Prospect: Information for the User

Ciprofloxacino Stada 500 mg Film-Coated Tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

2.What you need to know before starting to take Ciprofloxacino Stada

3.How to take Ciprofloxacino Stada

4.Possible adverse effects

1. Storage of Ciprofloxacino Stada
2. Contents of the package and additional information

Ciprofloxacino Stada 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

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

• respiratory tract infections
• prolonged or recurrent ear or sinus infections
• urinary tract infections
• male and female genital tract infections
• gastrointestinal and intrabdominal infections
• skin and soft tissue infections
• bone and joint infections
• prevention of infections caused by the bacteriaNeisseria meningitidis
• exposure to anthrax by inhalation

Ciprofloxacin may be used to treat patients with low white blood cell count (neutropenia) who have suspected bacterial fever.

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 ciprofloxacin.

Children and adolescents

Ciprofloxacin 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

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

Do not take Ciprofloxacino Stada:

• if you are allergic to the active ingredient, other quinolones, or any of the other components of this medication (listed in section 6)

• if you take tizanidina (see section 2 “Other Medications and Ciprofloxacino Stada”)

Warnings and Precautions

Before starting to take this medication

You should not take fluoroquinolone or quinolone antibacterial medications, including ciprofloxacin, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is your case, you should inform your doctor as soon as possible.

Consult your doctor before starting to take Ciprofloxacino Stada:

• if you have ever had kidney problems, as your treatment may need to be adjusted
• if you suffer from epilepsy or other neurological conditions
• if you have a history of tendon problems during previous antibiotic treatment with ciprofloxacin
• if you are diabetic, as you may be at risk of hypoglycemia with ciprofloxacin

• if you suffer from myasthenia gravis (a type of muscle weakness) as symptoms may worsen
• if you have heart problems. You should exercise caution when taking ciprofloxacin if you were born or have a family history of prolonged QT interval (seen on ECG, heart electrical recording), have electrolyte imbalances in the blood (especially low levels of potassium and magnesium), have a slow heart rate (bradycardia), have a fragile heart (cardiac arrest), have a history of heart attacks (myocardial infarction), you are a woman or an elderly person, or you are taking other medications that cause abnormal ECG changes (see section 2 “Other Medications and Ciprofloxacino Stada”)
• if you know that you or a family member has a deficiency of glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin
• if you have been diagnosed with an enlarged or “bulge” of a large blood vessel (aortic aneurysm or aneurysm of a large peripheral vessel)
• if you have had a previous episode of aortic dissection (tear in the aorta wall)
• if you have been diagnosed with heart valve insufficiency (valve regurgitation)
• if you have a family history of aortic dissection or aneurysm, congenital heart valve disease, or other risk factors or 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))

For the treatment of some genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If you do not see an improvement in symptoms after 3 days of treatment, please consult your doctor.

During treatment with this medication

Inform your doctor immediately if any of the following situations occur while taking ciprofloxacin. Your doctor will decide if you need to stop taking ciprofloxacin.

• 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 experience dizziness when standing up.If this happens, do not take more ciprofloxacin and contact your doctor immediately.

• Severe, incapacitating, prolonged, and potentially irreversible adverse effectsCiprofloxacin has been associated with rare but severe adverse effects, some of which were persistent for months or years, incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinpricks, numbness, tingling, or burning (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 taking ciprofloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide if you should continue or stop treatment, considering also the use of another class of antibiotic.

• In rare cases, you may experiencejoint pain and swelling, inflammation, or tendon rupture. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping ciprofloxacin treatment. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ciprofloxacin, contact your doctor, and keep the painful area at rest. Avoid unnecessary exercise, as this may increase the risk of tendon rupture.

• If you experience asudden and intense pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately.

You may be at increased risk if you are receiving systemic corticosteroid treatment.

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

• 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 taking ciprofloxacin and contact your doctor immediately.

• In rare cases, you may experiencenerve damage (neuropathy)such as pain, burning, numbness, tingling, and/or weakness, especially in your feet and legs or hands and arms. If this happens, stop taking ciprofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• You may experiencepsychiatric reactionsfor the first time when taking ciprofloxacin. If you suffer fromdepressionorpsychosis, your symptoms may worsen with ciprofloxacin treatment. In rare cases, depression or psychosis may progress to suicidal thoughts, attempts, or completed suicide. If this occurs, stop taking ciprofloxacin and contact your doctor immediately.

• Quinolone antibiotics can cause an increase in your blood sugar levels above normal levels (hyperglycemia), or a decrease in your blood sugar levels below normal levels, which in severe cases can cause a 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 taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If diarrhea becomes intense or persistent, or if you notice that your stools contain blood or mucus, stop taking ciprofloxacin immediately, as this may put your life at risk. Do not take medications that slow down or delay bowel movements and consult your doctor.

• While taking ciprofloxacin, inform your doctor or laboratory personnel if you need to undergo ablood or urine test.

• Ciprofloxacin can causeliver damage. If you notice symptoms such as loss of appetite, jaundice (yellow skin), dark urine, itching, or stomach pain, stop taking ciprofloxacin immediately and consult your doctor 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 local infection symptoms such as sore throat/pharynx/mouth, or urinary problems, you must consult your doctor immediately. They will perform a blood test to examine the possible decrease in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

• Your skin becomes moresensitive to sunlight or ultraviolet (UV) lightwhen taking ciprofloxacin. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.

• Consult an ophthalmologist immediately if yourvision worsensor you experience any eye problems.

Other Medications and Ciprofloxacino Stada

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

Do not take ciprofloxacin at the same time as tizanidina, as this may cause adverse effects, such as low blood pressure and drowsiness (see section 2 “Do not take Ciprofloxacino Stada”).

We know that the following medications interact with ciprofloxacin in your body. If you take ciprofloxacin 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:

• anticoagulant medications (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, or rheumatoid arthritis)
• theophylline (for respiratory problems)
• tizanidina (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)
• metoclopramide (for nausea and vomiting)
• ciclosporin (for skin diseases, rheumatoid arthritis, and organ transplants)
• other medications that may alter your heart rhythm: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (macrolides), and some antipsychotics.

Ciprofloxacin mayincreasethe levels of the following medications in your blood:

• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic polyneuropathy, or incontinence)
• lidocaine (for heart disease or anesthetic use)
• sildenafil (e.g., for erectile dysfunction)
• agomelatine (for depression)
• zolpidem (for sleep disorders)

Some medicationsreducethe effect of ciprofloxacin. Inform your doctor if you are taking or wish to take:

• antacids
• omeprazole
• mineral supplements
• sucralfate
• a polymeric phosphate chelator (e.g., sevelamer or lanthanum carbonate)
• medications or supplements containing calcium, magnesium, aluminum, or iron

If these preparations are essential, takeciprofloxacinapproximatelytwohours before orfourhours after taking these preparations.

Taking Ciprofloxacino Stada with food and drinks

Although you take ciprofloxacin with meals, you should not eat or drink any dairy products (such as milk or yogurt) or beverages with added calcium when taking the tablets, as they may affect the absorption of the active ingredient.

Pregnancy, breastfeeding, and fertility

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

It is recommended to avoid using ciprofloxacin during pregnancy.

Do not takeciprofloxacinduring breastfeeding, as ciprofloxacin is excreted through breast milk and may cause harm to your baby.

Driving and using machines

Ciprofloxacin may reduce your alertness. You may experience some neurological effects. Therefore, make sure you know how you react tociprofloxacinbefore driving a vehicle or using a machine. If in doubt, consult your doctor.

Ciprofloxacino Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will explain exactly how muchciprofloxacinyou should take, 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 it may be necessary to adjust your dose.

The treatment usually lasts from5 to21 days, but may last longer for severe infections. Follow exactly the administration instructions for this medication as indicated by your doctor. Consult your doctor or pharmacist again if you have doubts about how many tablets ofciprofloxacinand how to take them.

Remember to drink a large amount of liquids while taking this medication.

If you take more Ciprofloxacin Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Ciprofloxacin Stada

Take the normal dose as soon as possible and, afterwards, continue the treatment as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue as usual. Do not take a double dose to compensate for the missed dose. Make sure to complete the treatment cycle.

If you interrupt the treatment with Ciprofloxacin Stada

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

• nausea, diarrhea
• joint pain in children

Less frequent(may affect up to 1 in 100 people):

• superficial fungal infections
• elevated eosinophil count, a type of white blood cell
• decreased appetite
• hyperactivity or agitation
• headache, dizziness, sleep problems, or taste disturbances
• vomiting, abdominal pain, digestive problems such as indigestion or acid reflux, or flatulence
• increased levels of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching, or hives
• joint pain in adults
• renal function impairment
• muscle and bone pain, feeling unwell (asthenia), or fever
• increased alkaline phosphatase in the blood (a blood substance)

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

• inflammation of the intestine (colitis) linked to antibiotic use (may be fatal in rare cases) (see section 2 “Warnings and precautions”)
• changes in blood cell count (leucopenia, leucocytosis, neutropenia, anemia), increased or decreased levels of blood clotting factor (thrombocytes)
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema)
• increased blood sugar (hyperglycemia)
• decreased blood sugar (hypoglycemia) (see section 2 “Warnings and precautions”)
• confusion, disorientation, anxiety reactions, strange dreams, depression (potentially leading to suicidal thoughts, attempts, or completed suicides) or hallucinations
• tingling and numbness, unusual sensitivity to stimuli, decreased skin sensitivity, tremors, convulsions (see section 2 “Warnings and precautions” or “dizziness”)
• vision problems (including double vision)
• tinnitus (ringing in the ears), hearing loss, or impaired hearing
• increased heart rate (tachycardia)
• vasodilation, decreased blood pressure, or fainting
• difficulty breathing, including asthma-like symptoms
• liver problems, jaundice (icterus colestático), hepatitis
• light sensitivity (see section 2 “Warnings and precautions”)
• muscle pain, joint inflammation, increased muscle tone, or muscle cramps
• renal insufficiency, blood or crystals in the urine (see section 2 “Warnings and precautions”), urinary tract inflammation
• fluid retention or excessive sweating
• increased amylase enzyme levels

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

• a type of anemia (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis), a decrease in the number of white and red blood cells and platelets (pancytopenia), with a risk of death, and bone marrow depression, also with a risk of death (see section 2 “Warnings and precautions”)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with a risk of death - serum disease) (see section 2 “Warnings and precautions”)
• mental disorders (psychotic reactions potentially leading to suicidal thoughts, attempts, or completed suicides) (see section 2 “Warnings and precautions”)
• migraine, coordination disorders, gait instability (gait disorders), olfactory disorders (olfactory disorders); increased intracranial pressure and pseudotumor cerebri
• color vision distortions
• inflammation of the blood vessel wall (vasculitis)
• pancreatitis
• liver cell death (hepatic necrosis), which rarely leads to liver insufficiency with a risk of death
• petechiae (small pinpoint bleeding under the skin), various skin eruptions or exanthems (e.g., Stevens-Johnson syndrome with a risk of death or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, tendon rupture – especially of the long posterior tendon of the ankle (Achilles tendon) (see section 2 “Warnings and precautions”), worsening of myasthenia gravis symptoms (see section 2 “Warnings and precautions”)

Frequency unknown(cannot be estimated from available data)

• problems associated with the nervous system such as pain, burning, tingling, numbness, and/or weakness in the extremities (peripheral neuropathy or polyneuropathy)
• abnormal heart rhythm, irregular heart rhythm with a risk to life, alteration of heart rhythm (called “prolongation of the QT interval”, observed in ECG, heart electrical activity)
• pustular rash
• influence on blood coagulation (in patients treated with vitamin K antagonists)
• feeling extremely excited (mania) or a feeling of great optimism and hyperactivity (hypomania), a hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
• 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) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinpricks, tingling, numbness, burning, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, 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 heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse 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 this medication after the expiration date that appears on the packaging or in the blister pack, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Please ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Ciprofloxacin Stada Composition

-The active ingredient is ciprofloxacin. Each tablet contains 500 mg of ciprofloxacin (as hydrochloride).

-The other components are: crospovidone, microcrystalline cellulose, sodium carboxymethyl cellulose (type A) (from potato), anhydrous colloidal silica, magnesium stearate. The components of the film coating are: hypromellose, titanium dioxide (E-171) and triacetin.

Appearance of the product and contents of the package

Ciprofloxacin Stada 500 mg are film-coated, capsule-shaped, white tablets with a notch on one side. The notch serves to break and facilitate swallowing, but not to divide into equal doses.

Each package contains 1, 14 or 500 (clinical package) film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet:October 2020

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

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 specifically for your current illness.

Even with 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 delay your recovery or reduce the effectiveness of antibiotics if you do not respect:

• the dose,
• the treatment program
• the duration of treatment

As a result, 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 doctor's prescription, even if you want to treat a similar illness.
4. Never give your antibiotic to someone else; 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.