CIPROFLOXACIN STADA 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ciprofloxacin Stada 500 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What you need to know before you take Ciprofloxacin Stada
2. How to take Ciprofloxacin Stada
3. Possible side effects
   1. Storage of Ciprofloxacin Stada
   2. Contents of the pack and further information

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

Ciprofloxacin Stada is an antibiotic belonging to the fluoroquinolone family. 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 flu or common cold.

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

Do not store or reuse this medicine. If you have any leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Adults

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

• respiratory tract infections
• long-term or recurrent ear or sinus infections
• urinary tract infections
• male and female genital tract infections
• gastrointestinal and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• prevention of infections caused by the bacteria Neisseria meningitidis
• inhalation exposure to anthrax

Ciprofloxacin may be used in the treatment of patients with a low white blood cell count (neutropenia) who have fever suspected to be due to a bacterial infection.

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.

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 infections that have reached the kidneys (pyelonephritis)
• inhalation exposure to anthrax

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

2. What you need to know before you take Ciprofloxacin Stada

Do not take Ciprofloxacin Stada:

• if you are allergic to the active substance, other quinolones, or any of the other ingredients of this medicine (listed in section 6)

• if you are taking tizanidine (see section 2 "Other medicines and Ciprofloxacin Stada")

Warnings and precautions

Before you start taking this medicine

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, if you have experienced any serious side effects in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor before taking Ciprofloxacin Stada:

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

• if you suffer from severe myasthenia (a type of muscle weakness), as symptoms may worsen
• if you have heart problems. Caution should be exercised when administering ciprofloxacin if you were born with or have a family history of prolonged QT interval (seen on the ECG, electrical recording of the heart), have an electrolyte imbalance (especially low potassium and magnesium levels in the blood), have a very slow heart rate (known as bradycardia), have a fragile heart (cardiac arrest), have a history of heart attacks (myocardial infarction), you are a woman or an elderly person, or are taking other medicines that result in abnormal ECG changes (see section 2 "Other medicines and Ciprofloxacin 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 "bulging" of a large blood vessel (aortic aneurysm or large peripheral 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 dissection or aneurysm, 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, 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 there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

During treatment with this medicine

Inform your doctor immediately if any of the following occur while taking ciprofloxacin. Your doctor will decide whether it is necessary to interrupt treatment with ciprofloxacin.

• 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 the following symptoms: chest tightness, feeling of dizziness, nausea, or fainting, or experiencing dizziness when standing up. If this happens, do not take any more ciprofloxacin and contact your doctor immediately.

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

If you experience any of these side effects after taking ciprofloxacin, 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.

• In rare cases, 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), have received an organ transplant, have kidney problems, or are being treated with 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 taking ciprofloxacin, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you experience sudden and severe abdominal, chest, or back pain, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately.

The risk may increase if you are receiving systemic corticosteroid treatment.

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

• If you suffer from epilepsyor other neurological disorders, such as cerebral ischemia or infarction, you may experience side effects associated with the central nervous system. If this occurs, stop taking ciprofloxacin and contact your doctor immediately.

• In rare cases, you may experience nerve damage symptoms (neuropathy)such as pain, burning, tingling, numbness, and/or weakness, especially in the 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 experience psychiatric reactionswhen taking ciprofloxacin for the first time. If you suffer from depressionor psychosis, your symptoms may worsen with ciprofloxacin treatment. In rare cases, depression or psychosis may progress to suicidal thoughts, attempted suicide, or completed suicide. If this occurs, stop taking ciprofloxacin and contact your doctor immediately.

• Quinolone antibiotics may 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 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 while you are taking antibiotics, including ciprofloxacin, or even several weeks after you have stopped taking them. If the diarrhea becomes severe or persistent, or if you notice that the stools contain blood or mucus, stop taking ciprofloxacin immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements, and consult your doctor.

• 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, yellowing of the skin (jaundice), dark urine, itching, or stomach pain, stop taking ciprofloxacin immediately and consult your doctor immediately.

• Ciprofloxacin may cause a decrease in your white blood cell count and 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, consult your doctor immediately. They will perform a blood test to examine the possible decrease in white blood cells (agranulocytosis). It is essential that you inform your doctor about your medication.

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

• Consult an ophthalmologist immediately if your vision worsensor you have any problems with your eyes.

Other medicines and Ciprofloxacin Stada

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

Do not take ciprofloxacin at the same time as tizanidine, as this may cause side effects such as low blood pressure and drowsiness (see section 2 "Do not take Ciprofloxacin Stada").

It is known that the following medicines interact with ciprofloxacin in your body. If you take ciprofloxacin 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.

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 antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)
• metoclopramide (for nausea and vomiting)
• cyclosporine (for skin diseases, rheumatoid arthritis, and organ transplants)
• other medicines that may alter your heart rhythm: medicines belonging to the group of antiarrhythmics (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the group of macrolides), some antipsychotics.

Ciprofloxacin may increasethe blood levels of the following medicines:

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

Some medicines decreasethe effect of ciprofloxacin. Inform your doctor if you are taking or plan to take:

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

If these preparations are essential, take ciprofloxacin approximately twohours before or fourhours after you have taken these preparations.

Taking Ciprofloxacin Stada with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

It is preferable to avoid the use of ciprofloxacin during pregnancy.

Do not take ciprofloxacin 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 before driving a vehicle or using a machine. If in doubt, consult your doctor.

Ciprofloxacin Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Ciprofloxacin Stada

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

Your doctor will explain exactly how much ciprofloxacin you 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.

Treatment usually lasts from 5 to 21 days, but it can last longer for severe infections. Follow the administration instructions of this medication exactly as indicated by your doctor. Consult your doctor or pharmacist again if you have doubts about how many ciprofloxacin tablets to take and how to take them.

1. Swallow the tablets with a large amount of liquid. Do not chew the tablets because their taste is unpleasant.
2. Try to take the tablets at the same time every day.
3. You can take the tablets with or between meals. The calcium you take as part of a meal will not seriously affect the absorption of the medication. However, do nottake ciprofloxacin tablets with dairy products such as milk or yogurt, or with fruit juices enriched with minerals (e.g., calcium-enriched orange juice).

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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the package and the medication leaflet to the healthcare professional.

If you forget to take Ciprofloxacin Stada

Take the normal dose as soon as possible and then 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 make up for the missed doses. Make sure to complete the treatment cycle.

If you interrupt treatment with Ciprofloxacin Stada

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

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

4. Possible side effects

Like all medications, this medication 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

Uncommon(may affect up to 1 in 100 people):

• fungal superinfections
• high levels of eosinophils, a type of white blood cell
• decreased appetite
• hyperactivity or agitation
• headache, dizziness, sleep problems, or taste disorders
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/heartburn) or flatulence
• increased levels of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching, or hives
• joint pain in adults
• kidney dysfunction
• muscle and bone pain, feeling of discomfort (asthenia), or fever
• increased alkaline phosphatase in the blood

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

• antibiotic-associated colitis (which can be fatal in very rare cases) (see section 2 "Warnings and precautions")
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), increased or decreased levels of blood clotting factors (thrombocytes)
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema)
• high blood sugar (hyperglycemia)
• low blood sugar (hypoglycemia) (see section 2 "Warnings and precautions")
• confusion, disorientation, anxiety reactions, unusual dreams, depression (potentially leading to suicidal thoughts, suicide 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, impaired hearing
• rapid heart rate (tachycardia)
• blood vessel dilation (vasodilation), decreased blood pressure, or fainting
• breathing difficulties, including asthma-like symptoms
• liver disorders, jaundice (cholestatic jaundice), hepatitis
• photosensitivity (see section 2 "Warnings and precautions")
• muscle pain, tendon inflammation, tendon rupture – especially of the long tendon in the back of the ankle (Achilles tendon) (see section 2 "Warnings and precautions"), worsening of myasthenia gravis symptoms (see section 2 "Warnings and precautions")

Very rare(may affect up to 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), 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 sickness) (see section 2 "Warnings and precautions")
• mental disorders (psychotic reactions potentially leading to suicidal thoughts, suicide attempts, or completed suicides) (see section 2 "Warnings and precautions")
• migraine, coordination disorder, walking instability (gait disorders), disorders of the sense of smell (olfactory disorders); brain pressure (intracranial pressure and pseudotumor cerebri)
• visual color distortions
• inflammation of blood vessel walls (vasculitis)
• pancreatitis
• liver cell death (hepatic necrosis), which can very rarely lead to liver failure with a risk of death
• small pinpoint bleeding under the skin (petechiae), various skin rashes 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 tendon in the back of the ankle (Achilles tendon) (see section 2 "Warnings and precautions"), worsening of myasthenia gravis symptoms (see section 2 "Warnings and precautions")

Frequency not known(cannot be estimated from available data)

• nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs (peripheral neuropathy or polyneuropathy)
• abnormal rapid heart rhythm, life-threatening irregular heart rhythm, heart rhythm disorder (called "prolonged QT interval", observed in the ECG, heart electrical activity)
• pustular rash
• effect on blood clotting (in patients treated with vitamin K antagonists)
• feeling very excited (mania) or feeling of great optimism and hyperactivity (hypomania), hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
• syndrome associated with deficient water secretion and low sodium levels (SIADH, by its English acronym)
• 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, walking difficulties, abnormal sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), fatigue, decreased memory and concentration, effects on mental health (which can 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.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which can lead to rupture and be fatal, and heart valve disorders in patients who have received fluoroquinolones. See also section 2.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Ciprofloxacin Stada

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the package or blister, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ciprofloxacin Stada

• The active ingredient is ciprofloxacin. Each tablet contains 500 mg of ciprofloxacin (as hydrochloride).
• The other ingredients are: crospovidone, microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), colloidal anhydrous silica, magnesium stearate. The film-coating ingredients are: hypromellose, titanium dioxide (E-171), and triacetin.

Appearance and package contents

Ciprofloxacin Stada 500 mg are film-coated tablets, capsule-shaped, white, and scored on one side. The score line is to facilitate breaking and swallowing, but not to divide into equal doses.

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of last revision of this leaflet:December 2024

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

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

• the dose,
• the schedule
• the treatment duration

Consequently, to maintain the effectiveness of this medication:

1. Use antibiotics only when 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 someone else; it may not be suitable for their illness.
5. After completing a treatment, return all unused medications to the pharmacy to ensure they are disposed of correctly.