Label: information for the user

Zoledronic Acid Altan 5 mg/100 ml solution for infusion EFG

Read this label carefully before you receive this medication, because 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.

Additional information

Zoledronic Acid Altan 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.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. In menopause, a woman's ovaries stop producing estrogens (female hormones) that help maintain bone health. After menopause, there is a loss of bone, 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 bone loss observed in men. Zoledronic acid strengthens the bone in women and men, and therefore it 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 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, the bones can deform, cause pain, and break. Zoledronic acid works by normalizing 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 they administer Zoledronic Acid Altan.

Zoledronic Acid Altan should not be administered

• 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 AltanAltan,

• if you are being treated with any medication that contains zoledronic acid, which is also the active ingredient in Zoledronic Acid Altan (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 occur 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 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 Altan.

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

Children and adolescentsandadolescents.

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

Other medications and Zoledronic Acid Altan

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 Altan 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 Altan, do not drive or operate machinery until you feel better.

Zoledronic Acid Altan contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per dose, making it 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 administerzoledronic acidtwo 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 acidacts 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. Thezoledronic acidmay 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 ofzoledronic acid. It is essential to follow this recommendation strictly to prevent a significant 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 Altan 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 prevent dehydration. On the day you are administered 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 Altan Zoledronic Acid

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

If you interrupt treatment with Altan Zoledronic Acid

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

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

Like all medicines,thismedicinecan cause side effects, although not everyone will experience them.

The 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 cold, 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 resolve within three days. Your doctor may recommend a weak pain reliever, such as ibuprofen or paracetamol, to reduce these side effects. The likelihood of these side effects decreases with subsequent doses ofZoledronic AcidAltan.

Some side effects can be severe

Frequent (may affect up to 1 in 10 people)

In patients who are administeredZoledronic Acid Altanfor the treatment of postmenopausal osteoporosis, an irregular heart rhythm (atrial fibrillation) has been observed. It is not yet clear whetherZoledronic Acid Altancauses the irregular heart rhythm, but if you experience these symptoms after having been administered Zoledronic Acid Altan, you should inform your doctor.

Rare (may affect up to 1 in 100 patients)

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

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

Consult 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 unknown (cannot be estimated from available data)

Mouth pain, and/or jaw pain, swelling, or difficulty healing mouth or jaw ulcers, discharge, numbness, or a feeling of heaviness in the jaw or loss of a tooth; these may be signs of bone damage to the jaw (osteonecrosis). If you experience these symptomswhile being treated with Zoledronic Acid Altan 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 do a blood test to check your kidney function before each dose of Zoledronic Acid Altan. It is essential that you drink at least 2 glasses of liquid (such as water), a few hours before receiving Zoledronic Acid Altan, as instructed by your healthcare professional.

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

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

Zoledronic Acid Altan may cause other side effects

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

Fever

Frequent (may 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 (may 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 (may 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 levels of phosphate in the blood.

Unknown (cannot be estimated from available data)

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use (www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Your doctor, pharmacist, or nurse knows how to properly conserveZoledronic Acid Altan.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

The unopened bag does not require special conservation conditions.

Zoledronic Acid Altan Composition

• The active ingredient is zoledronic acid. Each 100 ml bag of solution contains 5mg 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 injection preparations.

Appearance of the product and contents of the package

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

ALTAN PHARMACEUTICALS, S.A.

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

Office F. Prisma Building, Las Rozas,

28230 Madrid

Spain

Responsible manufacturer

ALTAN PHARMACEUTICALS, S.A.

Bernedo Industrial Estate, s/n

01118 Bernedo (Álava)

Spain

Dateofthelastreviewofthisleaflet09/2024

The detailed information of 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 doctors or healthcare professionals (see section 3):

How to prepare and administer Zoledronic Acid Altan

• Zoledronic Acid Altan is prepared for use.

For single use. Any unused solution should be discarded. Only the transparent, particle-free and colorless 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 calcium-containing solution. 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 Altan

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