):

• Decreased heart rate.
• Confusion.

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

Very rare(affect 1 in 10,000 people):

• Fainting due to low blood pressure.
• Severe pain in bones, joints, and/or muscles, occasionally incapacitating.
• Painful redness of the eye and/or swelling.

Tell 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.If you think any of the side effects you are experiencing are seriousor if you notice any side effects not listed in this leaflet, tell your doctor, nurse, or pharmacist.

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 side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zoledronic Acid NORMON

Your doctor, nurse, or pharmacist knows how to store Zoledronic Acid NORMON properly (see section 6).

The product will be administered by your doctor, nurse, or pharmacist.

6. Contents of the pack and other information

Composition of Zoledronic Acid NORMON

• The active substance of Zoledronic Acid NORMON is zoledronic acid. One vial contains 4 mg of anhydrous zoledronic acid, equivalent to 4.26 mg of zoledronic acid monohydrate.
• The other ingredients are: mannitol (E421), sodium citrate (E331), water for injections.

Appearance of the product and pack contents

Zoledronic Acid NORMON is supplied as a concentrate for solution for infusion. The concentrate is a clear and colorless solution.

Each pack contains one vial of concentrate. Zoledronic Acid NORMON is supplied in packs containing 1 vial.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of last revision of this leaflet: May 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.