Package Leaflet: Information for the User

Ciprofloxacin Aurovitas 750 mg Film-Coated Tablets

Ciprofloxacin hydrochloride

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ciprofloxacin Aurovitas contains the active ingredient ciprofloxacin. Ciprofloxacin is an antibiotic that belongs to the family of fluoroquinolones. 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,
• genital tract infections in men and women,
• intra-abdominal 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 in the management of patients with low white blood cell count (neutropenia) who have fever suspected to be caused by a bacterial infection.

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:

• respiratory and bronchial infections in children and adolescents with cystic fibrosis
• complicated urinary tract infections, including kidney infections (acute pyelonephritis)
• exposure to anthrax by inhalation

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

Do not take Ciprofloxacino Aurovitas:

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

Warnings and precautions

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

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

• if you have ever had kidney problems, as your treatment may need to be adjusted.
• if you have epilepsy or other neurological conditions.
• 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 have myasthenia gravis (a type of muscle weakness) as symptoms may worsen.
• if you have heart problems. You should exercise caution when using ciprofloxacin if you were born with or have a family history of prolonged QT interval (seen on ECG, heart electrical recording), if you have electrolyte imbalances in the blood (especially low levels of potassium or magnesium), have a very slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), are a woman or elderly person, or are taking other medications that can cause abnormal ECG changes (see section 2: other medications and Ciprofloxacino 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 "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 wall of the aorta).
• if you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., 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 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 there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

While taking Ciprofloxacino Aurovitas

Inform your doctor immediately if any of the following situations occur while taking this medication:

• 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 experiencing dizziness when standing up.If this happens, do not take more ciprofloxacin and contact your doctor immediately.
• In rare cases, you may experience pain and swelling in the joints 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 taking corticosteroids. Tendon inflammation and rupture can occur in 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 affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.
• If you have epilepsy or another neurological condition, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If seizures occur, stop taking ciprofloxacin and contact your doctor immediately.
• You may experience psychiatric reactions, even when taking quinolone antibiotics, including ciprofloxacin, for the first time. If you experience depression or psychosis, your symptoms may worsen with ciprofloxacin treatment. In rare cases, depression or psychosis may progress to suicidal thoughts and self-harm behaviors such as attempted suicide or completed suicide (see section 4 Possible side effects). If you experience depression, psychosis, suicidal thoughts, or self-harm 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 condition.
• 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 important for people with diabetes. If you have diabetes, your blood sugar levels should be closely monitored.
• Consult an ophthalmologist immediately if you experience any changes in your vision or have any eye problems.
• You may develop diarrhea while taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If diarrhea becomes intense or persistent, or if you notice that your stool contains blood or mucus, stop taking this medication and consult your doctor immediately, as this may put your life at risk. Do not take medications that slow down or delay bowel movements.
• While taking this medication, inform your doctor or laboratory staff if you need to undergo a blood or urine test.
• If you have kidney problems, speak with your doctor as your dose may need to be adjusted.
• Ciprofloxacin can cause liver damage. If you experience symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, consult your doctor immediately.
• Ciprofloxacin can cause a decrease in white blood cell count and may reduce 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. 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.
• Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking this medication. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.
• If you experience severe and sudden pain in the abdomen, chest, 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 taking corticosteroid systemic treatment.
• If you start experiencing sudden onset of 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), inform your doctor immediately.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone antibiotics, 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 and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, or burning, 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 whether to continue or discontinue treatment, considering the use of an antibiotic from a different class.

Other medications and Ciprofloxacino Aurovitas

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

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

We know that the following medications interact with ciprofloxacin in your body. If you take this medication at the same time as these medications, it 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 (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),
• ciclosporin (for skin problems, rheumatoid arthritis, and organ transplants),
• other medications that can alter your heart rhythm: antiarrhythmic medications (such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (which belong to the macrolide group), some antipsychotics.
• zolpidem (for sleep disorders).

Ciprofloxacin mayincreasethe blood levels of the following medications:

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

Some medicationsdecreasethe effect of this medication. Inform your doctor if you are taking or wish to take:

• antacids,
• omeprazole,
• mineral supplements,
• sucralfate,
• polymyxin E phosphate binders (e.g., sevelamer or lanthanum carbonate),
• medications or supplements containing calcium, magnesium, aluminum, or iron.

If these preparations are essential, take this medication approximatelytwohours before orfourhours after taking these preparations.

Taking Ciprofloxacino 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 fortified with calcium (e.g., orange juice with added calcium), will not significantly affect the absorption of this medication.

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

Therefore, ciprofloxacin tablets should be taken 1-2 hours before or not before 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, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

It is preferable to avoid using this medication during pregnancy.

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

Driving and operating machinery

Ciprofloxacin may reduce your alertness. You may experience some neurological effects. Make sure you know how you react to this medication before driving a vehicle or operating a machine. If in doubt, consult your doctor.

Sodium

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

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

Inform your doctor if you have kidney problems, as it may be necessary to adjust your dose.

The treatment usually lasts 5 to 21 days, but may last longer for severe infections. Follow exactly the administration instructions for this medication as indicated by your doctor. 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.

Ciprofloxacin tablets should be taken one or two hours before or not before four hours after dairy products or calcium-rich beverages taken separately from meals.

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

If you take more Ciprofloxacin 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ciprofloxacin Aurovitas

If you forget to takeciprofloxacinand there are:

•6 hours or morebefore the next scheduled dose, take the missed dose immediately. Then take the next dose at the usual time.

•less than 6 hoursbefore 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 compensate for the missed doses. Make sure to complete the treatment cycle.

If you interrupt the treatment with Ciprofloxacin Aurovitas

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 questions 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.

The following section contains the most serious side effects that you may be able to recognize yourself:

Stop taking ciprofloxacin and contact your doctor immediatelyto consider another antibiotic treatment if you notice any of the following serious side 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 and sudden 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 Achilles tendon (see section 2: Warnings and precautions).

- Skin eruptions 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 reaction to a drug that causes skin rash, fever, internal organ inflammation, hematological changes, and systemic disease (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms, PEAG - Acute Generalized Pustular Exanthema).

Other side effects that have been observed during treatment with ciprofloxacin are listed below according to the probability that they present:

Frequent(may affect up to 1 in 10 people)

• nausea, diarrhea
• joint pain and inflammation in children

Infrequent(may affect up to 1 in 100 people)

• superficial fungal infections
• elevated eosinophil count, a type of white blood cell
• loss of appetite (anorexia)
• hyperactivity or agitation
• headache, dizziness, sleep problems, or taste disturbances
• 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 dysfunction
• 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)

• muscle pain, joint inflammation, increased muscle tone, and cramps
• inflammation of the intestine (antibiotic-associated colitis) linked to the use of antibiotics (may be fatal in rare cases) (see section 2: Warnings and precautions)
• changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anemia), increased or decreased levels of a blood clotting factor (thrombocytes)
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions)
• 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 suicide) (see section 2: Warnings and precautions) or hallucinations
• sensations of numbness and tingling, unusual sensitivity to sensory 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, or deterioration of hearing
• increased heart rate (tachycardia)
• vasodilation, decreased blood pressure, or fainting
• breathing difficulties, including asthma-like symptoms
• liver problems, jaundice (icterus colestático) or hepatitis
• light sensitivity (see section 2: Warnings and precautions)
• renal insufficiency, blood or crystals in the urine, or 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 type of anemia (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 blood cells 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 disorders, gait disturbances (gait disorders), olfactory disorders (olfactory disorders); increased intracranial pressure and pseudotumor cerebri
• color vision disturbances
• inflammation of the blood vessel walls (vasculitis)
• pancreatitis
• liver cell death (hepatic necrosis), which very rarely leads to liver insufficiency with a risk of death (see section 2: Warnings and precautions)
• small pinpoint hemorrhages under the skin (petechiae), various skin eruptions, 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, or alteration of heart rhythm (prolongation of the QT interval, seen on the ECG, heart electrical activity)
• influence on blood coagulation (in patients treated with vitamin K antagonists)
• feeling highly excited (mania) or feeling extremely optimistic and hyperactive (hypomania)
• 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.

Other side effects include:

• increased blood sugar (hyperglycemia) or decreased blood sugar that leads 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 or permanent adverse reactions (even months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, unusual sensations such as pinching, tingling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disturbances, 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: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 this medication after the expiration date that appears on the blister pack or container, 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. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Ciprofloxacino Aurovitas Composition

• The active ingredient is ciprofloxacin. Each film-coated tablet contains 750 mg of ciprofloxacin (as hydrochloride).
• The other components are:

Tablet core:microcrystalline cellulose, sodium carboxymethyl starch (type A), povidone (K 30), anhydrous colloidal silica, magnesium stearate.

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

Appearance of Ciprofloxacino Aurovitas and packaging contents

Film-coated tablets.

White to off-white film-coated tablets, capsule-shaped, marked with “C” on one face and with “93” on the other face of the tablet. The size is 22.3 mm x 8.2 mm.

Ciprofloxacino Aurovitas film-coated tablets are available in blisters.

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

Only some packaging sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D,

28036, Madrid

Spain

Manufacturer responsible:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

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

Bélgica:Ciprofloxacine AB 750 mg, filmomhulde tabletten

Luxemburgo:Ciprofloxacin AB 750 mg,filmomhulde tabletten/ Filmtabletten

Países Bajos:Ciprofloxacine Aurobindo 750 mg, filmomhulde tabletten

España:Ciprofloxacino Aurovitas 750 mg comprimidos recubiertos con película EFG

Last review date of this leaflet:February2025

Advice on proper use:

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:

-the dose,

-the program,

-the 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 doctor's 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.

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