Patient Information Leaflet

Eoxin 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets

Ciprofloxacin
Generic medicine
Please read all of 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Eoxin is and what it is used for

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

Adults
Eoxin 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
to treat infections in patients with very low white blood cell count (neutropenia)
to prevent infections in patients with very low white blood cell count (neutropenia)
to prevent infections caused by the bacterium Neisseria meningitidis
exposure to inhalation of anthrax spores

If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe another antibiotic treatment in addition to Eoxin.

Children and adolescents
Eoxin 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

Eoxin 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 Eoxin

Do not take Eoxin:

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 “Other medicines and Eoxin”)

Warnings and precautions
Talk to your doctor before taking Eoxin
Before taking Eoxin
You must not take antibacterial medicines belonging to the quinolone/fluoroquinolone class, including Eoxin, 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 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 Eoxin
you suffer from severe myasthenia (a type of muscle weakness)
you have heart problems. Particular caution is required when using Eoxin 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 an elderly patient, or if you are taking other

medicines that may cause abnormal changes on the ECG (see section “Other
medicines and Eoxin”)

if you have been diagnosed with enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta)
if you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation)
if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., 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, Behçet’s disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).

If you experience sudden pain in the abdomen, chest, or back, go immediately
to the emergency room.
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 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 Eoxin
Rarely, joint pain and swelling, tendon inflammation or tendon rupture may occur. The risk is higher if you are elderly (over 60 years of age), 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 Eoxin. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Eoxin, consult your doctor, and rest the affected area. Avoid any unnecessary physical activity. The risk of tendon rupture may otherwise increase.
Inform your doctor immediately if any of the following conditions occur during treatment with Eoxin. Your doctor will decide whether treatment with Eoxin should be discontinued.

A severe and sudden allergic reaction (an 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 cases, stop treatment with Eoxin and contact your doctor immediately.
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 such cases, stop treatment with Eoxin and contact your doctor immediately.
Psychiatric reactions may occur the first time you take Eoxin. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Eoxin. In rare cases, depression and psychosis may progress to suicidal thoughts, suicide attempts, or suicide. In such cases, stop treatment with Eoxin and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness may occur, particularly in the feet and legs or hands and arms. In such cases, stop treatment with Eoxin and inform your doctor immediately to avoid permanent nerve damage.
If you experience sudden and severe pain in the abdomen, chest, or back, which may be a sign of aneurysm or aortic dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroids.
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).
Quinolone antibiotics may cause blood sugar levels to rise above normal (hyperglycaemia) or fall below normal 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, blood sugar levels must be closely monitored.
During treatment with antibiotics, including Eoxin, 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 Eoxin immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal motility.
Inform your doctor or laboratory staff that you are taking Eoxin if you need to have blood or urine tests.
Eoxin 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 Eoxin and contact your doctor immediately.
Eoxin may cause a reduction in the number of white blood cells, which may lead to 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, 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.
Serious, prolonged, disabling, and potentially irreversible adverse effects Fluoroquinolone/quinolone antibacterial medicines, including Eoxin, have been associated with very rare but serious adverse effects, some of which are prolonged (lasting months or years), disabling, or may not improve. 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 disorders such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these adverse effects after taking Eoxin, consult 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.

If your vision deteriorates or your eyes are otherwise affected, consult an ophthalmologist immediately.

While taking EOXIN, the skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as tanning beds.

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

vitamin K antagonists (e.g., warfarin) 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.

Eoxin may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
glibenclamide (for diabetes)
duloxetine (for depression)
lidocaine (a local anaesthetic)
sildenafil (for impotence)
agomelatine
zolpidem

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

antacids
omeprazole (to reduce stomach acid production)
mineral supplements
sucralfate (for gastric or duodenal ulcers)
a polymeric phosphate binder (e.g., sevelamer)
medicines or supplements containing calcium, magnesium, aluminium, or iron If these preparations are essential, take Eoxin approximately two hours before or no sooner than four hours after taking them.

Eoxin with food and drinks
Unless you are taking Eoxin with meals, do not eat or drink dairy products (such as milk or yoghurt) or drinks fortified with calcium when taking the tablets, as they may interfere with the absorption of the active substance.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Avoid using Eoxin during pregnancy. Inform your doctor if you are planning a pregnancy.
Do not take Eoxin while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Eoxin may affect your level of alertness. Since neurological adverse events may occur, check your response to Eoxin before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take Eoxin

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much Eoxin 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.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.
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 taken during meals does not significantly affect absorption. However, do not take Eoxin tablets with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with Eoxin.

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

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

If you stop taking Eoxin
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 antibiotic resistance.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
If any of the adverse effects worsen, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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

nausea, diarrhoea
joint pain in children

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

fungal superinfections
high concentration of eosinophils, a type of white blood cells
loss of appetite (anorexia)
hyperactivity, agitation
headache, dizziness, sleep disturbances, taste disturbances
vomiting, abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn), flatulence
increased levels of certain substances in the blood (transaminases and/or bilirubin)
skin rash, itching, urticaria
joint pain in adults
reduced kidney function
muscle and bone pain, malaise (asthenia), fever
increased alkaline phosphatase in the blood (a certain substance present in the blood)

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

inflammation of the bowel (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section “Warnings and precautions”)
changes in blood cell counts (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)
increased blood sugar (hyperglycaemia)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially lead to suicidal ideation/thoughts or suicide attempts or suicide) (see section “Warnings and precautions”), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor, seizures (see section “Warnings and precautions”), dizziness
visual disturbances, including double vision
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 “Warnings and precautions”)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in urine (see section “Warnings and precautions”), inflammation of the urinary tract
fluid retention, excessive sweating
abnormal levels of a coagulation factor (prothrombin), increased levels of amylase enzyme

Very rare adverse effects (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); reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal (see section “Warnings and precautions”)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section “Warnings and precautions”)
psychiatric disorders (psychotic reactions, which may potentially lead to suicidal ideation/thoughts or suicide attempts or completed suicide) (see section “Warnings and precautions”)
migraine, coordination disorders, unsteady gait (gait disturbances), smell disturbances (olfactory disturbances), pressure in the brain (intracranial hypertension)
colour vision disturbances
inflammation of blood vessel walls (vasculitis)
pancreatitis
death of liver cells (hepatic necrosis), which very rarely may lead to life-threatening liver failure
pinpoint bleeding under the skin (petechiae); various types of skin rashes (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section “Warnings and precautions”); worsening of symptoms of myasthenia gravis (see section “Warnings and precautions”)

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

disorders related to the nervous system, such as pain, burning, tingling, numbness and/or weakness of the extremities
abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as “prolongation of the QT interval”, visible on ECG, electrical activity of the heart)
pustular skin rashes
effect on blood clotting (increase in INR) (in patients treated with vitamin K antagonists)
feeling of intense excitement (mania) or feeling of extreme optimism and hyperactivity (hypomania)
hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
syndrome associated with impaired water excretion and low sodium levels (SIADH)
loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Cases of dilation and weakening of the aortic wall 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.
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, tickling, 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), 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.

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

5. How to store Eoxin

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 packaging after "exp." The
expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
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 Eoxin contains
The active substance is ciprofloxacin hydrochloride.
Eoxin 250 mg film-coated tablets
Each film-coated tablet contains 291 mg of ciprofloxacin hydrochloride, equivalent to 250 mg of
ciprofloxacin.
Eoxin 500 mg film-coated tablets
Each film-coated tablet contains 582 mg of ciprofloxacin hydrochloride, equivalent to 500 mg of
ciprofloxacin.
Eoxin 750 mg film-coated tablets
Each film-coated tablet contains 873 mg of ciprofloxacin hydrochloride, equivalent to 750 mg of
ciprofloxacin.
The other components are:
microcrystalline cellulose (E460), sodium starch glycolate (type A), crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), macrogol 4000.
Description of the appearance of Eoxin and contents of the pack
Film-coated tablets

pack of 10 tablets of 250 mg
pack of 6 tablets of 500 mg
pack of 12 tablets of 750 mg

Marketing Authorization Holder
LABORATORIO FARMACEUTICO C.T. S.r.l. – Via Dante Alighieri, 71 – Sanremo (IM)
Manufacturer
LABORATORIO FARMACOLOGICO MILANESE S.r.l. – Via Monterosso, 273 – Caronno Pertusella (VA)
Advice/health 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 called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You may even promote the development of bacterial resistance, delay recovery, or reduce the effectiveness of antibiotics if you do not follow:

dosage
frequency of administration
duration of treatment

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