Zoledronic Acid Altan 5 mg/100 ml Solution for Infusion

Introduction

Package Leaflet: Information for the User

Zoledronic Acid Altan 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 pack

1. What Zoledronic Acid Altan is and what it is used for
2. What you need to know before you are given Zoledronic Acid Altan
3. How Zoledronic Acid Altan is given
4. Possible side effects
5. Storage of Zoledronic Acid Altan

Additional information

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

Zoledronic Acid Altan 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 bones to become thin and weak, and is common in women after the menopause, but can also occur in men. During the menopause, the ovaries stop producing oestrogen (female hormones), which help to keep bones healthy. After the menopause, bone loss occurs, and bones become weaker and more fragile. Osteoporosis can also occur in men and women due to the long-term use of steroids, which can affect bone strength. Many patients with osteoporosis do not have any symptoms but are at risk of fractures of bones weakened by osteoporosis. Decreased levels of sex hormones, mainly oestrogen 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 are therefore at risk of suffering new fractures of the bones.

Paget's Disease of the Bone

It is normal for old bone to be 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 new bone is formed in a disorganized way, making it more fragile than normal. If the disease is not treated, the bones can become deformed, cause pain, and break. Zoledronic acid works by normalizing the bone remodelling process, ensuring the formation of normal bone, and thus restoring bone strength.

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

Follow carefully all instructions given to you by your doctor, pharmacist, or nurse before you are given Zoledronic Acid Altan.

Zoledronic Acid Altan 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

Talk to your doctor before starting treatment with Zoledronic Acid Altan

• if you are being treated with any medicine that contains zoledronic acid, which is also the active ingredient of Zoledronic Acid Altan (zoledronic acid is used in adult patients with certain types of cancer to prevent bone complications or to reduce the amount of calcium).
• 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 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 important 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 should be taken.

Before receiving treatment with zoledronic acid, tell 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 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 examination before starting treatment with Zoledronic Acid Altan.

While being treated with zoledronic acid, 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), inform your doctor about your dental treatment and inform your dentist that you are being treated with Zoledronic Acid Altan. Contact your doctor and your dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling, or difficulty healing of mouth or jaw ulcers, discharge, numbness, or a feeling of heaviness in the jaw, as these may be signs of osteonecrosis of the jaw.

Monitoring tests

Your doctor should perform a blood test to check your kidney function (creatinine levels) before each dose of Zoledronic Acid Altan. It is important that you drink at least two glasses of fluid (such as water) a few hours before receiving Zoledronic Acid Altan, as indicated by your doctor.

Children and adolescents

Zoledronic Acid Altan is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Zoledronic Acid Altan

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 taking any medicine that may affect your kidneys (e.g. aminoglycosides) or diuretics that may cause dehydration.

Pregnancy and breast-feeding

Zoledronic Acid Altan 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 Altan, do not drive or use machines until you feel better.

Zoledronic Acid Altan contains sodium

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

3. How to use Zoledronic Acid Altan

Follow exactly all instructions given to you by your doctor or nurse. If you are unsure, talk to 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 that zoledronic acid be administered two or more weeks after surgical repair.

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

For osteoporosis, zoledronic acid works 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 the treatment of Paget's disease of the bone.

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 may work 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 10 days after administration of zoledronic acid. It is essential that you follow this recommendation strictly to prevent the level of calcium in the blood from becoming too low (hypocalcaemia) in the period after the infusion. Your doctor will inform you about the symptoms associated with hypocalcaemia.

Using Zoledronic Acid Altan with food and drinks

Make sure you drink enough fluids (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 Altan

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

If you stop treatment with Zoledronic Acid Altan

If you are considering stopping treatment with zoledronic acid, attend your next scheduled 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, thismedicinecancausesideeffects, althoughnoteverybodygetsthem.

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 Altan. 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 occurring decreases with subsequent doses of Zoledronic Acid Altan.

Some side effects can be serious

Common (may affect up to 1 in 10 people)

In patients given Zoledronic Acid Altan for the treatment of postmenopausal osteoporosis, an irregular heart rhythm (atrial fibrillation) has been observed. It is not yet clear whether Zoledronic Acid Altan causes irregular heart rhythm, but if you experience these symptoms after receiving Zoledronic Acid Altan, 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 of ulcers in the mouth or jaw, discharge, numbness, or a feeling of heaviness in the jaw, or tooth loss; these may be signs of bone damage in the jaw (osteonecrosis). If you experience these symptoms while being treated with Zoledronic Acid Altan or after stopping treatment, inform your doctor and dentist immediately.

You may experience kidney problems (e.g. decreased amount of urine). Your doctor should perform a blood test to check your kidney function before each dose of Zoledronic Acid Altan. It is essential that you drink at least two glasses of fluid (such as water) a few hours before receiving Zoledronic Acid Altan, as indicated by your doctor.

Kidney inflammation (tubulointerstitial nephritis): signs and symptoms may include reduced urine volume, blood in the urine, nausea, feeling unwell.

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

Zoledronic Acid Altan 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, arm, or leg pain, flu-like symptoms (e.g. fatigue, chills, muscle and joint pain), chills, feeling tired, 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 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 awareness, 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, increased blood pressure, flushing, cough, shortness of breath (dyspnoea), 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, 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 may be early signs of a possible fracture of the femur. Low levels of phosphate in the blood.

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 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, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Zoledronic Acid Altan

Your doctor, pharmacist, or nurse knows how to store Zoledronic Acid Altan correctly.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month stated.

The unopened bag does not require special storage conditions.

6. Container Content and Additional Information

Zoledronic Acid Altan Composition

• The active ingredient is zoledronic acid. Each 100 ml bag of solution contains 5 mg of zoledronic acid.
• One ml of solution contains 0.05 mg of zoledronic acid.
• The other components are mannitol (E421), sodium citrate (E331), and water for injectable preparations.

Product Appearance and Container Content

Zoledronic Acid Altan is a clear and colorless solution. It is presented in 100 ml plastic bags as a ready-to-use solution for infusion. It is presented in single units containing one bag or multiples containing 5 units with one bag each.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

ALTAN PHARMACEUTICALS, S.A.

C/ Cólquide, No. 6, Portal 2, 1st Floor,

Office F, Prisma Building, Las Rozas,

28230 Madrid

Spain

Manufacturer

ALTAN PHARMACEUTICALS, S.A.

Polígono Industrial de Bernedo, s/n

01118 Bernedo (Álava)

Spain

Date of Last Revision of this Leaflet09/2024

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/

INFORMATION FOR HEALTHCARE PROFESSIONALS

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

How to Prepare and Administer Zoledronic Acid Altan

• Zoledronic Acid Altan is ready for use.

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

How to Store Zoledronic Acid Altan

• Keep out of sight and reach of children.
• Do not use Zoledronic Acid Altan after the expiration date stated on the container.
• The unopened bag does not require any special storage conditions.
• After opening the bag, the product should be used immediately to avoid microbial contamination.