Package leaflet: Information for the user

CIPROFLOXACIN DOC Generics 250 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.

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

Contents of this leaflet:

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

1. What CIPROFLOXACINA DOC Generici is and what it is used for

CIPROFLOXACINA DOC Generici 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 specific strains of bacteria.
Adults
CIPROFLOXACINA DOC Generici 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 organ infections in women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
treatment of infections in patients with very low white blood cell count (neutropenia)
prevention of infections in patients with very low white blood cell count (neutropenia)
prevention of infections caused by the bacterium Neisseria meningitidis
exposure to inhalation of anthrax spores

If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe another antibiotic treatment in addition to CIPROFLOXACINA DOC Generici.
Children and adolescents
CIPROFLOXACINA DOC Generici 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

CIPROFLOXACINA DOC Generici may also be used to treat other specific severe infections in children and adolescents, when considered necessary by the physician.

2. What you should know before taking CIPROFLOXACINA DOC Generici

Do not take CIPROFLOXACINA DOC Generici

if you are allergic to ciprofloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6)
if you are taking tizanidine (see section 2 “Other medicines and CIPROFLOXACINA DOC Generici”).

Warnings and precautions
Talk to your doctor before taking CIPROFLOXACINA DOC Generici:

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 had tendon problems during previous treatment with antibiotics such as CIPROFLOXACINA DOC Generici
if you have severe myasthenia (a type of muscle weakness)
if you have experienced heart rhythm disturbances (arrhythmias)
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 a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure, or known atherosclerosis). If you experience sudden abdominal, chest, or back pain, go immediately to the emergency room.

Use this medicine with caution if you have: congenital QT prolongation or a family history of QT interval prolongation
(documented by ECG, recording of the heart's electrical activity)
electrolyte imbalances (especially low potassium or magnesium levels in the blood)
very slow heart rate (bradycardia)
heart failure
myocardial infarction
if you are female or elderly
if you are taking other medicines that may cause abnormal ECG findings (see section
Taking CIPROFLOXACINA DOC Generici with other medicines).

While taking CIPROFLOXACINA DOC Generici
Inform your doctor immediately if any of the following conditions occur during treatment with CIPROFLOXACINA DOC Generici. Your doctor will decide whether treatment should be discontinued.

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, lightheadedness when standing. In this case, stop taking CIPROFLOXACINA DOC Generici and contact your doctor immediately.
Occasionally, CIPROFLOXACINA DOC Generici may cause joint pain and swelling and tendinitis, especially if you are elderly or receiving corticosteroid treatment. Tendon inflammation and rupture may occur as early as within the first 48 hours of treatment or even several months after stopping therapy with ciprofloxacin. At the first sign of pain or inflammation, stop taking CIPROFLOXACINA DOC Generici and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
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 this case, stop taking CIPROFLOXACINA DOC Generici and contact your doctor immediately.
Psychiatric reactions may occur the first time you take CIPROFLOXACINA DOC Generici. If you suffer from depression or psychosis, your symptoms may worsen during treatment with CIPROFLOXACINA DOC Generici. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempt, or suicide. In this case, stop taking CIPROFLOXACINA DOC Generici and contact your doctor immediately.
You may experience symptoms of neuropathy, such as pain, burning, tingling, numbness, and/or weakness. In this case, stop taking CIPROFLOXACINA DOC Generici and contact your doctor immediately.
During treatment with antibiotics, including CIPROFLOXACINA DOC Generici, or even several weeks after, you may develop diarrhea. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking CIPROFLOXACINA DOC Generici immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal motility and contact your doctor.
Inform your doctor or laboratory staff that you are taking CIPROFLOXACINA DOC Generici if you need to undergo blood or urine tests.
CIPROFLOXACINA DOC Generici may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach tenderness, stop taking CIPROFLOXACINA DOC Generici and contact your doctor immediately.
CIPROFLOXACINA DOC Generici may cause a reduction in the number of white blood cells, leading to decreased resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of general condition, or fever with signs of localized infection such as sore throat, throat or mouth pain, or urinary problems, 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 your vision deteriorates or if your eyes are otherwise affected, consult an ophthalmologist immediately.
Inform your doctor if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anemia with ciprofloxacin.
While taking CIPROFLOXACINA DOC Generici, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to strong sunlight and artificial UV light, such as sunbeds.

Other medicines and CIPROFLOXACINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take CIPROFLOXACINA DOC Generici together with tizanidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2 “Do not take CIPROFLOXACINA DOC Generici”).
The following medicines interact with CIPROFLOXACINA DOC Generici in the body. Taking CIPROFLOXACINA DOC Generici together with these medicines may affect their therapeutic effect. It may also increase the likelihood of adverse effects.
You must inform your doctor if you are taking 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.
Inform your doctor if you are taking:

vitamin K antagonists (e.g. warfarin) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
metoclopramide (for nausea and vomiting)
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)
- agomelatine (an antidepressant)
ropinirole (for Parkinson’s disease)
phenytoin (for epilepsy)
ciclosporin (for certain skin conditions, rheumatoid arthritis, and organ transplants)
glibenclamide (for diabetes).

CIPROFLOXACINA DOC Generici may increase blood levels of the following medicines:

agomelatine
zolpidem
- pentoxifylline (for circulatory disorders)
- caffeine
- duloxetine (for depression, nerve damage caused by diabetes, or incontinence)
- lidocaine (for heart problems or used as an anesthetic)
- sildenafil (for erectile dysfunction).

Some medicines reduce the effect of CIPROFLOXACINA DOC Generici. Inform your doctor if you are taking or intend to take:

antacids
omeprazole
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 CIPROFLOXACINA DOC Generici approximately two hours before or no sooner than four hours after taking them.

CIPROFLOXACINA DOC Generici 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 ingredient.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine.
It is preferable to avoid using CIPROFLOXACINA DOC Generici during pregnancy.
Do not take CIPROFLOXACINA DOC Generici while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
CIPROFLOXACINA DOC Generici may affect your level of alertness. Since neurological adverse events may occur, check how you react to CIPROFLOXACINA DOC Generici before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take CIPROFLOXACIN DOC Generici

Your doctor will explain exactly how much CIPROFLOXACIN DOC Generici 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 dosage may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Always take the tablets exactly as directed by your doctor. If you are unsure about the dosage or how to take CIPROFLOXACIN DOC Generici, consult your doctor or pharmacist.
a. Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.
b. Try to take the tablets at approximately the same time each day.
c. You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take CIPROFLOXACIN DOC Generici with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with CIPROFLOXACIN DOC Generici.

If you take more CIPROFLOXACIN DOC Generici than you should
If you take more than the prescribed dose, contact your doctor immediately. If possible, take the tablets or the packaging along to show the doctor.

If you forget to take CIPROFLOXACIN DOC Generici
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 your regular dosing 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 CIPROFLOXACIN DOC Generici
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 antibiotic resistance.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Common (may affect from 1 to 10 people in 100):

nausea, diarrhoea
joint pain in children.

Uncommon (may affect from 1 to 10 people in 1,000):

fungal superinfections
high concentration of eosinophils, a type of white blood cells
loss of appetite (anorexia)
hyperactivity, agitation
headache, dizziness, sleep disturbances, taste disturbances
vomiting, abdominal pain, digestive problems such as stomach discomfort (indigestion/heartburn) or intestinal gas
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 certain substance present in the blood).

Rare (may affect from 1 to 10 people in 10,000):

inflammation of the intestine (colitis) associated with the use of antibiotics (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 coagulation factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially progress to suicidal thoughts, suicide attempt or suicide), hallucinations
tingling, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremor, seizures (including status epilepticus) (see section 2 “Warnings and precautions”), dizziness
visual disturbances (e.g. 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 “Warnings and precautions”)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in urine (see section 2 “Warnings and precautions”), inflammation of the urinary tract
fluid retention, excessive sweating
increased levels of the enzyme amylase.

Very rare (may affect less than 1 person in 10,000):

a particular type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis); a reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow suppression, which may also be fatal (see section 2 “Warnings and precautions”)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2 “Warnings and precautions”)
mental disorders (psychotic reactions), which may potentially progress to suicidal thoughts, suicide attempt or suicide (see section 2 “Warnings and precautions”)
migraine, coordination disorders, unsteady gait (gait disturbances), smell disorders (olfactory disturbances), pressure on the brain (intracranial hypertension)
distortions in colour perception
inflammation of blood vessel walls (vasculitis)
pancreatitis
death of liver cells (hepatic necrosis), which very rarely may lead to life-threatening liver failure
pinpoint bleeding under the skin (petechiae); various types of skin rashes (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon located at the back of the ankle (Achilles tendon) (see section 2 “Warnings and precautions”); worsening of symptoms of myasthenia gravis (see section 2 “Warnings and precautions”).

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

disorders associated with the nervous system, such as pain, burning, tingling, numbness and/or weakness of the extremities
abnormal increase in heart rate, life-threatening irregular heartbeat, changes in heart rhythm (called “prolongation of the QT interval”, documented by ECG, electrical activity of the heart)
skin rash with pustules
effect on blood coagulation (in patients treated with vitamin K antagonists)
feeling of euphoria (mania) or sensation of great optimism and hyperactivity (hypomania)
hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
Syndrome associated with impaired water excretion and low sodium levels (SIADH)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CIPROFLOXACIN DOC Generici

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 packaging after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 CIPROFLOXACINA DOC Generici contains

The active substance is ciprofloxacin. Each tablet contains 250 mg of ciprofloxacin (as hydrochloride).
The other components are: Tablet core: maize starch, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, macrogol 4000, titanium dioxide (E171).

Description of the appearance of CIPROFLOXACINA DOC Generici and contents of the pack
CIPROFLOXACINA DOC Generici 250 mg film-coated tablets are white, round, biconvex, coated tablets with a score line on one side.
CIPROFLOXACINA DOC Generici 250 mg film-coated tablets are available in packs of 10 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l. – Via Turati 40 – 20121 – Milan - Italy.
Manufacturer:
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43 - 24041 Brembate (BG) – Italy.

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: CIPROFLOXACINA DOC Generici 250 mg film-coated tablets.

Advice/health education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed you antibiotics, you need them specifically 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 prescribed:

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 treating 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 so they can be properly disposed of.

Patient Information Leaflet: Information for the User

CIPROFLOXACIN DOC Generics 500 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CIPROFLOXACINA DOC Generici is and what it is used for

CIPROFLOXACINA DOC Generici 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
CIPROFLOXACINA DOC Generici 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 very low white blood cell count (neutropenia)
to prevent infections in patients with very low white blood cell count (neutropenia)
to prevent infections caused by the bacterium Neisseria meningitidis
exposure to inhalation of anthrax spores

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

CIPROFLOXACINA DOC Generici may also be used to treat other specific severe infections in children and adolescents, when considered necessary by the physician.

2. What you need to know before taking CIPROFLOXACIN DOC Generics

Do not take CIPROFLOXACIN DOC Generics

if you are allergic to ciprofloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6)
if you are taking tizanidine (see section 2 “Other medicines and CIPROFLOXACIN DOC Generics”).

Warnings and precautions
Talk to your doctor before taking CIPROFLOXACIN DOC Generics:

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 had tendon problems during previous treatment with antibiotics such as CIPROFLOXACIN DOC Generics
if you suffer from severe myasthenia (a type of muscle weakness)
if you have experienced heart rhythm disturbances (arrhythmias)
if you have been diagnosed with an 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 a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure, or known atherosclerosis). If you experience sudden abdominal, chest, or back pain, go immediately to the emergency room.

Use this medicine with caution if you have:
congenital QT prolongation or a family history of QT interval prolongation
(documented by ECG, recording of the heart's electrical activity)
electrolyte imbalances (especially low potassium or magnesium levels in the blood)
very slow heart rate (bradycardia)
heart failure
myocardial infarction
if you are female or elderly
if you are taking other medicines that may cause abnormal ECG findings (see section
"Taking CIPROFLOXACIN DOC Generics with other medicines").

While taking CIPROFLOXACIN DOC Generics
Inform your doctor immediately if any of the following conditions occur during treatment with CIPROFLOXACIN DOC Generics. Your doctor will decide whether you should stop treatment with
CIPROFLOXACIN DOC Generics.

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, dizziness upon standing. In this case, stop treatment with CIPROFLOXACIN DOC Generics and contact your doctor immediately.
Occasionally, CIPROFLOXACIN DOC Generics may cause joint pain and swelling and tendinitis, especially if you are elderly or receiving corticosteroid treatment. Tendon inflammation and rupture may occur as early as within the first 48 hours of treatment or even several months after stopping therapy with ciprofloxacin. At the first sign of pain or inflammation, stop taking CIPROFLOXACIN DOC Generics and rest the affected area. Avoid unnecessary physical activity, as it may increase the risk of tendon rupture.
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 a case, stop taking CIPROFLOXACIN DOC Generics and contact your doctor immediately.
Psychiatric reactions may occur the first time you take CIPROFLOXACIN DOC Generics. If you suffer from depression or psychosis, your symptoms may worsen during treatment with CIPROFLOXACIN DOC Generics. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempt, or suicide. In such a case, stop taking CIPROFLOXACIN DOC Generics and contact your doctor immediately.
You may experience symptoms of neuropathy, such as pain, burning, tingling, numbness, and/or weakness. In this case, stop taking CIPROFLOXACIN DOC Generics and contact your doctor immediately.
During treatment with antibiotics, including CIPROFLOXACIN DOC Generics, or even several weeks afterwards, diarrhea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking CIPROFLOXACIN DOC Generics 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 CIPROFLOXACIN DOC Generics if you need to have blood or urine tests.
CIPROFLOXACIN DOC Generics may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, stop taking CIPROFLOXACIN DOC Generics and contact your doctor immediately.
CIPROFLOXACIN DOC Generics may reduce the number of white blood cells, which may lead to decreased resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with symptoms of localized infection such as sore throat, throat or mouth pain, or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.
If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
Inform your doctor if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anemia with ciprofloxacin.
During treatment with CIPROFLOXACIN DOC Generics, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as tanning beds.

Other medicines and CIPROFLOXACIN DOC Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take CIPROFLOXACIN DOC Generics together with tizanidine, as this may cause adverse effects such as low blood pressure and drowsiness (see section 2 “Do not take CIPROFLOXACIN DOC Generics”).
The following medicines interact with CIPROFLOXACIN DOC Generics in the body. Taking CIPROFLOXACIN DOC Generics together with these medicines may affect their therapeutic effect. It may also increase the likelihood of adverse effects.
You must inform your doctor if you are taking 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.
Inform your doctor if you are taking:

vitamin K antagonists (e.g. warfarin) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
metoclopramide (for nausea and vomiting)
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)
- agomelatine (an antidepressant)
ropinirole (for Parkinson's disease)
phenytoin (for epilepsy)
ciclosporin (for certain skin conditions, rheumatoid arthritis, and organ transplants)
glibenclamide (for diabetes).

CIPROFLOXACIN DOC Generics may increase blood levels of the following medicines:

agomelatine
zolpidem
- pentoxifylline (for circulatory disorders)
- caffeine
- duloxetine (for depression, nerve damage caused by diabetes, or incontinence)
- lidocaine (for heart problems or used as an anesthetic)
- sildenafil (for erectile dysfunction).

Certain medicines reduce the effect of CIPROFLOXACIN DOC Generics. Inform your doctor if you are taking or planning to take:

antacids
omeprazole
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 CIPROFLOXACIN DOC Generics approximately two hours before or no sooner than four hours after taking them.

CIPROFLOXACIN DOC Generics with food and drinks
Unless otherwise directed, do not eat or drink dairy products (such as milk or yogurt) or calcium-fortified beverages at the same time as taking the tablets, as they may interfere with the absorption of the active ingredient.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
It is preferable to avoid using CIPROFLOXACIN DOC Generics during pregnancy.
Do not take CIPROFLOXACIN DOC Generics while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
CIPROFLOXACIN DOC Generics may affect your level of alertness. Since neurological adverse events may occur, check how you react to CIPROFLOXACIN DOC Generics before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take CIPROFLOXACIN DOC Generici

Your doctor will explain exactly how much CIPROFLOXACIN DOC Generici 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 dosage may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Always take
the tablets exactly as directed by your doctor. Consult your doctor or pharmacist if you are unsure
about how many tablets to take or how to take CIPROFLOXACIN DOC Generici.
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 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 CIPROFLOXACIN DOC Generici 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 CIPROFLOXACIN DOC Generici.
If you take more CIPROFLOXACIN DOC Generici 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 CIPROFLOXACIN DOC Generici
Take the missed dose as soon as possible and then continue as prescribed. However, if it is almost time for
your next dose, do not take the missed dose and continue your regular dosing 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 CIPROFLOXACIN DOC Generici
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.

Common (may affect from 1 to 10 people in 100):

nausea, diarrhoea
joint pain in children.

Uncommon (may affect from 1 to 10 people in 1,000):

fungal superinfections
high concentration of eosinophils, a type of white blood cells
loss of appetite (anorexia)
hyperactivity, agitation
headache, dizziness, sleep disturbances, taste disturbances
vomiting, abdominal pain, digestive problems such as stomach discomfort (indigestion/heartburn) or intestinal gas
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 certain substance present in the blood).

Rare (may affect from 1 to 10 people in 10,000):

inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2 “Warnings and precautions”)
changes in the number of blood cells (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood coagulation factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially progress to suicidal thoughts, suicide attempt or suicide), hallucinations
tingling, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremor, seizures (including status epilepticus) (see section 2 “Warnings and precautions”), dizziness
visual disturbances (e.g. seeing double)
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”)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in the urine (see section 2 “Warnings and precautions”), inflammation of the urinary tract
fluid retention, excessive sweating
increased levels of amylase enzyme.

Very rare (may affect less than 1 person in 10,000):

a particular type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis); a reduction 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 “Warnings and precautions”)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2 “Warnings and precautions”)
mental disorders (psychotic reactions), which may potentially progress to suicidal thoughts, suicide attempt or suicide (see section 2 “Warnings and precautions”)
migraine, coordination disorders, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), pressure in the brain (intracranial hypertension)
colour vision disturbances
inflammation of blood vessel walls (vasculitis)
pancreatitis
liver cell death (hepatic necrosis), which very rarely may lead to life-threatening liver failure
pinpoint bleeding under the skin (petechiae); various types of skin rashes (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2 “Warnings and precautions”); worsening of symptoms of myasthenia gravis (see section 2 “Warnings and precautions”).

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

nervous system-related disorders such as pain, burning, tingling, numbness and/or weakness of the extremities
abnormal increase in heart rate, life-threatening irregular heartbeat, changes in heart rhythm (called “QT interval prolongation”, documented by ECG, electrical activity of the heart)
skin rash with pustules
effects on blood coagulation (in patients treated with vitamin K antagonists)
feeling of euphoria (mania) or sensation of great optimism and hyperactivity (hypomania)
hypersensitivity reaction identified as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
Syndrome associated with impaired water excretion and low sodium levels (SIADH)

Reporting of side effects
If you experience any side effects, 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 the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CIPROFLOXACIN DOC Generici

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 that month.
This medicine requires no special storage conditions.
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 CIPROFLOXACIN DOC Generici contains

The active substance is ciprofloxacin. Each tablet contains 500 mg of ciprofloxacin (as hydrochloride).
The other components are:

Tablet core: maize starch, microcrystalline cellulose, crospovidone, anhydrous colloidal silica,
magnesium stearate.
Tablet coating: hypromellose, macrogol 4000, titanium dioxide (E171).

Description of the appearance of CIPROFLOXACIN DOC Generici and package contents
CIPROFLOXACIN DOC Generici 500 mg film-coated tablets are white, oblong, biconvex, film-coated tablets with a break line on one side.
CIPROFLOXACIN DOC Generici 500 mg film-coated tablets are available in packs of 6 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l. – Via Turati 40 - 20121 Milan - Italy.
Manufacturer:
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43 - 24041 Brembate (BG) – Italy.

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: CIPROFLOXACIN DOC Generici 500 mg film-coated tablets.

Advice/health 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 multiply. This phenomenon is known as resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. If you do not follow the prescribed:

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 by a doctor.
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 another person; they may not be suitable for their condition.
5 – At the end of treatment, return any unused medicines to a pharmacy for proper disposal.

Package leaflet: Information for the user

CIPROFLOXACIN DOC Generics 750 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CIPROFLOXACINA DOC Generici is and what it is used for

CIPROFLOXACINA DOC Generici is an antibiotic belonging to the fluoroquinolone family.
The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections.
It is effective only against specific strains of bacteria.
Adults
CIPROFLOXACINA DOC Generici 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
genital infections in women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
to treat infections in patients with very low white blood cell count (neutropenia)
to prevent infections in patients with very low white blood cell count (neutropenia)
to prevent infections caused by the bacterium Neisseria meningitidis
exposure to inhaled anthrax spores

If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe another antibiotic in addition to CIPROFLOXACINA DOC Generici.
Children and adolescents
CIPROFLOXACINA DOC Generici 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 inhaled anthrax spores

CIPROFLOXACINA DOC Generici may also be used to treat other specific severe infections in children and adolescents, when considered necessary by the physician.

2. What you should know before taking CIPROFLOXACIN DOC Generics

Do not take CIPROFLOXACIN DOC Generics

if you are allergic to ciprofloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6)
if you are taking tizanidine (see section 2 “Other medicines and CIPROFLOXACIN DOC Generics”).

Warnings and precautions
Talk to your doctor before taking CIPROFLOXACIN DOC Generics:

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 had tendon problems during previous treatment with antibiotics such as CIPROFLOXACIN DOC Generics
if you suffer from severe myasthenia (a type of muscle weakness)
if you have experienced heart rhythm disturbances (arrhythmias)
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 a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, high blood pressure, or known atherosclerosis). If you experience sudden abdominal, chest, or back pain, go immediately to the emergency room.

Caution is required when using this medicine if you have: congenital QT prolongation or a family history of QT interval prolongation
(documented by ECG, recording of the heart's electrical activity)
electrolyte imbalances (especially low potassium or magnesium levels in the blood)
very slow heart rate (bradycardia)
heart failure
myocardial infarction
if you are female or elderly
if you are taking other medicines that may cause abnormal ECG findings (see section
“Taking CIPROFLOXACIN DOC Generics with other medicines”).

While taking CIPROFLOXACIN DOC Generics
Inform your doctor immediately if any of the following conditions occur during treatment with CIPROFLOXACIN DOC Generics. Your doctor will decide whether treatment should be discontinued.

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. In this case, stop taking CIPROFLOXACIN DOC Generics and contact your doctor immediately.
Occasionally, CIPROFLOXACIN DOC Generics may cause joint pain and swelling and tendinitis, especially if you are elderly or receiving corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping ciprofloxacin therapy. At the first sign of pain or inflammation, stop taking CIPROFLOXACIN DOC Generics and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.
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 this case, stop taking CIPROFLOXACIN DOC Generics and contact your doctor immediately.
Psychiatric reactions may occur the first time you take CIPROFLOXACIN DOC Generics. If you suffer from depression or psychosis, your symptoms may worsen during treatment with CIPROFLOXACIN DOC Generics. Rarely, depression or psychosis may progress to suicidal thoughts, suicide attempts, or suicide. In this case, stop taking CIPROFLOXACIN DOC Generics and contact your doctor immediately.
You may experience symptoms of neuropathy, such as pain, burning, tingling, numbness, and/or weakness. In this case, stop taking CIPROFLOXACIN DOC Generics and contact your doctor immediately.
During treatment with antibiotics, including CIPROFLOXACIN DOC Generics, or even several weeks afterwards, you may develop diarrhea. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking CIPROFLOXACIN DOC Generics immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal motility and contact your doctor.
Inform your doctor or laboratory staff that you are taking CIPROFLOXACIN DOC Generics if you are scheduled for blood or urine tests.
CIPROFLOXACIN DOC Generics may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, stop taking CIPROFLOXACIN DOC Generics and contact your doctor immediately.
CIPROFLOXACIN DOC Generics may reduce the number of white blood cells, which can lead to reduced resistance to infections. If you develop an infection with symptoms such as fever and severe deterioration in general condition, or fever with localized infection symptoms such as sore throat, throat or mouth pain, or urinary problems, contact your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.
If your vision deteriorates or your eyes are otherwise affected, consult an ophthalmologist immediately.
Inform your doctor if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anemia with ciprofloxacin.
During treatment with CIPROFLOXACIN DOC Generics, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to strong sunlight and artificial UV light, such as sunbeds.

You must inform your doctor if you are taking 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.

Inform your doctor if you are taking:

vitamin K antagonists (e.g. warfarin) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
metoclopramide (for nausea and vomiting)
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)
- agomelatine (an antidepressant)
ropinirole (for Parkinson’s disease)
phenytoin (for epilepsy)
ciclosporin (for certain skin conditions, rheumatoid arthritis, and organ transplants)
glibenclamide (for diabetes)

CIPROFLOXACIN DOC Generics may increase blood levels of the following medicines:

agomelatine
zolpidem
- pentoxifylline (for circulatory disorders)
- caffeine
- duloxetine (for depression, nerve damage caused by diabetes, or incontinence)
- lidocaine (for heart problems or used as an anesthetic)
- sildenafil (for erectile dysfunction)

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

antacids
omeprazole
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 CIPROFLOXACIN DOC Generics approximately two hours before or no sooner than four hours after taking them.

CIPROFLOXACIN DOC Generics with food and drinks
Unless otherwise directed, do not consume dairy products (such as milk or yogurt) or calcium-fortified drinks at the same time as taking the tablets, as they may interfere with the absorption of the active ingredient.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
It is preferable to avoid using CIPROFLOXACIN DOC Generics during pregnancy.
Do not take CIPROFLOXACIN DOC Generics while breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

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

3. How to take CIPROFLOXACIN DOC Generici

Your doctor will tell you exactly how much CIPROFLOXACIN DOC Generici 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 dosage may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may be longer for severe infections. Always take the tablets exactly as your doctor has instructed. If you are unsure about how many tablets to take or how to take CIPROFLOXACIN DOC Generici, consult your doctor or pharmacist.
a. Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.
b. Try to take the tablets at approximately the same time each day.
c. You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take CIPROFLOXACIN DOC Generici with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with CIPROFLOXACIN DOC Generici.
If you take more CIPROFLOXACIN DOC Generici than you should
If you take more than the prescribed dose, contact your doctor immediately. If possible, take the tablets or the packaging with you to show the doctor.
If you forget to take CIPROFLOXACIN DOC Generici
Take the missed 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 your regular dosing schedule. Do not take a double dose to make up for a missed dose. Make sure you complete the full course of treatment.
If you stop taking CIPROFLOXACIN DOC Generici
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 antibiotic resistance.
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 everyone experiences them.

Common (may affect from 1 to 10 people in 100):

nausea, diarrhoea
joint pain in children.

Uncommon (may affect from 1 to 10 people in 1,000):

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

Rare (may affect from 1 to 10 people in 10,000):

inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2 “Warnings and precautions”)
changes in the number of blood cells (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood clotting factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially progress to suicidal thoughts, suicide attempt or suicide), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor, seizures (including status epilepticus) (see section 2 “Warnings and precautions”), dizziness
visual disturbances (e.g. double vision)
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”)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in the urine (see section 2 “Warnings and precautions”), inflammation of the urinary tract
fluid retention, excessive sweating
increased levels of amylase enzyme.

Very rare (may affect less than 1 person in 10,000):

a particular type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis); a reduction 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 “Warnings and precautions”)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2 “Warnings and precautions”)
mental disorders (psychotic reactions), which may potentially progress to suicidal thoughts, suicide attempt or suicide (see section 2 “Warnings and precautions”)
migraine, coordination disorders, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), pressure on the brain (intracranial hypertension)
distortions in colour perception
inflammation of blood vessel walls (vasculitis)
pancreatitis
liver cell death (hepatic necrosis), which very rarely may lead to life-threatening liver failure
pinpoint bleeding under the skin (petechiae); various types of skin rashes (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2 “Warnings and precautions”); worsening of symptoms of myasthenia gravis (see section 2 “Warnings and precautions”).

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

disorders related to the nervous system, such as pain, burning, tingling, numbness and/or weakness of the extremities
abnormal increase in heart rate, life-threatening irregular heartbeat, changes in heart rhythm (known as “QT interval prolongation”, documented by ECG, electrical activity of the heart)
skin rash with pustules
effects on blood coagulation (in patients treated with vitamin K antagonists)
sensation of euphoria (mania) or sensation of excessive optimism and hyperactivity (hypomania)
Hypersensitivity reaction identified as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
Syndrome associated with impaired water excretion and low sodium levels (SIADH)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store CIPROFLOXACIN DOC Generici

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 that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CIPROFLOXACINA DOC Generici contains

The active substance is ciprofloxacin. Each tablet contains 750 mg of ciprofloxacin (as hydrochloride).
The other components are: Tablet core: maize starch, microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate. Tablet coating: hypromellose, macrogol 4000, titanium dioxide (E171).

Description of the appearance of CIPROFLOXACINA DOC Generici and package contents
CIPROFLOXACINA DOC Generici 750 mg film-coated tablets are white, elliptical, biconvex, film-coated tablets with the number '6' printed on one side.
CIPROFLOXACINA DOC Generici 750 mg film-coated tablets are available in packs of 12 tablets.

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: CIPROFLOXACINA DOC Generici 750 mg film-coated tablets.

Advice/health education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, it is because you specifically need them 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 prescribed:

dosage
frequency of administration
duration of treatment

you may 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 treating a similar illness.
4 – Never give your antibiotics to another person; they may not be suitable for their condition.
5 – At the end of treatment, return any unused medicines to your pharmacy, to ensure they are properly disposed of.

Ciprofloxacin Doc Generici

Package leaflet: Information for the user

CIPROFLOXACIN DOC Generics 250 mg film-coated tablets

1. What CIPROFLOXACINA DOC Generici is and what it is used for

2. What you should know before taking CIPROFLOXACINA DOC Generici

3. How to take CIPROFLOXACIN DOC Generici

4. Possible side effects

5. How to store CIPROFLOXACIN DOC Generici

6. Package contents and other information

Patient Information Leaflet: Information for the User

CIPROFLOXACIN DOC Generics 500 mg film-coated tablets

1. What CIPROFLOXACINA DOC Generici is and what it is used for

2. What you need to know before taking CIPROFLOXACIN DOC Generics

3. How to take CIPROFLOXACIN DOC Generici

4. Possible side effects

5. How to store CIPROFLOXACIN DOC Generici

6. Package contents and other information

Package leaflet: Information for the user

CIPROFLOXACIN DOC Generics 750 mg film-coated tablets

1. What CIPROFLOXACINA DOC Generici is and what it is used for

2. What you should know before taking CIPROFLOXACIN DOC Generics

3. How to take CIPROFLOXACIN DOC Generici

4. Possible side effects

5. How to store CIPROFLOXACIN DOC Generici

6. Package contents and other information