Ciprofloxacin Bioindustria L.I.M.

Package leaflet: Information for the user

CIPROFLOXACIN Bioindustria L.I.M. 200 mg/100 ml solution for infusion, 400 mg/200 ml solution for infusion

ciprofloxacin
Generic medicine
Read all of this leaflet carefully before using 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 nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What CIPROFLOXACIN Bioindustria L.I.M. is and what it is used for
2. What you need to know before receiving CIPROFLOXACIN Bioindustria L.I.M.
3. How to use CIPROFLOXACIN Bioindustria L.I.M.
4. Possible side effects
5. How to store CIPROFLOXACIN Bioindustria L.I.M.
6. Contents of the pack and other information

1. WHAT IS CIPROFLOXACIN BIOINDUSTRIA L.I.M. AND WHAT IS IT USED FOR?

CIPROFLOXACIN BIOINDUSTRIA L.I.M. contains the active substance ciprofloxacin, which belongs to a group
of medicines called fluoroquinolone antibiotics that work by killing the bacteria causing infections.
It is effective only against certain strains of bacteria.
This medicine is indicated in the following cases:
Adults
infections of the bronchi and lungs (lower respiratory tract), for example pneumonia, acute exacerbations of
chronic obstructive bronchopulmonary disease, bronchopulmonary infections occurring in a genetic disease (cystic
fibrosis) or in the presence of dilatation of certain airways (bronchiectasis);
long-lasting or recurrent ear infections (chronic suppurative otitis media, malignant external otitis);
long-lasting or recurrent infections of the paranasal sinuses (chronic sinusitis);
urinary tract infections (kidneys, prostate);
infections of the male genital organs (epididymo-orchitis), including cases of gonorrhoea (a sexually transmitted
disease);
infections of the female genital organs (pelvic inflammatory disease), including gonorrhoea;
infections of the stomach or intestine (gastrointestinal, e.g. traveller’s diarrhoea) and of the abdomen
(intra-abdominal);
skin and soft tissue infections;
bone and joint infections;
prevention (prophylaxis) and treatment (therapy) of infections in patients with reduced numbers of a type
of white blood cells (neutropenia);
prevention (prophylaxis) and treatment (therapy) of infections caused by exposure to inhaled anthrax spores
(a bacterium).
If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe an additional
antibiotic treatment alongside CIPROFLOXACIN BIOINDUSTRIA L.I.M.
Children and adolescents
CIPROFLOXACIN BIOINDUSTRIA L.I.M. is used in children and adolescents, under specialist supervision,
to treat the following bacterial infections:
pulmonary and bronchial infections in children and adolescents suffering from cystic fibrosis;
complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis);
prevention (prophylaxis) and treatment (therapy) of infections caused by exposure to inhaled anthrax spores.
CIPROFLOXACIN BIOINDUSTRIA L.I.M. may also be used to treat other severe infections in children and adolescents,
when deemed necessary by the physician.

2. WHAT YOU SHOULD KNOW BEFORE RECEIVING CIPROFLOXACIN BIOINDUSTRIA L.I.M.

Do not take CIPROFLOXACIN BIOINDUSTRIA L.I.M.:
if you are allergic to ciprofloxacin, to other quinolones or to any of the other ingredients of this
medicine (see section 6);
if you are taking tizanidine, used for multiple sclerosis (see section 2: “Other medicines and
CIPROFLOXACIN BIOINDUSTRIA L.I.M.”).

Warnings and precautions
Exercise special caution with CIPROFLOXACIN BIOINDUSTRIA L.I.M.

Before taking CIPROFLOXACIN BIOINDUSTRIA L.I.M.
Do not take quinolone/fluoroquinolone antibacterial medicines, including CIPROFLOXACIN
BIOINDUSTRIA L.I.M., if you have previously experienced any serious adverse reaction during treatment with a
quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.

Inform your doctor before receiving CIPROFLOXACIN BIOINDUSTRIA L.I.M. if:
you have kidney problems, as your treatment may need adjustment;
you suffer from epilepsy or other neurological disorders;
you have had tendon problems during previous treatment with antibiotics such as CIPROFLOXACIN
BIOINDUSTRIA L.I.M.;
you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin;
you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen;
you have had heart problems;
you have been diagnosed with enlargement or “bulging” of a large blood vessel
(aortic aneurysm or peripheral aneurysm of a large blood vessel);
you have previously experienced episodes of aortic dissection (a tear in the aortic wall);
you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
you have a family history of aortic aneurysm or aortic dissection, or 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 suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, high blood pressure, known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]);
you have heart problems. 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), 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 a woman or elderly patient, or if you are taking other medicines that can cause abnormal changes on the ECG (see section “Other medicines and CIPROFLOXACIN BIOINDUSTRIA L.I.M.”).

Inform your doctor if you or a family member is known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to CIPROFLOXACIN BIOINDUSTRIA L.I.M.

If there are no signs of improvement after 3 days of treatment, consult your doctor.

During treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M.
Inform your doctor immediately if any of the following conditions occur during treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M. Your doctor will decide whether treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M. should be discontinued.

Severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema).
There is a remote possibility of a severe and sudden allergic reaction even after the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, dizziness upon standing. In such a case, inform your doctor immediately, as administration of CIPROFLOXACIN BIOINDUSTRIA L.I.M. must be stopped.

Serious, prolonged, disabling and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including CIPROFLOXACIN BIOINDUSTRIA L.I.M., have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling or potentially irreversible. These include pain in tendons, muscles and joints of arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, tickling, numbness or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell or hearing, depression, memory impairment, severe fatigue and severe sleep disturbances. If you experience any of these side effects after taking CIPROFLOXACIN BIOINDUSTRIA L.I.M., contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may also consider using an antibiotic from another class.

Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years 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 the end of treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M., contact your doctor and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture may increase.

If you experience sudden, severe pain in the abdomen, chest or back, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.

Inform your doctor immediately if you notice a rapid onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).

If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience adverse effects affecting the central nervous system. In such a case, stop treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M. and contact your doctor immediately.

Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such a case, stop treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M. and inform your doctor immediately to prevent permanent nerve damage.

Psychiatric reactions may occur even when taking quinolone antibiotics, including CIPROFLOXACIN BIOINDUSTRIA L.I.M., for the first time. If you suffer from depression or psychosis, your symptoms may worsen during treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M. In such a case, stop treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M. and contact your doctor immediately. In rare cases, depression and psychosis may progress to suicidal thoughts and self-harming behaviours such as suicide attempts or suicide (see section 4: “Possible side effects”). If you experience depression, psychosis, suicidal thoughts or behaviours, contact your doctor immediately.

Quinolone antibiotics may cause an increase above your normal levels of sugar in the blood (hyperglycaemia) or a decrease below your normal levels of sugar in the blood (hypoglycaemia), 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 CIPROFLOXACIN BIOINDUSTRIA L.I.M., or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, inform your doctor immediately. Treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M. must be stopped immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.

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

During treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M., your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.

Inform your doctor or laboratory staff that you are taking CIPROFLOXACIN BIOINDUSTRIA L.I.M. if you need to undergo blood or urine tests.

Inform your doctor if your kidney function is impaired, as dose adjustment may be necessary to avoid an increase in adverse reactions due to accumulation of ciprofloxacin.

CIPROFLOXACIN BIOINDUSTRIA L.I.M. may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or abdominal pain, contact your doctor immediately.

CIPROFLOXACIN BIOINDUSTRIA L.I.M. 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, pain in the throat or mouth, or urinary problems, you must consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.

Other medicines and CIPROFLOXACIN BIOINDUSTRIA L.I.M.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine.

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 use CIPROFLOXACIN BIOINDUSTRIA L.I.M. together with tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2 “Do not take CIPROFLOXACIN BIOINDUSTRIA L.I.M.”).

The following medicines interact with CIPROFLOXACIN BIOINDUSTRIA L.I.M. in the body. Taking CIPROFLOXACIN BIOINDUSTRIA L.I.M. together with these medicines may affect their therapeutic effect and increase the likelihood of side effects.

Inform your doctor if you are taking:
vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anticoagulants (to thin the blood);
probenecid (for gout);
methotrexate (for certain types of cancer, psoriasis or rheumatoid arthritis);
theophylline (for respiratory problems);
tizanidine (for muscle spasticity in multiple sclerosis);
olanzapine (an antipsychotic), clozapine (an antipsychotic);
ropinirole (for Parkinson’s disease);
phenytoin (for epilepsy);
cyclosporine (for skin conditions, rheumatoid arthritis and for prevention of organ transplant rejection);
other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics;
zolpidem (for sleep disorders).

CIPROFLOXACIN BIOINDUSTRIA L.I.M. 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.

CIPROFLOXACIN BIOINDUSTRIA L.I.M. with food and drinks
Food and drinks have no influence on treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before this medicine is administered.

This medicine should not be administered during pregnancy unless clearly necessary.

Do not use CIPROFLOXACIN BIOINDUSTRIA L.I.M. during breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.

Driving and use of machines
This medicine may affect your level of alertness. Since neurological adverse events may occur, check your response to CIPROFLOXACIN BIOINDUSTRIA L.I.M. before driving a vehicle or operating machinery. If in doubt, discuss with your doctor.

CIPROFLOXACIN BIOINDUSTRIA L.I.M. infusion solution contains sodium
This medicine contains 354 mg (15.4 mmol) of sodium (the main component of table salt) per 100 ml of solution. This corresponds to 17.7% of the maximum daily intake recommended in the adult diet.

The maximum daily dose of this medicine contains 2124 mg of sodium (component of table salt). This corresponds to 106.2% of the maximum daily intake recommended in the adult diet.

Talk to your doctor or pharmacist if you need CIPROFLOXACIN BIOINDUSTRIA L.I.M. on a daily basis for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. HOW TO USE CIPROFLOXACIN BIOINDUSTRIA L.I.M.

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
The recommended dose varies depending on the condition being treated, the severity and site of infection,
the susceptibility to ciprofloxacin of the bacteria responsible for the infection, renal function, and, in children and adolescents, body weight.
The duration of treatment depends on the severity of the disease and its course.
Remember to drink plenty of fluids during treatment with this medicine.
After initial intravenous administration, if appropriate, your doctor may decide to continue treatment orally with tablets or oral suspension.

If you use more CIPROFLOXACIN BIOINDUSTRIA L.I.M. than you should
In case of overdose, symptoms such as dizziness, feeling of instability, tremor, headache, fatigue, seizures, hallucinations, confusion, abdominal discomfort, impaired renal and liver function, crystalluria (presence of crystals in urine), and haematuria (blood in urine) may occur.

If you stop treatment with CIPROFLOXACIN BIOINDUSTRIA L.I.M.
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 using this medicine too early, the infection may not be completely cured, and symptoms may return or worsen. You may also develop resistance to the antibiotic.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following section lists the most serious adverse reactions you may notice on your own:
Stop taking CIPROFLOXACIN Bioindustria L.I.M. and contact your doctor immediately—who will consider alternative antibiotic therapy—if you experience any of the following serious adverse reactions:

Uncommon (may affect up to 1 in 100 people)

• Seizures (see section 2: Warnings and precautions).

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

• Severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, feeling unwell, or fainting, or dizziness upon standing (anaphylactic shock) (see section 2: Warnings and precautions);
• Tendon rupture—especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions).

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

• Severe, sudden allergic reaction with symptoms such as chest tightness, dizziness, feeling unwell, or fainting, or dizziness upon standing (anaphylactic reaction/anaphylactic shock) (see section 2: Warnings and precautions);
• Muscle weakness, tendon inflammation that may lead to tendon rupture, especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions);
• A life-threatening skin rash, usually presenting as blisters or ulcers in the mouth, throat, nose, eyes, and other mucous membranes such as the genital area, which may progress to widespread blistering or skin peeling (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).

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

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

Other adverse reactions observed during treatment with CIPROFLOXACIN Bioindustria L.I.M. are listed below by frequency:

Common (may affect up to 1 in 10 people)

• Nausea, diarrhoea;
• Local reaction at the injection or infusion site.

Uncommon (may affect up to 1 in 100 people)

• Joint pain in adults (arthralgia);
• Fungal superinfections;
• High concentration of eosinophils, a type of white blood cell;
• Decreased appetite;
• Hyperactivity, restlessness;
• Headache, dizziness, sleep disturbances, taste disturbances;
• Vomiting, gastrointestinal and abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn), intestinal gas (flatulence);
• Skin rash, itching, urticaria;
• Reduced kidney function, kidney failure;
• Muscle and bone pain (e.g., limb pain, lower back pain, chest pain);
• Malaise (asthenia), fever;
• Increased transaminases and bilirubin;
• Increased alkaline phosphatase in blood (a certain substance in the blood).

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

• Muscle pain (myalgia), joint inflammation (arthritis), increased muscle tone, cramps;
• Inflammation of the intestine (colitis) associated with antibiotic use (in rare cases may be fatal) (see section 2 “Warnings and precautions”);
• Changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anaemia), reduced platelet count (thrombocytopenia), increased platelet count (thrombocytosis);
• Allergic reaction, allergic swelling (edema), sudden 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, unusual dreams (altered dream activity), depression (which may progress to suicidal thoughts, suicide attempts, or suicide), hallucinations (see section 2 “Warnings and precautions”);
• Altered sensation (paraesthesia, dysaesthesia), reduced skin sensitivity (hypoesthesia), tremor, seizures (including epileptic status; see section 2 “Warnings and precautions”), vertigo;
• Tinnitus (ringing in the ears), decreased or loss of hearing;
• Increased heart rate (tachycardia);
• Vasodilation;
• Decreased blood pressure (hypotension);
• Fainting (syncope);
• Shortness of breath, including asthma-like symptoms (dyspnoea);
• Impaired liver function;
• Cholestatic jaundice (due to obstruction of bile ducts, presenting with yellowing of the skin and whites of the eyes);
• Hepatitis;
• Light sensitivity (photosensitivity) (see section 2 “Warnings and precautions”);
• Muscle pain (myalgia), joint inflammation (arthritis), increased muscle tone, cramps;
• Impaired kidney function (kidney failure);
• Blood in urine (haematuria);
• Crystals in urine (crystalluria) (see section 2 “Warnings and precautions”);
• Inflammation of the urinary tract (tubulointerstitial nephritis);
• Fluid accumulation (oedema);
• Excessive sweating (hyperhidrosis);
• Abnormal levels of a coagulation factor (prothrombin), increased amylase enzyme levels;
• Visual disturbances, e.g., diplopia (double vision).

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

• Reduced number of red blood cells with rupture (haemolytic anaemia), reduced number of a type of white blood cells (agranulocytosis), life-threatening reduction in blood cells (pancytopenia), life-threatening reduced bone marrow activity (bone marrow depression);
• Severe allergic reaction (anaphylactic reaction and life-threatening anaphylactic shock, serum sickness-like reaction) (see section 2 “Warnings and precautions”);
• Psychotic reactions (which may progress to suicidal ideation, suicide attempts, or suicide) (see section 2 “Warnings and precautions”);
• Headache (migraine);
• Impaired coordination (gait disturbances), olfactory nerve disturbances, increased pressure in the head (intracranial hypertension, including pseudotumor cerebri);
• Altered colour perception (chromatic perception);
• Inflammation of blood vessels (vasculitis);
• Inflammation of the pancreas (pancreatitis);
• Liver tissue death (hepatic necrosis), very rarely progressing to life-threatening liver failure (see section 2 “Warnings and precautions”);
• Pinpoint red spots under the skin (petechiae);
• Severe skin reactions (erythema multiforme, nodular erythema, Stevens-Johnson Syndrome, potentially life-threatening, and potentially life-threatening Toxic Epidermal Necrolysis);
• Muscle weakness;
• Tendon inflammation (tendinitis), tendon rupture (predominantly of the Achilles tendon) (see section 2 “Warnings and precautions”);
• Worsening of symptoms in myasthenia gravis (a muscle disease) (see section 2 “Warnings and precautions”).

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

• Syndrome associated with impaired water excretion and low sodium levels (SIADH);
• Feeling highly excited (mania) or feeling excessive optimism and hyperactivity (hypomania);
• Peripheral neuropathy and polyneuropathy (see section 2 “Warnings and precautions”);
• Altered heart rhythm (ventricular arrhythmia and torsade de pointes, mostly reported in patients with known risk factors for QT prolongation), QT prolongation on ECG (electrocardiogram, which records the heart’s electrical activity) (see sections 2 “Warnings and precautions” and 3 “If you take more CIPROFLOXACIN Bioindustria L.I.M.”);
• Skin rash, red, with crusts and swellings under the skin and blisters (acute generalized exanthematous pustulosis);
• Drug reaction with eosinophilia and systemic symptoms (DRESS);
• Altered blood clotting times (increased international normalized ratio in patients treated with vitamin K antagonists);
• Loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic). See section 2.

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (including 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 aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

The following adverse reactions have been reported in cases of intravenous therapy followed by oral therapy:

Common (may affect up to 1 in 10 people):
Vomiting, transient increase in transaminases (liver blood tests indicating liver disturbances), rash.

Uncommon (may affect up to 1 in 100 people):
Reduced platelet count (thrombocytopenia), increased platelet count (thrombocytosis), confusion and disorientation, hallucinations, altered sensation (paraesthesia and dysaesthesia), seizures, dizziness, visual disturbances, hearing loss, increased heart rate (tachycardia), vasodilation, reduced blood pressure (hypotension), transient impaired liver function, liver inflammation with bile duct obstruction causing yellowing of the skin and whites of the eyes (cholestatic jaundice), kidney failure, fluid accumulation (oedema).

Rare (may affect up to 1 in 1,000 people):
Reduced number of blood cells (pancytopenia), reduced bone marrow activity (bone marrow depression), severe allergic reaction (anaphylactic shock), psychotic reactions, neurological disease presenting as headache (migraine), smell disturbances, hearing loss, inflammation of blood vessels (vasculitis), pancreas inflammation (pancreatitis), liver tissue death (hepatic necrosis), pinpoint red spots under the skin (petechiae), tendon rupture.

Additional adverse reactions in children
Joint disease (arthropathy) is commonly observed in children.

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

5. HOW TO STORE CIPROFLOXACIN BIOINDUSTRIA L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”.
The expiry date refers to the last day of that month.
Store in the original packaging and protect from light. Since the infusion solution is light-sensitive, remove vials from the box only immediately before use.
If the product is stored at low temperatures, precipitation of the solute may occur; this will redissolve at room temperature (15–25°C). Therefore, it is recommended not to store the infusion solution in the refrigerator.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What CIPROFLOXACINA Bioindustria L.I.M. contains
CIPROFLOXACINA Bioindustria L.I.M. 100 ml vial

• The active substance is ciprofloxacin lactate. 100 ml of solution contain 254.4 mg of ciprofloxacin lactate, equivalent to 200 mg of ciprofloxacin.
• The other components are: lactic acid (E270), sodium chloride, hydrochloric acid (for pH adjustment) (E507), water for injections.

CIPROFLOXACINA Bioindustria L.I.M. 200 ml vial

• The active substance is ciprofloxacin lactate. 200 ml of solution contain 508.8 mg of ciprofloxacin lactate, equivalent to 400 mg of ciprofloxacin.
• The other components are: lactic acid (E270), sodium chloride, hydrochloric acid (for pH adjustment) (E507), water for injections.

Description of the appearance of CIPROFLOXACINA Bioindustria L.I.M. and contents of the pack
Pack containing 5, 10 or 25 vials of 100 ml of infusion solution.
Pack containing 5, 10 or 25 vials of 200 ml of infusion solution.

Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinale S.p.A. (Bioindustria L.I.M. S.p.A.),
Via De Ambrosiis n. 2 – 15067 Novi Ligure (Alessandria) – ITALY

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 called resistance:
some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You may even promote the development of resistance in bacteria, delaying recovery or reducing 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:
1 – Use antibiotics only when prescribed.
2 – Follow your doctor's instructions strictly.
3 – Do not reuse an antibiotic without a medical prescription, even if you are treating a similar illness.
4 – Never give your antibiotic to another person; it may not be suitable for their condition.
5 – At the end of treatment, return all unused medicines to a pharmacy, to ensure they are properly disposed of.

Package leaflet: information for the physician

CIPROFLOXACIN Bioindustria L.I.M. 200 mg/100 ml infusion solution, 400 mg/200 ml infusion solution

The following information is intended exclusively for medical professionals or healthcare operators
The ciprofloxacin infusion solution should be visually inspected before use. It must not be used if cloudy.
Ciprofloxacin must be administered by intravenous infusion. In children, the infusion duration is 60 minutes. In adult patients, the infusion duration is 60 minutes for CIPROFLOXACIN Bioindustria L.I.M. 400 mg and 30 minutes for CIPROFLOXACIN Bioindustria L.I.M. 200 mg. Slow infusion into a large vein reduces both patient discomfort and the risk of venous irritation. The infusion solution may be administered alone or in combination with other compatible infusion solutions.
This medicinal product must not be mixed with other products except those listed below.
The infusion solution must always be administered separately unless compatibility with other solutions or infusion drugs has been demonstrated. Visible signs of incompatibility include, for example, precipitation, cloudiness, and color change.
Incompatibility occurs with all solutions or infusion medicines that are physically or chemically unstable at the pH of the solutions (e.g. penicillins, heparin solutions), particularly when associated with solutions adjusted to an alkaline pH (pH of ciprofloxacin solutions: 3.9–4.5).
After initial intravenous administration, treatment may be continued orally.
CIPROFLOXACIN Bioindustria L.I.M. 2 mg/ml is compatible with:

• Sodium chloride 0.9% solution (normal saline),
• Ringer's lactate solution,
• 5% and 10% glucose solutions,
• 5% glucose with 0.9% sodium chloride solution.

Due to the potential risk of contamination and sensitivity to light, when CIPROFLOXACIN Bioindustria L.I.M. intravenous infusion solution is mixed with other compatible infusion solutions, the resulting solution should be administered immediately after preparation.

Children and adolescents:

Elderly:
Elderly patients should be treated with a dose determined according to the severity of the infection and the patient's creatinine clearance.

Renal and hepatic impairment:
Recommended initial and maintenance doses for patients with impaired renal function:

Creatinine Clearance  Serum Creatinine  Intravenous Dose
[ml/min/1.73 m²]    [µmol/l]       [mg]

60           < 124          See usual dosage
30 – 60        124 – 168       200 – 400 mg every 12 hours
< 30           > 169          200 – 400 mg every 24 hours
Haemodialysis patients  > 169          200 – 400 mg every 24 hours
                                       (after dialysis)
Peritoneal dialysis patients > 169          200 – 400 mg every 24 hours

No dosage adjustment is required in patients with impaired hepatic function.

Administration in children with impaired renal and/or hepatic function has not been studied.

For further information, consult the Summary of Product Characteristics.