PATIENT INFORMATION LEAFLET

Ciprofloxacin Altan 2 mg/ml infusion solution EFG

Ciprofloxacin

Ciprofloxacino Altan is an antibiotic that belongs to the family of fluoroquinolones. The active ingredient is ciprofloxacin. Ciprofloxacin acts by eliminating the bacteria that cause infections. It only acts on specific strains of bacteria.

Adults

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

• respiratory tract infections
• prolonged or recurrent ear or sinus infections
• urinary tract infections
• testicular infections
• female genital organ infections
• gastrointestinal and intrabdominal 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)
• exposure to anthrax by inhalation

In cases of severe infection or infection caused by multiple types of bacteria, it is possible that additional antibiotic treatment will be administered in addition to Ciprofloxacino Altan.

Children and adolescents

Ciprofloxacino 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 kidney infections (pyelonephritis)
• exposure to anthrax by inhalation

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

You should not be given Ciprofloxacino Altan

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

Warnings and precautions

Before Ciprofloxacino Altan is administered

You should not use antibacterial medications that contain fluoroquinolones or quinolones, including Ciprofloxacino Altan, if you have had a severe adverse reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.

Inform 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 Ciprofloxacino Altan.
• You suffer from myasthenia gravis (a type of muscle weakness).
• You have a history of abnormal heart rhythms (arrhythmias).
• You have been diagnosed with an enlarged or a <> of a large blood vessel (aortic aneurysm or a large peripheral vessel aneurysm).
• You have had a previous episode of aortic dissection (tear in the aorta 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 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, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

While being treated with Ciprofloxacino Altan

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

• Severe and sudden allergic reaction(anaphylactic reaction, 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 occurs, inform your doctor immediately, as treatment with Ciprofloxacino Altan must be interrupted.

• In rare cases, you may experiencejoint pain and swelling, and inflammation or rupture of tendons. 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 corticosteroids. Tendon inflammation and rupture can occur in the first 48 hours of treatment and even several months after interrupting treatment with ciprofloxacin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop using Ciprofloxacino Altan, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you suffer fromepilepsyor anotherneurological condition, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If this occurs, stop using Ciprofloxacino Altan and contact your doctor immediately.

• You may experiencepsychiatric reactionsafter the first administration of ciprofloxacin. If you suffer fromdepressionorpsychosis, your symptoms may worsen with treatment with ciprofloxacin. If this occurs, stop using Ciprofloxacino Altan and contact your doctor immediately.

• In rare cases, you may experience symptoms ofnerve 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 Ciprofloxacino Altan and inform your doctor immediately to prevent the development of a potentially irreversible condition.

• Antibiotics such as quinolones can cause anincrease in your blood sugar levelsabove normal levels (hyperglycemia), ordecrease in your blood sugar levelsbelow normal levels, which in severe cases can cause loss of consciousness (hypoglycemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels should be carefully controlled.

• You may developdiarrheawhile using antibiotics, including ciprofloxacin, or even several weeks after stopping them. If this becomes intense or persistent, or if you notice that your stools contain blood or mucus, inform your doctor immediately. Treatment with Ciprofloxacino Altan should be interrupted immediately, as it may put your life at risk. Do not take medications that slow down or delay bowel movements.

• Inform your doctor or laboratory personnel immediately if you need to undergo ablood or urine testwhile using ciprofloxacin.

• Ciprofloxacin can causeliver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, interrupt treatment with Ciprofloxacino Altan immediately.

• Ciprofloxacin can cause a decrease in white blood cell count and mayreduce 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. A blood test will be performed to examine the possible decrease in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

• Inform 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 moresensitive to sunlight or ultraviolet (UV) lightduring treatment with ciprofloxacin. Avoid exposure to intense sunlight or artificial ultraviolet light, such as tanning beds.

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

• If you experience a strong and sudden pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. You may be at increased risk 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 palpitations (sensation of rapid or irregular heartbeat), you should inform your doctor immediately.

• Severe, incapacitating, prolonged, and potentially irreversible effects

Fluoroquinolone-containing antibacterial medications, including ciprofloxacin, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness, or weakness (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

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

Other medications and Ciprofloxacino Altan

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not use Ciprofloxacino Altan at the same time as tizanidine, as this may cause adverse effects, such as low blood pressure and drowsiness (see section 2: “You should not be given Ciprofloxacino Altan”).

We know that the following medications interact with Ciprofloxacino Altan in your body.

If you use Ciprofloxacino Altan at the same time as these medications, this may affect the therapeutic effect of these medications. It may also increase the likelihood of adverse effects.

Inform 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 mayincreasethe blood levels of the following medications:

• pentoxifylline (for circulatory disorders)
• caffeine

Use of Ciprofloxacino Altan with food and drinks

Foods and drinks do not affect your treatment with Ciprofloxacino Altan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

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

Do not use Ciprofloxacino Altan during breastfeeding, as ciprofloxacin is excreted through breast milk and may cause harm to your baby.

Driving and operating machines

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

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

Ciprofloxacino Altan contains glucose

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

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

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

Treatment usually lasts from5 to21 days, but may be longer for more serious infections.

Your doctor will administer each dose through a slow infusion, into a vein, directly into the bloodstream. In children, the infusion lasts 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. The slow administration of the infusion helps prevent immediate adverse reactions.

Remember to drink plenty of liquids while taking Ciprofloxacino Altan.

If you interrupt treatment with Ciprofloxacino Altan

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

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Frequent side effects(it is likely that they will occur in 1 to 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 levels of certain substances (transaminases)

Less frequent side effects(it is likely that they will occur in 1 to 10 out of every 1,000 people):

- fungal superinfections

- elevated eosinophil count, 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 disturbances, paresthesia and numbness, unusual sensitivity to sensory stimuli, seizures (see section 2: Warnings and precautions), vertigo

- vision problems

- hearing loss

- increased heart rate (tachycardia)

- vasodilation, decreased blood pressure

- abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux), flatulence

- liver function alteration, increased levels of a substance in the blood (bilirubin), jaundice (icterus cholestatic)

- itching, rashes

- joint pain in adults

- impaired renal function, renal insufficiency

- muscle and bone pain, feeling unwell (asthenia), fever, fluid retention

- increased alkaline phosphatase levels in the blood (a blood substance)

Rare side effects(it is likely that they will occur in 1 to 10 out of every 10,000 people):

- antibiotic-associated colitis (inflammation of the intestine) linked to the use of antibiotics (may be fatal in rare cases) (see section 2: Warnings and precautions)

- changes in blood cell count (leucopenia, leucocytosis, neutropenia, anemia), decrease in the number of red and white blood cells and platelets (pancytopenia) that can put the patient's life at risk, medullary depression that can put the patient's life at risk (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 levels (hyperglycemia)

- anxiety reactions, strange dreams, depression, mental alterations (psychotic reactions) (see section 2: Warnings and precautions)

- decreased skin sensitivity, tremors, migraine, disturbances of the sense of smell

- tinnitus (ringing in the ears), hearing deterioration

- fainting, inflammation of blood vessels (vasculitis)

- breathing difficulties, including asthma-like symptoms

- pancreatitis

- hepatitis, liver cell death (necrosis hepática), which very rarely leads to liver insufficiency with risk of death

- light sensitivity (see section 2: Warnings and precautions), small hemorrhages under the skin (petechiae)

- muscle pain, joint inflammation, increased muscle tone, cramps, tendon rupture – especially 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), urinary tract inflammation

- excessive sweating

- abnormal levels of the coagulation factor (prothrombin) or increased concentrations of the amylase enzyme

Very rare side effects(it is likely that they will occur in less than 1 in 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 while walking (gait disturbances), increased intracranial pressure

- color vision distortions

- various skin eruptions 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)

- problems associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in the limbs

- severe cardiac rhythm disorders, irregular heart rhythm (Torsades de Pointes)

- syndrome associated with deficient water secretion and low sodium concentrations (SIADH, in English)

-loss of consciousness due to severe decrease 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-lasting or permanent adverse reactions (even months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment and hearing, vision, taste and smell disturbances, 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 cause rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects

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

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

Do not use Ciprofloxacino Altan after the expiration date that appears on the packaging, after “CAD”. The expiration date is 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 sensitive to light, the overwrap of the bag will 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 ingredient.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Ciprofloxacino Altan Composition

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

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

Appearance of the product and contents of the package:

Ciprofloxacino Altan is presented in the form of an infusion solution in a bag. Each package contains bags with 100 ml or 200 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1st Floor – Office F

28230 Las Rozas. Madrid

Responsible for manufacturing:

Altan Pharmaceuticals, S.A.

Pol.Ind.De Bernedo s/n

01118 Bernedo (Álava)

This leaflet was approved in December 2020

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Advice/medical 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.

Abuse 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:

-dose

-program

-duration of treatment

Consequently, in order to maintain the effectiveness of this medication:

1. Use antibiotics only when prescribed.

2. Follow the prescription strictly.

3. Do not 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 adapted to their illness.

5. After completing a treatment, return all unused medications to the pharmacy to ensure they are disposed of correctly.

The following information is intended only for doctors or healthcare professionals

Ciprofloxacino Altanmust 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 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 infused directly.

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

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

The detailed and updated information on this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/