CIPROFLOXACIN ALTAN 2 mg/ml SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Altan 2 mg/ml solution for infusion EFG

Ciprofloxacin

Contents of the pack

1. What is Ciprofloxacin Altan and what is it used for
2. What you need to know before you are given Ciprofloxacin Altan
3. How to use Ciprofloxacin Altan
4. Possible side effects
5. Storage of Ciprofloxacin Altan
6. Contents of the pack and other information

1. What is Ciprofloxacin Altan and what is it used for

Ciprofloxacin Altan is an antibiotic that belongs to the family of fluoroquinolones. The active substance is ciprofloxacin. Ciprofloxacin works by killing the bacteria that cause infections. It only works with specific strains of bacteria.

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or the common cold.

It is essential that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Adults

Ciprofloxacin Altan is used in adults to treat the following bacterial infections:

• respiratory tract infections
• long-term or recurrent ear or sinus infections
• urinary tract infections
• testicular infections
• female genital organ infections
• gastrointestinal and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• treatment of infections in patients with a very low white blood cell count (neutropenia)
• prevention of infections in patients with a very low white blood cell count (neutropenia)
• inhalation exposure to anthrax

In case you have a severe infection or if the infection is caused by more than one type of bacteria, you may be given additional antibiotic treatment, in addition to Ciprofloxacin Altan.

Children and adolescents

Ciprofloxacin Altan is used in children and adolescents, under specialized medical supervision, to treat the following bacterial infections:

• lung and bronchial infections in children and adolescents with cystic fibrosis
• complicated urinary tract infections, including those that have reached the kidneys (pyelonephritis)
• inhalation exposure to anthrax

Ciprofloxacin Altan may also be used to treat severe infections in children and adolescents when necessary.

2. What you need to know before you are given Ciprofloxacin Altan

Ciprofloxacin Altan should not be given to you

• If you are allergic to ciprofloxacin, other quinolones, or any of the other components of this medication (listed in section 6).
• If you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin Altan).

Warnings and precautions

Before you are given Ciprofloxacin Altan

You should not use antibacterial medicines that contain fluoroquinolones or quinolones, including Ciprofloxacin Altan, if you have experienced any severe side effects in the past when using a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Tell your doctor if:

• you have ever had kidney problems because your treatment may need to be adjusted
• you have epilepsy or other neurological conditions
• you have a history of tendon problems during previous treatment with antibiotics like Ciprofloxacin Altan
• you have severe myasthenia (a type of muscle weakness)
• you have a history of abnormal heart rhythms (arrhythmias)
• if you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
• if you have had a previous episode of aortic dissection (tear in the aortic wall)
• if you have been diagnosed with heart valve insufficiency (regurgitation of the heart valves)
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disorders, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection).

While you are being treated with Ciprofloxacin Altan

Tell your doctor immediately if any of the following situations occur during treatment with Ciprofloxacin Altan.Your doctor will decide if it is necessary to interrupt treatment with Ciprofloxacin Altan.

• Severe and sudden allergic reaction(anaphylactic reaction or shock, angioedema). There is a reduced possibility that, even with the first dose, you may experience a severe allergic reaction, with the following symptoms: chest tightness, dizziness, nausea, or fainting, or dizziness when standing up. If this happens, tell your doctor immediately, as administration of Ciprofloxacin Altan should be discontinued.

• Rarely, pain and swelling in the joints and inflammation or rupture of tendonsmay occur. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are being treated with systemic corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with ciprofloxacin. At the first sign of pain or inflammation of a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop using Ciprofloxacin Altan, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you have epilepsyor other neurological conditions, such as cerebral ischemia or infarction, you may experience side effects associated with the central nervous system. If this happens, stop using Ciprofloxacin Altan and contact your doctor immediately.

• You may experience psychiatric reactionsafter the first administration of ciprofloxacin. If you experience depressionor psychosis, your symptoms may worsen with ciprofloxacin treatment. If this happens, stop using Ciprofloxacin Altan and contact your doctor immediately.

• Rarely, you may experience symptoms of nerve damage (neuropathy)such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop using Ciprofloxacin Altan and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• Fluoroquinolone antibiotics may cause an increase in your blood sugar levelsabove normal levels (hyperglycemia) or a decrease in your blood sugar levelsbelow normal levels, which in severe cases can lead to loss of consciousness (hypoglycemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully monitored.

• Diarrheamay develop during the use of antibiotics, including ciprofloxacin, or even several weeks after stopping them. If this becomes severe or persistent, or if you notice that your stools contain blood or mucus, tell your doctor immediately. Treatment with Ciprofloxacin Altan should be discontinued immediately, as it can be life-threatening. Do not take medicines that stop or slow down bowel movements.

• While you are using ciprofloxacin, inform your doctor or laboratory staff if you need to have a blood or urine test.

• Ciprofloxacin may cause liver damage. If you notice symptoms such as loss of appetite, yellowing of the skin (jaundice), dark urine, itching, or stomach pain, stop using Ciprofloxacin Altan immediately.

• Ciprofloxacin may cause a decrease in your white blood cell countand may decrease your resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth, or urinary problems, you should consult your doctor immediately. You will have a blood test to check for a possible decrease in white blood cells (agranulocytosis). It is essential that you inform your doctor about your medication.

• Tell your doctor if you or a family member has a proven deficiency of glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin.

• Your skin becomes more sensitive to sunlight or ultraviolet (UV) lightduring treatment with ciprofloxacin. Avoid exposure to intense sunlight or ultraviolet artificial light, such as tanning beds.

• Consult an ophthalmologist immediately if you experience any vision changes or eye problems.

• If you experience severe and sudden chest, abdominal, or back pain, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.

• Severe, long-lasting, and potentially irreversible side effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including ciprofloxacin, have been associated with very rare but severe side effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, tingling, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, or hearing, depression, decreased memory, severe fatigue, and severe sleep disorders.

If you experience any of these side effects after using Ciprofloxacin Altan, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, also considering the use of an antibiotic from another class.

Other medicines and Ciprofloxacin Altan

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Do not use Ciprofloxacin Altan at the same time as tizanidine, as this may cause side effects such as low blood pressure and drowsiness (see section 2: "Ciprofloxacin Altan should not be given to you").

It is known that the following medicines interact with Ciprofloxacin Altan in your body.

If you use Ciprofloxacin Altan at the same time as these medicines, this may affect the therapeutic effect of these medicines. It may also increase the likelihood of you experiencing side effects.

Tell your doctor if you are taking:

• warfarin or other oral anticoagulants (to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
• theophylline (for respiratory problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)

Ciprofloxacin may increaseblood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine

Using Ciprofloxacin Altan with food and drinks

Food and drinks do not affect your treatment with Ciprofloxacin Altan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is recommended to avoid using Ciprofloxacin Altan during pregnancy. Inform your doctor if you plan to become pregnant.

Do not use Ciprofloxacin Altan during breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and using machines

Ciprofloxacin may decrease your alertness. Some neurological effects may occur.

Therefore, make sure you know how you react to Ciprofloxacin Altan before driving a vehicle or using a machine. If in doubt, consult your doctor.

Ciprofloxacin Altan contains glucose

This medicine contains glucose. Patients with diabetes mellitus should note that this medicine contains 0.05 g of glucose per ml of solution for infusion.

3. How to use Ciprofloxacin Altan

Your doctor will explain exactly how much ciprofloxacin should be administered to you, how often, and for how long. This will depend on the type of infection you have and its severity.

Tell your doctor if you have kidney problems, as your dose may need to be adjusted.

Treatment usually lasts from 5 to 21 days but may last longer for severe infections.

Your doctor will administer each dose by slow infusion, through a vein, into the bloodstream. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacin Altan and 30 minutes for 200 mg of Ciprofloxacin Altan. The slow infusion of the treatment prevents immediate side effects.

Remember to drink plenty of fluids while taking Ciprofloxacin Altan.

If you stop treatment with Ciprofloxacin Altan

• It is essential that you complete the full treatment, even if you start to feel better after a few days. If you stop using this medicine too soon, your infection may not be completely cured, and symptoms may return or worsen. You may develop resistance to the antibiotic.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Frequent Adverse Effects(it is likely that they will affect between 1 and 10 out of every 100 people):

• nausea, diarrhea, vomiting
• joint pain in children
• local reaction at the injection site, skin rash
• temporary increase in blood substance levels (transaminases)

Uncommon Adverse Effects(it is likely that they will affect between 1 and 10 out of every 1,000 people):

• fungal superinfections
• high levels of eosinophils, a type of white blood cell, increase or decrease in a blood clotting factor (thrombocytes)
• loss of appetite (anorexia)
• hyperactivity, agitation, confusion, disorientation, hallucinations
• headache, dizziness, sleep problems or taste disorders, tingling and numbness, unusual sensitivity to sensory stimuli, convulsions (see section 2: Warnings and Precautions), vertigo
• vision problems
• hearing loss
• increased heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decrease in blood pressure
• abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux), flatulence
• liver function alteration, increase in blood substance levels (bilirubin), jaundice (cholestatic jaundice)
• itching, hives
• joint pain in adults
• renal function impairment, renal failure
• muscle and bone pain, feeling of discomfort (asthenia), fever, fluid retention
• increase in blood alkaline phosphatase levels (a blood substance)

Rare Adverse Effects(it is likely that they will affect between 1 and 10 out of every 10,000 people):

• inflammation of the intestine (colitis) related to antibiotic use (can be fatal in very rare cases) (see section 2: Warnings and Precautions)
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), decrease in the number of red and white blood cells and platelets (pancytopenia) that can be life-threatening, bone marrow depression that can be life-threatening (see section 2: Warnings and Precautions)
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema), severe allergic reaction (anaphylactic shock) with risk of death (see section 2: Warnings and Precautions)

(angioedema), severe allergic reaction (anaphylactic shock) with risk of death (see section 2: Warnings and Precautions)

• increase in blood sugar levels (hyperglycemia)
• anxiety reactions, strange dreams, depression, mental disorders (psychotic reactions) (see section 2: Warnings and Precautions)
• decrease in skin sensitivity, tremors, migraine, disorders of the sense of smell
• tinnitus (ringing in the ears), hearing impairment
• fainting, inflammation of blood vessels (vasculitis)
• difficulty breathing, including asthmatic symptoms
• pancreatitis
• hepatitis, liver cell death (necrosis), which can very rarely lead to liver failure with risk of death
• sensitivity to light (see section 2: Warnings and Precautions), small bleeding spots under the skin (petechiae)
• muscle pain, joint inflammation, increased muscle tone, cramps, tendon rupture – especially the long tendon in the back of the ankle (Achilles tendon) (see section 2: Warnings and Precautions)
• blood or crystals in the urine, (see section 2: Warnings and Precautions), inflammation of the urinary tract
• excessive sweating
• abnormal levels of the coagulation factor (prothrombin) or increase in amylase enzyme concentrations

Very Rare Adverse Effects(it is likely that they will affect less than one in every 10,000 people):

• a special type of decrease in blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis)
• severe allergic reactions with risk of death (anaphylactic reaction or anaphylactic shock, serum sickness) (see section 2: Warnings and Precautions)
• coordination disorder, instability when walking (gait disorders), pressure in the brain (intracranial pressure)
• visual distortions of colors
• various skin rashes or exanthems (e.g., the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, worsening of myasthenia gravis symptoms (see section 2: Warnings and Precautions)

Unknown Frequency(cannot be estimated from available data)

• nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs
• serious heart rhythm disorders, irregular heart rhythm (Torsades de Pointes)
• syndrome associated with inadequate water secretion and low sodium levels (SIADH)
• loss of consciousness due to severely low blood sugar levels (hypoglycemic coma). See section 2.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, prickling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal thoughts), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and cardiac valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Ciprofloxacino Altan

Keep this medicine out of sight and reach of children.

Do not use Ciprofloxacino Altan after the expiration date shown on the packaging, after "CAD". The expiration date is the last day of the month indicated.

Keep in the original packaging. Do not store at a temperature above 30°C. Do not freeze.

Protect from light. Since ciprofloxacin is sensitive to light, the overwrap will only be removed from the bag immediately before administration.

Aqueous solutions should be used within 24 hours of preparation, for microbiological reasons and due to the stability of the active ingredient.

Medicines should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Ciprofloxacino Altan

The active ingredient is Ciprofloxacin (lactate). Each ml contains 2 mg of ciprofloxacin (as lactate). Each 100 ml bag of solution for infusion contains 200 mg of ciprofloxacin (as lactate). Each 200 ml bag of solution for infusion contains 400 mg of ciprofloxacin (as lactate).

The other components (excipients) are: lactic acid, glucose, hydrochloric acid, and water for injection.

Appearance of the Product and Package Contents:

Ciprofloxacino Altan is presented as a solution for infusion in a bag. Each package contains bags with 100 ml or 200 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1ª Planta – Oficina F

28230 Las Rozas. Madrid

Manufacturer:

Altan Pharmaceuticals, S.A.

Pol. Ind. De Bernedo s/n

01118 Bernedo (Álava)

This prospectus was approved in May 2025

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Medical Advice/Education

Antibiotics are used to cure bacterial infections. They are not effective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You can even help bacteria become more resistant and, therefore, delay your recovery or reduce the effectiveness of antibiotics if you do not respect:

• the dose
• the program
• the duration of treatment

Consequently, to maintain the effectiveness of this medicine:

1. Use antibiotics only when they are prescribed.
2. Follow the prescription strictly.
3. Never reuse an antibiotic without a medical prescription, even if you want to treat a similar illness.
4. Never give your antibiotic to another person; it may not be suitable for their illness.
5. After finishing a treatment, return all unused medicines to the pharmacy, to ensure they are disposed of correctly.

The following information is intended only for doctors or healthcare professionals

Ciprofloxacino Altan should be administered through intravenous infusion. In children, the infusion duration is 60 minutes. In adult patients, the infusion time is 60 minutes for 400 mg of Ciprofloxacino Altan and 30 minutes for 200 mg of Ciprofloxacino Altan. A slow infusion in a large vein will minimize patient discomfort and reduce the risk of venous irritation. The infusion solution can be administered directly.

Unless compatibility with other infusion solutions or medications has been confirmed, the infusion solution should always be administered separately. Visual signs of incompatibility are, for example, precipitation, clouding, and color change.

After starting intravenous treatment, it can also be continued orally.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/