Package leaflet: Information for the user

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

Ciprofloxacin
Equivalent medicine
Please read this leaflet carefully before taking this medicine.

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 any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What BATTIZER is and what it is used for
Before you take BATTIZER
How to take BATTIZER
Possible side effects
How to store BATTIZER
Contents of the pack and other information

1. WHAT BATTIZER IS AND WHAT IT IS USED FOR

BATTIZER contains the active substance ciprofloxacin, 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
BATTIZER is used in adults:

for the treatment of respiratory tract infections;
for the treatment of long-lasting or recurrent ear or paranasal sinus infections;
for the treatment of urinary tract infections;
for the treatment of testicular infections;
for the treatment of genital organ infections in women;
for the treatment of gastrointestinal and intra-abdominal infections;
for the treatment of skin and soft tissue infections;
for the treatment of bone and joint infections;
to treat infections in patients with a very low white blood cell count (neutropenia);
to prevent infections in patients with a very low white blood cell count (neutropenia);
to prevent infections caused by the bacterium Neisseria meningitidis (which causes meningitis);
to prevent and treat infections caused by 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 BATTIZER.

Children and adolescents
BATTIZER is used in children and adolescents under specialist supervision:

to treat lung and bronchial infections in children and adolescents with cystic fibrosis;
to treat complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis);
to prevent and treat infections caused by inhalation of anthrax spores.

BATTIZER 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 BATTIZER

Do not take BATTIZER

if you are allergic (hypersensitive) to ciprofloxacin or to other quinolones or to any of the other ingredients of this medicine (listed in section 6)
if you are being treated with tizanidine (see section: "Other medicines and BATTIZER")

Warnings and precautions
Talk to your doctor or pharmacist before taking BATTIZER:

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, aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an autoimmune inflammatory disease], or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, high blood pressure, known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).

If you experience sudden 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.
Immediately inform your doctor 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 (feeling of rapid or irregular heartbeat).
Before taking BATTIZER
Before taking this medicine
Do not take antibacterial medicines containing quinolones/fluoroquinolones, including BATTIZER, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such case, inform your doctor as soon as possible.
Inform your doctor:

if you have kidney problems, as your treatment may need to be adjusted to avoid an increase in adverse drug reactions caused by accumulation of ciprofloxacin
if you suffer from epilepsy or other neurological disorders
if you have had tendon problems during previous treatment with antibiotics such as BATTIZER
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)
if you have experienced disturbances in heart rhythm (arrhythmias)

Heart problems
Special caution is required when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on ECG, a recording of the heart's electrical activity), 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 attacks (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section “Other medicines and BATTIZER”).
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 BATTIZER
When taking this medicine
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 being treated with corticosteroids.
Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with BATTIZER. At the first signs of pain or inflammation in a tendon (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop treatment with BATTIZER, consult your doctor, and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture could increase.
Immediately inform your doctor if while taking BATTIZER you experience any of the conditions listed below. Your doctor will decide whether treatment with BATTIZER should be discontinued.

A severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). There is a small 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 when standing. In such case, stop treatment with BATTIZER and contact your doctor immediately.
If you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke, you may experience adverse effects on the central nervous system. In such case, stop treatment with BATTIZER and contact your doctor immediately.
Psychiatric reactions may occur the first time you take BATTIZER. If you suffer from depression or psychosis, your symptoms may worsen during treatment with BATTIZER. In such case, stop treatment with BATTIZER 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 BATTIZER and inform your doctor immediately to prevent permanent nerve damage.
Quinolone antibiotics may cause an increase above your normal levels of blood sugar (hyperglycaemia) or a decrease below your normal levels of blood sugar, 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 BATTIZER, 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 BATTIZER 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 BATTIZER if you need to have blood or urine tests.
BATTIZER may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, stop taking BATTIZER and contact your doctor immediately.
BATTIZER may cause a reduction in the number of white blood cells, which may result in decreased resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with symptoms of localized infection such as sore throat or pain in the throat or mouth 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.
Inform your doctor if you or a family member suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin.
While taking BATTIZER, your skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as from sunbeds.
If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.

Serious, prolonged, disabling, and potentially irreversible adverse effects
Fluoroquinolone/quinolone antibacterial medicines, including BATTIZER, have been associated with very rare but serious adverse effects, some of which are prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in the 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, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these adverse effects after taking BATTIZER, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will also consider using an antibiotic from another class.
Other medicines and BATTIZER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take BATTIZER together with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "What you should know before taking BATTIZER").
You must inform your doctor if you are taking other medicines that may alter heart rhythm: medicines belonging to the class of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics.
Some medicines interact with BATTIZER in the body. Taking BATTIZER together with these medicines may affect their therapeutic effect and increase the likelihood of adverse effects.
Inform your doctor if you are taking:

vitamin K antagonists (e.g. warfarin) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
theophylline (for respiratory problems)
tizanidine (for muscle spasticity in multiple sclerosis)
clozapine (an antipsychotic)
ropinirole (for Parkinson’s disease)
phenytoin (for epilepsy)
olanzapine (an antipsychotic)
metoclopramide (for nausea and vomiting)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
glibenclamide (for diabetes)

BATTIZER 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 (for erectile dysfunction or high blood pressure)
agomelatine
zolpidem

Certain medicines reduce the effect of BATTIZER. 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 BATTIZER approximately two hours before or no sooner than four hours after taking them.
BATTIZER with food and drink
Food taken during meals does not significantly affect absorption.
However, concomitant administration of ciprofloxacin on an empty stomach with dairy products, dairy derivatives, or mineral-enriched drinks (e.g. milk, yoghurt, or orange juice fortified with calcium) should be avoided, as absorption of ciprofloxacin may be reduced.
Tablets may be taken independently of meals.
Taking the medicine on an empty stomach accelerates absorption of the active substance.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is preferable to avoid using BATTIZER during pregnancy. Inform your doctor if you are planning a pregnancy.
Breastfeeding
Do not take BATTIZER while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
BATTIZER may interfere with your level of attention. Since neurological adverse events may occur, check your response to BATTIZER before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take BATTIZER

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much BATTIZER you should take, how often, and for how long. This will depend on the type and severity of your infection.
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 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 BATTIZER.

Instructions for administration
a. Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.
b. Try to take the tablets at approximately the same time each day.
c. You may take the tablets with meals or between meals. Calcium taken during meals does not significantly affect absorption. However, do not take BATTIZER tablets with dairy products such as milk or yogurt, or with fruit juices fortified with minerals (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with BATTIZER.

If you take more BATTIZER 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 BATTIZER
Take the missed dose as soon as you remember, then continue as prescribed. However, if it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a forgotten dose. Make sure you complete the full course of treatment.

If you stop treatment with BATTIZER
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 product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, BATTIZER may cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

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 (stomach discomfort, indigestion/heartburn), intestinal gas
increase in certain blood substances (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 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 blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increase or decrease in platelet count
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes which may cause difficulty in breathing and swallowing (angioedema)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially lead to suicidal ideation/thoughts or attempted suicide or completed suicide) (see section 2: "Warnings and precautions"), hallucinations (seeing or hearing things that do not exist)
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor, seizures (see section 2: "Warnings and precautions"), dizziness
visual disturbances (e.g. diplopia)
tinnitus, hearing loss, decreased hearing
rapid heartbeat (tachycardia)
dilation of blood vessels (vasodilation), low blood pressure, transient loss of consciousness (syncope)
breathlessness, 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 urine (see section 2: "Warnings and precautions"), inflammation of the urinary tract
fluid retention, excessive sweating
abnormal levels of a coagulation factor (prothrombin), increased levels of amylase enzyme, sign of pancreatic impairment

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")
psychiatric disorders (psychotic reactions which may potentially lead to suicidal ideation/thoughts or attempted suicide or completed suicide) (see section 2: "Warnings and precautions"), migraine, coordination disorders, unsteady gait (gait disturbances), smell disturbances (olfactory disturbances), pressure on the brain (increased intracranial pressure including pseudotumour cerebri)
colour vision disturbances
inflammation of blood vessel walls (vasculitis)
pancreatitis (inflammation of the pancreas)
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., erythema multiforme, erythema nodosum, Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
muscle weakness, tendon inflammation, tendon rupture – particularly of the large tendon at the back of the ankle (Achilles tendon) (see section 2: Special warnings with BATTIZER); worsening of symptoms of myasthenia gravis (see section 2: "Warnings and precautions")

Not known (cannot be estimated from the available data)

nervous system disorders such as pain, burning, tingling, numbness and/or weakness of the extremities
Syndrome associated with impaired water elimination and low sodium levels (SIADH)
Loss of consciousness due to a severe decrease in blood sugar levels (hypoglycaemic coma). See section 2.
heart problems: abnormally fast heart rhythm, life-threatening irregular heart rhythm, changes in heart rhythm (called “prolongation of the QT interval”, seen on ECG, electrical activity of the heart)
acute generalised exanthematous pustulosis (AGEP)
increased international normalized ratio (INR) (in patients treated with vitamin K antagonists)
Feeling of over-excitement (mania) or feeling of extreme 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)

Very rare cases of prolonged (lasting for months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, 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 thoughts), 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 adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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.

5. HOW TO STORE BATTIZER

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use BATTIZER after the expiry date stated on the blister and carton after “Exp.”. The expiry date refers to the last day of the month.
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 BATTIZER contains
The active substance is ciprofloxacin hydrochloride monohydrate.
BATTIZER 250 mg film-coated tablets
One film-coated tablet contains 291 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 250 mg of
ciprofloxacin.
BATTIZER 500 mg film-coated tablets
One film-coated tablet contains 582 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 500 mg of
ciprofloxacin.
BATTIZER 750 mg film-coated tablets
One film-coated tablet contains 873 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 750 mg of
ciprofloxacin.
The other components are: Microcrystalline cellulose (E460), sodium starch glycolate, crospovidone (E1202),
corn starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose
(E464), macrogol 4000.
Description of the appearance of BATTIZER and pack contents
BATTIZER 250 mg film-coated tablets
White, round, film-coated tablets.
Pack size: 10 tablets
BATTIZER 500 mg film-coated tablets
White, oval, film-coated tablets with a score line.
Pack size: 6 tablets
BATTIZER 750 mg film-coated tablets
White, oval, film-coated tablets.
Pack size: 12 tablets
Marketing Authorization Holder
S.F. GROUP srl
Via Tiburtina n 1143 – 00156 Rome, Italy
Manufacturer
Special Product's Line S.p.A
Via Fratta Rotonda Vado Largo, n° 1

Battizer