Zoledronic Acid Normon 5 mg/100 ml Solution for Infusion

Introduction

Package Leaflet: Information for the User

Zoledronic AcidNormon5 mg/100 ml solution for infusion EFG

zoledronic acid

Read all of this leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 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 take Zoledronic Acid Normon
3. How to take Zoledronic Acid Normon
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

This medicine 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 bone in adults.

Osteoporosis

Osteoporosis is a disease that causes your bones to become thin and weak, which can lead to fractures. It is common in women after the menopause, but it can also occur in men. During the menopause, the ovaries stop producing oestrogen (female hormones), which help to keep your bones healthy. After the menopause, bone loss occurs, and your 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 they are at risk of fractures. Lower levels of sex hormones, mainly oestrogen formed from androgens, also play a role in the more gradual bone loss seen in men. Zoledronic Acid Normon strengthens bone in women and men and reduces the risk of fractures.

Zoledronic Acid Normon is also used in patients who have recently had a hip fracture due to a low-energy trauma, such as a fall, and are at risk of further fractures.

Paget's disease of bone

Normally, old bone is removed and replaced by new bone material. This process is called bone remodelling. In Paget's disease, the bone remodelling process is too fast, and the new bone is formed in a disorganized way, making it more fragile than normal. If left untreated, the bones can become deformed, causing pain and fractures. Zoledronic acid works by normalizing the bone remodelling process, ensuring that normal bone is formed and restoring bone strength.

2. What you need to know before you take Zoledronic Acid Normon

Follow carefully all instructions given to you by your doctor, pharmacist, or nurse before you are given this medicine.

Zoledronic Acid Normon should not be given to you

• 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 hypocalcaemia (low levels of calcium in the blood).
• if you have severe kidney problems.
• if you are pregnant.
• if you are breast-feeding.

Warnings and precautions

Tell your doctor before you start taking Zoledronic Acid Normon:

• if you are being treated with any medicine that contains zoledronic acid, which is used in adult patients with certain types of cancer to prevent bone complications or to reduce high levels of calcium.
• if you have or have had kidney problems.
• if you cannot take daily calcium supplements.
• if you have had your parathyroid glands removed or have had any part of your intestine removed.

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

It is important to try to prevent ONJ from developing, as it can be 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 you receive treatment with this medicine, tell your doctor, pharmacist, or nurse:

• if you have any 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 check-ups 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 have a dental check-up before starting treatment with this medicine.

While you are being treated with Zoledronic Acid Normon, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups. If you wear dentures, you should ensure they fit properly. If you are undergoing dental treatment or are about to undergo dental surgery (e.g. tooth extraction), tell your doctor about your dental treatment and inform your dentist that you are being treated with Zoledronic Acid Normon. 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 could be signs of osteonecrosis of the jaw.

Monitoring tests

Your doctor will perform a blood test to check your kidney function (creatinine levels) before each dose of zoledronic acid. It is important that you drink at least two glasses of fluid (such as water) a few hours before receiving this medicine, as instructed by your healthcare professional.

Children and adolescents

This medicine is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Zoledronic Acid Normon

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

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

Pregnancy and breast-feeding

Zoledronic acid should not be given to you if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.

Ask your doctor, pharmacist, or nurse for advice before taking 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 Normon contains sodium

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

3. How to take Zoledronic Acid Normon

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

Osteoporosis

The usual dose is 5 mg per year, given as an intravenous infusion by your doctor or nurse. The infusion takes at least 15 minutes.

If you have recently had a hip fracture, it is recommended that Zoledronic Acid Normon is given two or more weeks after surgical repair.

It is important to take calcium and vitamin D supplements (e.g. tablets) as instructed by your doctor.

For osteoporosis, Zoledronic Acid Normon works for one year. Your doctor will tell you when you need to return for your next dose.

Paget's disease of bone

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

The usual dose is 5 mg, given as an initial intravenous infusion by your doctor or nurse. The infusion takes at least 15 minutes. Zoledronic acid can work for more than one year, and your doctor will tell 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 10 days after receiving this medicine. It is essential that you follow this advice to prevent low levels of calcium in the blood (hypocalcaemia) after the infusion. Your doctor will inform you about the symptoms associated with hypocalcaemia.

Taking Zoledronic Acid Normon with food and drink

Make sure you drink enough fluids (at least one or two glasses) before and after treatment with this medicine, as instructed 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 Normon

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

If you stop taking Zoledronic Acid Normon

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

If you have any further questions on 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 flu-like symptoms, muscle or joint pain, and headache, occur within the first three days after administration of this medicine. 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 reported.

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)

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.

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

Pain in the mouth, teeth, or jaw, swelling or ulcers in the mouth, numbness or a feeling of heaviness in the jaw or tooth loss. These could be signs of bone damage in the jaw (osteonecrosis). If you experience these symptoms while being treated with zoledronic acid or after stopping treatment, tell your doctor and dentist immediately.

You may experience changes in your kidneys (e.g. decreased urine production). Your doctor will 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 fluid (such as water) a few hours before receiving this medicine, as instructed by your healthcare professional.

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

Zoledronic Acid Normon 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, diarrhoea, muscle pain, bone or joint pain, back pain, arm or leg pain, flu-like symptoms (e.g. fatigue, cold, 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 levels of calcium in the blood, such as muscle spasms or numbness, or a tingling sensation, especially around the mouth, have been reported.

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, high blood pressure, flushing, cough, shortness of breath, 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, chest, or ribcage, inflammation of the joints, 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. Tell your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as these could be early signs of a possible fracture of the femur.

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, dehydration due to post-administration symptoms such as fever, vomiting, and diarrhoea.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://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, pharmacist, or nurse knows how to store Zoledronic Acid Normon correctly.

• 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 after EXP.
• The unopened bag does not require any special storage conditions. Store in the original package.
• After opening the bag, 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 handler and should not exceed 24 hours at 2°C - 8°C. Allow the refrigerated solution to reach room temperature before administration.

6. Container Content and Additional Information

Composition of Zoledronic Acid Normon

• The active ingredient is zoledronic acid. Each 100 ml bag of solution contains 5 mg of anhydrous zoledronic acid (as monohydrate). One ml of solution contains 0.05 mg of zoledronic acid (as monohydrate).
• The other components are mannitol (E-421), sodium citrate (E-331), and water for injectable preparations.

Appearance of the Product and Container Content

Zoledronic Acid Normon is a clear and colorless solution. It is presented in 100 ml bags prepared for use in perfusion. It is supplied in containers containing one bag as a single unit.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

This medicinal product is authorized in the EEA Member States under the following names:

Portugal: Zoledronic Acid Zentiva 5 mg/100 ml Solution for perfusion

Germany: Zoledronsäure NORMON 5 mg/100 ml Infusionslösung

Spain: Zoledronic Acid Normon 5 mg/100 ml solution for perfusion EFG

Date of revision of this leaflet: January 2023

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

Information for Healthcare Professionals

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

How to Prepare and Administer Zoledronic Acid Normon

• Zoledronic Acid Normon 5 mg solution for perfusion is ready for use.

For single use only. Any unused portion of the solution should be discarded. Only the clear and particle-free solution should be used. Zoledronic Acid Normon should not be mixed or administered intravenously with any other medicinal product and should be administered through a perfusion line with a separate air intake at a constant perfusion rate. The perfusion time should not be less than 15 minutes. Zoledronic Acid Normon 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 perfusion preparation. Perfusion should be performed according to usual clinical practice.

How to Store Zoledronic Acid Normon

• Keep this medicinal product out of the sight and reach of children.
• Do not use this medicinal product after the expiry date stated on the container after CAD.
• The unopened bag does not require any special storage conditions. Store in the original container.
• After opening the bag, the product should be used immediately to avoid microbial contamination. If not used immediately, the storage times and 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.