Zoledronic acid Altan

PACKAGE LEAFLET: INFORMATION FOR THE USER

Zoledronic Acid Altan 5 mg/100 ml solution for infusion

Zoledronic acid
Generic medicine
Please 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 questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

What is in this leaflet

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 to use Zoledronic Acid Altan
4. Possible side effects
5. How to store Zoledronic Acid Altan
6. Contents of the pack and other information

1. What Acido Zoledronico Altan is and what it is used for

Acido Zoledronico Altan contains the active substance zoledronic acid. It belongs to a group of medicines called bisphosphonates and is used to treat postmenopausal women and adult men with osteoporosis or steroid-induced osteoporosis caused by treatment with corticosteroids used to treat inflammation, as well as Paget's disease of bone in adults.
Osteoporosis
Osteoporosis is a disease that causes thinning and weakening of the bones and is common in women after menopause, but can also occur in men. At menopause, the ovaries stop producing the female hormone estrogen, which helps maintain bone health. After menopause, bone loss occurs, bones become weaker and are more likely to break. Osteoporosis can also occur in men and women due to long-term use of steroids, which can affect bone strength. Many patients with osteoporosis have no symptoms, but are still at risk of bone fracture because osteoporosis has made their bones more fragile. Reduced levels of circulating sex hormones, primarily estrogens converted from androgens, also play a role in the more gradual bone loss observed in men.
In both women and men, Acido Zoledronico Altan strengthens bones and reduces the risk of fracture. Acido Zoledronico Altan is also used in patients who have recently experienced a hip fracture due to minor trauma such as a fall and are therefore at risk of further bone fractures.
Paget's disease of bone
It is normal for old bone to be removed and replaced by new bone tissue. This process is called bone remodelling. In Paget's disease, bone remodelling occurs too rapidly and the new bone forms in a disorganised way, making it weaker than normal. If the disease is not treated, bones may become deformed and painful, and may break. Acido Zoledronico Altan works by normalising the bone remodelling process, ensuring normal bone formation and thereby restoring bone strength.

2. What you need to know before you are given Acido Zoledronico Altan

Carefully follow all instructions provided by your doctor, pharmacist, or nurse before
Acido Zoledronico Altan is administered to you.
Acido Zoledronico Altan must not be given to you

• if you are allergic to zoledronic acid, other bisphosphonates, or any of the excipients of this medicine (listed in section 6).
• if you have hypocalcaemia (that is, if your blood calcium levels are too low).
• if you have severe kidney problems.
• if you are pregnant.
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor before you are given Acido Zoledronico Altan:

• if you are being treated with any medicine containing zoledronic acid, which is also the active substance in Acido Zoledronico 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 kidney problems, or have had them in the past.
• if you cannot take a daily calcium supplement.
• if you have had part or all of your parathyroid glands in the neck surgically removed.
• if sections of your intestine have been removed.

An adverse effect called osteonecrosis of the jaw/mandible (bone damage of the jaw/mandible) has been reported in post-marketing experience in patients treated with Acido Zoledronico Altan (zoledronic acid) for the treatment of osteoporosis.
Osteonecrosis of the jaw/mandible may also occur after discontinuation of treatment.
It is important to try to prevent the onset of osteonecrosis of the jaw/mandible, as it is a painful condition that can be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/mandible, there are certain precautions you should take.
Before receiving treatment with Acido Zoledronico Altan, talk to your doctor, pharmacist, or nurse if:

• you have any mouth or dental problems such as poor dental health, gum disease, or if you have planned a dental extraction;
• you do not receive routine dental care or have not had a dental check-up for a long time;
• you are a smoker (as this may increase the risk of dental problems);
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders);
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
• you have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with
Acido Zoledronico Altan.
During treatment with Acido Zoledronico Altan, you must maintain good oral hygiene (including regular tooth cleaning) and receive routine dental check-ups.
If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or need to have dental surgery (e.g. tooth extractions), inform your doctor and tell your dentist that you are being treated with Acido Zoledronico Altan. Immediately inform your doctor and dentist if you experience any mouth or dental problems such as tooth loss, pain, swelling, non-healing sores, or discharge, as these may be signs of osteonecrosis of the jaw/mandible.
Monitoring tests
Your doctor must take a blood sample to check your kidney function (creatinine levels) before each infusion of Acido Zoledronico Altan. It is important that you drink at least two glasses of fluid (e.g. water) within a few hours before treatment with Acido Zoledronico Altan, as instructed by your healthcare provider.
Children and adolescents
Acido Zoledronico Altan is not recommended for use in individuals under 18 years of age.
Other medicines and Acido Zoledronico Altan
Inform 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 already taking other medicines that may be potentially harmful to the kidneys (e.g. aminoglycosides) or diuretics (“water pills”) that may cause dehydration.
Pregnancy and breastfeeding
Acido Zoledronico Altan must not be given to you if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding.
Ask your doctor, pharmacist, or nurse for advice before taking this medicine.
Driving and using machines
If you feel dizzy while taking Acido Zoledronico Altan, do not drive or use machines until you feel better.
Acido Zoledronico Altan contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

3. How to use Acido Zoledronico Altan

Carefully follow all instructions given to you by your doctor or nurse. If you have any doubts,
consult your doctor or nurse.
Osteoporosis
The usual dose is 5 mg, administered by your doctor or nurse as a single intravenous infusion
once a year. The infusion will last at least 15 minutes.
In case of a recent hip fracture, administration of Acido Zoledronico Altan is recommended
two or more weeks after surgical repair of the hip fracture.
It is important to take calcium and vitamin D supplements (e.g. in tablet form) as directed
by your doctor.
For osteoporosis, Acido Zoledronico Altan is effective for one year. Your doctor will inform you
when to return for the next dose.
Paget's disease
For the treatment of Paget's disease, Acido Zoledronico Altan must be prescribed only by
physicians experienced in the management of bone Paget's disease.
The usual dose is 5 mg, administered by your doctor or nurse as an initial intravenous
infusion. The infusion will last at least 15 minutes. Acido Zoledronico Altan may remain
effective for more than one year, and your doctor will inform you whether further treatment
is needed.
Your doctor may advise you to take calcium and vitamin D supplements (e.g. in tablet form)
for at least the first ten days following administration of Acido Zoledronico Altan. It is
important that you follow this advice carefully to prevent blood calcium levels from becoming
too low in the period following the infusion. Your doctor will inform you about possible
symptoms associated with hypocalcemia.
Acido Zoledronico Altan with food and drink
Make sure you drink enough fluids (at least one or two glasses) before and after treatment
with Acido Zoledronico Altan, as advised by your doctor. This will help prevent dehydration.
On the day of treatment with Acido Zoledronico Altan, you may eat normally. This is
particularly important for patients taking diuretics ("water pills") and for elderly patients
(65 years of age or older).
If you miss a dose of Acido Zoledronico Altan
Contact your doctor or hospital as soon as possible to schedule a new appointment.
Before stopping treatment with Acido Zoledronico Altan
If you are considering stopping treatment with Acido Zoledronico Altan, attend your next
scheduled appointment and discuss this with your doctor. Your doctor can advise you and
decide how long treatment should continue.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects related to the first infusion are very common (occurring in more than 30%
of patients), but become less common with subsequent infusions. Most side effects such as fever and chills, muscle or joint pain, and headache occur within the first three days after administration of Acido Zoledronico Altan. Symptoms are usually mild to moderate and resolve within three days. Your doctor may recommend a mild pain reliever such as ibuprofen or paracetamol to reduce these side effects. The likelihood of experiencing side effects decreases with subsequent doses of Acido Zoledronico Altan.
Some side effects may be serious
Common (may affect up to 1 in 10 people)
In patients treated with Acido Zoledronico Altan for postmenopausal osteoporosis, irregular heart rhythm (atrial fibrillation) has been observed. It is currently unclear whether Acido Zoledronico Altan is the cause of this irregular heart rhythm, but you should inform your doctor if you experience such symptoms after receiving Acido Zoledronico Altan.
Uncommon (may affect up to 1 in 100 people)
Swelling, redness, pain, and itching in the eyes or sensitivity of the eyes to light.
Very rare (may affect up to 1 in 10,000 people)
Contact your doctor if you experience ear pain, ear discharge, and/or ear infection. These episodes could be signs of bone damage in the ear.
Not known (frequency cannot be estimated from available data)
Pain in the mouth and/or jaw, swelling or sores in the mouth or jaw that do not heal, discharge, numbness, or a feeling of heaviness in the jaw, or tooth loss; these could be signs of severe deterioration of the jawbone (osteonecrosis). Inform your doctor and dentist immediately if such symptoms occur while you are being treated with Acido Zoledronico Altan or after stopping treatment.
Kidney problems (e.g. reduced urine output) may occur. Your doctor will need to take a blood sample to check your kidney function before each infusion of Acido Zoledronico Altan. It is important that you drink at least one or two glasses of fluid (e.g. water) within a few hours before treatment with Acido Zoledronico Altan, as advised by your healthcare provider.

• Inflammation of the kidney (tubulointerstitial nephritis): signs and symptoms may include reduced urine volume, blood in the urine, nausea, and a general feeling of being unwell.

If you experience any of these side effects, inform your doctor immediately.
Acido Zoledronico Altan may also 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, malaise, vomiting, diarrhoea, muscle pain, bone and/or joint pain, back, arm or leg pain, flu-like symptoms (e.g. fatigue, chills, joint and muscle pain), chills, feeling tired and lack of interest, weakness, pain, feeling unwell, swelling and/or pain at the infusion site.
In patients with Paget's disease, symptoms due to low calcium levels in the blood have been reported, such as muscle spasms, numbness, or tingling, particularly around the mouth.
Uncommon (may affect up to 1 in 100 people)
Influenza, upper respiratory tract infections, decreased red blood cell count, loss of appetite, insomnia, drowsiness which may include reduced alertness and consciousness, sensation of tingling or numbness, extreme fatigue, tremor, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, feeling dizzy, increased blood pressure, hot flushes, cough, shortness of breath, stomach ache, abdominal pain, constipation, dry mouth, heartburn, rash, excessive sweating, itching, skin redness, neck pain, muscle, bone and/or joint stiffness, joint swelling, muscle spasms, shoulder pain, chest and rib cage muscle pain, joint inflammation, muscle weakness, abnormal kidney test results, abnormally frequent need to urinate, swelling of the hands, ankles or feet, thirst, toothache, altered taste.
Rare (may affect up to 1 in 1,000 people)
Rarely, particularly in patients receiving long-term treatment for osteoporosis, an unusual femur fracture may occur. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as this could be an early sign of a possible femur fracture. Low levels of phosphate in the blood.
Not known (frequency cannot be estimated from available data)
Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, low blood pressure, dehydration secondary to post-infusion symptoms such as fever, vomiting, and diarrhoea.
Reporting of side effects
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zoledronic Acid Altan

Your doctor, pharmacist or nurse is informed about the appropriate way to store
Zoledronic Acid Altan.
Keep this medicine out of the sight and reach of children.
Do not use Zoledronic Acid Altan after the expiry date stated on the carton and bag
after Exp. The expiry date refers to the last day of that month.
The unopened bag does not require any special storage conditions.
After opening the bag, the product should be used immediately to avoid microbial contamination. If not used immediately, the times and conditions of storage prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C – 8°C. Allow the solution taken from the refrigerator to reach room temperature before use.

6. Package contents and other information

What Acido Zoledronico Altan contains

• The active substance 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 excipients are mannitol (E421), sodium citrate (E331), and water for injections.

Description of the appearance of Acido Zoledronico Altan and contents of the pack
Acido Zoledronico Altan is a clear, colourless solution. It is supplied in a 100 ml plastic bag as an infusion solution ready for use. It is available in cartons containing one bag for single-pack presentation or in multi-pack cartons containing 5 packs, each with 1 bag. Not all pack sizes may be marketed.
Marketing Authorization Holder
Altan Pharmaceuticals S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid, Spain
Manufacturer
ALTAN PHARMACEUTICAL, S.A.
Polígono Industrial de Bernedo, s/n
01118 Bernedo (Álava)
Spain
This summary of product characteristics was last approved in 06/2025
INFORMATION FOR HEALTHCARE PROFESSIONALS
The following information is intended exclusively for physicians or healthcare professionals (see section 3):
How to prepare and administer Acido Zoledronico Altan

• Acido Zoledronico Altan 5 mg solution for infusion is ready to use.

For single use only. Any unused solution must be discarded. The solution should only be used if it is clear, free from particles, and shows no change in colour. Acido Zoledronico Altan must not be mixed or administered intravenously with other medicinal products and must be administered through a separate infusion line with a vented membrane at a constant infusion rate. The infusion time must not be less than 15 minutes. Acido Zoledronico Altan must not come into contact with calcium-containing solutions. If stored in a refrigerator, allow the solution to reach room temperature before administration. Aseptic techniques must be followed during infusion preparation. The infusion must be administered in accordance with standard medical practice.
How to store Acido Zoledronico Altan

• Keep Acido Zoledronico Altan out of the sight and reach of children.
• Do not use Acido Zoledronico Altan after the expiry date stated on the carton and bag.
• The unopened bag does not require any special storage conditions.
• After opening the bag, the product must be used immediately to avoid microbial contamination. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2°C - 8°C. Allow refrigerated solution to reach room temperature before administration.