Chinocid

Package leaflet: Information for the patient

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

Ciprofloxacin
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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CHINOCID is and what it is used for

CHINOCID 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
CHINOCID 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
• 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
• 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 CHINOCID.
Children and adolescents
CHINOCID 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

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

2. What you should know before taking CHINOCID

Do not take CHINOCID if:

• you are allergic to the active substance, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6)
• you are taking tizanidine (see section 2: Other medicines and CHINOCID)

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing quinolones/fluoroquinolones, including CHINOCID, if
you have previously experienced any severe adverse reaction during treatment with a quinolone or
fluoroquinolone. In such 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 CHINOCID
• you suffer from severe myasthenia (a type of muscle weakness)
• you have experienced heart rhythm disturbances (arrhythmias)
• if your vision becomes impaired or if you experience any eye-related effects, consult an ophthalmologist immediately
• 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 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 the abdomen, chest, or back, go immediately to the emergency department.

Heart problems
Particular 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), 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 attacks (myocardial infarction), if you are female or an elderly patient, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and CHINOCID”).

While taking CHINOCID
Inform your doctor immediately if during treatment with CHINOCID any of the following conditions occur.
Your doctor will decide whether treatment with CHINOCID 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 symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing. In such case, stop taking CHINOCID and contact your doctor immediately.

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 CHINOCID. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking CHINOCID, consult your doctor, and rest the affected area. Avoid unnecessary movements, 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 undesirable effects on the central nervous system. In such case, stop taking CHINOCID and contact your doctor immediately.

• Psychiatric reactions may occur the first time you take CHINOCID. If you suffer from depression or psychosis, your symptoms may worsen during treatment with CHINOCID. In such case, stop taking CHINOCID 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 case, stop taking CHINOCID and inform your doctor immediately to prevent permanent nerve damage.

• During treatment with antibiotics, including CHINOCID, or even several weeks afterwards, diarrhea may develop. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking CHINOCID 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 CHINOCID if you need to undergo blood or urine tests.

• CHINOCID 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 CHINOCID and contact your doctor immediately.

• CHINOCID may reduce the number of white blood cells, which may decrease resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in your general condition, or fever with localized infection symptoms such as sore throat, mouth or throat 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.

• Inform your doctor if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anemia with ciprofloxacin.

• During treatment with CHINOCID, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to strong sunlight and artificial UV light, such as tanning beds.

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

• if you experience sudden, severe pain in the abdomen, chest, or back, which may be a sign of aortic aneurysm or dissection, go immediately to the emergency department. 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).

Serious, prolonged, disabling, and potentially irreversible adverse effects
Antibacterial medicines containing fluoroquinolones/quinolones, including CHINOCID, 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 tingling, prickling, itching, numbness, or burning (paresthesia), 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 CHINOCID, 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.

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

• 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)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson’s disease)
• phenytoin (for epilepsy)

CHINOCID may increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine
• agomelatine
• zolpidem

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

• antacids
• 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 CHINOCID approximately two hours before or no sooner than four hours after taking them.

CHINOCID with food and drinks
Unless otherwise directed, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified beverages at the same time as taking CHINOCID 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 a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using CHINOCID during pregnancy. Inform your doctor if you are planning a pregnancy.
Do not take CHINOCID while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.

Driving and using machines
CHINOCID may affect your level of alertness. Since neurological adverse events may occur, assess your response to CHINOCID before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take CHINOCID

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 CHINOCID 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.
Treatment usually lasts from 5 to 21 days, but may last 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 CHINOCID.

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 CHINOCID tablets with dairy products such as milk or yogurt, or with fruit juices fortified with minerals (e.g. calcium-fortified orange juice).

Remember to drink plenty of fluids during treatment with CHINOCID.

If you take more CHINOCID than you should

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

If you forget to take CHINOCID

• Take the missed dose as soon as possible, then continue as directed. However, if it is almost time for your next dose, skip the missed dose and continue with your regular 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 CHINOCID

• 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 doubts about using this product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, 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), 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 side effects (may affect from 1 to 10 people in 10,000):

• inflammation of the bowel (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2)
• 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)
• confusion, disorientation, anxious reaction, unusual dreams, depression, hallucinations
• tingling, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremor, seizures (see section), dizziness
• 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)
• muscle pain, joint inflammation, increased muscle tone, cramps
• kidney failure, blood or crystals in the urine (see section 2), inflammation of the urinary tract
• fluid retention, excessive sweating
• abnormal levels of a clotting factor (prothrombin), increased levels of the enzyme amylase

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

• a particular type of decrease in red blood cells (haemolytic anaemia); a dangerous decrease in a type of white blood cells (agranulocytosis); a decrease in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal (see section 2)
• severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2)
• mental disorders (psychotic reactions) (see section 2)
• migraine, coordination disorders, unsteady gait (gait disturbances), smell disorders (olfactory disturbances), pressure in the brain (intracranial hypertension)
• distortions in colour perception
• 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 2); worsening of symptoms of myasthenia gravis (see section 2)

Frequency not known (the frequency cannot be determined from the available data):

• nervous system disorders such as pain, burning, tingling, numbness and/or weakness of the extremities
• heart problems: abnormally fast heart rhythm, life-threatening irregular heart rhythm, changes in heart rhythm (known as “QT interval prolongation”, seen on ECG, electrical activity of the heart)
• feeling of intense excitement (mania) or feeling of extreme optimism and hyperactivity (hypomania), hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)

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, 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), 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 ruptures 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 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 CHINOCID

No special storage conditions required.
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp.".
The expiry date refers to the last day of that month.
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 CHINOCID contains
The active substance is ciprofloxacin hydrochloride monohydrate.
CHINOCID 250 mg film-coated tablets
One film-coated tablet contains 291 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 250 mg of
ciprofloxacin.
The other components are:
Microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), macrogol 4000.
CHINOCID 500 mg film-coated tablets
One film-coated tablet contains 582 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 500 mg of
ciprofloxacin.
The other components are:
Microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), macrogol 4000.
CHINOCID 750 mg film-coated tablets
One film-coated tablet contains 873 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 750 mg of
ciprofloxacin.
The other components are:
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 CHINOCID and contents of the pack
CHINOCID 250 mg film-coated tablets
Film-coated tablets, white, oval.
Pack size: 10 tablets
CHINOCID 500 mg film-coated tablets
Film-coated tablets, white, oval.
Pack size: 6 tablets
CHINOCID 750 mg film-coated tablets
Film-coated tablets, white, oval.
Pack size: 12 tablets

Marketing Authorization Holder
ELLEVA PHARMA S.r.l.
Via San Francesco n. 5
80034 Marigliano (NA)

Manufacturer
FOR 250 MG, 500 MG AND 750 MG
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo 1– 03012 Anagni (FR)
FOR 500 MG AND 750 MG
LACHIFARMA srl
Laboratorio Chimico Farmaceutico Salentino
SS16, 73010 Zona Industriale Zollino (LE) - Italy