GENERFLON 250 mg Film-Coated Tablets

Зміст інструкції

1. GENERFLON 250 mg film-coated tablets
   1. What Generflon is and what it is used for
   2. What you need to know before taking Generflon
   3. How to take Generflon
   4. Possible side effects
   5. How to store Generflon
   6. Contents of the pack and other information

GENERFLON 250 mg film-coated tablets

GENERFLON 500 mg film-coated tablets
GENERFLON 750 mg film-coated tablets
ciprofloxacin
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Generflon is and what it is used for
• 2. What you need to know before you take Generflon
• 3. How to take Generflon
• 4. Possible side effects
• 5. How to store Generflon
• 6. 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 ingredient is
ciprofloxacin. Ciprofloxacin works by killing the bacteria that cause infections. It only works on
specific strains of bacteria.
Adults
Generflon is used in adults to treat the following bacterial infections:

• respiratory tract infections;
• long-lasting or recurrent ear or sinus infections;
• urinary tract infections;
• testicular infections;
• infections of the female genital organs;
• gastrointestinal and intra-abdominal infections;
• skin and soft tissue infections;
• bone and joint infections;
• to treat infections in patients with a very low number of white blood cells (neutropenia);
• to prevent infections in patients with a very low number of white blood cells (neutropenia);
• to prevent infections caused by the bacterium Neisseria meningitidis;
• exposure to inhalation of anthrax spores.

Ciprofloxacin can be used to manage patients with a low number of white blood cells
(neutropenia) who develop a fever suspected to be due to bacterial infection.
If you have a serious infection, or one caused by more than one type of bacteria, you may be prescribed 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 suffering from cystic fibrosis;
• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis);
• exposure to inhalation of anthrax spores.

Generflon can also be used to treat other specific serious infections in children and
adolescents, if deemed necessary by the doctor.

2. What you need to know before taking Generflon

Quinolone antibiotics can cause an increase above your normal levels of blood sugars
(hyperglycemia) or a decrease below your normal blood sugar levels, which
in severe cases can potentially lead to a loss of consciousness (hypoglycemic coma) (see
paragraph 4). This is important for people who have diabetes. If you suffer from diabetes, blood
sugar levels must be carefully monitored.

Do not take Generflon if:

• you are allergic (hypersensitive) to the active ingredient, to other quinolones or to any of the other components of this medicine (see paragraph 6);
• you are taking tizanidine (see paragraph 2: Taking Generflon with other medicines).

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines based on quinolones/fluoroquinolones, including Generflon, if in
the past you have had any serious adverse reactions during treatment with a quinolone or
fluoroquinolone. In this case, inform your doctor as soon as possible.

Talk to your doctor or pharmacist before taking Generflon:

• if you have had kidney problems, as the treatment may need to be adjusted;
• if you suffer from epilepsy or other neurological disorders;
• if you have had tendon problems during a previous treatment with antibiotics such as Generflon;
• if you suffer from myasthenia gravis (a type of muscle weakness);
• if you have suffered from heart rhythm disturbances (arrhythmias);
• if your vision is impaired or if your eyes seem to be otherwise affected, consult an ophthalmologist immediately;
• if you have been diagnosed with an enlargement of, 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 and mitral regurgitation);
• if you have a family history of aneurysm or dissection of the aorta or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or 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, high blood pressure or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [an inflammation of the heart]).

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For the treatment of some infections of the genital tract, 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 care must be taken when using this type of medicine, if you were born with or have a
family history of prolonged QT interval (displayed on an ECG, an electrical recording of the heart), have
an electrolyte imbalance in the blood (especially a low level 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 can cause abnormal changes in the ECG (see section

Taking Generflon with other medicines”).

If you experience sudden abdominal, chest, or back pain, go to the emergency room immediately.
While taking Generflon
Immediately inform your doctor if during the intake of Generflonyou experience any of the conditions
listed below. The doctor will decide whether to interrupt the treatment with Generflon.

• If your vision should decrease or if your eyes should be affected in any other way, consult an ophthalmologist immediately.
• A severe and sudden allergic reaction(anaphylactic/anaphylactic shock, angioedema). There is a remote possibility that a severe and sudden allergic reaction may occur even with the first dose, with the following symptoms: tightness in the chest, dizziness, nausea or fainting, dizziness when standing up. In this case, stop treatment with Generflon and contact your doctor immediately.
• if you experience severe, sudden abdominal, chest, or back pain, which may be a symptom of aneurysm and dissection of the aorta, go to the emergency room immediately. The risk may be greater if you are taking systemic corticosteroids.
• Immediately inform your doctor if you notice a rapid onset of shortness of breath, especially when lying in bed, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of rapid or irregular heartbeat).
• Pain and swelling of the joints and inflammation or rupture of the tendons can rarely occur. The risk is greater if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems or are being treated with corticosteroids. Inflammation and rupture of the tendons can occur within the first 48 hours of treatment and up to several months after the end of therapy with Generflon. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop treatment with Generflon, consult your doctor and keep the painful part at rest. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
• If you suffer from epilepsyor other neurological disorders, such as cerebral ischemia or stroke, you may experience adverse effects on the central nervous system. In this case, stop treatment with Generflon and contact your doctor immediately.
• Psychiatric reactionscan occur the first time you take Generflon. If you suffer from depressionor psychosis, your symptoms may worsen during treatment with Generflon. In rare cases, depression or psychotic reactions can lead to suicidal thoughts, suicide attempts or suicide. In this case, stop treatment with Generflon and contact your doctor immediately.
• Symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms, can rarely occur. In this case, stop treatment with Generflon and immediately inform your doctor, to prevent nerve damage from becoming permanent.

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During treatment with antibiotics, including Generflon, or even several weeks later, diarrheacan develop. If it worsens or persists, or if you notice blood or mucus in your stool, you should stop taking Generflon immediately, as it may be a life-threatening form. Do not take medicines that block or reduce bowel movements and contact your doctor.

Inform your doctor or laboratory staff that you are taking Generflon if you need to have blood or urine tests.

Generflon can cause liver damage. If you notice symptoms such as loss of appetite, jaundice(yellowing of the skin), dark urine, itching or abdominal tenderness, stop takingGenerflon and contact your doctor immediately.

Generflon can cause a reduction in the number of white blood cells, which can lead to a lower resistance to infections. If you experience an infection with symptoms such as fever and marked deterioration of general conditions, or fever with symptoms of localized infection, such as sore throat or sore throat or mouth problems or urinary problems, you should consult your doctor immediately. You will be given a blood test to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about the medicine.

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

During the intake of Generflon, the skin becomes more sensitive to sunlight or ultraviolet (UV) radiation.Avoid exposure to intense sunlight and artificial UV radiation, such as from tanning beds.

Serious, prolonged, disabling and non-improving side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including Generflon, have been associated with
very rare but serious side effects, some of which are prolonged (lasting months or years), disabling
or that may not improve. These include pain in the tendons, muscles and joints of arms
and legs, difficulty walking, abnormal sensations such as tingling, tingling, itching, numbness
or burning (paresthesia), disorders of the senses such as altered vision, taste, smell and
hearing, depression, impaired memory, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking Generflon, contact
your doctor immediately before continuing treatment. The doctor will decide together with you whether
to continue treatment and will also consider the use of an antibiotic from another class.

Other medicines and Generflon
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
You must inform your doctor if you are taking other medicines that can alter the heart rate:

• medicines that belong to the class of antiarrhythmics (for example quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
• tricyclic antidepressants;
• some antimicrobials (which belong to the macrolide group);
• some antipsychotics.

Do not take Generflon together with tizanidine,as it may cause side effects such as low
blood pressure and drowsiness (see paragraph 2: "Do not take Generflon").
The following medicines interact with Ciprofloxacin in the body. Taking Generflon together with
these medicines can affect their therapeutic effect and increase the likelihood of
side effects.
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Tell your doctor if you are taking:

• warfarin or other oral anticoagulants (to thin the blood);
• probenecid (for gout);
• methotrexate (for certain types of cancer, for psoriasis or for rheumatoid arthritis);
• theophylline (for breathing problems);
• tizanidine (for muscle spasticity in multiple sclerosis);
• clozapine (an antipsychotic);
• ropinirole (for Parkinson's disease);
• phenytoin (for epilepsy);
• cyclosporine (in case of transplants);
• glibenclamide (for diabetes).

Generflon can increasethe levels of the following medicines in the blood:

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

Certain medicines reducethe effect of Generflon. Tell your doctor if you are taking or intend to take:

• antacids;
• omeprazole (antacid);
• mineral supplements;
• sucralfate;
• a polymeric phosphate binder (e.g. sevelamer);
• medicines or supplements containing calcium, magnesium, aluminum or iron. If these preparations are essential, take Generflon about two hours before their intake, or no earlier than four hours after.

Generflon with food, beverages and alcohol
Unless you take Generflon during meals, do not eat or drink dairy products (such as milk or yogurt) or
beverages supplemented with calcium when taking the tablets, as they may interfere with
the absorption of the active ingredient.

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.
It is preferable to avoid the use of Ciprofloxacin during pregnancy. Tell your doctor if you are planning
a pregnancy.
Do not take Generflon during breastfeeding, as ciprofloxacin is excreted in
breast milk and may be harmful to your baby .
Driving and operating machinery
Generflon can interfere with your state of attention. As neurological adverse events may occur,
check your reactions to Generflon before driving a vehicle or operating machinery. If you
are in doubt, talk to your doctor.
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3. How to take Generflon

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The doctor will explain to you exactly how much Generflon you need to take, how often and for how
long.
This will depend on the type of infection you have and its severity.
Tell your doctor if you have kidney problems, as a dosage adjustment may be necessary.
Usually the treatment lasts from 5 to 21 days, but may last longer for severe infections.
Always take the tablets following exactly the doctor's instructions. Consult your doctor or
pharmacist if you are not sure how many tablets to take and how to take Generflon.

• a. Swallow the tablets with plenty of fluid. Do not chew the tablets as they have an unpleasant taste.
• b. Try to take the tablets at about the same time each day.
• c. You can take the tablets with meals or in between meals. Calcium taken during meals does not significantly affect absorption. However, do nottake Generflon 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 Generflon.

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

If you forget to take Generflon
Take the normal dose as soon as possible and then continue as prescribed. However, if it is almost time for
the next dose, do not take the missed dose and continue as usual. Do not take a double dose to
make up for a missed dose. Make sure to complete the course of treatment.

If you stop taking Generflon
It is important that you complete the course of treatmenteven if you start to feel better after a few days.
If you stop taking this medicine too soon, the infection may not be completely
cured and the symptoms of the infection may return or worsen. You may also develop
antibiotic resistance.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Generflon can cause side effects, although not everybody gets them.
If any of these side effects gets serious, or if you notice any side effect not listed here, tell your doctor or pharmacist.
The following paragraph lists the serious side effects that you may experience on your own:

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

• convulsions (see section 2: While taking Generflon)

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

• severe allergic reaction (anaphylactic reaction, including anaphylactic shock, which can be fatal - serum sickness) (see section 2: While taking Generflon); 6/10
• muscle weakness, tendon inflammation, tendon rupture - especially of the large tendon located 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 haemorrhages 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 available data)

• disorders associated with the nervous system, such as pain, burning, tingling, numbness and/or weakness of the extremities;
• appearance of widespread pustules (Acute Generalized Exanthematous Pustulosis - AGEP);
• allergic reaction called DRESS (Drug Reaction with eosinophilia and systemic symptoms).

The following paragraph lists other side effects that have been observed during treatment
with ciprofloxacin, based on 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):

• superinfections caused by fungi;
• high concentration of eosinophils, a type of white blood cells;
• decreased appetite;
• hyperactivity, agitation;
• headache, dizziness, sleep disorders, taste disturbances;
• vomiting, abdominal pain, digestive problems (stomach upset, indigestion/heartburn), intestinal gas;
• increased levels of certain substances in the blood (transaminases and/or bilirubin);
• skin rash, itching, hives;
• joint pain in adults;
• reduced kidney function;
• muscle and bone pain, feeling unwell (asthenia), fever;
• increased alkaline phosphatase in the blood (a certain substance present in the blood).

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

• inflammation of the intestine (colitis) associated with the use of antibiotics (in very rare cases it can be fatal) (see section 2: While taking Generflon);
• changes in the number of blood cells (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease of a blood coagulation factor (platelets);
• allergic reaction, swelling (edema), acute swelling of the skin and mucous membranes (angioedema);
• increased blood sugar (hyperglycemia);
• decreased blood sugar (hypoglycemia) (see section 2 “Warnings and Precautions”);
• confusion, disorientation, anxiety reaction, unusual dreams, depression (potentially culminating in suicidal ideation/suicidal thoughts, suicide and attempted suicide) (see section 2: While taking GENERFLON), hallucinations;
• tingling, unusual sensitivity to stimuli, decreased skin sensitivity, tremor, vertigo;
• visual disturbances (double vision);
• tinnitus, hearing loss, decreased hearing;
• fast heartbeat (tachycardia);
• dilation of blood vessels (vasodilation), low blood pressure, fainting;

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• shortness of breath, including asthma symptoms;
• liver disorders, jaundice (cholestatic jaundice), hepatitis;
• sensitivity to light (see section 2: While taking Generflon);
• muscle pain, inflammation of the joints, increased muscle tone, cramps;
• renal failure, blood or crystals in the urine (see section 2: Pay particular attention with Generflon), inflammation of the urinary tract;
• fluid retention, excessive sweating;
• abnormal levels of a coagulation factor (prothrombin), increased levels of the amylase enzyme.

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

• a particular type of decrease in red blood cells (hemolytic anemia); a dangerous decrease in a type of white blood cells (agranulocytosis); a decrease in red blood cells, white blood cells and platelets (pancytopenia), which can be fatal; bone marrow depression, which can also be fatal (see section 2: While taking Generflon);
• mental disorders (psychotic reactions potentially culminating in suicidal ideation/suicidal thoughts, suicide and attempted suicide) (see section 2: While taking Generflon);
• migraine, coordination disorders, unsteady gait (walking disorders), disturbances of smell (olfactory disorders), pressure on the brain (increased intracranial pressure and pseudotumor cerebri);
• distortions in color perception;
• inflammation of the blood vessel walls (vasculitis);
• pancreatitis;
• death of liver cells (hepatic necrosis), which very rarely can lead to liver failure that is life-threatening.

Not known(frequency cannot be estimated from available data)

• abnormally fast heart rate, dangerously irregular heart rhythm, alteration of heart rhythm (called “prolongation of the QT interval”, shown on the ECG, heart electrical activity);
• increased blood clotting time (increased International Normalized Ratio
• INR);
• feeling very 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 a severe decrease in blood sugar levels (hypoglycemic coma). See section 2.

Very rare cases of adverse drug reactions, prolonged (lasting months or years) or permanent, 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, impaired memory and concentration, effects on mental health
(which may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation),
alteration of hearing, vision, taste and smell, have been associated with the use of antibiotics of the
quinolone and fluoroquinolone type, in some cases regardless of pre-existing risk factors.
Cases of dilation and weakening of the aortic wall or tearing of the aortic wall (aneurysms and
dissections), with possible ruptures that can be fatal, as well as cases of backflow of blood from the
heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
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If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Generflon

No particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use Generflon after the expiry date which is reported on the blister or on the carton after "Scad.". The date
of expiry refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect
the environment.

6. Contents of the pack and other information

What Generflon contains
Generflon 250 mg film-coated tablets
One film-coated tablet contains:

Active ingredient:ciprofloxacin hydrochloride monohydrate: 291 mg (equivalent to ciprofloxacin 250 mg)

Excipients:microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202, corn starch,
anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E 171), macrogol

• 4000.

Generflon 500 mgtabletsfilm-coated
One film-coated tablet contains:

Active ingredient:ciprofloxacin hydrochloride monohydrate: 582 mg (equivalent to ciprofloxacin 500 mg)

Excipients:microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202, corn starch,
anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E 171), macrogol
4000

Generflon 750 mg film-coated tablets
One film-coated tablet contains:

Active ingredient:ciprofloxacin hydrochloride monohydrate: 873 mg (equivalent to ciprofloxacin 750 mg)

Excipients:microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202, corn starch,
anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E 171), macrogol

• 4000.

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

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

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 for viral infections.
If your doctor has prescribed antibiotics, you need them precisely for the current illness.
Despite antibiotics, certain bacteria can survive and grow. This phenomenon is called
resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You can even promote the development of resistance
in bacteria and delay healing or decrease the effectiveness of antibiotics if you do not adhere to:

• dosage
• frequency of intake
• duration of treatment

Consequently, to safeguard 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 prescription, even if you want to treat a similar illness.
• 4 - Never give your antibiotic to another person; it may not be suitable for their illness.
• 5 - At the end of treatment, return all unused medicines to the pharmacy to ensure they are disposed of correctly

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