CIPROFLOXACIN AUROVITAS 250 mg FILM-COATED TABLETS

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

Do not take Ciprofloxacin Aurovitas:

• if you are allergic to ciprofloxacin, 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 Aurovitas”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ciprofloxacin Aurovitas:

• 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;

• if you have ever had kidney problems, as your treatment may need 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 myasthenia gravis (a type of muscle weakness), as symptoms may worsen;
• if you have heart problems. You should be cautious when using ciprofloxacin if you were born with or have a family history of prolonged QT interval (seen on the ECG, electrical recording of the heart), if you have an imbalance of salts in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), are a woman or an elderly person, or are taking other medicines that may result in abnormal ECG changes (see section 2: “Other medicines and Ciprofloxacin Aurovitas”);
• if you or a family member has a deficiency in 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 aneurysm or aortic dissection, congenital heart valve disorders, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome or Ehlers-Danlos vascular 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, or 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.

While taking Ciprofloxacin Aurovitas

Inform your doctor immediately if any of the following situations occur while taking this medicine. 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, dizziness, nausea, or fainting, or experience dizziness when standing up. If this happens, do not take any more ciprofloxacin and contact your doctor immediately.
• In rare cases, pain and swelling may occur in the joints and inflammation or rupture of the tendons. The risk is greater 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 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 suffer from epilepsyor other neurological disorders, such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system. If seizures occur, stop taking ciprofloxacin and contact your doctor immediately.
• You may experience psychiatric reactionseven when taking quinolone antibiotics, including 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 and self-harming behaviors, such as attempted suicide or completed suicide (see section 4: “Possible side effects”). If you experience depression, psychosis, suicidal thoughts, or behaviors, contact your doctor immediately.
• In rare cases, you may experience symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking ciprofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
• 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.
• Consult an ophthalmologist immediately if you experience any changes in your vision or have any eye problems.
• Diarrhea may 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 stool contains blood or mucus, stop taking this medicine and consult your doctor immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements.
• While taking this medicine, inform your doctor or laboratory staff that you are taking it if you need to have a blood testor urine test.
• If you have kidney problems, talk to your doctor, as your dose may need to be adjusted.
• Ciprofloxacin may cause liver damage. If you notice symptoms such as loss of appetite, yellowing of the skin, dark urine, itching, or stomach pain, consult your doctor immediately.
• Ciprofloxacin may cause a decrease in the 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, you should consult your doctor immediately. You will have 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 this medicine. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.
• If you feel a sudden and severe pain in the abdomen, chest, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.

Severe, disabling, long-lasting, 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 (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of 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, and 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 with the treatment, also considering the use of an antibiotic from another class.

Other medicines and Ciprofloxacin Aurovitas

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

Do not take Ciprofloxacin Aurovitas 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 Aurovitas”).

It is known that the following medicines interact with ciprofloxacin in your body. If you take this medicine at the same time as these medicines, it may affect the therapeutic effect of these medicines. It may also increase the likelihood of you experiencing side effects.

Tell your doctor if you are taking:

• vitamin K antagonists (such as warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood);
• theophylline (for respiratory problems);
• phenytoin (for epilepsy);
• probenecid (for gout);
• ropinirole (for Parkinson's disease);
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis);
• tizanidine (for muscle spasticity in multiple sclerosis);
• olanzapine (an antipsychotic);
• clozapine (an antipsychotic);
• metoclopramide (for vomiting and nausea);
• cyclosporine (for skin problems, 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;
• zolpidem (for sleep disorders).

Ciprofloxacin may increaseblood 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);
• agomelatine (for depression).

Some medicines decreasethe effect of this medicine. Tell your doctor if you are taking or want 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 this medicine approximately twohours before or fourhours after you have taken these preparations.

Taking Ciprofloxacin Aurovitas with food and drinks

Calcium ingested as part of a meal, including dairy products and calcium-rich beverages (such as milk or yogurt) or fruit juices enriched with calcium (e.g., orange juice with added calcium), will not significantly affect the absorption of this medicine.

However, ciprofloxacin tablets administered simultaneously with dairy products and calcium-rich beverages when these dairy products or beverages are taken alone and separate from meals may reduce the effect of this medicine.

Consequently, ciprofloxacin tablets should be taken 1-2 hours before or no sooner than 4 hours after dairy products or calcium-rich beverages taken alone and separate from meals (see also section 3).

Pregnancy and breastfeeding

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 using this medicine during pregnancy.

Do not take this medicine during breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and using machines

Ciprofloxacin may reduce your alertness. Some neurological effects may occur. Therefore, make sure you know how you react to this medicine before driving a vehicle or using a machine. If in doubt, consult your doctor.

Sodium

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

3. How to take Ciprofloxacino Aurovitas

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

Inform your doctor if you have kidney problems because 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 indicated by your doctor exactly. In case of doubt, consult your doctor or pharmacist again about how many tablets of this medication you should take and how you should take them.

1. Swallow the tablets with a large amount of liquid.
2. Do not chew the tablets because their taste is not pleasant.
3. Try to take the tablets at the same time every day.
4. You can take the tablets with or between meals.

You can take ciprofloxacin tablets during meals that contain dairy products (such as milk or yogurt) or with calcium-rich beverages (for example, orange juice fortified with calcium). However, do nottake ciprofloxacin tablets at the same time as dairy products or calcium-rich beverages when these products are taken alone, separate from meals.

Ciprofloxacin tablets should be taken one or two hours before or no earlier than four hours after dairy products or calcium-rich beverages taken alone, separate from meals.

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

If you take more Ciprofloxacino Aurovitas than you should

If you take a larger amount than prescribed, seek medical help immediately. If possible, bring the tablets or the box with you to show the doctor.

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.

If you forget to take Ciprofloxacino Aurovitas

If you forget to take ciprofloxacinand:

• 6 hours or more are left for the next scheduled dose, take the missed dose immediately. Then take the next dose at the usual time.
• less than 6 hours are left for the next scheduled dose, do not take the missed dose. Take the next dose at the usual time.

Do not take a double dose to make up for missed doses. Make sure to complete the treatment cycle.

If you interrupt treatment with Ciprofloxacino Aurovitas

It is important 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 adverse effects

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

The following section contains the most serious adverse effects that you may recognize yourself:

Stop taking ciprofloxacin and contact your doctor immediatelyto consider another antibiotic treatment if you notice any of the following serious adverse effects:

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

• seizures (see section 2: Warnings and precautions).

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

• severe allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness when standing up (anaphylactic reaction or shock) (see section 2: "Warnings and precautions");
• muscle weakness, tendon inflammation that can lead to tendon rupture, especially the long tendon in the back of the ankle (Achilles tendon) (see section 2: "Warnings and precautions");
• skin rashes with a risk of death, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes, such as the genitals, which can progress to generalized blistering or skin peeling (Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• unusual sensations of pain, burning, tingling, numbness, or muscle weakness in the limbs (neuropathy) (see section 2: "Warnings and precautions");
• a drug reaction that causes skin rash, fever, inflammation of internal organs, blood disorders, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEAG - Generalized Acute Pustular Exanthem).

Other adverse effects that have been observed during treatment with ciprofloxacin are listed below according to their probability:

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

• nausea, diarrhea;
• joint pain and inflammation in children.

Uncommon(may affect up to 1 in 100 people)

• fungal superinfections;
• an elevated concentration of eosinophils, a type of white blood cell;
• decreased appetite (anorexia);
• hyperactivity or agitation;
• headache, dizziness, sleep problems, or taste disorders;
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/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 impairment;
• 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):

• muscle pain, joint inflammation, increased muscle tone, and cramps
• inflammation of the intestine (colitis) associated with antibiotic use (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 a blood clotting factor (thrombocytosis);
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema) (see section 2: "Warnings and precautions");
• increased blood sugar levels (hyperglycemia);
• decreased blood sugar levels (hypoglycemia) (see section 2: "Warnings and precautions");
• confusion, disorientation, anxiety reactions, unusual dreams, depression (potentially leading to suicidal thoughts, attempts, or completed suicide) (see section 2: "Warnings and precautions") or hallucinations;
• tingling, numbness, unusual sensitivity to stimuli, decreased skin sensitivity, tremors, or dizziness;
• vision problems, including double vision (see section 2: "Warnings and precautions");
• tinnitus (ringing in the ears), hearing loss, deterioration of hearing.
• increased heart rate (tachycardia);
• vasodilation, decreased blood pressure, or fainting;
• difficulty breathing, including asthma-like symptoms;
• liver disorders, jaundice (cholestatic jaundice), or hepatitis;
• sensitivity to light (see section 2: "Warnings and precautions");
• renal failure, blood or crystals in the urine, inflammation of the urinary tract;
• fluid retention or excessive sweating;
• increased amylase enzyme levels.

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) (see section 2: "Warnings and precautions"), 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;
• an allergic reaction called serum sickness-like reaction (see section 2: "Warnings and precautions");
• mental disorders (psychotic reactions potentially leading to suicidal thoughts, attempts, or completed suicide) (see section 2: "Warnings and precautions");
• migraine, coordination disorder, instability when walking (gait disorders), disorders of the sense of smell (olfactory disorders); increased pressure in the brain (intracranial pressure and pseudotumor cerebri);
• visual distortions of colors;
• inflammation of the blood vessel walls (vasculitis);
• pancreatitis;
• death of liver cells (necrosis), which very rarely leads to liver failure with a risk of death (see section 2: "Warnings and precautions");
• small pinpoint hemorrhages under the skin (petechiae), various skin rashes, or exanthems;
• worsening of myasthenia gravis symptoms (see section 2: "Warnings and precautions").

Frequency not known(cannot be estimated from available data)

• abnormal rapid heart rhythm, life-threatening irregular heart rhythm, alteration of heart rhythm (called QT interval prolongation, seen in the ECG, heart electrical activity);
• influence on blood coagulation (in patients treated with vitamin K antagonists);
• feeling highly excited (mania) or feeling very optimistic and hyperactive (hypomania);
• syndrome associated with deficient water secretion and low sodium concentrations (SIADH, by its English acronym);
• loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma). See section 2.

Other adverse effects include:

• increased blood sugar levels (hyperglycemia) or decreased blood sugar levels leading to coma (hypoglycemic coma). This is important for people with diabetes.

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, unusual 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 could lead to rupture and be fatal, and cardiac valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ciprofloxacino Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister or box, 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 thrown down the drain or into the trash. Deposit the containers and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ciprofloxacino Aurovitas

• The active ingredient is ciprofloxacin. Each film-coated tablet contains 250 mg of ciprofloxacin (as hydrochloride).
• The other components are:

Core of the tablet:microcrystalline cellulose, sodium carboxymethyl starch of potato (type A), povidone (K 30), colloidal anhydrous silica, magnesium stearate.

Coating:hypromellose, titanium dioxide (E-171), macrogol 400.

Appearance of Ciprofloxacino Aurovitas and package contents

Film-coated tablets.

White to off-white, round (diameter 11.1 mm), marked with "F" and "23" on either side of the score line on one face and with a score line on the other face of the tablet. The tablet can be divided into equal doses.

Ciprofloxacino Aurovitas film-coated tablets are available in blisters.

Package sizes: 1, 8, 10, 14, 16, 20, 50, and 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D,

28036, Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medication is authorized in the member states of the European Economic Area with the following names:

Belgium: Ciprofloxacine AB 250 mg, filmomhulde tabletten

Luxembourg: Ciprofloxacin AB 250 mg, filmomhulde tabletten/ Filmtabletten

Netherlands: Ciprofloxacine Aurobindo 250 mg, filmomhulde tabletten

Spain: Ciprofloxacino Aurovitas 250 mg film-coated tablets EFG

Date of the last revision of this leaflet:March 2025

Medical advice/education:

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

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

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

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

• the dose,
• the schedule,
• the duration of treatment.

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 another person; 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.

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