Ciproxin: detailed information

Package leaflet: Information for the user

Ciproxin 500 mg/5 mL granules and solvent for oral suspension

Ciprofloxacin
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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ciproxin is and what it is used for

Ciproxin contains the active substance ciprofloxacin. Ciproxin 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
Ciproxin 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 have fever suspected to be due to a bacterial infection.
If you have a severe infection, or an infection caused by more than one type of bacteria, your doctor may prescribe another antibiotic in addition to Ciproxin.
Children and adolescents
Ciproxin 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

Ciproxin may also be used to treat other specific severe infections in children and adolescents, when deemed necessary by the physician.

2. What you should know before taking Ciproxin

Do not take Ciproxin:

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 Ciproxin)

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

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 previously experienced tendon problems during treatment with antibiotics such as Ciproxin
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 Ciproxin 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 an elderly patient, or if you are taking other medicines that may cause abnormal changes on ECG (see section 2 “Other medicines and Ciproxin”)
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 Ciproxin
Inform your doctor immediately if any of the following conditions occur during treatment with Ciproxin. Your doctor will decide whether treatment with Ciproxin should be discontinued.

A severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility that a severe and sudden allergic reaction may occur even after the first dose, with symptoms such as chest tightness, chest pain, shortness of breath, dizziness, nausea or fainting, or dizziness upon standing. In such a case, stop treatment with Ciproxin and contact your doctor or emergency services immediately.
Severe, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Ciproxin, 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 pain in tendons, muscles, and joints of arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness, or burning (paresthesia), 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 Ciproxin, 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 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 Ciproxin. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Ciproxin, consult your doctor, and rest the affected area. Avoid any unnecessary movement, 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 and 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 (a sensation of rapid or irregular heartbeat).
If you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke, or are taking other medicines known to trigger epilepsy or lower the seizure threshold (see section 2: Other medicines and Ciproxin), you may experience adverse effects on the central nervous system. If seizures occur, stop treatment with Ciproxin 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 treatment with Ciproxin and inform your doctor immediately to prevent permanent nerve damage.
Psychiatric reactions may occur even when taking quinolone antibiotics, including Ciproxin, for the first time. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciproxin. In rare cases, depression and psychosis may progress to suicidal thoughts or self-destructive behaviour such as suicide attempts or suicide (see section 4: Possible side effects). If you experience depression, psychotic reactions, suicidal thoughts or behaviour, contact your doctor immediately.
Quinolone antibiotics may cause elevated 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
During treatment with antibiotics, including Ciproxin, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, you must stop taking Ciproxin 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.
During treatment with Ciproxin, your skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to strong sunlight and artificial UV light, such as tanning beds.
Inform your doctor or laboratory staff that you are taking Ciproxin if you need to undergo blood or urine tests.
If you have kidney problems, inform your doctor, as you may require a dosage adjustment.
Ciproxin 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.
Ciproxin 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 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 Ciproxin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Ciproxin together with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciproxin").
The following medicines interact with Ciproxin in the body. Taking Ciproxin 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, 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)
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)
other medicines that may increase the risk of seizures, such as, but not limited to, tramadol and certain antidepressants belonging to Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., citalopram, escitalopram, fluoxetine, paroxetine, etc.).

Ciproxin 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 Ciproxin. Inform your doctor if you are taking or intend 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 Ciproxin approximately two hours before or no sooner than four hours after taking them.

Ciproxin with food and drinks
Consumption of calcium as part of a meal, including dairy products and calcium-rich drinks (such as milk or yogurt) or calcium-fortified fruit juices (e.g., calcium-fortified orange juice), does not significantly affect the absorption of this medicine.
However, administering oral ciprofloxacin suspension together with dairy products and calcium-rich drinks when these products or drinks are taken alone between meals may reduce the effectiveness of this medicine.
Therefore, oral ciprofloxacin suspension 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, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Ciproxin oral suspension is not recommended during pregnancy.
Do not take Ciproxin while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciproxin may affect your level of alertness. Since neurological adverse events may occur, check how you react to Ciproxin before driving a vehicle or operating machinery. If in doubt, discuss with your doctor.
Ciproxin contains benzyl alcohol
This medicine contains 18.1 mg of benzyl alcohol per vial, equivalent to 18.1 mg/100 ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with a risk of serious adverse effects, including breathing problems ("gasping syndrome"), in young children. Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by your doctor or pharmacist.
The use of this medicine is not recommended if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).
Consult your doctor or pharmacist if you have hepatic or renal impairment. This is because high amounts of benzyl alcohol may accumulate in your body and cause adverse effects (called “metabolic acidosis” or “altered respiration”).
Ciproxin contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking Ciproxin 500 mg/5 mL granules and solvent for oral suspension. Since Ciproxin contains 1.3 g of sucrose per 5 mL dose, this should be taken into account in patients with diabetes mellitus. This product may harm teeth.

3. How to take Ciproxin

Your doctor will explain exactly how much Ciproxin you should take, how often, and for how long.
This will depend on the type of infection you have and its severity.
Always take this medicine exactly as instructed by your doctor. If you are unsure about how to take Ciproxin,
consult your doctor or pharmacist.
To prepare the oral suspension (see subsection "How to prepare and take the suspension"),
use the dosing spoon supplied with the bottle.
Dosage
Adults
The usual recommended dose of Ciproxin is 250 mg to 750 mg twice daily (every 12 hours), depending on the severity and type of infection:

½ dosing spoon corresponds to 250 mg
1 dosing spoon corresponds to 500 mg
1½ dosing spoons correspond to 750 mg (maximum single dose).

Children and adolescents:
Your doctor will calculate the correct dose for your child based on body weight, severity, and type of infection.
Doses are calculated according to the child's body weight in kilograms (kg).
The usual recommended dose is 10 mg to 20 mg per kilogram of body weight per administration, given twice daily (every 12 hours). The maximum recommended dose is 750 mg per single dose.
A practical guide indicating the number of dosing spoons for each of the two daily administrations of Ciproxin oral suspension, according to the recommended dose in mg/kg of body weight, is provided in the table below:

500 mg/5 mL oral suspension½ teaspoon = 250 mg; 1 teaspoon = 500 mg; 1 teaspoon + ½ teaspoon = 750 mg (maximum dose)
Body weight (kg)	Practical guide for each of the two daily administrations of Ciproxin oral suspension according to recommended dose in mg/kg of body weight
	10 mg/kg	20 mg/kg
9 - 20 kg	Use the lowest strength (250 mg/mL) of Ciproxin oral suspension which is most appropriate
21-29 kg	½ teaspoon	1 teaspoon
30-31 kg	½ teaspoon	1 teaspoon + ½ teaspoon
32-58 kg	1 teaspoon	1 teaspoon + ½ teaspoon
59 kg and over	1 teaspoon + ½ teaspoon	1 teaspoon + ½ teaspoon

Renal problems:
Inform your doctor if you have renal problems, as a dosage adjustment may be necessary.

How to prepare and take the suspension
Use only after reconstitution: the small brown bottle contains ciprofloxacin granules. Add these to the solvent in the larger white bottle.

The product is supplied in two bottles: a small brown bottle and a larger white bottle. The small brown bottle contains granules that must be added to the solvent in the larger white bottle.

Black silhouette of two medicine bottles of different sizes with cap and label on white background

Open both bottles. Press down on the child-resistant cap and turn it counterclockwise to unscrew.

Black silhouette of two medicine bottles of different sizes, one larger and one smaller, on white background

Pour the contents of the small brown bottle containing the granules into the opening of the larger white bottle containing the solvent. Do not add water to the solvent. Discard the empty small brown bottle.

Syringe tilted, drawing liquid from a medicine vial with screw cap on white background

Close the large white bottle containing the solvent and granules, turn it sideways, and shake well for about 15 seconds.
Shake well for about 15 seconds before each dose.
Write the expiration date after reconstitution (i.e., the date of reconstitution + 14 days) in the designated space on the label of the large bottle containing the solvent. The reconstituted suspension is stable for no more than approximately 14 days, even if stored in the refrigerator.
Try to take the suspension at approximately the same time each day.
Always use the dosing spoon provided. A full dosing spoon corresponds to a dose of 500 mg of Ciproxin.
Do not chew the granules present in the suspension; simply swallow them.
After taking the dose, you may drink a glass of water.
You may take the suspension with meals or between meals. You may take oral ciprofloxacin suspension with meals containing dairy products (such as milk or yogurt) or calcium-rich beverages (e.g., calcium-fortified orange juice). However, do not take Ciproxin oral suspension together with dairy products or calcium-rich beverages when these are taken alone, outside of meals. Oral ciprofloxacin suspension must be taken either one or two hours before, or at least four hours after, the intake of dairy products or calcium-rich beverages taken alone outside of meals.

If you take more Ciproxin than you should
If you take more than the prescribed dose, contact your doctor immediately. If possible, bring the oral suspension or the carton with you to show the doctor.

If you forget to take Ciproxin
If you forget to take Ciproxin and:

there are 6 hours or more until your next scheduled dose, take the missed dose immediately. Then take the next dose as planned.
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 Ciproxin
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 everyone will experience them.
The following section lists the most serious side effects that you may notice on your own:
Stop taking Ciproxin and contact your doctor immediately if you experience any of the following serious side effects, as they may need to switch you to another antibiotic treatment:
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 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 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)
chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects observed during treatment with Ciproxin are listed below, categorized 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 levels of eosinophils, a type of white blood cell
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
increased levels of 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 substance present in the blood)

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

muscle pain, joint inflammation, increased muscle tone, and muscle cramps
inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases, this 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), 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, anxiety 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 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)
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), disturbances in smell (olfactory disturbances), increased pressure in the brain (intracranial hypertension including pseudotumor 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 eruptions; 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 feelings of extreme optimism and hyperactivity (hypomania)
abnormally rapid heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as "prolongation of the QT interval", seen on ECG, the heart's electrical activity)
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 adverse drug reactions that are prolonged (lasting months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (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 tearing (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 http://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 Ciproxin

Granules:
Do not store above 25°C.

Solvent:
Do not store above 25°C. Do not freeze. Avoid storing the bottle upside down.

After reconstitution, the ready-to-use suspension remains stable for only 14 days if stored at room temperature below 30°C or in the refrigerator (between 2°C and 8°C). The oral suspension must not be taken after this period. Do not freeze the ready-to-use suspension.

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. Contents of the pack and other information

What Ciproxin contains
The active substance is ciprofloxacin.
1 dosing spoon (approximately 5.0 mL of suspension) contains approximately 500 mg of ciprofloxacin.
½ dosing spoon (approximately 2.5 mL of suspension) contains approximately 250 mg of ciprofloxacin.
The excipients are:
Granules: hypromellose, magnesium stearate, polyacrylate dispersion 30%, polysorbate 20, povidone.
Solvent: soybean lecithin, medium-chain saturated triglycerides, strawberry flavour (contains benzyl alcohol),
sucrose, purified water.

Description of the appearance of Ciproxin and contents of the pack
Granules and solvent for oral suspension
Packs:
One pack containing one amber glass bottle with 15.9 g of granules and one white HDPE bottle containing 86 mL of solvent. The pack includes one graduated blue plastic dosing spoon.
One pack containing five amber glass bottles with 15.9 g of granules and five white HDPE bottles containing 86 mL of solvent. The pack includes five graduated blue plastic dosing spoons.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Bayer S.p.A.
Viale Certosa, 130
20156 Milan, Italy

Manufacturer
Bayer HealthCare Manufacturing S.r.l., Via delle Groane, 126, Garbagnate Milanese (MI)

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Ciflox
Germany: Ciprobay
Greece: Ciproxin
Italy: Ciproxin
Netherlands: Ciproxine
Sweden: Ciproxin

Advice/health education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed you antibiotics, it is because you specifically need them for your current illness.
Despite antibiotic treatment, certain bacteria may survive or multiply. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. If you do not follow the:

dosage,
frequency of administration,
duration of treatment,
you may even promote the development of bacterial resistance, delay recovery, or reduce the effectiveness of antibiotics.

Therefore, to preserve the effectiveness of this medicine:
1 – Use antibiotics only when prescribed by a doctor.
2 – Follow your doctor's instructions exactly.
3 – Do not reuse an antibiotic without a new medical prescription, even if you are treating a similar illness.
4 – Never give your antibiotics to another person; they may not be suitable for their condition.
5 – At the end of treatment, return any unused medicines to a pharmacy, to ensure they are properly disposed of.

Patient Information Leaflet: Information for the User

Ciproxin 250 mg/5 mL granules and solvent for oral suspension

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

1. What Ciproxin is and what it is used for

Ciproxin contains the active substance ciprofloxacin. Ciproxin is an antibiotic belonging to the family of
fluoroquinolones. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only against
specific strains of bacteria.
Adults
Ciproxin 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
prevention of infections caused by the bacterium Neisseria meningitidis
exposure to inhaled anthrax spores

Ciprofloxacin may be used to manage patients with a low number of white blood cells
(neutropenia) who have 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 Ciproxin.
Children and adolescents
Ciproxin 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

Ciproxin may also be used to treat other specific severe infections in children and adolescents, when deemed necessary by the physician.

2. What you should know before taking Ciproxin

Do not take Ciproxin:

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 Ciproxin)

Warnings and precautions
Before taking this medicine
You must not take antibacterial quinolone/fluoroquinolone medicines, including Ciproxin, 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.
Inform your doctor before taking Ciproxin

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 Ciproxin
If you are diabetic, because there may be a risk of hypoglycaemia when using ciprofloxacin
If you have 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 your 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 Ciproxin 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 Ciproxin”)
Inform your doctor if you or a family member know you 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 Ciproxin
Inform your doctor immediately if any of the following conditions occur during treatment with Ciproxin. Your doctor will decide whether treatment with Ciproxin should be discontinued.

Severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility that a severe and sudden allergic reaction may occur even after the first dose, with symptoms such as chest tightness, chest pain, shortness of breath, dizziness, nausea or fainting, dizziness upon standing. In such a case, stop treatment with Ciproxin and contact your doctor or emergency services immediately.
Serious, prolonged, disabling, and potentially irreversible side effects. Fluoroquinolone/quinolone antibacterial medicines, including Ciproxin, 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 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 Ciproxin, 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), 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 Ciproxin. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Ciproxin, contact your doctor, and rest the affected area. Avoid unnecessary movement, 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 sudden 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, or are taking other medicines known to trigger epilepsy or lower the seizure threshold (see section 2: Other medicines and Ciproxin), you may experience adverse effects on the central nervous system. If seizures occur, stop treatment with Ciproxin 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 treatment with Ciproxin and inform your doctor immediately to prevent permanent nerve damage.
Psychiatric reactions may occur even when taking quinolone antibiotics, including Ciproxin, for the first time. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciproxin. In rare cases, depression and psychosis may progress to suicidal thoughts or self-harming behaviour, including suicide attempts or suicide (see section 4: Possible side effects). If you experience depression, psychotic reactions, suicidal thoughts, or behaviour, contact your doctor immediately.
Quinolone antibiotics may cause blood sugar levels to rise above normal (hyperglycaemia) or fall below normal (hypoglycaemia), 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.
During treatment with antibiotics, including Ciproxin, 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 Ciproxin 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, consult an ophthalmologist immediately.
While taking Ciproxin, your skin becomes 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 Ciproxin if you need to undergo blood or urine tests.
If you have kidney problems, inform your doctor, as you may require a dosage adjustment.
Ciproxin 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.
Ciproxin 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 general condition, or fever with signs of localized infection such as sore throat, 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 Ciproxin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Ciproxin with tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciproxin").
The following medicines interact with Ciproxin in the body. Taking Ciproxin 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)
other medicines that may increase the risk of seizures, such as tramadol and certain antidepressants belonging to the Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., citalopram, escitalopram, fluoxetine, paroxetine, etc.)

Ciproxin 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 Ciproxin. Inform your doctor if you are taking or plan 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 Ciproxin approximately two hours before or no sooner than four hours after taking them.

Ciproxin 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 oral ciprofloxacin suspension 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, oral ciprofloxacin suspension 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, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The use of Ciproxin oral suspension is not recommended during pregnancy.
Do not take Ciproxin while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.

Driving and using machines
Ciproxin may affect your level of alertness. Since neurological adverse events may occur, check how you react to Ciproxin before driving or operating machinery. If in doubt, consult your doctor.

Ciproxin contains benzyl alcohol
This medicine contains 19.6 mg of benzyl alcohol per vial, equivalent to 19.6 mg/100 ml.
Benzyl alcohol may cause allergic reactions.
Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome"), in young children. Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by your doctor or pharmacist.
The use of this medicine is not recommended if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").
Ask your doctor or pharmacist for advice if you have impaired liver or kidney function. This is because high levels of benzyl alcohol may accumulate in your body and cause adverse effects (called "metabolic acidosis" or "altered respiration").

Ciproxin contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking Ciproxin 250 mg/5 mL granules and solvent for oral suspension. Since Ciproxin contains 1.4 g of sucrose per 5 mL (one dosing spoonful), this should be taken into account in patients with diabetes mellitus. This product may harm teeth.