Package leaflet: Information for the patient

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

ciprofloxacin
Equivalent medicine
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. Never give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Generflon is and what it is used for

Generflon 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 certain strains of bacteria.

Adults
Generflon 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;
after exposure to inhaled anthrax spores.

Ciprofloxacin may be used to manage patients with a low white blood cell count (neutropenia) who develop fever suspected to be due to a bacterial infection.
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 Generflon.
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Children and adolescents
Generflon 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.

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

2. What you should know before taking Generflon

Quinolone antibiotics can cause blood sugar levels to rise above normal (hyperglycemia) or fall below normal levels, 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.
Do not take Generflon if:

you are allergic (hypersensitive) to the active substance, to other quinolones, or to any of the other ingredients of this medicine (see section 6);
you are taking tizanidine (see section 2: "Taking Generflon with other medicines").

Warnings and precautions
Before taking this medicine
You should not take antibacterial quinolone/fluoroquinolone medicines, including Generflon, 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.
Talk to your doctor or pharmacist before taking Generflon:

if you have kidney problems, as your treatment may need to be adjusted;
if you suffer from epilepsy or other neurological disorders;
if you have previously experienced tendon problems during treatment with antibiotics such as Generflon;
if you suffer from myasthenia gravis (a type of muscle weakness);
if you have experienced heart rhythm disturbances (arrhythmias);
if your vision becomes impaired or if your eyes appear otherwise affected, 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 disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).

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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.
Heart conditions
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 potassium or magnesium levels), have a very slow heart rate (called bradycardia), have heart weakness (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes on ECG (see section "Taking Generflon with other medicines").
If you experience sudden abdominal, chest, or back pain, go immediately to the emergency room.
While taking Generflon
Inform your doctor immediately if any of the following conditions occur during treatment with Generflon. Your doctor will decide whether treatment with Generflon should be discontinued.

If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
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 treatment with Generflon and contact your doctor immediately.
If you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom of aneurysm or aortic 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).
Rarely, joint pain and swelling, or tendon inflammation or rupture, may occur. The risk is higher if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping Generflon. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Generflon, 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 such case, stop treatment with Generflon and contact your doctor immediately.
Psychiatric reactions may occur the first time you take Generflon. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Generflon. In rare cases, depression or psychotic reactions may lead to suicidal thoughts, suicide attempts, or suicide. In such case, stop treatment with Generflon and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness may occur, particularly in the feet and legs or in the hands and

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arms. In such case, stop treatment with Generflon and inform your doctor immediately to prevent permanent nerve damage.

During treatment with antibiotics, including Generflon, 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 Generflon 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 Generflon if you need to undergo blood or urine tests.
Generflon 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 Generflon and contact your doctor immediately.
Generflon may reduce the number of white blood cells, which can lead to decreased resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with 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.
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 Generflon, your skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as tanning beds.

Serious, prolonged, disabling, and potentially irreversible adverse effects
Fluoroquinolone/quinolone antibacterial medicines, including Generflon, have been associated with very rare but serious adverse effects, some of which are 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 itching, tingling, prickling, 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 Generflon, 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 Generflon
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
You must inform your doctor if you are taking other medicines that may alter heart rhythm:

medicines belonging to the antiarrhythmic class (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
tricyclic antidepressants;
certain antimicrobials (belonging to the macrolide group);
certain antipsychotics.

Do not take Generflon together with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "Do not take Generflon").
The following medicines interact with ciprofloxacin in the body. Taking Generflon together with these medicines may affect their therapeutic effect and increase the likelihood of adverse effects.
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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);
cyclosporine (in transplant patients);
glibenclamide (for diabetes).

Generflon may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders);
caffeine;
lidocaine (for anesthesia);
sildenafil (for erectile dysfunction);
duloxetine (an antidepressant);
agomelatine;
zolpidem.

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

antacids;
omeprazole (an antacid);
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 Generflon approximately two hours before or no sooner than four hours after taking them.

Generflon with food, drinks, and alcohol
Unless you are taking Generflon with meals, 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, breastfeeding, and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
It is preferable to avoid using ciprofloxacin during pregnancy. Inform your doctor if you are planning a pregnancy.
Do not take Generflon while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Generflon may affect your level of alertness. Since neurological adverse events may occur, check how you react to Generflon before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.
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3. How to take Generflon

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 Generflon you should take, how often, and for how long.
This will depend on the type of infection you have and its severity.
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 Generflon.
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 Generflon tablets with dairy products such as milk or yogurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with Generflon.

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

If you forget to take Generflon
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 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 Generflon
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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Generflon can cause side effects, although not everybody will get 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.

The following section lists the serious side effects you may notice on your own:

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

seizures (see section 2: While taking Generflon)

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

severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2: While taking Generflon);
muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2: While taking Generflon); worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions);
pinpoint bleeding under the skin (petechiae); various types of skin rashes (for example, Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal).

Side effects with unknown frequency (frequency cannot be estimated from the available data):

nervous system disorders such as pain, burning, tingling, numbness and/or weakness in the extremities;
appearance of widespread pustules (Acute Generalized Exanthematous Pustulosis – AGEP);
an allergic reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms).

The following section lists other side effects observed during treatment with ciprofloxacin, according to their frequency:

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

nausea, diarrhoea;
joint pain in children.

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

fungal superinfections;
high concentration of eosinophils, a type of white blood cells;
loss of appetite;
hyperactivity, restlessness;
headache, dizziness, sleep disturbances, taste disturbances;
vomiting, abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn), flatulence;
increase in 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 substance present in the blood).

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

inflammation of the bowel (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2: While taking Generflon);
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 (potentially leading to suicidal ideation/suicidal thoughts, suicide and attempted suicide) (see section 2: While taking Generflon), hallucinations;
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor, dizziness;
visual disturbances (double vision);
tinnitus, hearing loss, decreased hearing;
rapid heartbeat (tachycardia);
dilation of blood vessels (vasodilation), low blood pressure, fainting;
shortness of breath, including symptoms of asthma;
liver disorders, jaundice (cholestatic jaundice), hepatitis;
sensitivity to light (see section 2: While taking Generflon);
muscle pain, joint inflammation, increased muscle tone, cramps;
kidney failure, blood or crystals in urine (see section 2: Special warnings with Generflon), inflammation of the urinary tract;
fluid retention, excessive sweating;
abnormal levels of a clotting factor (prothrombin), increased levels of the enzyme amylase.

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

a specific 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: While taking Generflon);
mental disorders (psychotic reactions potentially leading to suicidal ideation/suicidal thoughts, suicide and attempted suicide) (see section 2: While taking Generflon);
migraine, coordination disorders, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), pressure on the brain (increased intracranial pressure and pseudotumour cerebri);
disturbances 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.

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

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);
increased blood clotting time (increase in International Normalized Ratio – INR);
feeling extremely excited (mania) or feeling of great optimism and hyperactivity (hypomania);
syndrome associated with impaired water excretion and low sodium levels (SIADH);
loss of consciousness due to severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of prolonged (lasting for 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 ideation), 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.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Generflon

No special storage conditions required.
Keep this medicine out of the sight and reach of children.
Do not use Generflon after the expiry date stated on the blister or carton after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Generflon contains
Generflon 250 mg film-coated tablets
One film-coated tablet contains:
Active substance: ciprofloxacin hydrochloride monohydrate: 291 mg (equivalent to 250 mg ciprofloxacin)
Excipients: microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize starch,
anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol
4000.

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

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

Description of the appearance of Generflon and contents of the pack
Generflon 250 mg film-coated tablets
Film-coated, white, convex tablets with a break line.
Pack containing 10 tablets.

Generflon 500 mg film-coated tablets
Film-coated, white, oval tablets with a break line.
Pack containing 6 tablets.

Generflon 750 mg film-coated tablets
Film-coated, white, oval tablets with a break line.
Pack containing 12 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
So.Se.PHARM S.r.l.
Via dei Castelli Romani, 22
00071 Pomezia (Roma)
Italy

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
Italy

Advice/health education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics for you, it is because you specifically need them for your current illness.
Despite antibiotic treatment, certain bacteria may survive and grow. This phenomenon is called 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:
1 - Use antibiotics only when prescribed.
2 - Strictly follow your doctor's instructions.
3 - Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
4 - Never give your antibiotics to another person; they may not be suitable for their illness.
5 - At the end of treatment, return all unused medicines to a pharmacy, to ensure they are properly disposed of.
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