Prospecto: information for the user

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

Read this prospect carefully before this medicine is administered to you, because it contains important information for you

-Keep this prospect, 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 prospect. See section 4.

1.What is Zoledronic Acid Altan and how it is used

2.What you need to know before starting to use Zoledronic Acid Altan

3.How to use Zoledronic Acid Altan

4.Possible adverse effects

5.Storage of Zoledronic Acid Altan

6.Contents of the package and additional information

The active ingredient of Zoledronic Acid Altan is zoledronic acid, which belongs to a group of substances called bisphosphonates. Zoledronic acid acts by binding to bones and reducing the rate of bone remodeling. It is used for:

• Preventing bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from the primary site to the bone).
• Reducing the amount of calciumin the blood in adult patients where it is too high due to the presence of a tumor. Tumors can accelerate normal bone remodeling in such a way that the release of calcium from the bone is increased. This condition is known as tumor-induced hypercalcemia (TIH).

Follow carefully all the instructions given by your doctor.

Your doctor will perform blood tests before starting treatment with Altan Zoledronic Acid and will monitor your response to the treatment at regular intervals.

Do not use Altan Zoledronic Acid:

-if you are breastfeeding

-if you are allergic to this medication, another bisphosphonate (a group of substances to which acid zoledronic belongs), or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Before using this medication, consult your doctor:

-if you have or have had akidney problem.

-if you have or have hadjaw pain, swelling, or numbness, or a feeling of heaviness in the jaw or a tooth that moves. Your doctor may recommend a dental examination before starting treatment with acid zoledronic.

-if you are receivingdental treatmentor are about to undergo dental surgery, inform your dentist that you are being treated with acid zoledronic and inform your doctor about your dental treatment.

While being treated with acid zoledronic, you should maintain good oral hygiene (including regular brushing of your 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 in healing ulcers or discharge, as these may be signs of a condition called osteonecrosis of the jaw.

Patients receiving chemotherapy and/or radiation therapy, taking corticosteroids, undergoing dental surgery, not receiving regular dental care, having gum disease, being smokers, or having received previous treatment with a bisphosphonate (used to treat or prevent bone disorders) may be at a higher risk of developing osteonecrosis of the jaw.

Reduced levels of calcium in the blood (hypocalcemia) have been described in patients who have received acid zoledronic, which may manifest as muscle cramps, dry skin, and a burning sensation. Severe hypocalcemia has been associated with irregular heart rhythm (cardiac arrhythmia), convulsions, spasms, and involuntary muscle contractions (tetany). In some cases, hypocalcemia may be potentially fatal. If you experience any of these conditions, inform your doctor immediately. If you have a pre-existing hypocalcemia, it should be corrected before receiving the first dose of acid zoledronic. You will be provided with adequate calcium and vitamin D supplements.

People 65 years and older

Altan Zoledronic Acid may be administered to people 65 years and older. There is no evidence to suggest that additional precautions are necessary.

Use in children and adolescents

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

Other medications and Altan Zoledronic Acid

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. It is especially important to inform your doctor if you are also taking:

• Aminoglycosides (medications used to treat severe infections), calcitonin (a type of medication used to treat postmenopausal osteoporosis and hypercalcemia), diuretics (a type of medication for treating high blood pressure or edema), or other medications that decrease calcium, as the combination of these with bisphosphonates may significantly decrease blood calcium levels.
• Talidomide (a medication used to treat a type of blood cancer that affects the bone) or any other medication that may harm the kidneys.
• Other medications that also contain acid zoledronic and are used to treat osteoporosis and other non-cancerous bone disorders, or any other bisphosphonate, as the combined effects of these medications with acid zoledronic are unknown.
• Anti-angiogenic medications (used to treat cancer), as the combination of these medications with Zometa has been associated with a higher risk of osteonecrosis of the jaw (ONJ).

Pregnancy and lactation

Do not administer Altan Zoledronic Acid if you are pregnant. Inform your doctor if you are or think you may be pregnant.

Do not administer Altan Zoledronic Acid if you are breastfeeding.

Consult your doctor before using any medication if you are pregnant or during lactation.

Driving and operating machinery

In rare cases, drowsiness and numbness have been observed with the use of acid zoledronic. Therefore, you should exercise caution when driving, operating machinery, or performing other activities that require close attention.

Altan Zoledronic Acid contains sodium (as sodium citrate).

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

• This medication should only be administered by experienced healthcare professionals in the administration of intravenous bisphosphonates, i.e., administered through 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, pharmacist, or nurse.

What amount of Zoledronic Acid Altan is administered

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

How often is Zoledronic Acid Altan administered

• If you are being treated for the prevention of bone complications due to bone metastases, you will be administered a zoledronic acid infusion every three to four weeks.
• If you are being treated to reduce the amount of calcium in the blood, you will usually only be administered a single zoledronic acid infusion.

How is Zoledronic Acid Altan administered

• This medication is administered as an intravenous infusion that must last at least 15 minutes and must be administered as a single intravenous solution in a separate infusion line.

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

If you are administered more Zoledronic Acid Altan than you should

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The most common ones are generally mild and will probably disappear after a short period of time.

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

Frequent (may affect up to 1 in 10 patients):

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

Not common (may affect up to 1 in 100 patients):

• Pain in the mouth, teeth, and/or jaw, swelling or difficulty healing of sores inside the mouth or jaw, discharge, numbness or heaviness in the jaw, or tooth loss. These may be signs of jaw bone damage (osteonecrosis). Inform your doctor and dentist immediately if you experience these symptoms while being treated with Zoledronic Acid Altan or after completing treatment.
• Irregular heart rhythm (atrial fibrillation) has been observed in patients treated with zoledronic acid for postmenopausal osteoporosis. The current cause of this irregular heart rhythm is unknown, but you should inform your doctor if you experience these symptoms after receiving zoledronic acid.
• Severe allergic reaction: difficulty breathing, swelling, especially of the face and throat.

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

• As a consequence of low calcium levels: irregular heart rhythm (cardiac arrhythmia; secondary to hypocalcemia).

• A kidney function alteration called Fanconi syndrome (usually detected by your doctor with a urine test).

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

• As a consequence of low calcium levels: seizures, numbness, and tetany (secondary to hypocalcemia).
• Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These may be signs of bone damage in the ear.
• There have also been rare cases of osteonecrosis in other bones, especially in the hip or thigh. Inform your doctor immediately if you experience symptoms such as new pain, worsening pain, or stiffness while receiving treatment with zoledronic acid or after stopping treatment.

Frequency not known: cannot be estimated from available data.

-Renal inflammation (tubulointerstitial nephritis): symptoms may include reduced urine volume, blood in the urine, nausea, general feeling of discomfort.

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

Very frequent (may affect more than 1 in 10 patients):

• Low phosphate levels in the blood.

Frequent (may affect up to 1 in 10 patients):

• Headache and flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills, and bone, joint, and/or muscle pain. In most cases, no specific treatment is required, and symptoms will 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 red blood cell count in the blood (anemia).

Not common (may affect up to 1 in 100 patients):

• Hypersensitivity reactions.
• Low blood pressure.
• Chest pain.
• Reactions on the skin (redness and swelling) at the infusion site, rash, itching.
• High blood pressure, difficulty breathing, dizziness, anxiety, sleep disturbances, taste alterations, tremors, numbness or tingling in the hands or feet, diarrhea, constipation, abdominal pain, dry mouth.
• Decreased white blood cell and platelet count.
• Low magnesium and potassium levels in the blood. Your doctor will monitor and take any necessary measures.
• Weight gain
• Increased sweating
• Numbness.
• Blurred vision, eye watering, sensitivity to light.
• Sudden cooling with fainting, weakness, or collapse.
• Difficulty breathing with wheezing or coughing.
• Urticaria.

Rare (may affect up to 1 in 1,000 patients):

• Decreased heart rate.
• Confusion.
• Atypical fractures of the femur (thigh bone) that may occur in rare cases, especially in patients receiving prolonged treatment for osteoporosis. Inform your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early signs of a possible femur fracture.
• Pulmonary interstitial disease (inflammation of the tissue surrounding the lung air sacs).
• Symptoms similar to the flu, including arthritis and joint swelling.
• Red, painful eye and/or swelling.

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

• Fainting due to low blood pressure.
• Intense pain in the bones, joints, and/or muscles, occasionally incapacitating.

Reporting of suspected adverse reactions:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse through the Spanish Medicinal Product Vigilance System:https://www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Your doctor, nurse, or pharmacist knows how to store this medication properly (see section 6)

Composition of Zoledronic Acid Altan

-The active ingredient is zoledronic acid. A vial contains 4 mg of zoledronic acid equivalent to 4.264 mg of zoledronic acid monohydrate

-The other components are: mannitol (E-421), sodium citrate (E-331), water for injection preparations.

Appearance of Zoledronic Acid Altan and contents of the package

It is supplied as a transparent and colorless liquid concentrate in a vial. A vial contains 4 mg of zoledronic acid.

Each package contains the vial of concentrate. Zoledronic Acid Altan is supplied in packages containing 1 vial.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the marketing authorization:

Altan Pharmaceuticals, S.A.

C/Cólquide Nº 6, Portal 2, 1ª Planta – Office F, Edificio Prisma

28230 Las Rozas (Madrid)

Spain

Responsible for manufacturing

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo, s/n

01118 Bernedo (Álava)

Spain

Altan Pharmaceuticlas, S.A.

Avda. de la Constitución, 198-199,

Polígono Industrial Monte Boyal,

Casarrubios del Monte, 45950 Toledo

Date of the last review of this leaflet: 09/2024

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL

How to prepare and administer Zoledronic Acid Altan

-To prepare the solution for perfusion containing 4 mg of zoledronic acid, you must dilute Zoledronic Acid Altan concentrate (5.0 ml) with 100 ml of perfusion solution free of calcium or other divalent cations. If a lower dose of zoledronic acid is required, remove the appropriate volume first as indicated below and dilute it later with 100 ml of perfusion solution. To avoid possible incompatibilities, the perfusion solution used for dilution must be sodium chloride 0.9% w/v or glucose 5% w/v solution.

Do not mix Zoledronic Acid Altan concentrate with solutions containing calcium or other divalent cations, such as lactated Ringer's solution.

Instructions for preparing lower doses of zoledronic acid:

Remove the appropriate volume of the liquid concentrate as indicated below:

-4.4 ml for a dose of 3.5 mg

-4.1 ml for a dose of 3.3 mg

-3.8 ml for a dose of 3.0 mg

-For single use only. Any unused portion of the solution must be discarded. Only transparent, particle-free, and colorless solutions should be used. During the preparation of the perfusion, aseptic techniques should be used.

-From a microbiological point of view, the diluted perfusion solution should be used immediately. If not used immediately, the time and storage conditions during its use before administration are the responsibility of the user and should not exceed 24 hours at 2°C – 8°C. The solution stored in the refrigerator should reach room temperature before administration.

-The solution containing zoledronic acid is administered as a single intravenous infusion over 15 minutes. Before and after administration of zoledronic acid, the hydration status of the patients should be evaluated to ensure they are adequately hydrated.

- Studies with various types of infusion lines made of polyvinyl chloride, polyethylene, and polypropylene did not show incompatibility with zoledronic acid.

-Since there are no available data on the compatibility of zoledronic acid with other substances administered intravenously, zoledronic acid should not be mixed with other medications/substances and should be administered through a separate infusion line.

How to store Zoledronic Acid Altan

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

-Do not use this medicine after the expiration date that appears on the package after CAD.

-The unopened vial does not require special storage conditions.

-The diluted perfusion solution of zoledronic acid should be used immediately to avoid microbial contamination.