Ciprofloxacin Aurovitas 500 mg film-coated tablets EFG

Spain
Brand name Ciprofloxacin Aurovitas 500 mg film-coated tablets EFG
Form tablets, film-coated
Active substance / Dosage
Prescription type Prescription Only Medicine
Registration number 80160
Ciprofloxacin Aurovitas 500 mg film-coated tablets EFG tablets, film-coated

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ciprofloxacin Aurovitas 500 mg film-coated tablets EFG

Ciprofloxacin hydrochloride

Read the entire leaflet carefully before you start taking 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

  1. What Ciprofloxacin Aurovitas is and what it is used for
  2. What you need to know before taking Ciprofloxacin Aurovitas
  3. How to take Ciprofloxacin Aurovitas
  4. Possible side effects
  5. How to store Ciprofloxacin Aurovitas
  6. Contents of the pack and other information

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

Ciprofloxacin Aurovitas contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic that belongs to the fluoroquinolone family. Ciprofloxacin works by eliminating bacteria that cause infections. It only acts against specific strains of bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dosage, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Adults

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

  • respiratory tract infections,
  • long-lasting 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 bacterium Neisseria meningitidis,
  • inhalational exposure to anthrax.

Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have fever suspected to be caused by a bacterial infection.

If 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 alongside 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 (acute pyelonephritis),
  • inhalational exposure to anthrax.

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

2. What you need to know before taking Ciprofloxacin Aurovitas

Do not take Ciprofloxacin Aurovitas:

  • if you are allergic to ciprofloxacin, to other quinolones, or to 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 must not take antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible;
  • if you have ever had kidney problems, as your treatment may require dose adjustment;
  • if you suffer from 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 QT interval prolongation (seen on ECG, the electrical recording of the heart), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), have a very slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), are female or elderly, or are taking other medicines that may cause abnormal changes in the ECG (see section 2: “Other medicines and Ciprofloxacin Aurovitas”);
  • if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anemia with ciprofloxacin;
  • if you have been diagnosed with an enlarged blood vessel or a “bulge” in a large blood vessel (aortic aneurysm or peripheral large-vessel aneurysm);
  • if you have previously experienced aortic dissection (tearing of the aortic wall);
  • 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 disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular 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, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

For the treatment of certain 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 you are taking this medicine. Your doctor will decide whether treatment with ciprofloxacin should be discontinued.

  • Sudden, severe 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 feel dizzy upon standing. If this happens, do not take any more ciprofloxacin and contact your doctor immediately.
  • Rarely, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping ciprofloxacin. 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 rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
  • If you suffer from epilepsy or another neurological condition, such as cerebral ischemia or stroke, you may experience adverse effects related to 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 suffer from depression or psychosis, your symptoms may worsen with ciprofloxacin treatment. In rare cases, depression or psychosis may progress to suicidal thoughts and self-harming behaviors, including suicide attempts or completed suicide (see section 4: “Possible side effects”). If depression, psychosis, suicidal thoughts, or behaviors occur, contact your doctor immediately.
  • Rarely, 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 occurs, stop taking ciprofloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.
  • Quinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycemia), or a decrease in blood sugar levels below normal, which in severe cases may lead to 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 closely monitored.
  • Consult an ophthalmologist immediately if you experience any changes in vision or any eye problems.
  • Diarrhea may develop while taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If diarrhea becomes severe or persistent, or if you notice blood or mucus in your stools, stop taking this medicine and consult your doctor immediately, as this may be life-threatening. Do not take medicines that stop or delay intestinal movements.
  • While taking this medicine, inform your doctor or laboratory staff if you need to undergo a blood test or urine test.
  • If you have kidney problems, speak to your doctor, as dose adjustment may be required.
  • Ciprofloxacin may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, consult your doctor immediately.
  • Ciprofloxacin may cause a decrease in white blood cell count and possibly reduce your resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth, or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible low white blood cell count (agranulocytosis). It is important to inform your doctor about this medication.
  • Your skin may become more sensitive to sunlight or ultraviolet (UV) light while taking this medicine. Avoid exposure to intense sunlight or artificial UV light, such as tanning beds.
  • If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to an emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.
  • If you suddenly develop shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), 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 rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory loss, severe fatigue, and serious 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 treatment, considering also the use of an antibiotic from another class.

Other medicines and Ciprofloxacin Aurovitas

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

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

The following medicines are known to interact with ciprofloxacin in your body. Taking this medicine together with these medicines may affect their therapeutic effect and may increase the likelihood of adverse effects.

Inform 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 nausea and vomiting);
  • ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplantation);
  • other medicines that may alter your heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (macrolide group), and some antipsychotics;
  • zolpidem (for sleep disorders).

Ciprofloxacin may increase blood 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 decrease the effect of this medicine. Inform your doctor if you are taking or intend to take:

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

If these preparations are essential, take this medicine approximately two hours before or four hours after taking these preparations.

Taking Ciprofloxacin Aurovitas with food and drink

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

However, ciprofloxacin tablets taken simultaneously with dairy products or calcium-rich drinks, when these products or drinks are taken alone and separately from meals, may reduce the effectiveness of this medicine.

Therefore, ciprofloxacin tablets should be taken 1–2 hours before or no less than 4 hours after consuming dairy products or calcium-rich drinks taken alone and separately from meals (see also section 3).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

It is preferable to avoid using this medicine during pregnancy.

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

Driving and using machines

Ciprofloxacin may reduce your level of alertness. Some neurological effects may occur. Therefore, ensure you know how you react to this medicine before driving or operating machinery. If in doubt, consult your doctor.

Sodium

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

3. How to take Ciprofloxacin Aurovitas

Follow exactly the dosing instructions for ciprofloxacin given to you by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Always follow your doctor's instructions regarding this medicine. If in doubt, consult your doctor or pharmacist about how many tablets of this medicine you should take and how to take them.

  1. Swallow the tablets with plenty of fluid.
  2. Do not chew the tablets, as they have an unpleasant taste.
  3. Try to take the tablets at the same time each day.
  4. You may take the tablets with or between meals.

You may take ciprofloxacin tablets during meals containing dairy products (such as milk or yoghurt) or with calcium-rich drinks (for example, orange juice fortified with calcium). However, do not take ciprofloxacin tablets at the same time as dairy products or calcium-rich drinks when these are taken alone, separately from meals.

Ciprofloxacin tablets must be taken either one or two hours before, or at least four hours after, consuming dairy products or calcium-rich drinks taken alone and separately from meals.

Remember to drink plenty of fluids while taking this medicine.

If you take more Ciprofloxacin Aurovitas than you should

If you take more than prescribed, seek medical help immediately. If possible, bring the tablets or the pack with you to show the doctor.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ciprofloxacin Aurovitas

If you forget to take ciprofloxacin and:

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

Do not take a double dose to make up for a missed dose. Make sure you complete the full course of treatment.

If you stop taking Ciprofloxacin Aurovitas

It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop taking this medicine too early, your infection may not be completely cured and symptoms may worsen again. You may also develop resistance to the antibiotic.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

The following section describes the most serious adverse effects that you can recognize yourself:

Stop taking ciprofloxacin and contact your doctor immediately to consider alternative 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 and sudden allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or experiencing dizziness upon standing (anaphylactic reaction or shock) (see section 2: "Warnings and precautions");
  • muscle weakness, tendon inflammation that may lead to tendon rupture, especially of the long tendon at the back of the ankle (Achilles tendon) (see section 2: "Warnings and precautions");
  • skin rashes with risk of death, typically presenting as blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes such as the genitals, which may progress to widespread 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 causing skin rash, fever, internal organ inflammation, hematological abnormalities, and systemic illness (DRESS – Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP – Acute Generalized Exanthematous Pustulosis).

Other adverse effects observed during treatment with ciprofloxacin are listed below by their frequency:

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

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

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

  • fungal superinfections (due to fungi);
  • elevated levels of eosinophils, a type of white blood cell;
  • loss of appetite (anorexia);
  • hyperactivity or agitation;
  • headache, dizziness, sleep disturbances, or taste disturbances;
  • 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;
  • impaired kidney function;
  • muscle and bone pain, feeling of malaise (asthenia), or fever;
  • increased alkaline phosphatase in blood (a blood parameter).

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 (may be fatal in very rare cases) (see section 2: "Warnings and precautions");
  • changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in platelet count (a blood clotting factor);
  • 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, suicide attempts, or completed suicide) (see section 2: "Warnings and precautions"), or hallucinations;
  • tingling and numbness sensations, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, or dizziness;
  • vision problems, including double vision (see section 2: "Warnings and precautions");
  • tinnitus (ringing in the ears), hearing loss, or hearing deterioration;
  • increased heart rate (tachycardia);
  • blood vessel dilation (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");
  • kidney failure, blood or crystals in urine, inflammation of the urinary tract;
  • fluid retention or excessive sweating;
  • increased levels of the enzyme amylase.

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

  • a specific type of decreased blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cells (agranulocytosis) (see section 2: "Warnings and precautions"), a decrease in both red and white blood cells and platelets (pancytopenia), with risk of death, and bone marrow suppression, also with 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, suicide attempts, or completed suicide) (see section 2: "Warnings and precautions");
  • migraine, coordination disorder, unsteadiness when walking (gait disorders), disturbances in the sense of smell (olfactory disorders); pressure in the brain (increased intracranial pressure and pseudotumor cerebri);
  • visual distortions of colors;
  • inflammation of blood vessel walls (vasculitis);
  • pancreatitis;
  • death of liver cells (hepatic necrosis), which very rarely leads to liver failure with risk of death (see section 2: "Warnings and precautions");
  • small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems;
  • worsening of symptoms of myasthenia gravis (see section 2: "Warnings and precautions").

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

  • abnormally fast heart rate, life-threatening irregular heart rhythm, disturbances in heart rhythm (called QT interval prolongation, seen on ECG, electrical activity of the heart);
  • effects on blood clotting (in patients treated with vitamin K antagonists);
  • feeling highly excited (mania) or feeling excessive optimism and hyperactivity (hypomania);
  • syndrome associated with deficient water excretion and low sodium concentrations (SIADH);
  • loss of consciousness due to severely low 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 use 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, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may 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.

Cases of enlargement and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and may be fatal, and heart valve insufficiency have been reported in patients receiving fluoroquinolones. See also section 2.

Reporting of adverse effects

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

5. Storage of Ciprofloxacin Aurovitas

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

Do not use this medicine after the expiry date which is stated on the blister or carton, following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any medicines you no longer need at the SIGRE point located at your pharmacy. Ask your pharmacist how to properly dispose of any unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ciprofloxacin Aurovitas

  • The active substance is ciprofloxacin. Each film-coated tablet contains 500 mg of ciprofloxacin (as hydrochloride).
  • The other components are:

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

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

Appearance of Ciprofloxacin Aurovitas and contents of the pack

Film-coated tablets.

White to off-white, capsule-shaped film-coated tablets, marked "F22" on one side and with a score line on the other side. The tablet can be divided into equal doses. The size is 18.2 mm x 8.1 mm.

Ciprofloxacin Aurovitas film-coated tablets are available in blisters.

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

Only certain pack 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 medicinal product is authorized in the European Economic Area member states under the following names:

Belgium: Ciprofloxacin AB 500 mg, filmomhulde tabletten

Latvia: Ciprofloxacin Aurobindo 500 mg apvalkotas tabletes

Luxembourg: Ciprofloxacin AB 500 mg, filmomhulde tabletten / Filmtabletten

Netherlands: Ciprofloxacin Aurobindo 500 mg, filmomhulde tabletten

Spain: Ciprofloxacin Aurovitas 500 mg film-coated tablets EFG

Date of the most recent review of this leaflet: March 2025

Advice / Medical education:

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

If your doctor has prescribed antibiotics, they are specifically needed for your current illness.

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

Improper use of antibiotics increases resistance. You may even help bacteria become more resistant, thereby delaying recovery or reducing antibiotic effectiveness if you do not follow:

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

Therefore, to maintain the effectiveness of this medicine:

  1. Use antibiotics only when prescribed by a doctor.
  2. Follow the prescription exactly.
  3. Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
  4. Never give your antibiotics to another person; they may not be suitable for their condition.
  5. After completing a course of treatment, return any unused medicines to the pharmacy, to ensure they are properly disposed of.

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