Patient Information Leaflet

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

Ciprofloxacin
Equivalent medicine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PROCIFLOR is and what it is used for

PROCIFLOR contains the active substance ciprofloxacin. PROCIFLOR is an antibiotic belonging to the family of fluoroquinolones. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only against specific strains of bacteria.
Adults
PROCIFLOR is used in adults to treat the following bacterial infections:

respiratory tract infections
long-lasting or recurrent ear or paranasal sinus infections
urinary tract infections
genital infections in men and women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
prevention of infections caused by the bacterium Neisseria meningitidis
exposure to inhalation of anthrax spores

Ciprofloxacin may be used to manage patients with low white blood cell count (neutropenia) who develop fever suspected to be due to bacterial infection.
If you have a severe infection, or one caused by more than one type of bacteria, you may be prescribed another antibiotic treatment in addition to PROCIFLOR.
Children and adolescents
PROCIFLOR 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

PROCIFLOR 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 PROCIFLOR

Do not take PROCIFLOR if:

you are allergic to the active substance, to other quinolones, or to any of the excipients of this medicine listed in section 6
you are taking tizanidine (see section 2 “Other medicines and PROCIFLOR”)

Warnings and precautions
Talk to your doctor or pharmacist before taking PROCIFLOR.
Tell your doctor if:

you have had 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 PROCIFLOR
you have diabetes, because hypoglycemia or hyperglycemia may occur while using ciprofloxacin
you suffer from severe myasthenia (a type of muscle weakness), as symptoms may worsen
you have heart problems. Special caution is required when using PROCIFLOR 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 an elderly patient, or if you are taking other medicines that may cause abnormal changes on the ECG (see section 2 “Other medicines and PROCIFLOR”)
you have been diagnosed with an 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 wall of the aorta)
you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation)
you or a family member have a history of aortic aneurysm or 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])

You must not take antibacterial medicines containing quinolones/fluoroquinolones, including Prociflor,
if you have previously experienced any serious adverse reaction during treatment with a
quinolone or fluoroquinolone. In such case, inform your doctor as soon as possible.
Inform your doctor if you or a family member have glucose-6-phosphate dehydrogenase (G6PD)
deficiency, as you may be at risk of developing anemia with ciprofloxacin.
Quinolone antibiotics can cause an increase above your normal blood sugar levels (hyperglycemia)
or a decrease below your normal blood sugar levels (hypoglycemia), which in severe cases may
potentially lead to loss of consciousness (hypoglycemic coma) (see section 4). This is particularly
important for people with diabetes. If you have diabetes, your blood sugar levels must be closely
monitored.
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 PROCIFLOR
Inform your doctor immediately if any of the following conditions occur during treatment with
PROCIFLOR. Your doctor will decide whether to discontinue treatment with PROCIFLOR.

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 after the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, or vertigo when standing up. In such case, stop taking PROCIFLOR and contact your doctor immediately.
Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), if you have had 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 PROCIFLOR. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking PROCIFLOR, 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 cerebral ischemia or stroke, you may experience adverse effects on the central nervous system. In case of seizures, stop taking PROCIFLOR 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 PROCIFLOR and inform your doctor immediately to avoid permanent nerve damage.
Psychiatric reactions may occur the first time you take PROCIFLOR. If you suffer from depression or psychosis, your symptoms may worsen during treatment with PROCIFLOR. In rare cases, depression and psychosis may progress to suicidal thoughts, suicide attempts, or suicide. In such case, contact your doctor immediately.
Hypoglycemia has been reported very frequently in diabetic patients, especially in the elderly population. If this occurs, contact your doctor immediately.
Diarrhea may develop during treatment with antibiotics, including PROCIFLOR, or even several weeks afterwards. If it worsens or persists, or if you notice blood or mucus in your stool, you must stop taking PROCIFLOR and contact your doctor immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal motility.
If your vision deteriorates or if your eyes are otherwise affected, consult an ophthalmologist immediately.
While taking PROCIFLOR, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to strong sunlight and artificial UV light, such as from sunbeds.
Inform your doctor or laboratory staff that you are taking PROCIFLOR if you need to have blood or urine tests.
If you have kidney problems, inform your doctor, as you may need a dosage adjustment.
PROCIFLOR 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.
PROCIFLOR may cause a reduction in the number of white blood cells, which may lead to reduced resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with localized infection symptoms such as sore throat, mouth pain, 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.
If you experience sudden and severe abdominal, chest, or back pain, which may be a symptom of aortic aneurysm or dissection, go to the emergency room immediately. The risk may be higher if you are taking systemic corticosteroids.
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
Fluoroquinolone/quinolone antibacterial medicines, including PROCIFLOR, 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 the arms and legs,
difficulty walking, abnormal sensations such as pricking, tingling, 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 PROCIFLOR, contact 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 PROCIFLOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Do not take PROCIFLOR with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "Do not take PROCIFLOR").
The following medicines interact with PROCIFLOR in the body.
Taking PROCIFLOR 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, 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)
metoclopramide (for nausea and vomiting)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics
glibenclamide (for diabetes)
zolpidem (for sleep disorders)

PROCIFLOR 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 anesthetic use)
sildenafil (for erectile dysfunction)
agomelatine (for depression)

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

antacids
omeprazole
mineral supplements
sucralfate
a phosphate polymer binder (e.g. sevelamer or lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium, or iron. If these preparations are essential, take PROCIFLOR approximately two hours before or no sooner than four hours after taking them.

Taking PROCIFLOR with food and drink
Unless otherwise directed, do not eat or drink dairy products (such as milk or yogurt) or calcium-fortified beverages when taking the tablets, as they may interfere with the absorption of the active substance.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using PROCIFLOR during pregnancy. Inform your doctor if you are planning a pregnancy.
Do not take PROCIFLOR while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
PROCIFLOR may affect your level of alertness. Since neurological adverse events may occur, check how you react to PROCIFLOR before driving a vehicle or operating machinery. If in doubt, discuss with your doctor.
PROCIFLOR contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially sodium-free.

3. How to take PROCIFLOR

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much PROCIFLOR 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 dose 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 PROCIFLOR.

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 PROCIFLOR 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 this medicine.

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

If you forget to take PROCIFLOR
Take the missed 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. 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 PROCIFLOR
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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following section lists the most serious side effects that you may notice on your own:
Stop taking PROCIFLOR and contact your doctor immediately if you notice any of the following serious side effects, so that your doctor can consider alternative antibiotic treatment:

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

seizures (see section 2 “Warnings and precautions”)

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

severe and sudden allergic reaction with symptoms such as chest tightness, dizziness, feeling unwell or fainting, or dizziness when standing (anaphylactic reaction/anaphylactic shock) (see section 2: Warnings and precautions)
muscle weakness, tendon inflammation which 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)

Not known (frequency cannot be estimated from the available data)

unusual sensation of pain, burning, tingling, numbness, or muscle weakness in the extremities (neuropathy) (see section 2: Warnings and precautions)
a reaction causing skin rashes, fever, internal organ inflammation, blood abnormalities, and systemic symptoms (DRESS: Drug Reaction with Eosinophilia and Systemic Symptoms; AGEP: Acute Generalized Exanthematous Pustulosis)

Other side effects observed during treatment with PROCIFLOR are listed below according to their frequency:

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

nausea, diarrhoea
joint pain and joint inflammation in children

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

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

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

muscle pain, joint inflammation, increased muscle tone and cramps
inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2: Warnings and precautions)
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) (see section 2: Warnings and precautions)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)
confusion, disorientation, anxious reaction, unusual dreams, depression (which in rare cases may progress to suicidal thoughts or suicide attempts or suicide) (see section 2: Warnings and precautions), or hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, dizziness
visual disturbances, including double vision (see section 2: Warnings and precautions)
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: Warnings and precautions)
kidney failure, blood or crystals in urine, inflammation of the urinary tract
fluid retention, excessive sweating
increased levels of the enzyme amylase

Very rare (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) (see section 2: Warnings and precautions); a reduction in red blood cells, white blood cells, and platelets (pancytopenia), which may be fatal; bone marrow suppression, which may also be fatal; an allergic reaction called serum sickness-like reaction (see section 2: Warnings and precautions)
mental disorders (psychotic reactions which in rare cases may progress to suicidal thoughts or suicide attempts or suicide) (see section 2: Warnings and precautions)
migraine, coordination problems, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), increased pressure in the brain (intracranial hypertension, including Pseudotumor Cerebri)
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 (see section 2: Warnings and precautions)
pinpoint skin bleeding (petechiae); various types of skin rashes or rash
worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

Not known (frequency cannot be estimated from the available data)

syndrome associated with impaired water elimination and low sodium levels (SIADH)
loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2.
intense feeling of excitement (mania), feeling of extreme optimism and hyperactivity (hypomania)
abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as QT interval prolongation, seen on ECG, electrical activity of the heart)
effects on blood clotting (in patients treated with vitamin K antagonists)

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, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal ideation), as well as hearing, vision, taste, and smell disturbances, 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.

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 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 PROCIFLOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after "Exp.".
The expiry date refers to the last day of the 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 PROCIFLOR contains
The active substance is ciprofloxacin. Each tablet contains 250 mg, 500 mg or 750 mg of
ciprofloxacin (as hydrochloride).
The other components are microcrystalline cellulose (E460), sodium starch glycolate (type A),
crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium
dioxide (E171), hypromellose (E464), macrogol 4000.

Description of the appearance of PROCIFLOR and contents of the pack
PROCIFLOR 250 mg film-coated tablets
Pack containing 10 tablets in PVC/PE/PVDC/Al blisters
PROCIFLOR 500 mg film-coated tablets
Pack containing 6 tablets in PVC/PE/PVDC/Al blisters
PROCIFLOR 750 mg film-coated tablets
Pack containing 12 tablets in PVC/PE/PVDC/Al blisters

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ)
Manufacturer
Laboratorio Farmacologico Milanese S.r.l. – Via Monterosso, 273 – 21042 Caronno Pertusella (VA)

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 they are specifically needed for your current illness.
Despite antibiotic treatment, certain bacteria may survive or multiply. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. If you do not follow the instructions regarding:

dosage
frequency of administration
duration of treatment

you may even promote the development of bacterial resistance, delay recovery, or reduce the effectiveness of antibiotics.

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