Ciprofloxacin Eg: detailed information

Package leaflet: Information for the user

Ciprofloxacin EG 250 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. 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 other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Ciprofloxacin EG is and what it is used for
What you need to know before taking Ciprofloxacin EG
How to take Ciprofloxacin EG
Possible side effects
How to store Ciprofloxacin EG
Contents of the pack and other information

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

Ciprofloxacin EG contains the active substance ciprofloxacin. Ciprofloxacin EG is an antibiotic belonging to the family of fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections. It is effective only against certain strains of bacteria.

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

respiratory tract infections;
long-lasting or recurrent ear or paranasal sinus infections;
urinary tract infections;
genital infections in men and women;
gastrointestinal and intra-abdominal infections;
skin and soft tissue infections;
bone and joint infections;
prevention of infections caused by the bacterium Neisseria meningitidis;
after exposure to inhaled anthrax spores.

Ciprofloxacin may be used to manage patients with low white blood cell counts (neutropenia) who develop fever suspected to be due to a bacterial infection.
If you have a severe infection or an infection caused by more than one type of bacteria, your doctor may prescribe another antibiotic in addition to Ciprofloxacin EG.

Children and adolescents
Ciprofloxacin EG is used in children and adolescents, under specialist 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);
after exposure to inhaled anthrax spores.

Ciprofloxacin EG may also be used to treat other specific severe infections in children and adolescents, when considered necessary by the physician.

2. What you should know before taking Ciprofloxacin EG

Do not take Ciprofloxacin EG if:

you are allergic to the active substance, to other quinolones, or to any of the excipients of this medicine (listed in section 6);
you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin EG).

Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Ciprofloxacin EG,
if you have previously experienced any serious adverse reaction during treatment with a quinolone or
fluoroquinolone. In such a case, inform your doctor as soon as possible.
Inform your doctor before taking Ciprofloxacin EG if:

you have kidney problems, as your treatment may need to be adjusted;
you suffer from epilepsy or other neurological disorders;
you have had tendon problems during previous treatment with antibiotics such as Ciprofloxacin EG;
you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin;
you suffer from severe myasthenia (a type of muscle weakness), as symptoms may worsen;
you have been diagnosed with enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel);
you have previously experienced episodes of aortic dissection (a tear in the aortic wall);
you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
you have a family history of aortic aneurysm or aortic dissection, 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, Sjögren’s syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
You have heart problems. Special caution is required when using Ciprofloxacin EG if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), 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), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes on ECG (see section 2 “Other medicines and Ciprofloxacin EG”).
Inform your doctor if you or a family member are known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there are no signs of improvement after 3 days of treatment, consult your doctor.
While taking Ciprofloxacin EG
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin EG. Your doctor will decide whether treatment should be discontinued.

A severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility of a severe and sudden allergic reaction even after the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, dizziness upon standing. In such a case, stop treatment with Ciprofloxacin EG and contact your doctor immediately.
Serious, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin EG, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling, or may not resolve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness, or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell, and hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Ciprofloxacin EG, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will also consider using an antibiotic from another class.
Rarely, joint pain and swelling, and 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 being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping Ciprofloxacin EG. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin EG, contact your doctor, and rest the affected area. Avoid unnecessary movements, as the risk of tendon rupture may increase.
If you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).
If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience adverse effects on the central nervous system. In case of seizures, stop treatment with Ciprofloxacin EG and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such a case, stop treatment with Ciprofloxacin EG and inform your doctor immediately to prevent permanent nerve damage.
Psychiatric reactions may occur the first time you take Ciprofloxacin EG. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin EG. In rare cases, depression and psychosis may progress to suicidal thoughts, suicide attempts, or suicide. In such a case, contact your doctor immediately.
Quinolone antibiotics may cause an increase above your normal blood sugar levels (hyperglycaemia) or a decrease below your normal blood sugar levels, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
During treatment with antibiotics, including Ciprofloxacin EG, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking Ciprofloxacin EG and contact your doctor immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.
If your vision deteriorates or if your eyes are otherwise affected, consult an ophthalmologist immediately.
While taking Ciprofloxacin EG, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin EG if you are undergoing blood or urine tests.
If you have kidney problems, inform your doctor, as you may need a dosage adjustment.
Ciprofloxacin EG may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, stop taking Ciprofloxacin EG and contact your doctor immediately.
Ciprofloxacin EG may reduce the number of white blood cells, leading to reduced resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with signs of localized infection such as sore throat, mouth pain, or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.

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

Do not take Ciprofloxacin EG with tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciprofloxacin EG").
The following medicines interact with Ciprofloxacin EG in the body. Taking Ciprofloxacin EG together with these medicines may affect their therapeutic effect and increase the likelihood of 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, or 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);
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants);
other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics;
zolpidem (for sleep disorders).

Ciprofloxacin EG may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders);
caffeine;
duloxetine (for depression, diabetic neuropathy, or incontinence);
lidocaine (for heart problems or anaesthetic use);
sildenafil (e.g., for erectile dysfunction);
agomelatine (for depression).

Certain medicines reduce the effect of Ciprofloxacin EG. Inform your doctor if you are taking or intend to take:

antacids;
omeprazole;
mineral supplements;
sucralfate;
a polymer phosphate binder (e.g., sevelamer or lanthanum carbonate);
medicines or supplements containing calcium, magnesium, aluminium, or iron. If these preparations are essential, take Ciprofloxacin EG approximately two hours before or no sooner than four hours after taking them.

Ciprofloxacin EG with food and drink
Unless otherwise directed, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified beverages when taking the tablets, as they may interfere with the absorption of the active substance.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin EG during pregnancy.
Do not take Ciprofloxacin EG while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin EG may affect your level of alertness. As neurological adverse events may occur, assess your response to Ciprofloxacin EG before driving or operating machinery.
If in doubt, discuss with your doctor.
Ciprofloxacin EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially ‘sodium-free’.

3. How to take Ciprofloxacina EG

Your doctor will explain exactly how much Ciprofloxacina EG you should take, how often, and for how long. This will depend on the type and severity of your infection.
Inform your doctor if you have kidney problems, as your dosage may need to be adjusted.
The usual duration of treatment is 5 to 21 days, but it may last longer for severe infections. Always take this medicine exactly as instructed by your doctor. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacina EG.
a. Swallow the tablets with plenty of liquid. Do not chew the tablets as they have an unpleasant taste.
b. Try to take the tablets at approximately the same time each day.
c. You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take Ciprofloxacina EG tablets with dairy products such as milk or yoghurt, or with fruit juices fortified with minerals (e.g. orange juice fortified with calcium).
Remember to drink plenty of fluids during treatment with this medicine.

If you take more Ciprofloxacina EG than you should
If you take more than the prescribed dose, contact your doctor immediately. If possible, bring the tablets or the pack with you to show the doctor.

If you forget to take Ciprofloxacina EG
Take the missed dose as soon as possible and then continue as prescribed. However, if it is almost time for the next dose, do not take the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten dose. Make sure you complete the full course of treatment.

If you stop taking Ciprofloxacina EG
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, the infection may not be completely cured, and symptoms may return or worsen. You may also develop resistance to the antibiotic.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following section lists the most serious side effects that you may notice on your own:
Stop taking Ciprofloxacin EG and contact your doctor immediately so they can consider alternative antibiotic treatment if you experience 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, feeling unwell or fainting, or dizziness when standing (anaphylactic reaction/anaphylactic shock) (see section 2: Warnings and precautions);
muscle weakness, tendon inflammation which may lead to tendon rupture – especially in the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions);
a life-threatening skin rash, usually presenting as blisters or ulcers in the mouth, throat, nose, eyes and other mucous membranes such as the genital area, which may progress to widespread blistering or peeling of the skin (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).

Not known (frequency cannot be estimated from the available data)

unusual sensation of pain, burning, tingling, numbness or muscle weakness in the extremities (neuropathy) (see section 2: Warnings and precautions);
a reaction causing skin rash, fever, internal organ inflammation, blood abnormalities and systemic symptoms (DRESS: Drug Reaction with Eosinophilia and Systemic Symptoms; AGEP: Acute Generalized Exanthematous Pustulosis).

Other side effects observed during treatment with Ciprofloxacin EG are listed below by frequency:

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

nausea, diarrhoea;
joint pain and joint inflammation in children.

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

joint pain in adults;
fungal superinfections;
high concentration of eosinophils, a type of white blood cells;
decreased appetite;
hyperactivity, restlessness;
headache, dizziness, sleep disturbances, taste disturbances;
vomiting, abdominal pain, digestive problems (such as stomach discomfort, indigestion/heartburn) or intestinal gas;
increase in certain substances in the blood (transaminases and/or bilirubin);
skin rash, itching, urticaria;
reduced kidney function;
muscle and bone pain, malaise (asthenia) or fever;
increased alkaline phosphatase in the blood (a substance present 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 (in very rare cases may be fatal) (see section 2: Warnings and precautions);
changes in the number of blood cells (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood coagulation factor (platelets);
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions);
increased blood sugar (hyperglycaemia);
decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions);
confusion, disorientation, anxious reaction, unusual dreams, depression (which in rare cases may progress to suicidal thoughts or suicide attempts) (see section 2: Warnings and precautions), or hallucinations;
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, dizziness;
visual disturbances including double vision (see section 2: Warnings and precautions);
tinnitus, hearing loss, decreased hearing;
rapid heartbeat (tachycardia);
dilation of blood vessels (vasodilation), low blood pressure, fainting;
shortness of breath, including asthma-like symptoms;
liver disorders, jaundice (cholestatic jaundice), 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 amylase enzyme.

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

a specific type of decrease in red blood cells (haemolytic anaemia); a dangerous decrease in a type of white blood cells (agranulocytosis) (see section 2: Warnings and precautions); a decrease in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow suppression, which may also be fatal;
allergic reaction – known as serum sickness-like reaction (see section 2: Warnings and precautions);
psychiatric disorders (psychotic reactions which in rare cases may progress to suicidal thoughts or suicide attempts or suicide) (see section 2: Warnings and precautions);
migraine, coordination problems, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), pressure in the brain (intracranial hypertension including pseudotumour cerebri);
colour vision disturbances;
inflammation of blood vessel walls (vasculitis);
pancreatitis;
liver cell death (hepatic necrosis), which very rarely may lead to life-threatening liver failure (see section 2: Warnings and precautions);
pinpoint skin bleeding (petechiae); various types of skin rashes or eruptions;
worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions).

Not known (frequency cannot be estimated from the available data)

syndrome associated with impaired water excretion and low sodium levels (SIADH);
feeling of intense excitement (mania) or feeling of extreme optimism and hyperactivity (hypomania);
abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as “prolongation of the QT interval”, seen on ECG, electrical activity of the heart);
effect on blood clotting (in patients treated with vitamin K antagonists);
loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin EG

Keep this medicine out of the sight and reach of children.
Do not use Ciprofloxacin EG after the expiry date stated on the blister or carton after "Exp.". The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacina EG contains
The active substance is ciprofloxacin hydrochloride.
Each film-coated tablet contains 296.95 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 250 mg of ciprofloxacin.
The other components are: croscarmellose sodium, microcrystalline cellulose, anhydrous colloidal silica, maize starch, sodium lauryl sulfate, magnesium stearate, talc, hypromellose/macrogol 400/titanium dioxide (Opadry Y-1-7000).

Description of the appearance of Ciprofloxacina EG and pack sizes
Film-coated tablets for oral use, pack size: 10 tablets

Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milano, Italy

Manufacturer
Laboratorios Cinfa, S.A., Olaz-Chipi, 10 - Polígono Industrial Areta, 31620 Huarte (Spain)

This instruction leaflet was last updated on

Advice/health education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, you need them specifically for your current illness.
Despite antibiotic treatment, certain bacteria may survive or multiply. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Inappropriate use of antibiotics increases resistance. You may even promote the development of bacterial resistance and delay recovery or reduce antibiotic effectiveness if you do not adhere to:

dosage
frequency of administration
duration of treatment

Therefore, to preserve the effectiveness of this medicine:

Use antibiotics only when prescribed.
Follow your doctor's instructions exactly.
Do not reuse an antibiotic without a medical prescription, even if you are trying to treat a similar illness.
Never give your antibiotics to someone else; they may not be suitable for their condition.
At the end of treatment, return all unused medicines to a pharmacy so they can be properly disposed of.

Package leaflet: Information for the user

Ciprofloxacin EG 500 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Ciprofloxacin EG is and what it is used for
What you need to know before taking Ciprofloxacin EG
How to take Ciprofloxacin EG
Possible side effects
How to store Ciprofloxacin EG
Contents of the pack and other information

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

Ciprofloxacin EG contains the active substance ciprofloxacin. Ciprofloxacin EG is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause infections. It is effective only against certain strains of bacteria.

Adults
Ciprofloxacin EG 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 infections in men and women;
gastrointestinal and intra-abdominal infections;
skin and soft tissue infections;
bone and joint infections;
prevention of infections caused by the bacterium Neisseria meningitidis;
exposure to inhaled anthrax spores.

Ciprofloxacin may be used to manage patients with low white blood cell counts (neutropenia) who develop fever suspected to be due to bacterial infection.
If you have a severe infection or an infection caused by more than one type of bacteria, your doctor may prescribe another antibiotic in addition to Ciprofloxacin EG.

Children and adolescents
Ciprofloxacin EG is used in children and adolescents, under specialist 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);
exposure to inhaled anthrax spores.

Ciprofloxacin EG may also be used to treat other specific severe infections in children and adolescents, when considered necessary by the doctor.

2. What you need to know before taking Ciprofloxacin EG

Do not take Ciprofloxacin EG if:

you are allergic to the active substance, to other quinolones, or to any of the excipients of this medicine (listed in section 6);
you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin EG).

Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Ciprofloxacin EG,
if you have previously experienced any serious adverse reaction during treatment with a quinolone or
fluoroquinolone. In such a case, inform your doctor as soon as possible.
Tell your doctor before taking Ciprofloxacin EG if:

you have kidney problems, as your treatment may need to be adjusted;
you suffer from epilepsy or other neurological disorders;
you have had tendon problems during a previous treatment with antibiotics such as Ciprofloxacin EG;
you have diabetes, because there may be a risk of hypoglycaemia when using ciprofloxacin;
you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen;
you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel);
you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta);
you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
you have a family history of aortic aneurysm or aortic dissection, 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, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
You have heart problems. Special caution is required when using Ciprofloxacin EG if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), have an electrolyte imbalance 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), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes on the ECG (see section 2 “Other medicines and Ciprofloxacin EG”).
Inform your doctor if you or a family member is known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in
addition to ciprofloxacin. If there are no symptoms of improvement after 3 days of treatment, consult
your doctor.
While taking Ciprofloxacin EG
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin EG.
Your doctor will decide whether treatment with Ciprofloxacin EG should be discontinued.

A severe and sudden allergic reaction (an anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility that a severe and sudden allergic reaction may occur even with the first dose, with the following symptoms: chest tightness, dizziness, nausea or fainting, lightheadedness upon standing. In such a case, stop treatment with Ciprofloxacin EG and contact your doctor immediately.
Serious, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin EG, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling, or may not resolve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness, or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Ciprofloxacin EG, seek medical advice immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), if you have received an organ transplant, if you have kidney problems, or if you are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with Ciprofloxacin EG. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Ciprofloxacin EG, consult your doctor, and rest the affected area. Avoid unnecessary movements, as the risk of tendon rupture may increase.
If you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a rapid onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).
If you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke, you may experience adverse effects on the central nervous system. In case of seizures, stop treatment with Ciprofloxacin EG and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such a case, stop treatment with Ciprofloxacin EG and inform your doctor immediately to prevent permanent nerve damage.
Psychiatric reactions may occur the first time you take Ciprofloxacin EG. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin EG. In rare cases, depression and psychosis may progress to suicidal thoughts, suicide attempts, or suicide. In such a case, contact your doctor immediately.
Quinolone antibiotics can cause blood sugar levels to rise above normal (hyperglycaemia) or fall below normal, which in severe cases could potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, blood sugar levels must be closely monitored.
Diarrhoea may develop during treatment with antibiotics, including Ciprofloxacin EG, or even several weeks afterwards. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking Ciprofloxacin EG and contact your doctor immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.
If your vision deteriorates or your eyes are otherwise affected, consult an ophthalmologist immediately.
During treatment with Ciprofloxacin EG, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as from sunbeds.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin EG if you need to have blood or urine tests.
If you have kidney problems, inform your doctor, as you may need a dosage adjustment.
Ciprofloxacin EG may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, stop taking Ciprofloxacin EG and contact your doctor immediately.
Ciprofloxacin EG may cause a reduction in the number of white blood cells, which may result in reduced resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with symptoms of localized infection such as sore throat, mouth or throat pain, or urinary problems, consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about the medicine.

Other medicines and Ciprofloxacin EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Ciprofloxacin EG together with tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciprofloxacin EG").
The following medicines interact with Ciprofloxacin EG in the body. Taking Ciprofloxacin EG together with these medicines may affect their therapeutic effect and increase the likelihood of side effects.
Inform your doctor if you are taking:

vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or phenindione) or other oral anticoagulants (to thin the blood);
probenecid (for gout);
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis);
theophylline (for respiratory problems);
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);
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants);
other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobials (belonging to the macrolide group), certain antipsychotics;
zolpidem (for sleep disorders).

Ciprofloxacin EG may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders);
caffeine;
duloxetine (for depression, diabetic neuropathy, or incontinence);
lidocaine (for heart problems or anaesthetic use);
sildenafil (e.g., for erectile dysfunction);
agomelatine (for depression).

Certain medicines reduce the effect of Ciprofloxacin EG. 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 Ciprofloxacin EG approximately two hours before or no less than four hours after taking them.

Ciprofloxacin EG with food and drink
Unless you are taking Ciprofloxacin EG with meals, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified drinks when taking the tablets, as they may interfere with the absorption of the active substance.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin EG during pregnancy.
Do not take Ciprofloxacin EG while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin EG may affect your level of alertness. Since neurological adverse events may occur, check your response to Ciprofloxacin EG before driving a vehicle or operating machinery.
If in doubt, discuss this with your doctor.
Ciprofloxacin EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially 'sodium-free'.

3. How to take Ciprofloxacin EG

Your doctor will explain exactly how much Ciprofloxacin EG you should take, how often, and for how long. This will depend on the type and severity of the infection you have.
Inform your doctor if you have kidney problems, as your dosage may need to be adjusted.
The usual duration of treatment is between 5 and 21 days, but it may last longer for severe infections. Always take this medicine exactly as instructed by your doctor. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacin EG.
d. Swallow the tablets with plenty of fluid. Do not chew the tablets, as they have an unpleasant taste.
e. Try to take the tablets at approximately the same time each day.
f. You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take Ciprofloxacin EG tablets with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (e.g. orange juice fortified with calcium).
Remember to drink plenty of fluids during treatment with this medicine.
If you take more Ciprofloxacin EG than you should
If you take more than the prescribed dose, contact your doctor immediately. If possible, take the tablets or the packaging with you to show the doctor.
If you forget to take Ciprofloxacin EG
Take the missed dose as soon as possible and then continue as prescribed. However, if it is almost time for the next dose, do not take the missed dose and continue your treatment as usual. Do not take a double dose to make up for a forgotten dose. Make sure you complete the full course of treatment.
If you stop taking Ciprofloxacin EG
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, the infection may not be completely cured, and symptoms may return or worsen. You may also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following section lists the most serious side effects you may notice on your own:
Stop taking Ciprofloxacin EG and contact your doctor immediately, who will consider an alternative antibiotic treatment, if you experience 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, feeling unwell or fainting, or dizziness upon standing (anaphylactic reaction/anaphylactic shock) (see section 2: Warnings and precautions);
muscle weakness, tendon inflammation which may lead to tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions);
a life-threatening skin rash, usually presenting as blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes such as the genital area, which may progress to widespread blistering or skin peeling (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).

Not known (frequency cannot be estimated from the available data)

unusual sensation of pain, burning, tingling, numbness, or muscle weakness in the extremities (neuropathy) (see section 2: Warnings and precautions);
a reaction causing skin rash, fever, internal organ inflammation, blood abnormalities, and systemic symptoms (DRESS: Drug Reaction with Eosinophilia and Systemic Symptoms; AGEP: Acute Generalized Exanthematous Pustulosis).

Other side effects observed during treatment with Ciprofloxacin EG are listed below according to their frequency:

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

nausea, diarrhoea;
joint pain and joint inflammation in children.

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

joint pain in adults;
fungal superinfections;
high concentration of eosinophils, a type of white blood cells;
decreased appetite;
hyperactivity, restlessness;
headache, dizziness, sleep disturbances, taste disturbances;
vomiting, abdominal pain, digestive problems (such as stomach discomfort, indigestion/heartburn), or intestinal gas;
increase in certain substances in the blood (transaminases and/or bilirubin);
skin rash, itching, urticaria;
reduced kidney function;
muscle and bone pain, malaise (asthenia), or fever;
increased alkaline phosphatase in the blood (a certain substance present 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 (in very rare cases may be fatal) (see section 2: Warnings and precautions);
changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increase or decrease in a blood coagulation factor (platelets);
allergic reaction, swelling (oedema), sudden swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions);
increased blood sugar (hyperglycaemia);
decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions);
confusion, disorientation, anxious reaction, unusual dreams, depression (which in rare cases may progress to suicidal thoughts or suicide attempts) (see section 2: Warnings and precautions), or hallucinations;
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, dizziness;
visual disturbances including double vision (see section 2: Warnings and precautions);
tinnitus, hearing loss, decreased hearing;
rapid heartbeat (tachycardia);
dilation of blood vessels (vasodilation), low blood pressure, fainting;
shortness of breath, including asthma-like symptoms;
liver disorders, jaundice (cholestatic jaundice), hepatitis;
sensitivity to light (see section 2: Warnings and precautions);
kidney failure, blood or crystals in the 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 decrease in red blood cells (haemolytic anaemia); a dangerous decrease in a type of white blood cells (agranulocytosis) (see section 2: Warnings and precautions); a decrease in red blood cells, white blood cells, and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal;
allergic reaction – known as serum sickness-like reaction (see section 2: Warnings and precautions);
mental disorders (psychotic reactions which in rare cases may progress to suicidal thoughts, suicide attempts, or suicide) (see section 2: Warnings and precautions);
migraine, coordination problems, unsteady gait (gait disturbances), smell disorders (olfactory disturbances), pressure in the brain (increased intracranial pressure including pseudotumour cerebri);
colour vision disturbances;
inflammation of blood vessel walls (vasculitis);
pancreatitis;
liver cell death (hepatic necrosis), which very rarely may lead to life-threatening liver failure (see section 2: Warnings and precautions);
pinpoint skin haemorrhages (petechiae); various types of skin rashes or eruptions;
worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions).

Not known (frequency cannot be estimated from the available data)

syndrome associated with impaired water excretion and low sodium levels (SIADH);
feeling of intense excitement (mania) or feeling of extreme optimism and hyperactivity (hypomania);
abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as “QT interval prolongation”, visible on ECG, electrical activity of the heart);
effects on blood clotting (in patients treated with vitamin K antagonists);
loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal ideation), and changes in hearing, vision, taste, and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin EG

Keep this medicine out of the sight and reach of children.
Do not use Ciprofloxacin EG after the expiry date which is stated on the blister or carton after "Exp.".
The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacin EG contains
The active substance is ciprofloxacin hydrochloride.
Each film-coated tablet contains 593.90 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 500 mg
of ciprofloxacin.
The other components are: croscarmellose sodium, microcrystalline cellulose, anhydrous colloidal silica, maize
starch, sodium lauryl sulfate, magnesium stearate, talc, hypromellose/macrogol 400/titanium dioxide (Opadry Y-1-
7000).
Description of the appearance of Ciprofloxacin EG and package contents
Film-coated tablets for oral use, pack containing 6 tablets.
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milan, Italy
Manufacturer
Laboratorios Cinfa, S.A., Olaz-Chipi, 10 - Polígono Industrial Areta, 31620 Huarte (Spain)
Health advice/education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed you antibiotics, it is because you specifically need them for your current illness.
Despite antibiotic treatment, certain bacteria may survive or multiply. This phenomenon is known as
resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You may even promote the development of bacterial resistance and delay recovery or reduce antibiotic effectiveness if you do not adhere to:

dosage
frequency of administration
duration of treatment

Therefore, to preserve the effectiveness of this medicine:

Use antibiotics only when prescribed by a doctor.
Strictly follow the doctor's instructions.
Do not reuse an antibiotic without a medical prescription, even if you are treating a similar illness.
Never give your antibiotic to another person; it may not be suitable for their condition.
At the end of treatment, return all unused medicines to a pharmacy for proper disposal.

Package leaflet: Information for the user

Ciprofloxacin EG 750 mg film-coated tablets

Equivalent medicinal product
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. 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 their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:

What Ciprofloxacin EG is and what it is used for
What you need to know before taking Ciprofloxacin EG
How to take Ciprofloxacin EG
Possible side effects
How to store Ciprofloxacin EG
Package contents and other information

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

Adults
Ciprofloxacin EG 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 infections in men and women;
gastrointestinal and intra-abdominal infections;
skin and soft tissue infections;
bone and joint infections;
prevention of infections caused by the bacterium Neisseria meningitidis;
exposure to inhalation of anthrax spores.

Ciprofloxacin may be used to manage patients with a low number of white blood cells (neutropenia) who have fever suspected to be due to a bacterial infection.
If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe another antibiotic in addition to Ciprofloxacin EG.

Children and adolescents
Ciprofloxacin EG is used in children and adolescents, under specialist 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);
exposure to inhalation of anthrax spores.

Ciprofloxacin EG may also be used to treat other specific severe infections in children and adolescents, when considered necessary by the doctor.

2. What you need to know before taking Ciprofloxacin EG

Do not take Ciprofloxacin EG if:

you are allergic to the active substance, to other quinolones, or to any of the excipients of this medicine (listed in section 6);
you are taking tizanidine (see section 2: Other medicines and Ciprofloxacin EG).

you have kidney problems, as your treatment may need to be adjusted;
you suffer from epilepsy or other neurological disorders;
you have had tendon problems during a previous treatment with antibiotics such as Ciprofloxacin EG;
you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin;
you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen;
you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel);
you have previously experienced episodes of aortic dissection (a tear in the aortic wall);
you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
you have a family history of aortic aneurysm or aortic dissection, 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, Sjögren’s syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet’s disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
You have heart problems. Special caution is required when using Ciprofloxacin EG if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), have an electrolyte imbalance 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), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes on the ECG (see section 2 “Other medicines and Ciprofloxacin EG”).
Inform your doctor if you or a family member is known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to
ciprofloxacin. If there are no symptoms of improvement after 3 days of treatment, consult your doctor.
While taking Ciprofloxacin EG
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin EG. Your doctor will decide whether treatment with Ciprofloxacin EG should be discontinued.

A severe and sudden allergic reaction (an anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility that a severe and sudden allergic reaction may occur even after the first dose, with the following symptoms: chest tightness, dizziness, nausea or fainting, dizziness upon standing. In such a case, stop treatment with Ciprofloxacin EG and contact your doctor immediately.
Serious, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin EG, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling, or may not resolve. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, tickling, numbness, or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Ciprofloxacin EG, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with Ciprofloxacin EG. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Ciprofloxacin EG, consult your doctor, and rest the affected area. Avoid unnecessary movement, as the risk of tendon rupture may increase.
If you experience sudden and severe abdominal, chest, or back pain, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (a sensation of rapid or irregular heartbeat).
If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience adverse effects affecting the central nervous system. In case of seizures, stop treatment with Ciprofloxacin EG and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such a case, stop treatment with Ciprofloxacin EG and inform your doctor immediately to prevent permanent nerve damage.
Psychiatric reactions may occur the first time you take Ciprofloxacin EG. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin EG. In rare cases, depression and psychosis may progress to suicidal thoughts, suicide attempts, or suicide. In such a case, contact your doctor immediately.
Quinolone antibiotics may cause blood sugar levels to rise above normal (hyperglycaemia) or fall below normal, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
During treatment with antibiotics, including Ciprofloxacin EG, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, you must stop taking Ciprofloxacin EG and contact your doctor immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.
If your vision deteriorates or your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
While taking Ciprofloxacin EG, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as tanning beds.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin EG if you need to have blood or urine tests.
If you suffer from kidney problems, inform your doctor, as you may need a dosage adjustment.
Ciprofloxacin EG may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, stop taking Ciprofloxacin EG and contact your doctor immediately.
Ciprofloxacin EG may cause a reduction in the number of white blood cells, which may result in decreased resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with symptoms of localized infection such as sore throat, throat or mouth pain, or urinary problems, you must consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.

Other medicines and Ciprofloxacin EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Ciprofloxacin EG with tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciprofloxacin EG").
The following medicines interact with Ciprofloxacin EG in the body. Taking Ciprofloxacin EG together with these medicines may affect their therapeutic effect and increase the likelihood of 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, or 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);
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants);
other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics;
zolpidem (for sleep disorders).

Ciprofloxacin EG may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders);
caffeine;
duloxetine (for depression, diabetic neuropathy, or incontinence);
lidocaine (for heart problems or anaesthetic use);
sildenafil (e.g., for erectile dysfunction);
agomelatine (for depression).

Certain medicines reduce the effect of Ciprofloxacin EG. Inform your doctor if you are taking or intend to take:

antacids;
omeprazole;
mineral supplements;
sucralfate;
a polymer phosphate binder (e.g., sevelamer or lanthanum carbonate);
medicines or supplements containing calcium, magnesium, aluminium, or iron. If these preparations are essential, take Ciprofloxacin EG approximately two hours before or no sooner than four hours after taking them.

Ciprofloxacin EG with food and drinks
Unless you are taking Ciprofloxacin EG with meals, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified drinks when taking the tablets, as they may interfere with the absorption of the active substance.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant, or if you are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin EG during pregnancy.
Do not take Ciprofloxacin EG while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin EG may affect your level of alertness. Since neurological adverse events may occur, check how you react to Ciprofloxacin EG before driving a vehicle or operating machinery.
If in doubt, discuss this with your doctor.
Ciprofloxacin EG contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is essentially ‘sodium-free’.

3. How to take Ciprofloxacin EG

Your doctor will explain exactly how much Ciprofloxacin EG you should take, how often, and for how long. This will depend on the type and severity of the infection you have.
Inform your doctor if you have kidney problems, as a dose adjustment may be necessary.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Always take this medicine exactly as your doctor has instructed. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacin EG.
g. Swallow the tablets with plenty of fluid. Do not chew the tablets, as they have an unpleasant taste.
h. Try to take the tablets at approximately the same time each day.
i. You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take Ciprofloxacin EG tablets with dairy products such as milk or yoghurt, or with fruit juices fortified with minerals (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with this medicine.
If you take more Ciprofloxacin EG than you should
If you take more than the prescribed dose, contact your doctor immediately. If possible, bring the tablets or the pack to show your doctor.
If you forget to take Ciprofloxacin EG
Take the missed dose as soon as possible and then continue as prescribed. However, if it is almost time for your next dose, do not take the missed dose and continue your treatment as usual. Do not take a double dose to make up for a forgotten dose. Make sure you complete the full course of treatment.
If you stop taking Ciprofloxacin EG
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, the infection may not be completely cured and symptoms may return or worsen. You may also develop resistance to the antibiotic.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following section lists the most serious side effects that you may notice yourself:
Stop taking Ciprofloxacin EG and contact your doctor immediately if you experience any of the following serious side effects. Your doctor will evaluate whether an alternative antibiotic treatment is needed:

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, feeling unwell or fainting, or dizziness when standing (anaphylactic reaction/anaphylactic shock) (see section 2: Warnings and precautions);
muscle weakness, tendon inflammation which may lead to tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions);
a life-threatening skin rash, usually 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).

Not known (frequency cannot be estimated from the available data)

unusual sensation of pain, burning, tingling, numbness or muscle weakness in the extremities (neuropathy) (see section 2: Warnings and precautions);
a reaction causing skin rashes, fever, internal organ inflammation, blood abnormalities and systemic symptoms (DRESS: Drug Reaction with Eosinophilia and Systemic Symptoms; AGEP: Acute Generalized Exanthematous Pustulosis).

Other side effects observed during treatment with Ciprofloxacin EG are listed below by frequency:
Common (may affect up to 1 in 10 people):

nausea, diarrhoea;
joint pain and joint inflammation in children.

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

joint pain in adults;
fungal superinfections;
high concentration of eosinophils, a type of white blood cells;
decreased appetite;
hyperactivity, restlessness;
headache, dizziness, sleep disturbances, taste disturbances;
vomiting, abdominal pain, digestive problems (such as stomach discomfort, indigestion/heartburn) or intestinal gas;
increase in certain substances in the blood (transaminases and/or bilirubin);
skin rash, itching, hives;
reduced kidney function;
muscle and bone pain, malaise (asthenia) or fever;
increased alkaline phosphatase in the blood (a substance present 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 bowel (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2: Warnings and precautions);
changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood clotting factor (platelets);
allergic reaction, swelling (oedema), sudden swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions);
increased blood sugar (hyperglycaemia);
decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions);
confusion, disorientation, anxious reaction, unusual dreams, depression (which in rare cases may progress to suicidal thoughts or suicide attempts) (see section 2: Warnings and precautions), or hallucinations;
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, dizziness;
visual disturbances including double vision (see section 2: Warnings and precautions);
tinnitus, hearing loss, decreased hearing;
rapid heartbeat (tachycardia);
dilation of blood vessels (vasodilation), low blood pressure, fainting;
shortness of breath, including asthma-like symptoms;
liver disorders, jaundice (cholestatic jaundice), 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 amylase enzyme.

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

a specific type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis) (see section 2: Warnings and precautions); a reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal;
allergic reaction – known as serum sickness-like reaction (see section 2: Warnings and precautions);
psychiatric disorders (psychotic reactions which in rare cases may progress to suicidal thoughts or suicide attempts or suicide) (see section 2: Warnings and precautions);
migraine, coordination problems, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), pressure in the brain (intracranial hypertension including pseudotumor cerebri);
colour vision disturbances;
inflammation of blood vessel walls (vasculitis);
pancreatitis;
liver cell death (hepatic necrosis), which very rarely may lead to life-threatening liver failure (see section 2: Warnings and precautions);
pinpoint bleeding under the skin (petechiae); various types of skin rashes or rash;
worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions).

Not known (frequency cannot be estimated from the available data)

syndrome associated with impaired water elimination and low sodium levels (SIADH);
feeling of intense excitement (mania) or feeling of extreme optimism and hyperactivity (hypomania);
abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as “QT interval prolongation”, seen on ECG, electrical activity of the heart);
effects on blood clotting (in patients treated with vitamin K antagonists);
loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of adverse drug reactions that are prolonged (lasting for months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal ideation) and changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible ruptures that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin EG

Keep this medicine out of the sight and reach of children.
Do not use Ciprofloxacin EG after the expiry date stated on the blister or carton after "Exp.".
The expiry date refers to the last day of that month.
Store this medicine at a temperature not exceeding 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacina EG contains
The active substance is ciprofloxacin hydrochloride.
Each film-coated tablet contains 890.85 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 750 mg
of ciprofloxacin.
The other components are: croscarmellose sodium, microcrystalline cellulose, anhydrous colloidal silica, maize
starch, sodium lauryl sulfate, magnesium stearate, talc, hypromellose/macrogol 400/titanium dioxide (Opadry Y-1-
7000).
Description of the appearance of Ciprofloxacina EG and pack sizes
Film-coated tablets for oral use, pack size: 12 tablets
Marketing Authorization Holder
EG S.p.A. - Via Pavia, 6 - 20136 Milano
Manufacturer
Laboratorios Cinfa, S.A., Olaz-Chipi, 10 - Polígono Industrial Areta, 31620 Huarte (Spain)
Health advice/education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed you antibiotics, it is because they are specifically needed for your current condition.
Despite antibiotic treatment, certain bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You could even promote the development of bacterial resistance and delay recovery or reduce the effectiveness of antibiotics if you do not adhere to:

dosage
frequency of administration
duration of treatment

Therefore, to preserve the effectiveness of this medicine:

Use antibiotics only when prescribed.
Strictly follow your doctor's instructions.
Do not reuse an antibiotic without a medical prescription, even if you are trying to treat a similar illness.
Never give your antibiotics to another person; they may not be suitable for their condition.
At the end of treatment, return all unused medicines to a pharmacy to ensure they are properly disposed of.