Package leaflet: Information for the user

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

ciprofloxacin
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, 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 dangerous.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What KINOX is and what it is used for

KINOX 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 strains of
bacteria.
Adults
KINOX is used in adults to treat the following bacterial infections:

respiratory tract infections
long-lasting or recurrent ear or sinus infections
urinary tract infections
testicular infections
genital infections in women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
to treat infections in patients with a very low white blood cell count (neutropenia)
to prevent infections in patients with a very low white blood cell count (neutropenia)
to prevent infections caused by the bacterium Neisseria meningitidis
after exposure to inhaled anthrax spores

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 KINOX.
Children and adolescents
KINOX 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

KINOX may also be used to treat other specific severe infections in children and adolescents, if deemed necessary by the doctor.
2. What you need to know before taking KINOX
Do not take KINOX if:

you are allergic (hypersensitive) to the active substance, to other quinolones, or to any of the excipients of KINOX (see section 6)
you are taking tizanidine (see section 2: Taking KINOX with other medicines)

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing quinolones/fluoroquinolones, including KINOX, if in
the past you have had any serious adverse reaction during treatment with a quinolone or
fluoroquinolone. In such a case, inform your doctor as soon as possible.
Talk to your doctor or pharmacist before taking KINOX.
In particular 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 KINOX
you suffer from myasthenia gravis (a type of muscle weakness)
you have had heart rhythm disorders (arrhythmias)
you have been diagnosed with enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
you are diabetic, as there may be a risk of hypoglycaemia when taking ciprofloxacin
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, aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular 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, Behçet's syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
If you experience sudden pain in your 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 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).

Special caution is required when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), if you have a very slow heart rate (called bradycardia), if you have a weak heart (heart failure), if you 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 "Taking with other medicines").
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 KINOX
Inform your doctor immediately if any of the following conditions occur during treatment with KINOX. Your doctor will decide whether to discontinue treatment with KINOX.

A severe and sudden allergic reaction (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 symptoms such as chest tightness, dizziness, nausea or fainting, dizziness upon standing. In such a case, stop taking KINOX and contact your doctor immediately.
When taking this medicine, joint pain and swelling, and tendon inflammation or rupture may rarely 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 taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping KINOX. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking KINOX, consult your doctor, and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
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 a case, stop taking KINOX and contact your doctor immediately.
Psychiatric reactions may occur the first time you take KINOX. If you suffer from depression or psychosis, your symptoms may worsen during treatment with KINOX. In such a case, stop taking KINOX and contact your doctor immediately.
Symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, may rarely occur, particularly in the feet and legs or hands and arms. In such a case, stop taking KINOX and inform your doctor immediately to prevent permanent nerve damage.

Quinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycaemia) or a decrease below normal 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.

During treatment with antibiotics, including KINOX, 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 KINOX 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 KINOX if you need to have blood or urine tests.
KINOX may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal tenderness, stop taking KINOX and contact your doctor immediately.
KINOX 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, 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 the medicine.
Inform your doctor if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin.
While taking KINOX, your skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.
If your vision deteriorates or your eyes are otherwise affected, consult an ophthalmologist immediately.

Serious, prolonged, disabling, and potentially irreversible adverse effects
Fluoroquinolone/quinolone antibacterial medicines, including KINOX, have been associated with very rare but serious adverse 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 pricking, tingling, 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 adverse effects after taking KINOX, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider using an antibiotic from another class.
Other medicines and KINOX
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
You must inform your doctor if you are taking other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic class (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide class), some antipsychotics.
Do not take KINOX with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "Do not take KINOX").
The following medicines interact with KINOX in the body.
Taking KINOX 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)
glibenclamide (for diabetes)

KINOX 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 (for erectile dysfunction or high blood pressure)
agomelatine
zolpidem

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

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

If these preparations are essential, take KINOX approximately two hours before or no sooner than four hours after taking them.
Taking KINOX with food and drinks
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 and breastfeeding
It is preferable to avoid using KINOX during pregnancy. Inform your doctor if you are planning a pregnancy.
Do not take KINOX while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
KINOX may interfere with your level of alertness. Since neurological adverse events may occur, check your response to KINOX before driving or operating machinery. If in doubt, discuss this with your doctor.

3. How to take KINOX

Your doctor will explain exactly how much KINOX 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. Always take the tablets 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 KINOX.

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 KINOX 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 KINOX.

If you take more KINOX 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 KINOX
➢ Take the missed dose as soon as possible, 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 KINOX
➢ 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 doubts about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, KINOX can cause side effects, although not everyone gets them.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, please inform your doctor or pharmacist.

Common side effects (may affect from 1 to 10 people in 100):

nausea, diarrhoea
joint pain in children

Uncommon side effects (may affect from 1 to 10 people in 1,000):

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), intestinal gas
increased levels of certain substances in the blood (transaminases and/or bilirubin)
skin rash, itching, hives
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 side effects (may affect from 1 to 10 people in 10,000):

inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2: Special warnings and precautions with KINOX)
changes in blood cell counts (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, anxious reaction, unusual dreams, depression, hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor, seizures (including epileptic status) (see section 2: Special warnings and precautions with KINOX), vertigo
visual disturbances
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: Special warnings and precautions with KINOX)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in urine (see section 2: Special warnings and precautions with KINOX), inflammation of the urinary tract
fluid retention, excessive sweating
increased levels of amylase enzyme

Very rare side effects (may affect less than 1 person in 10,000):

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: Special warnings and precautions with KINOX)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2: Special warnings and precautions with KINOX)
psychiatric disorders (psychotic reactions) (see section 2: Special warnings and precautions with KINOX)
migraine, coordination disturbances, unsteady gait (gait disturbances), disturbances of smell (olfactory disturbances), pressure in the brain (intracranial hypertension including pseudotumor cerebri)
distortions in colour perception
inflammation of blood vessel walls (vasculitis)
pancreatitis
liver cell death (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 2: Special warnings and precautions with KINOX); worsening of symptoms of myasthenia gravis (see section 2: Special warnings and precautions with KINOX)

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

nervous system disorders such as pain, burning, tingling, numbness and/or weakness of the extremities
loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2.
heart problems: abnormally fast heart rhythm, life-threatening irregular heart rhythm, changes in heart rhythm (known as QT interval prolongation, visible on ECG, electrical activity of the heart)
acute generalised exanthematous pustulosis (AGEP) (erythematous-edematous rash with formation of superficial pustules)
sensations of over-excitement (manic agitation) or sensations of excitement and hyperactivity (hypomanic agitation), a hypersensitivity reaction known as DRESS (drug reaction with eosinophilia and systemic symptoms)
Syndrome associated with impaired water elimination and low sodium levels (SIADH)

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, impaired memory and concentration, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), 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 blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Following the instructions contained in this leaflet reduces the risk of side effects.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may 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 KINOX

Keep this medicine out of the sight and reach of children.
Do not use KINOX 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.
The shelf life applies to the product in its original, undamaged packaging, correctly stored.
Medicines must not be disposed of 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 KINOX contains
KINOX 250 mg tablets
One film-coated tablet contains:
Active substance:
ciprofloxacin hydrochloride monohydrate 291 mg, equivalent to 250 mg of ciprofloxacin.
Excipients:
Microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), macrogol 4000.

KINOX 500 mg tablets
One film-coated tablet contains:
Active substance:
ciprofloxacin hydrochloride monohydrate 582 mg, equivalent to 500 mg of ciprofloxacin.
Excipients:
Microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), macrogol 4000.

KINOX 750 mg tablets
One film-coated tablet contains:
Active substance:
ciprofloxacin hydrochloride monohydrate 873 mg, equivalent to 750 mg of ciprofloxacin.
Excipients:
Microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), macrogol 4000.

Description of the appearance of KINOX and contents of the pack
Film-coated tablets
250 mg film-coated tablets – 10 tablets
500 mg film-coated tablets – 6 tablets
750 mg film-coated tablets – 12 tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
S.F. GROUP Srl
Via Tiburtina, 1143 – 00156 Rome
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 03012 Anagni (FR)
Lachifarma S.r.l. – Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica – Zona Industriale - 73010 Zollino (LE)
( ONLY for 500 mg and 750 mg packs)

April 2025

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 grow. 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 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 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.

Kinox