Ciprofloxacin Altan 2 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin Altan 2 mg/ml solution for infusion EFG

Ciprofloxacin

Package leaflet contents

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

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

Ciprofloxacin Altan is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by eliminating bacteria that cause infections. It only acts against specific strains of bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Adults

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

• respiratory tract infections
• long-lasting or recurrent ear or sinus infections
• urinary tract infections
• infections of the testicles
• infections of the female genital organs
• gastrointestinal and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• treatment of infections in patients with very low white blood cell counts (neutropenia)
• prevention of infections in patients with very low white blood cell counts (neutropenia)
• inhalational anthrax exposure

If you have a severe infection or if the infection is caused by more than one type of bacteria, you may also be given an additional antibiotic treatment alongside 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 infections that have reached the kidneys (pyelonephritis)
• inhalational anthrax exposure

Ciprofloxacin Altan may also be used for the treatment of severe infections in children and adolescents when considered necessary.

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

Do not use Ciprofloxacin Altan

• If you are allergic to ciprofloxacin, to other quinolones, or to any of the other components of this medicine (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 containing fluoroquinolones or quinolones, including Ciprofloxacin Altan, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

Tell your doctor if:

• you have ever had kidney problems, as your treatment may need to be adjusted.
• you suffer from epilepsy or other neurological conditions.
• you have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin Altan.
• you have diabetes, as you may be at risk of hypoglycemia with ciprofloxacin.
• you have myasthenia gravis (a type of muscle weakness).
• you have a history of abnormal heart rhythms (arrhythmias).
• you have been diagnosed with enlargement or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large-vessel aneurysm).
• you have previously experienced an aortic dissection (tearing of the aortic wall).
• you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing disorders (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, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection).
• you have heart problems. This type of medicine should be used with caution if you were born with or have a family history of prolonged QT interval (detected on ECG, electrocardiogram, or electrical recording of the heart), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), if you have a very slow heart rate (called bradycardia), if you have heart failure, a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking another medicine that causes abnormal changes in the electrocardiogram (see section 2 “Use of Ciprofloxacin Altan with other medicines”).
• you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

While you are being treated with Ciprofloxacin Altan

Inform your doctor immediately if any of the following situations occur during treatment with Ciprofloxacin Altan. Your doctor will decide whether treatment with Ciprofloxacin Altan needs to be discontinued.

• Severe and sudden allergic reaction (anaphylactic reaction or shock, angioedema). There is a small chance that even with the first dose, you may experience a severe allergic reaction, with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing. If this occurs, inform your doctor immediately, as administration of Ciprofloxacin Altan must be stopped.

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

• If you have epilepsy or another neurological condition, such as cerebral ischemia or stroke, you may experience adverse effects related to the central nervous system. If this occurs, stop using Ciprofloxacin Altan and contact your doctor immediately.

• You may experience psychiatric reactions after the first dose of ciprofloxacin. If you have depression or psychosis, your symptoms may worsen during treatment with ciprofloxacin. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempts, or completed suicide. If this occurs, 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 occurs, stop using Ciprofloxacin Altan and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

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

• Hypoglycemia has been observed more frequently in diabetic patients, particularly in elderly individuals. If this occurs, contact your doctor immediately.

• Diarrhea may develop during use of antibiotics, including ciprofloxacin, or even several weeks after stopping them. If it becomes severe or persistent, or if you notice blood or mucus in your stools, inform your doctor immediately. Treatment with Ciprofloxacin Altan must be stopped immediately, as it could be life-threatening. Do not take medicines that stop or delay intestinal movements.

• While taking ciprofloxacin, inform your doctor or laboratory staff if you need to undergo a blood or urine test.

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

• Ciprofloxacin may reduce the white blood cell count and possibly decrease your resistance to infections. If you develop an infection with symptoms such as fever and a significant deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth, or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about your medication.

• If you have kidney problems, inform your doctor, as your dose may need to be adjusted.

• Your skin may become more sensitive to sunlight or ultraviolet (UV) light during treatment with ciprofloxacin. Avoid exposure to strong sunlight or artificial UV light, such as tanning beds.

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

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

• If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.

• Severe, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious sleep disorders.

If you experience any of these adverse effects after using Ciprofloxacin Altan, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, considering also the use of an antibiotic from another class.

Other medicines and Ciprofloxacin Altan

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not use Ciprofloxacin Altan at the same time as tizanidine, as this could cause adverse effects such as low blood pressure and drowsiness (see section 2: “Do not use Ciprofloxacin Altan”).

The following medicines are known to interact with Ciprofloxacin Altan in your body.

If you take 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 experiencing adverse effects.

Inform your doctor if you are taking:

• Vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) 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)
• olanzapine (an antipsychotic)
• clozapine (an antipsicotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)
• cyclosporine (for skin diseases, rheumatoid arthritis, or organ transplantation)
• other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics

Ciprofloxacin may increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic nerve damage, or incontinence)
• lidocaine (for heart conditions or anesthetic use)
• sildenafil (e.g., for erectile dysfunction)

Use of 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 preferable 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 reduce your level of alertness. Some neurological effects may occur.

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

Ciprofloxacin Altan contains glucose

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

3. How to use Ciprofloxacin Altan

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

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

Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.

Your doctor will administer each dose by slow intravenous infusion into your 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. Slow infusion helps prevent immediate adverse reactions.

Remember to drink plenty of fluids while taking Ciprofloxacin Altan.

If you interrupt treatment with Ciprofloxacin Altan

• It is important that you complete the full course of 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 also 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 everyone experiences them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Frequent adverse effects (likely to 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 levels of substances in the blood (transaminases)

Uncommon adverse effects (likely to affect between 1 and 10 out of every 1,000 people):

• fungal superinfections (due to fungi)
• elevated levels of eosinophils, a type of white blood cell; increase or decrease in a blood coagulation factor (platelets)
• loss of appetite (anorexia)
• hyperactivity, agitation, confusion, disorientation, hallucinations
• headache, dizziness, sleep disturbances or taste disorders, tingling and numbness, unusual sensitivity to sensory stimuli, seizures (see section 2: Warnings and precautions), vertigo
• vision problems, including double vision
• hearing loss
• increased heart rate (tachycardia)
• dilation of blood vessels (vasodilation), decreased blood pressure
• abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux), flatulence
• impaired liver function, increased levels of a substance in the blood (bilirubin), jaundice (cholestatic jaundice)
• itching, hives
• joint pain in adults
• impaired kidney function, kidney failure
• muscle and bone pain, feeling of malaise (asthenia), fever, fluid retention
• increased blood alkaline phosphatase (a blood substance)

Rare adverse effects (likely to affect between 1 and 10 out of every 10,000 people):

• inflammation of the intestine (colitis) associated with antibiotic use (may be fatal in very rare cases) (see section 2: Warnings and precautions)
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), decreased levels of red blood cells, white blood cells, and platelets (pancytopenia) which may be life-threatening, bone marrow suppression which may 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)
• increased blood sugar (hyperglycemia)
• decreased blood sugar (hypoglycemia) (see section 2: Warnings and precautions)
• anxiety reactions, unusual dreams, depression (which may progress to suicidal thoughts, suicide attempts, or completed suicide), mental disturbances (psychotic reactions which may progress to suicidal thoughts, suicide attempts, or completed suicide) (see section 2: Warnings and precautions)
• decreased skin sensitivity, tremors, migraine, disturbances in the sense of smell
• tinnitus (ringing in the ears), hearing impairment
• fainting, inflammation of blood vessels (vasculitis)
• difficulty breathing, including asthma-like symptoms
• pancreatitis
• hepatitis, death of liver cells (hepatic necrosis), which very rarely leads to liver failure with risk of death
• photosensitivity (see section 2: Warnings and precautions), small hemorrhages appearing as spots under the skin (petechiae)
• muscle pain, joint inflammation, increased muscle tone, cramps, tendon rupture – especially of the long tendon at 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 a coagulation factor (prothrombin) or increased concentrations of the enzyme amylase

Very rare adverse effects (likely to affect fewer than 1 in 10,000 people):

• a specific type of decreased blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cells (agranulocytosis)
• severe allergic reactions with risk of death (anaphylactic reaction or anaphylactic shock, serum sickness) (see section 2: Warnings and precautions)
• Coordination disorders, unsteadiness when walking (gait disturbances), increased pressure in the brain (intracranial pressure and pseudotumor cerebri)
• visual distortions of colors
• various skin rashes or exanthems (e.g., the potentially life-threatening Stevens-Johnson syndrome or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

Frequency not known (cannot be estimated from available data):

• nervous system disorders such as pain, burning, tingling, numbness, and/or weakness in the limbs (peripheral neuropathy and polyneuropathy)
• serious heart rhythm disturbances, irregular heartbeat that may be life-threatening, changes in heart rhythm (known as "QT interval prolongation," detected on ECG, heart electrical activity)
• pustular skin rash
• effects on blood coagulation (in patients treated with Vitamin K antagonists)
• syndrome associated with deficient water excretion and low sodium levels (SIADH)
• loss of consciousness due to a severe drop in 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-term (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, 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 ideation), and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and may be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciprofloxacin Altan

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

Do not use Ciprofloxacin Altan after the expiry date stated on the carton, following “EXP”. The expiry date refers to the last day of the month indicated.

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

Protect from light. Since ciprofloxacin is light-sensitive, the overwrap of the pouch should only be removed immediately before administration.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ciprofloxacin Altan

The active substance is ciprofloxacin (lactate). Each ml contains 2 mg of ciprofloxacin (as lactate). Each 100 ml bag of infusion solution contains 200 mg of ciprofloxacin (as lactate). Each 200 ml bag of infusion solution 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 contents of the container:

Ciprofloxacin Altan is presented as an infusion solution in a bag. Each package contains bags of 100 ml or 200 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1st Floor, Office F. Edificio Prisma

28231 Las Rozas. Madrid

Spain

Manufacturer:

Altan Pharmaceuticals, S.A.

Pol. Ind. De Bernedo s/n

01118 Bernedo (Álava)

Date of the most recent revision of this leaflet: December 2025

Advice/medical education

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

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

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

Improper use of antibiotics increases resistance. Even you can help bacteria become more resistant and thus delay your recovery or reduce the effectiveness of antibiotics if you do not follow:

• the dose
• the schedule
• the duration of treatment

Therefore, in order to maintain the effectiveness of this medicine:

1. Use antibiotics only when prescribed by a doctor.
2. Strictly follow the prescription.
3. Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
4. Never give your antibiotics to another person; it may not be suitable for their condition.
5. After completing a course of treatment, return all unused medicines to the pharmacy to ensure they are properly disposed of.

The following information is intended exclusively for physicians or healthcare professionals

Ciprofloxacin Altan must be administered by intravenous infusion. 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. A slow infusion into a large vein will minimize patient discomfort and reduce the risk of venous irritation. The infusion solution may be administered directly.

Unless compatibility with other infusion solutions or drugs has been confirmed, the infusion solution must always be administered separately. Visual signs of incompatibility include, for example, precipitation, turbidity, and color change.

After initiation of intravenous treatment, therapy may also be continued orally.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/