Package leaflet: Information for the user

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

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

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

Contents of this leaflet:

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

1. What Bosix is and what it is used for

Bosix contains the active substance ciprofloxacin. Bosix is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only against certain strains of bacteria.
Adults
Bosix 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 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 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 in addition to Bosix.
Children and adolescents
Bosix 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

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

2. What you should know before taking Bosix

Do not take Bosix:

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 Bosix)

Warnings and precautions
Before taking this medicine
You must not take antibacterial medicines containing quinolones/fluoroquinolones, including Bosix, if in the past you have experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Inform your doctor before taking Bosix

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 Bosix
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 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 Bosix 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 Bosix”)
Inform your doctor if you or a family member are 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 Bosix
Inform your doctor immediately if while taking Bosix any of the following conditions occur. Your doctor will decide whether treatment with Bosix should be discontinued.

A severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility of a severe and sudden allergic reaction even after the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing. In such a case, stop taking Bosix and contact your doctor immediately.
Severe, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Bosix, 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, prickling, tickling, numbness, or burning (paraesthesia), sensory organ disorders 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 Bosix, 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), 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 Bosix. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Bosix, contact your doctor, and rest the affected area. Avoid any 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 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 adverse effects on the central nervous system. In case of seizures, stop taking Bosix and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) may occur, such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms. In such a case, stop taking Bosix and inform your doctor immediately to prevent permanent nerve damage.
Psychiatric reactions may occur even when taking quinolone antibiotics, including Bosix, for the first time. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Bosix. In rare cases, depression and psychosis may progress to suicidal thoughts and self-harming behaviours such as suicide attempts or suicide (see section 4: Possible side effects). If you experience depression, psychosis, or suicidal thoughts or behaviours, contact your doctor immediately.
Quinolone antibiotics may cause increased blood sugar levels above your normal range (hyperglycaemia) or decreased 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 particularly 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 Bosix, or even several weeks afterwards. If it worsens or persists, or if you notice blood or mucus in your stool, you must stop taking Bosix 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 your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
While taking Bosix, 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 Bosix if you need to have blood or urine tests.
If you have kidney problems, inform your doctor, as you may require a dosage adjustment.
Bosix 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.
Bosix may cause a reduction in the number of white blood cells, leading to reduced 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, mouth pain, or urinary problems, consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.

Other medicines and Bosix
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Bosix with tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2: Do not take Bosix).
The following medicines interact with Bosix in the body. Taking Bosix 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)
Clozapina (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)

Bosix 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 Bosix. 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 Bosix approximately two hours before or no sooner than four hours after taking them.
Bosix with food and drinks
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, 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 to become pregnant, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Bosix during pregnancy.
Do not take Bosix while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Bosix may affect your level of alertness. Since neurological adverse events may occur, check your response to Bosix before driving a vehicle or operating machinery. If in doubt, discuss with your doctor.

3. How to take Bosix

Your doctor will explain exactly how much Bosix you should take, how often, and for how long.
This will depend on the type of infection you have and its severity.
Inform your doctor if you have kidney problems, as your dosage may need to be adjusted.
Treatment usually lasts between 5 and 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 Bosix.
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 Bosix tablets together with dairy products or calcium-rich drinks when these dairy products or calcium-rich drinks are consumed alone and away from meals. Ciprofloxacin tablets must be taken either one or two hours before, or no sooner than four hours after, consuming dairy products or calcium-rich drinks taken alone away from meals.
Remember to drink plenty of fluids during treatment with this medicine.
If you take more Bosix 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 Bosix
If you forget to take Bosix 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 Bosix
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 experience them.
The following section lists the most serious side effects that you may notice on your own:
Stop taking Bosix and contact your doctor immediately, who will consider 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 up (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 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 side effects observed during treatment with Bosix 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
loss of 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 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 (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, 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 amylase enzyme

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

a specific type of reduction 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)
psychiatric 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 disorders (olfactory disturbances), pressure in the brain (intracranial hypertension including pseudotumour cerebri)
colour vision disturbances
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 eruptions
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)
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 (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 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, tickling, 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 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 the following website: 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 Bosix

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

6. Package contents and other information

What Bosix contains
The active substance is ciprofloxacin.
Each Bosix 250 mg film-coated tablet contains 250 mg of ciprofloxacin (equivalent to 291 mg of
ciprofloxacin hydrochloride monohydrate).
Each Bosix 500 mg film-coated tablet contains 500 mg of ciprofloxacin (equivalent to 582 mg of
ciprofloxacin hydrochloride monohydrate).
Each Bosix 750 mg film-coated tablet contains 750 mg of ciprofloxacin (equivalent to 873 mg of
ciprofloxacin hydrochloride monohydrate).
The excipients are: Maize starch, microcrystalline cellulose (E460), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), macrogol 4000, titanium dioxide (E171).

Description of the appearance of Bosix and contents of the pack
250 mg film-coated tablets - Pack containing 10 tablets.
500 mg film-coated tablets - Pack containing 6 tablets or 12 tablets.
750 mg film-coated tablets - Pack containing 12 tablets.

Marketing Authorization Holder
Genetic S.p.A., Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA)

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