Ciprofloxacin ABC: detailed information

Patient Information Leaflet

Ciprofloxacin ABC 250 mg film-coated tablets

Ciprofloxacin
Generic 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 they have the same symptoms as you, because 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 ABC is and what it is used for
What you need to know before taking Ciprofloxacin ABC
How to take Ciprofloxacin ABC
Possible side effects
How to store Ciprofloxacin ABC
Contents of the pack and other information

1. What Ciprofloxacin ABC is and what it is used for

Ciprofloxacin ABC contains the active substance ciprofloxacin. Ciprofloxacin ABC is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause infections. It is effective only against specific strains of bacteria.

Adults
Ciprofloxacin ABC is used in adults to treat the following bacterial infections:

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

Ciprofloxacin may be used to manage patients with a low number of white blood cells (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 Ciprofloxacin ABC.

Children and adolescents
Ciprofloxacin ABC 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

Ciprofloxacin ABC 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 ABC

Do not take Ciprofloxacin ABC:

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

Warnings and precautions
Before taking this medicine
You must not take antibacterial medicines containing quinolones/fluoroquinolones, including
Ciprofloxacin ABC, 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.
Tell your doctor before taking Ciprofloxacin ABC:

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 a previous treatment with antibiotics such as Ciprofloxacin ABC.
If you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin.
If you suffer from severe myasthenia (a type of muscle weakness), as symptoms may worsen.
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 been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation).
If you have a family history of aortic aneurysm or dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s syndrome, high blood pressure, known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
If you have heart problems. Special caution is required when using Ciprofloxacin ABC if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), 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 female or elderly, or if you are taking other medicines that may cause abnormal changes on the ECG (see section 2 “Other medicines and Ciprofloxacin ABC”).
Inform your doctor if you or a family member is known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another
antibiotic in addition to ciprofloxacin. If there are no signs of improvement after 3 days of
treatment, consult your doctor.
While taking Ciprofloxacin ABC
Inform your doctor immediately if during treatment with Ciprofloxacin ABC you experience any
of the following conditions. Your doctor will decide whether treatment with
Ciprofloxacin ABC should be discontinued.

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, lightheadedness when standing. In such case, stop treatment with Ciprofloxacin ABC and contact your doctor immediately.
Serious, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin ABC, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or irreversible. These include tendon, muscle, and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, tickling, numbness, or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Ciprofloxacin ABC, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), if you have received an organ transplant, if you have kidney problems, or if you are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with Ciprofloxacin ABC. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin ABC, contact your doctor, and rest the affected area. Avoid unnecessary movements, as the risk of tendon rupture may increase.
If you experience sudden and severe pain in the abdomen, chest, or back, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).
If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience side effects affecting the central nervous system. In case of seizures, stop treatment with Ciprofloxacin ABC and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such case, stop treatment with Ciprofloxacin ABC and inform your doctor immediately to avoid permanent nerve damage.
Psychiatric reactions may occur the first time you take Ciprofloxacin ABC. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin ABC. In rare cases, depression and psychosis may progress to suicidal thoughts, suicide attempts, or suicide. In such case, contact your doctor immediately.
Quinolone antibiotics may cause elevated blood sugar levels (hyperglycaemia) above your normal range or lowered blood sugar levels below your normal range, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
During treatment with antibiotics, including Ciprofloxacin ABC, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking Ciprofloxacin ABC and contact your doctor immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.
If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
While taking Ciprofloxacin ABC, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin ABC if you need to have blood or urine tests.
If you have kidney problems, inform your doctor, as you may need a dosage adjustment.
Ciprofloxacin ABC may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, contact your doctor immediately.
Ciprofloxacin ABC may cause a reduction in 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 marked deterioration in general condition, or fever with signs of localized infection such as sore throat, throat or mouth pain, or urinary problems, contact your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.

Other medicines and Ciprofloxacin ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Do not take Ciprofloxacin ABC with tizanidine, as it may cause side effects such as
low blood pressure and drowsiness (see section 2: Do not take Ciprofloxacin ABC).
The following medicines interact with Ciprofloxacin ABC in the body. Taking Ciprofloxacin
ABC together with these medicines may affect their therapeutic effect and increase the
likelihood of side effects.
Inform your doctor if you are taking:

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

Ciprofloxacin ABC may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathy, or incontinence)
lidocaine (for heart problems or anaesthetic use)
sildenafil (e.g., for erectile dysfunction)
agomelatine (for depression)

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

antacids
omeprazole
mineral supplements
sucralfate
a polymer phosphate binder (e.g., sevelamer or lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium, or iron

If these preparations are essential, take Ciprofloxacin ABC approximately two hours before or no sooner than four hours after taking them.
Ciprofloxacin ABC with food and drink
Calcium intake as part of a meal, including dairy products and calcium-rich drinks (such as milk or yoghurt) or fortified fruit juices (e.g., calcium-fortified orange juice), does not significantly affect the absorption of this medicine. However, taking ciprofloxacin tablets together with dairy products or calcium-rich drinks when these products or drinks are taken alone and away from meals may reduce the effectiveness of this medicine.
Therefore, ciprofloxacin tablets should be taken one or two hours before or no sooner than four hours after consuming dairy products or calcium-rich drinks taken alone and away from meals (see also section 3).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy,
consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin during pregnancy.
Do not take Ciprofloxacin ABC while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin ABC may affect your level of alertness. Since neurological adverse events may occur, check how you react to Ciprofloxacin ABC before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take Ciprofloxacin ABC

Your doctor will explain exactly how much Ciprofloxacin ABC 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 a dosage adjustment may be necessary.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.
Always take this medicine 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
ABC.
a. Swallow the tablets with plenty of fluid.
b. If you are unable to swallow the tablets, inform your doctor.
c. Do not chew or crush the tablets, as they have an unpleasant taste.
d. Try to take the tablets at approximately the same time each day.
e. You may take the tablets with meals or between meals. You may take
ciprofloxacin tablets with meals containing dairy products (such as milk or yogurt) or
calcium-rich drinks (e.g. calcium-fortified orange juice). However, do not take
Ciprofloxacin ABC tablets at the same time as dairy products or calcium-rich drinks when
these dairy products or calcium-rich drinks are taken alone and away from meals.
Ciprofloxacin tablets should be taken either one or two hours before, or at least four hours after,
dairy products or calcium-rich drinks taken alone and away from meals.
Remember to drink plenty of fluids during treatment with this medicine.
If you take more Ciprofloxacin ABC than you should
If you take more than the prescribed dose, consult your doctor immediately. If possible, bring the
tablets or the packaging to show your doctor.
If you forget to take Ciprofloxacin ABC
If you forget to take Ciprofloxacin ABC and:

There are 6 hours or more until your next scheduled dose, take the missed dose immediately. Then take the next dose as scheduled.
There are less than 6 hours until your next scheduled dose, do not take the missed dose. Take the next dose as scheduled.

Do not take a double dose to make up for a forgotten dose. Make sure you complete the
course of treatment.
If you stop taking Ciprofloxacin ABC
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 soon, the infection may not be completely cured and
symptoms may return or worsen. You may also develop resistance to the antibiotic.
If you have any further questions about the use of this 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.
The following section lists the most serious side effects you may notice on your own:
Stop taking Ciprofloxacin ABC and contact your doctor immediately, who will assess an alternative antibiotic treatment, if you experience any of the following serious side effects:

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

Seizures (see section 2: Warnings and precautions)

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

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

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

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

Other side effects observed during treatment with Ciprofloxacin ABC are listed below by frequency:

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

Nausea, diarrhoea
Joint pain and joint inflammation in children

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

Joint pain in adults
Fungal superinfections
High concentration of eosinophils, a type of white blood cells
Decreased appetite
Hyperactivity, restlessness
Headache, dizziness, sleep disturbances, taste disturbances
Vomiting, abdominal pain, digestive problems such as stomach discomfort (indigestion/heartburn) or intestinal gas
Increase in certain substances in the blood (transaminases and/or bilirubin)
Skin rash, itching, hives
Reduced function
Muscle and bone pain, malaise (asthenia), or fever
Increased alkaline phosphatase in the blood (a certain substance in the blood)

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

Muscle pain, joint inflammation, increased muscle tone, and cramps
Inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2: Warnings and precautions)
Changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood clotting factor (platelets)
Allergic reaction, swelling (oedema), sudden swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions)
Increased blood sugar (hyperglycaemia)
Decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)
Confusion, disorientation, anxious reaction, unusual dreams, depression (which in rare cases may progress to suicidal thoughts, suicide attempts, or suicide) (see section 2: Warnings and precautions), or hallucinations
Tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, dizziness
Visual disturbances including double vision (see section 2: Warnings and precautions)
Tinnitus, hearing loss, decreased hearing
Rapid heartbeat (tachycardia)
Blood vessel dilation (vasodilation), low blood pressure, fainting
Shortness of breath, including asthma-like symptoms
Liver disorders, jaundice (cholestatic jaundice), or hepatitis
Light sensitivity (see section 2: Warnings and precautions)
Kidney failure, blood or crystals in urine, inflammation of the urinary tract
Fluid retention or excessive sweating
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) (see section 2: Warnings and precautions); a decrease in red blood cells, white blood cells, and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal; an allergic reaction called serum sickness-like reaction (see section 2: Warnings and precautions)
Mental disorders (psychotic reactions which in rare cases may progress to suicidal thoughts, suicide attempts, or suicide) (see section 2: Warnings and precautions)
Migraine, coordination problems, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), pressure in the brain (increased intracranial pressure including pseudotumor cerebri)
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 (see section 2: Warnings and precautions)
Pinpoint bleeding under the skin (petechiae); various types of skin rashes or rash
Worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

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

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

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Ciprofloxacin ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp". The expiry date refers to the last day of the 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacina ABC contains

The active substance is ciprofloxacin hydrochloride monohydrate. Each tablet contains 291 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 250 mg of ciprofloxacin.
The other components are: microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), macrogol 4000.

Description of the appearance of Ciprofloxacina ABC and pack contents
Pack containing 10 film-coated tablets of 250 mg.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)

Patient information leaflet: information for the patient

Ciprofloxacin ABC 500 mg film-coated tablets

Ciprofloxacin
Generic Medicine
Please 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ciprofloxacin ABC is and what it is used for

Ciprofloxacin ABC contains the active substance ciprofloxacin. Ciprofloxacin ABC is an antibiotic belonging to the family of fluoroquinolones. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only against certain strains of bacteria.

Adults
Ciprofloxacin ABC is used in adults to treat the following bacterial infections:

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

Ciprofloxacin may be used to manage patients with low white blood cell counts (neutropenia) who develop fever suspected to be due to bacterial infection.
If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe another antibiotic in addition to Ciprofloxacin ABC.

Children and adolescents
Ciprofloxacin ABC 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

Ciprofloxacin ABC 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 Ciprofloxacin ABC

Do not take Ciprofloxacin ABC:

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

Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including
Ciprofloxacin ABC, if you have previously experienced any serious adverse reaction during
treatment with a quinolone or fluoroquinolone. In such cases, inform your doctor as soon as possible.
Tell your doctor before taking Ciprofloxacin ABC:

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 ABC
If you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin
If you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen
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])
If you have heart problems. Particular caution is required when using Ciprofloxacin ABC if you were born with, or have a family history of, prolonged QT interval (seen on ECG, an electrical recording of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), have a very slow heart rate (called bradycardia), have weak heart function (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 the ECG (see section 2 “Other medicines and Ciprofloxacin ABC”)
Inform your doctor if you or a family member is known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin

For the treatment of certain genital tract infections, your doctor may prescribe another
antibiotic in addition to ciprofloxacin. If there are no signs of improvement after 3 days of
treatment, consult your doctor.
While taking Ciprofloxacin ABC
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin ABC. Your doctor will decide whether treatment with
Ciprofloxacin ABC should be discontinued.

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, dizziness upon standing. In such a case, stop treatment with Ciprofloxacin ABC and contact your doctor immediately.
Severe, prolonged, disabling and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin ABC, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling or may not resolve. These include tendon, muscle and joint pain in arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell and hearing, depression, memory impairment, severe fatigue and severe sleep disturbances. If you experience any of these side effects after taking Ciprofloxacin ABC, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider using an antibiotic from another class.
Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years), if you have received an organ transplant, if you have kidney problems or if you are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with Ciprofloxacin ABC. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder or knee), stop taking Ciprofloxacin ABC, contact your doctor and rest the affected area. Avoid unnecessary movement, as the risk of tendon rupture may increase.
If you experience sudden, severe pain in the abdomen, chest or back, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency department. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a rapid onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).
If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience adverse effects on the central nervous system. In case of seizures, stop treatment with Ciprofloxacin ABC and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such cases, stop taking Ciprofloxacin ABC and inform your doctor immediately to prevent permanent nerve damage.
Psychiatric reactions may occur the first time you take Ciprofloxacin ABC. If you suffer from depression or psychosis, your symptoms may worsen during treatment with
Ciprofloxacin ABC. In rare cases, depression and psychosis may progress to suicidal thoughts, suicide attempts or suicide. In such cases, contact your doctor immediately.
Quinolone antibiotics may cause blood sugar levels to rise above normal (hyperglycaemia) or fall below normal levels, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
Diarrhoea may develop during treatment with antibiotics, including Ciprofloxacin ABC, or even several weeks afterwards. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking Ciprofloxacin ABC and contact your doctor immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.
If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
During treatment with Ciprofloxacin ABC, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin ABC if you need to have blood or urine tests.
If you have kidney problems, inform your doctor, as you may need a dosage adjustment.
Ciprofloxacin ABC may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or abdominal pain, contact your doctor immediately.
Ciprofloxacin ABC 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 marked deterioration in general condition, or fever with signs of localized infection such as sore throat, pain in the throat or mouth 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.

Other medicines and Ciprofloxacin ABC
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Do not take Ciprofloxacin ABC with tizanidine, as it may cause side effects such as
low blood pressure and drowsiness (see section 2: Do not take Ciprofloxacin ABC).
The following medicines interact with Ciprofloxacin ABC in the body. Taking Ciprofloxacin
ABC together with these medicines may affect their therapeutic effect and increase the
likelihood of side effects.
Inform your doctor if you are taking:

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

Ciprofloxacin ABC may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathy or incontinence)
lidocaine (for heart problems or anaesthetic use)
sildenafil (e.g., for erectile dysfunction)
agomelatine (for depression)

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

antacids
omeprazole
mineral supplements
sucralfate
a polymeric phosphate binder (e.g., sevelamer and lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium or iron

If these preparations are essential, take Ciprofloxacin ABC approximately two hours before or no earlier than four hours after taking them.
Ciprofloxacin ABC with food and drink
Calcium intake as part of a meal, including dairy products and calcium-rich drinks (such as milk or yoghurt) or fortified fruit juices (e.g., calcium-fortified orange juice), does not significantly affect the absorption of this medicine. However, taking ciprofloxacin tablets together with dairy products or calcium-rich drinks when these products or drinks are taken alone and away from meals may reduce the effectiveness of this medicine.
Therefore, ciprofloxacin tablets should be taken one or two hours before or no less than four hours after consuming dairy products or calcium-rich drinks taken alone and away from meals (see also section 3).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning a pregnancy,
consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin ABC during pregnancy.
Do not take Ciprofloxacin ABC while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin ABC may affect your ability to concentrate. Since neurological adverse events may occur, check your response to Ciprofloxacin ABC before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take Ciprofloxacin ABC

Your doctor will explain exactly how much Ciprofloxacin ABC 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 a dose adjustment may be necessary.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.
Always take this medicine exactly as your doctor has instructed. Consult your doctor
or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacin
ABC.
f. Swallow the tablets with plenty of fluid.
g. If you are unable to swallow the tablets, inform your doctor.
h. Do not chew or crush the tablets, as they have an unpleasant taste.
i. Try to take the tablets at approximately the same time each day.
j. You may take the tablets with meals or between meals. You may take ciprofloxacin tablets with meals containing dairy products (such as milk or yoghurt) or calcium-rich drinks (e.g. calcium-fortified orange juice). However, do not take Ciprofloxacin ABC tablets at the same time as dairy products or calcium-rich drinks when these are consumed alone and away from meals. Ciprofloxacin tablets must be taken either one or two hours before, or no less than four hours after, consuming dairy products or calcium-rich drinks taken alone and away from meals.
Remember to drink plenty of fluids during treatment with this medicine.
If you take more Ciprofloxacin ABC than you should
If you take more than the prescribed dose, consult your doctor immediately. If possible, bring the tablets or the pack with you to show your doctor.
If you forget to take Ciprofloxacin ABC
If you forget to take Ciprofloxacin ABC and:

There are 6 hours or more until your next scheduled dose, take the missed dose immediately. Then take the next dose as scheduled.
There are less than 6 hours until your next scheduled dose, do not take the missed dose. Take the next dose as scheduled.

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 ABC
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 further 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 will get them.
The following section lists the most serious side effects you may notice on your own:
Stop taking Ciprofloxacina ABC and contact your doctor immediately, who will assess an alternative antibiotic treatment, if you experience any of the following serious side effects:

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

seizures (see section 2: Warnings and precautions)

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

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

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

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

Other side effects observed during treatment with Ciprofloxacina ABC are listed below by frequency:

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

nausea, diarrhoea
joint pain and joint inflammation in children

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

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

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

muscle pain, joint inflammation, increased muscle tone and cramps
inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2: Warnings and precautions)
changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood coagulation factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)
confusion, disorientation, anxious reaction, unusual dreams, depression (which in rare cases may progress to suicidal thoughts or suicide attempts or suicide) (see section 2: Warnings and precautions), or hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, dizziness
visual disturbances including double vision (see section 2: Warnings and precautions)
tinnitus, hearing loss, decreased hearing
rapid heartbeat (tachycardia)
dilation of blood vessels (vasodilation), low blood pressure, fainting
shortness of breath, including asthma-like symptoms
liver disorders, jaundice (cholestatic jaundice) or hepatitis
sensitivity to light (see section 2: Warnings and precautions)
kidney failure, blood or crystals in urine, inflammation of the urinary tract
fluid retention or excessive sweating
increased levels of the enzyme amylase

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

a specific type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis) (see section 2: Warnings and precautions); a reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal; an allergic reaction called serum sickness-like reaction (see section 2: Warnings and precautions)
psychiatric disorders (psychotic reactions which in rare cases may progress to suicidal thoughts or suicide attempts or suicide) (see section 2: Warnings and precautions)
migraine, coordination problems, unsteady gait (gait disturbances), smell disturbances (olfactory disorders), pressure in the brain (intracranial hypertension including pseudotumour cerebri)
distortions in colour perception
inflammation of blood vessel walls (vasculitis)
pancreatitis
death of liver cells (hepatic necrosis), which very rarely may lead to life-threatening liver failure (see section 2: Warnings and precautions)
pinpoint bleeding under the skin (petechiae); various types of skin rashes or rash
worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

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

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

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disorders, 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 regurgitation of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via 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 Ciprofloxacin ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after
"Exp". The expiry date refers to the last day of the month.
This medicine requires no 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 Ciprofloxacin ABC contains

The active substance is ciprofloxacin hydrochloride monohydrate. Each tablet contains 582 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 500 mg of ciprofloxacin.
The other components are: microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), polyethylene glycol 4000.

Description of the appearance of Ciprofloxacin ABC and contents of the pack
Pack containing 6 film-coated tablets of 500 mg.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)

Patient information leaflet

Ciprofloxacin ABC 750 mg film-coated tablets

Ciprofloxacin
Generic Medicinal Product
Please 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. Do not give it to other people, even if their symptoms are the same as yours, as it could 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 ABC is and what it is used for
What you need to know before taking Ciprofloxacin ABC
How to take Ciprofloxacin ABC
Possible side effects
How to store Ciprofloxacin ABC
Contents of the pack and other information

7. What Ciprofloxacina ABC is and what it is used for

Ciprofloxacina ABC contains the active substance ciprofloxacin. Ciprofloxacina ABC is an antibiotic belonging to the family of fluoroquinolones. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only against certain strains of bacteria.

Adults
Ciprofloxacina ABC is used in adults to treat the following bacterial infections:

respiratory tract infections
long-lasting or recurrent ear or sinus infections
urinary tract infections
genital infections in men and women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
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 Ciprofloxacina ABC.

Children and adolescents
Ciprofloxacina ABC 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

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

8. What you need to know before taking Ciprofloxacin ABC

Do not take Ciprofloxacin ABC:

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

Warnings and precautions
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including
Ciprofloxacin ABC, if you have previously experienced any serious adverse reaction during
treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Tell your doctor before taking Ciprofloxacin ABC:

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 ABC
If you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin
If you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen
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]).
If you have heart problems. Special caution is required when using Ciprofloxacin ABC if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes on the ECG (see section 2 “Other medicines and Ciprofloxacin ABC”).
Inform your doctor if you or a family member is known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another
antibiotic in addition to ciprofloxacin. If there are no symptoms of improvement after 3 days of
treatment, consult your doctor.
While taking Ciprofloxacin ABC
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin ABC. Your doctor will decide whether treatment with Ciprofloxacin ABC should be discontinued.

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 with the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing. In such a case, stop treatment with Ciprofloxacin ABC and contact your doctor immediately.
Serious, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin ABC, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, abnormal sensations such as tingling, pins and needles, itching, numbness, or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances. If you experience any of these side effects after taking Ciprofloxacin ABC, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider using an antibiotic from another class.
Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with Ciprofloxacin ABC. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin ABC, contact your doctor, and rest the affected area. Avoid unnecessary movements, as the risk of tendon rupture may increase.
If you experience sudden, severe pain in the abdomen, chest, or back, which may be a symptom of aortic aneurysm or dissection, go to the emergency room immediately. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (feeling of rapid or irregular heartbeat).
If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience side effects affecting the central nervous system. In case of seizures, stop taking Ciprofloxacin ABC and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such a case, stop taking Ciprofloxacin ABC and contact your doctor immediately to avoid permanent nerve damage.
Psychiatric reactions may occur the first time you take Ciprofloxacin ABC. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin ABC. In rare cases, depression and psychosis may progress to suicidal thoughts, suicide attempts, or suicide. In such a case, contact your doctor immediately.
Quinolone antibiotics may cause increased blood sugar levels (hyperglycaemia) or decreased blood sugar levels below normal, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
During treatment with antibiotics, including Ciprofloxacin ABC, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking Ciprofloxacin ABC and contact your doctor immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.
If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
While taking Ciprofloxacin ABC, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as from sunbeds.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin ABC if you need to have blood or urine tests.
If you have kidney problems, inform your doctor, as you may need a dosage adjustment.
Ciprofloxacin ABC may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, contact your doctor immediately.
Ciprofloxacin ABC may cause a reduction in the number of white blood cells, which may lead to reduced resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in your general condition, or fever with symptoms of localized infection such as sore throat or pain in the throat or mouth or urinary problems, you must consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.

Other medicines and Ciprofloxacin ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Ciprofloxacin ABC with tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2: Do not take Ciprofloxacin ABC).
The following medicines interact with Ciprofloxacin ABC in the body. Taking Ciprofloxacin ABC together with these medicines may affect their therapeutic effect and increase the likelihood of side effects.
Inform your doctor if you are taking:

Vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
theophylline (for respiratory problems)
tizanidine (for muscle spasticity in multiple sclerosis)
olanzapine (an antipsychotic)
clozapine (an antipsychotic)
ropinirole (for Parkinson's disease)
phenytoin (for epilepsy)
metoclopramide (for nausea and vomiting)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic group (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics
zolpidem (for sleep disorders).

Ciprofloxacin ABC may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathy, or incontinence)
lidocaine (for heart problems or anaesthetic use)
sildenafil (e.g., for erectile dysfunction)
agomelatine (for depression).

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

antacids
omeprazole
mineral supplements
sucralfate
a polymeric phosphate binder (e.g., sevelamer or lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium, or iron

If these preparations are essential, take Ciprofloxacin ABC approximately two hours before or no sooner than four hours after taking them.
Ciprofloxacin ABC with food and drinks
Calcium intake as part of a meal, including dairy products and calcium-rich drinks (such as milk or yoghurt) or calcium-fortified fruit juices (e.g., calcium-enriched orange juice), does not significantly affect the absorption of this medicine. However, administering ciprofloxacin tablets together with dairy products or calcium-rich drinks when these products or drinks are taken alone between meals may reduce the effectiveness of this medicine.
Therefore, ciprofloxacin tablets should be taken one or two hours before or no sooner than four hours after consuming dairy products or calcium-rich drinks taken alone between meals (see also section 3).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin during pregnancy.
Do not take Ciprofloxacin ABC while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin ABC may affect your level of alertness. Since neurological adverse events may occur, check how you react to Ciprofloxacin ABC before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

9. How to take Ciprofloxacin ABC

Your doctor will explain exactly how much Ciprofloxacin ABC 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 this medicine exactly as instructed by your doctor. Consult your doctor
or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacin
ABC.
k. Swallow the tablets with plenty of fluid.
l. If you are unable to swallow the tablets, inform your doctor.
m. Do not chew or crush the tablets, as they have an unpleasant taste.
n. Try to take the tablets at approximately the same time each day.
o. You may take the tablets with meals or between meals. You may take
ciprofloxacin tablets with meals containing dairy products (such as milk or yogurt) or
calcium-rich drinks (e.g. calcium-fortified orange juice). However, do not take
Ciprofloxacin ABC tablets at the same time as dairy products or calcium-rich drinks when these are consumed alone and away from meals. Ciprofloxacin tablets must be taken either one or two hours before, or at least four hours after, consuming dairy products or calcium-rich drinks on their own and away from meals.
Remember to drink plenty of fluids during treatment with this medicine.

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

If you forget to take Ciprofloxacin ABC
If you forget to take Ciprofloxacin ABC and:

There are 6 hours or more until your next scheduled dose, take the missed dose immediately. Then take the next dose as scheduled.
There are less than 6 hours until your next scheduled dose, do not take the missed dose. Take the next dose as scheduled.

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 ABC
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 further questions about the use of this medicine, consult your doctor or pharmacist.

10. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following section lists the most serious adverse reactions that you may notice on your own:
Stop taking Ciprofloxacin ABC and contact your doctor immediately, who will assess an alternative antibiotic treatment, if you experience any of the following serious adverse reactions:

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

Seizures (see section 2: Warnings and precautions)

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

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

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

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

Other adverse reactions observed during treatment with Ciprofloxacin ABC are listed below according to their frequency:

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

Nausea, diarrhoea
Joint pain and joint inflammation in children

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

Joint pain in adults
Fungal superinfections
High concentration of eosinophils, a type of white blood cells
Decreased appetite
Hyperactivity, restlessness
Headache, dizziness, sleep disturbances, taste disturbances
Vomiting, abdominal pain, digestive problems such as stomach discomfort (indigestion/heartburn) or intestinal gas
Increase in certain substances in the blood (transaminases and/or bilirubin)
Skin rash, itching, urticaria
Reduced kidney function
Muscle and bone pain, malaise (asthenia), or fever
Increased alkaline phosphatase in the blood (a certain substance in the blood)

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

Muscle pain, joint inflammation, increased muscle tone, and cramps
Inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2: Warnings and precautions)
Changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increase or decrease in a blood clotting factor (platelets)
Allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions)
Increased blood sugar (hyperglycaemia)
Decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)
Confusion, disorientation, anxious reaction, unusual dreams, depression (which in rare cases may progress to suicidal thoughts, suicide attempts, or suicide) (see section 2: Warnings and precautions), or hallucinations
Tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, dizziness
Visual disturbances including double vision (see section 2: Warnings and precautions)
Tinnitus, hearing loss, decreased hearing
Rapid heartbeat (tachycardia)
Blood vessel dilation (vasodilation), low blood pressure, fainting
Shortness of breath, including asthma-like symptoms
Liver disorders, jaundice (cholestatic jaundice), or hepatitis
Sensitivity to light (see section 2: Warnings and precautions)
Kidney failure, blood or crystals in urine, inflammation of the urinary tract
Fluid retention or excessive sweating
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) (see section 2: Warnings and precautions); a decrease in red blood cells, white blood cells, and platelets (pancytopenia), which may be fatal; bone marrow suppression, which may also be fatal; an allergic reaction called serum sickness-like reaction (see section 2: Warnings and precautions)
Mental disorders (psychotic reactions which in rare cases may progress to suicidal thoughts, suicide attempts, or suicide) (see section 2: Warnings and precautions)
Migraine, coordination problems, unsteady gait (gait disturbances), smell disturbances (olfactory disturbances), pressure in the brain (intracranial hypertension including pseudotumour cerebri)
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 (see section 2: Warnings and precautions)
Pinpoint bleeding under the skin (petechiae); various types of skin rashes or rash
Worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

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

Syndrome associated with impaired water excretion and low sodium levels (SIADH)
Intense feeling of excitement (mania) or extreme optimism and hyperactivity (hypomania)
Abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as "QT interval prolongation", visible on ECG, the heart's electrical activity)
Effects on blood clotting (in patients treated with vitamin K antagonists)
Loss of consciousness due to severe drop in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, mental health effects (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal ideation), and changes in hearing, vision, taste, and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

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

11. How to store Ciprofloxacin ABC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after
"Exp". The expiry date refers to the last day of the 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 no longer required. This will help protect the environment.

12. Package contents and other information

What Ciprofloxacin ABC contains

The active substance is ciprofloxacin hydrochloride monohydrate. Each tablet contains 873 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 750 mg of ciprofloxacin.
The other ingredients are: microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose (E464), macrogol 4000.

Description of the appearance of Ciprofloxacin ABC and package contents
Pack containing 12 film-coated tablets of 750 mg.
Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin
Manufacturer
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR)