Patient Information Leaflet

Ibixacin 500 mg film-coated tablets

ciprofloxacin
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 other people, even if their symptoms are the same as yours, as it may 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 Ibixacin is and what it is used for
What you need to know before taking Ibixacin
How to take Ibixacin
Possible side effects
How to store Ibixacin
Contents of the pack and other information

1. What Ibixacin is and what it is used for

Ibixacin is an antibiotic belonging to the fluoroquinolone family. The active substance is
ciprofloxacin. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only
against specific types (strains) of bacteria.
Adults
Ibixacin is used in adults to treat the following bacterial infections:

respiratory tract infections
long-lasting or recurrent ear infections or infections of the air-filled cavities near the nose (paranasal sinuses)
urinary tract infections
infections of the testicles
genital infections in women
stomach, intestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
infections in patients with very low levels of white blood cells (neutropenia)
to prevent infections caused by the bacterium Neisseria meningitidis
exposure to inhalation of a bacterium in its dormant state (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 Ibixacin.
Children and adolescents
If you have a child or adolescent, Ibixacin may be used under the supervision of a specialist doctor to treat the following bacterial infections:

lung and bronchial infections in children and adolescents suffering from a genetic disease causing the production of thick, sticky, poorly flowing and difficult-to-clear mucus (cystic fibrosis)
complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
exposure to inhalation of a bacterium in its dormant state (anthrax spores).

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

2. What you should know before taking Ibixacin

Do not take Ibixacin

if you are allergic to ciprofloxacin, to other antibiotics of the same family as ciprofloxacin (quinolones), or to any of the other ingredients of this medicine (listed in section 6)
if you are taking tizanidine, a medicine used to relax muscles (see section 2 “Other medicines and Ibixacin”).

Warnings and precautions
Before taking this medicine
You must not take antibacterial medicines containing quinolones/fluoroquinolones, including Ibixacin, if in the past you have experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Quinolone antibiotics can cause an increase in blood sugar levels above normal (hyperglycaemia) or a decrease below normal blood sugar levels, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
Serious, prolonged, disabling, and potentially irreversible side effects
Antibacterial medicines containing fluoroquinolones/quinolones, including Ibixacin, have been associated with very rare but serious side effects, some of which may be 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, 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 Ibixacin, consult 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.
Talk to your doctor or pharmacist before taking Ibixacin:

if you have been diagnosed with an 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 heart valve insufficiency (heart valve regurgitation)
if you have a family history of aortic aneurysm, 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 if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [a joint disease], or endocarditis [inflammation of the heart])

Before taking Ibixacin
Inform your doctor:

if you have kidney problems, as your treatment may need to be adjusted
if you suffer from epilepsy or other neurological disorders
if you have previously experienced tendon problems during prior treatment with antibiotics such as Ibixacin
if you are diabetic, as there may be a risk of low blood sugar (hypoglycaemia) when using ciprofloxacin
if you have muscle weakness (myasthenia gravis), as symptoms may worsen
if you have heart problems. Special caution is required when using Ibixacin if you were born with or have a family history of heart rhythm disorders (prolonged QT interval seen on electrocardiogram, 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 in the heart function test known as electrocardiogram (see section 2 “Other medicines and Ibixacin”)
if you or a family member is known to be deficient in an enzyme called glucose-6-phosphate dehydrogenase (G6PD), as taking ciprofloxacin may lead to destruction of red blood cells in the blood (anaemia)
if your vision changes or if you experience any eye-related effects, you should immediately consult an ophthalmologist.

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to Ibixacin. If there are no signs of improvement after 3 days of treatment, consult your doctor.
While taking Ibixacin
Inform your doctor immediately if during treatment with Ibixacin you experience any of the following conditions. Your doctor will decide whether to discontinue treatment with Ibixacin.

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, or lightheadedness when standing. In such a case, stop taking Ibixacin and contact your doctor immediately
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 Ibixacin. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Ibixacin, consult your doctor, and rest the affected area. Avoid unnecessary movement, as the risk of tendon rupture may increase
if you suffer from epilepsy or other neurological disorders, such as reduced blood supply to the brain (cerebral ischaemia) or brain vessel damage (stroke), you may experience adverse effects on the central nervous system. In such a case, stop taking Ibixacin and contact your doctor immediately
psychiatric reactions may occur the first time you take Ibixacin. If you suffer from depression or mental balance disorders (psychosis), your symptoms may worsen during treatment with Ibixacin. In such a case, stop taking Ibixacin 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 taking Ibixacin and inform your doctor immediately to prevent permanent nerve damage
low blood sugar (hypoglycaemia) has been frequently reported in diabetic patients, especially in the elderly population. If this occurs, contact your doctor immediately
during treatment with antibiotics, including Ibixacin, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking Ibixacin immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements and contact your doctor
inform your doctor or laboratory staff that you are taking Ibixacin if you need to have blood or urine tests
if you have kidney problems, inform your doctor, as you may need a dose adjustment
Ibixacin may cause liver damage. If you notice symptoms such as loss of appetite, yellowing of the skin (jaundice), dark urine, itching, or abdominal pain, stop taking Ibixacin and contact your doctor immediately
Ibixacin may reduce the number of white blood cells, which could 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 signs 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
if your vision deteriorates or if your eyes are otherwise affected, consult an ophthalmologist immediately
if you experience sudden and severe pain in the abdomen, chest, or back, which may be a sign 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 (sensation of rapid or irregular heartbeat).

During treatment with Ibixacin, 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.
Other medicines and Ibixacin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
You must inform your doctor if you are taking other medicines that may affect heart rhythm: medicines belonging to the antiarrhythmic class (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobials belonging to the macrolide class, or certain medicines for mental disorders (antipsychotics).
Do not take Ibixacin together with tizanidine, a medicine used to relax muscles, as it may cause side effects such as low blood pressure and drowsiness (see section 2 "Do not take Ibixacin").
The following medicines interact with Ibixacin in the body. Taking Ibixacin 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 for mental disorders)
clozapine (an antipsychotic for mental disorders)
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 affect 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, or certain antipsychotics (for mental disorders).

Ibixacin may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine (a central nervous system stimulant)
duloxetine (for depression, diabetic nerve damage [diabetic neuropathy], or incontinence)
lidocaine (for heart problems or as an anaesthetic)
sildenafil (e.g. for erectile dysfunction or high blood pressure)
agomelatine (for depression)
zolpidem (for insomnia)

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

antacids
omeprazole (to treat damage to the inner lining of the stomach)
mineral supplements
sucralfate (to treat damage to the inner lining of the stomach)
a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate) (to treat high phosphate levels in the blood)
medicines or supplements containing calcium, magnesium, aluminium, or iron

If these preparations are essential, take Ibixacin approximately two hours before or no sooner than four hours after taking them.
Ibixacin with food and drink
Ibixacin may be taken with meals unless you consume 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 and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ibixacin during pregnancy.
Do not take Ibixacin while breastfeeding, as ciprofloxacin passes into breast milk and may be harmful to your baby.
Driving and using machines
Ibixacin may affect your level of alertness. Since neurological adverse events may occur, check how you react to Ibixacin before driving or operating machinery. If in doubt, discuss this with your doctor.

3. How to take Ibixacin

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you exactly how much Ibixacin to 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 dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may be longer for severe infections.
Always take the tablets exactly as directed by your doctor. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ibixacin.

a. Swallow the tablets with plenty of fluid. Do not chew the tablets, as they have an unpleasant taste.
b. Try to take the tablets at 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 Ibixacin 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 Ibixacin.

If you take more Ibixacin 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 Ibixacin

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

If you stop taking Ibixacin

If you have any questions about using this medicine, consult your doctor or pharmacist. 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.

4. Possible side effects

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

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

nausea, diarrhoea
joint pain in children

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

fungal infection (fungal superinfection)
high concentration of a type of white blood cells (eosinophils)
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 levels of a substance in the blood (alkaline phosphatase)

Rare side 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 2 “Warnings and precautions”)
changes in the number of blood cells (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood clotting factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section 2 “Warnings and precautions”)
confusion, disorientation, anxiety reaction, unusual dreams, depression (which may lead to suicidal thoughts or suicide attempts or suicide), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor,

seizures (including status epilepticus) (see section 2 “Warnings and precautions”),
dizziness

visual disturbances (e.g. double vision)
ringing in the ears (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, yellowing of the skin (jaundice, cholestatic jaundice), hepatitis
sensitivity to light (see section 2 “Warnings and precautions”)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in urine (see section 2 “Warnings and precautions”), inflammation of the urinary tract
fluid retention, excessive sweating
abnormal levels of a clotting factor (prothrombin) in blood (coagulation), increased levels of a substance in the blood (amylase enzyme)

Very rare side 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); a reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow suppression, which may also be fatal (see section 2 “Warnings and precautions”)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2 “Warnings and precautions”)
psychiatric disorders (psychotic reactions) which may lead to suicidal thoughts or suicide attempts or suicide (see section 2 “Warnings and precautions”)
migraine, coordination disorders, unsteady gait (gait disturbances), smell disorders (olfactory disturbances), increased pressure in the brain (intracranial hypertension including pseudotumor cerebri)
disturbances in colour perception
inflammation of the walls of blood vessels (vasculitis)
inflammation of the pancreas (pancreatitis)
death of liver cells (hepatic necrosis), which very rarely may lead to life-threatening liver failure
bleeding (haemorrhages), pinpoint bleeding under the skin (petechiae); various types of skin eruptions (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
muscle weakness, tendon inflammation, tendon rupture – particularly of the large tendon at the back of the ankle (Achilles tendon) (see section 2 “Warnings and precautions”), worsening of symptoms of severe muscle weakness (myasthenia gravis) (see section 2 “Warnings and precautions”)

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

nervous system disorders such as pain, burning, tingling, numbness and/or weakness of limbs
heart disorders: abnormally fast heart rate, irregular heartbeat, life-threatening changes in heart rhythm (known as 'QT interval prolongation', seen on electrocardiogram, electrical activity of the heart)
skin eruption with small pustules (acute generalised pustular eruption – AGEP)
intense feeling of excitement (mania) or feeling of extreme optimism and hyperactivity

(hypomania), severe hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)

increased values of a blood coagulation parameter: Increased International Normalised Ratio (in patients treated with vitamin K antagonists)
syndrome associated with impaired water excretion and low sodium levels (SIADH)
loss of consciousness due to severe decrease in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of prolonged (lasting for months or years) or permanent adverse reactions to the drug, 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), depression, fatigue, sleep disturbances, memory impairment 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 dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of regurgitation of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Ibixacin

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The expiry date refers to the last day of that month.
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 Ibixacin contains
The active substance is: ciprofloxacin hydrochloride monohydrate. One film-coated tablet contains 582 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 500 mg of ciprofloxacin.

The other components are: microcrystalline cellulose, povidone, crospovidone, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E 171), hypromellose, macrogol 4000

Description of the appearance of Ibixacin and pack contents
Film-coated tablets – pack of 6 tablets
Marketing Authorization Holder
Istituto Biochimico Italiano G. Lorenzini S.p.A.
Via Fossignano, 2
04011 Aprilia (LT)
e-mail: [email protected]
Manufacturer
Special Product’s Line
Via Paduni, 240
03012 Anagni (FR)