PACKAGE LEAFLET: INFORMATION FOR THE USER

Ciprofloxacin ratiopharm 250 mg film-coated tablets, 500 mg film-coated tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. 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 effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

Adults
Ciprofloxacin ratiopharm 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 tract 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

Ciprofloxacin may be used in the management of patients with low white blood cell count (neutropenia) who have fever suspected to be caused by 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 Ciprofloxacin ratiopharm.

Children and adolescents
Ciprofloxacin ratiopharm 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

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

2. What you need to know before taking Ciprofloxacin ratiopharm

Do not take Ciprofloxacin ratiopharm

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Ciprofloxacin ratiopharm

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 prior treatment with antibiotics such as Ciprofloxacin ratiopharm
if you have severe myasthenia gravis (a type of muscle weakness), as symptoms may worsen
if you have previously had heart rhythm disorders (arrhythmias) or heart problems; special caution is required when using ciprofloxacin if you were born with prolonged QT interval 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 in the ECG (see section 2: “Other medicines and Ciprofloxacin ratiopharm”)
if you or a family member suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency, as ciprofloxacin may increase the risk of anemia
if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel)
if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta) or if you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation)
if you have a family history of aortic aneurysm or dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis (an autoimmune inflammatory disease), or endocarditis (inflammation of the heart))
Quinolone antibiotics may cause an increase above your normal blood sugar levels (hyperglycemia), or a decrease below your normal blood sugar levels (hypoglycemia), which in severe cases (see section 4) could potentially lead to loss of consciousness (hypoglycemic coma). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.

Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including Ciprofloxacin ratiopharm, if you have previously had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.

When taking this medicine
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin ratiopharm. Your doctor will decide whether treatment with Ciprofloxacin ratiopharm should be stopped.

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 with the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, or dizziness upon standing. In such a case, stop taking Ciprofloxacin ratiopharm and contact your doctor immediately.
Rarely, joint pain and swelling, tendinitis, 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 Ciprofloxacin ratiopharm. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciprofloxacin ratiopharm, consult your doctor, and rest the affected area. Avoid unnecessary movement, as the risk of tendon rupture may increase.
If you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke, you may experience adverse effects on the central nervous system. In such a case, stop taking Ciprofloxacin ratiopharm and contact your doctor immediately.
Psychiatric reactions may occur the first time you take Ciprofloxacin ratiopharm. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin ratiopharm. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempts, or completed suicide. In such a case, stop taking Ciprofloxacin ratiopharm and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms, may occur. In such a case, stop taking Ciprofloxacin ratiopharm and contact your doctor immediately to avoid permanent nerve damage.
Hypoglycemia has been reported more frequently in diabetic patients, especially in the elderly population. If this occurs, contact your doctor immediately.
During treatment with antibiotics, including Ciprofloxacin ratiopharm, or even several weeks afterwards, diarrhea may develop. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking Ciprofloxacin ratiopharm immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal motility and contact your doctor.
If your vision becomes blurred or you experience other visual disturbances, consult an ophthalmologist immediately. (See section 4: "Possible side effects").
Your skin may become more sensitive to sunlight or ultraviolet (UV) light when taking ciprofloxacin. Avoid exposure to direct sunlight or artificial UV light, such as from sunbeds.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin ratiopharm if you need to have blood or urine tests.
Inform your doctor if you have kidney problems, as your dosage may need to be adjusted.
Ciprofloxacin ratiopharm 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 Ciprofloxacin ratiopharm and contact your doctor immediately.
Ciprofloxacin ratiopharm 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 your general condition, or fever with localized infection symptoms such as sore throat, throat or mouth pain, or urinary problems, consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.
If you experience sudden, severe abdominal, chest, or back pain, which may be a symptom of aortic aneurysm or dissection, go to the emergency room immediately. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a rapid onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).

Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin ratiopharm, 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 pricking, tingling, itching, numbness, or burning (paresthesia), 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 Ciprofloxacin ratiopharm, consult 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.

Other medicines and Ciprofloxacin ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Ciprofloxacin ratiopharm with tizanidine, as it may cause side effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciprofloxacin ratiopharm").
The following medicines interact with Ciprofloxacin ratiopharm in the body. Taking Ciprofloxacin ratiopharm 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 diseases, rheumatoid arthritis, and organ transplants)
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 class), some antipsychotics
glibenclamide (for diabetes)

Ciprofloxacin ratiopharm may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
lidocaine (for heart problems or as an anesthetic)
sildenafil (for erectile dysfunction)
duloxetine (for depression, diabetic neuropathy, or incontinence)
agomelatine (for treatment of depression)
zolpidem (for treatment of insomnia and certain mental disorders)

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

antacids (to prevent stomach hyperacidity)
omeprazole (to reduce stomach acid production)
mineral supplements
sucralfate (for stomach ulcers)
polymeric phosphate binders (e.g. sevelamer or lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium, or iron

If taking these preparations is essential, take Ciprofloxacin ratiopharm approximately two hours before or no less than four hours after taking the above preparations.

Ciprofloxacin ratiopharm with food and drink
Unless you are taking Ciprofloxacin ratiopharm with meals, do not consume dairy products (such as milk or yogurt) or calcium-fortified drinks at the same time as the tablets, as they may interfere with the absorption of the active ingredient.

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

Driving and using machines
Ciprofloxacin ratiopharm may impair your ability to concentrate. Neurological adverse events may occur. Therefore, check your response to Ciprofloxacin ratiopharm before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take Ciprofloxacin ratiopharm

Your doctor will explain exactly how much Ciprofloxacin ratiopharm you should take, how often,
and for how long. This will depend on the type of infection you have and its severity.
Inform your doctor if you have kidney problems, as a dose adjustment may be necessary.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.
Take this medicine exactly as instructed by your doctor. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacin ratiopharm.
a. Swallow the tablets with plenty of fluid. Do not chew the tablets as they have an unpleasant taste.
b. Try to take the tablets at approximately the same time each day.
c. You may take the tablets with meals or between meals. Calcium taken during meals does not significantly affect absorption. However, do not take Ciprofloxacin ratiopharm tablets with dairy products such as milk or yoghurt, or with fortified fruit juices (e.g. calcium-fortified orange juice) or mineral supplements (e.g. calcium, magnesium, aluminium, iron), as these may reduce the absorption of the active substance. Ciprofloxacin ratiopharm should be taken either 1–2 hours before or at least 4 hours after consuming the above-mentioned products.
Remember to drink plenty of fluids during treatment with this medicine.

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

If you forget to take Ciprofloxacin ratiopharm
Take the missed dose as soon as possible and then continue as prescribed. However, if it is almost time for the next dose, do not take the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten dose. Make sure you complete the full course of treatment.

If you stop taking Ciprofloxacin ratiopharm
It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop taking this medicine too early, the infection may not be completely cured and symptoms may return or worsen. You may also develop antibiotic resistance.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Common (may affect up to 1 in 10 people):

nausea, diarrhoea
joint pain in children

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

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

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

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

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

a specific type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis); 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 lead to suicidal thoughts, suicide attempts and completed suicide) (see section 2: "Warnings and precautions")
migraine, coordination problems, unsteady gait (gait disturbances), disturbances of smell (olfactory disturbances), pressure on the brain (intracranial hypertension and pseudotumour cerebri)
distortions in colour perception
inflammation of the walls of blood vessels (vasculitis)
pancreatitis
liver cell death (hepatic necrosis), which very rarely may lead to life-threatening liver failure
pinpoint bleeding under the skin (petechiae); various types of skin rashes (e.g. potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)
muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section 2: "Warnings and precautions"); worsening of symptoms of myasthenia gravis (see section 2: "Warnings and precautions")

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

nervous system disorders such as pain, burning, tingling, numbness and/or weakness of the extremities (peripheral neuropathy or polyneuropathy)
abnormally fast heart rhythm, life-threatening irregular heart rhythm, changes in heart rhythm (known as QT interval prolongation, seen on ECG, electrical activity of the heart)
a severe and rare skin rash, mainly caused by medicines (acute generalised exanthematous pustulosis – [AGEP])
effect on blood coagulation in patients treated with vitamin K antagonists, warfarin or phenprocoumon
feeling of great excitement (mania) or feeling of great optimism and hyperactivity (hypomania)
hypersensitivity reaction called DRESS (drug reaction with eosinophilia and systemic symptoms)
syndrome associated with impaired water excretion and low sodium levels (SIADH)
loss of consciousness due to a severe decrease in blood sugar levels (hypoglycaemic). 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, tingling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment 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 dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of regurgitation of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

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

5. How to store Ciprofloxacin ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacina ratiopharm contains
The active substance is ciprofloxacin.
Each film-coated tablet contains 250 mg of ciprofloxacin (as monohydrochloride monohydrate).
Each film-coated tablet contains 500 mg of ciprofloxacin (as monohydrochloride monohydrate).
The excipients are microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate,
hypromellose, macrogol 400, titanium dioxide (E171).

Description of the appearance of Ciprofloxacina ratiopharm and contents of the pack
Ciprofloxacina ratiopharm 250 mg: white or slightly yellowish, biconvex, round film-coated tablets with a diameter of 11 mm, with a notch on both sides and marked "C250" on one side.
Ciprofloxacina ratiopharm 500 mg: white or slightly yellowish, biconvex, oval-shaped film-coated tablets (8.2 x 17 mm), with a notch on one side and marked "C500" on the other side.

Ciprofloxacina ratiopharm 250 mg film-coated tablets
This medicine is available in blister packs containing 10, 20, or 100 film-coated tablets.

Ciprofloxacina ratiopharm 500 mg film-coated tablets
This medicine is available in blister packs containing 6, 10, 20, or 100 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm (Germany)

Manufacturer:
Merckle GmbH, Ludwig-Merckle Strasse 3, D-89143 Blaubeuren (Germany)

This medicine is authorized in the European Economic Area countries under the following names:
Italy: Ciprofloxacina ratiopharm X mg film-coated tablets

Medical advice/information
Antibiotics are used to treat bacterial infections and are ineffective against viral infections.
If your doctor has prescribed antibiotics for you, it means you need them to treat your specific illness.

Despite antibiotic use, some bacteria may survive or develop resistance. This phenomenon is called antimicrobial resistance: certain antibiotic treatments become ineffective.
Improper use of antibiotics can increase resistance. It may even help bacteria become resistant, thereby delaying treatment or reducing the antibiotic's effectiveness if the following are not properly respected:

dosages
regimens
duration of treatment

Therefore, to preserve the effectiveness of this medicine:
1 – Use antibiotics only when prescribed.
2 – Follow the prescription carefully.
3 – Do not reuse an antibiotic without a medical prescription, even for a similar illness.
4 – Never give antibiotics to another person; they may not be suitable for their condition.
5 – After completing treatment, return any unused medicines to the pharmacist to ensure proper disposal.

Ciprofloxacin Ratiopharm

PACKAGE LEAFLET: INFORMATION FOR THE USER