Ciprofloxacin Sandoz: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

Ciprofloxacin Sandoz 750 mg film-coated tablets
Ciprofloxacin
Generic medicine
Read this entire 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ciprofloxacina Sandoz is and what it is used for

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

Adults
Ciprofloxacina Sandoz 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 inhalation of anthrax spores

Ciprofloxacin may be used to treat patients with very low white blood cell count (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 Ciprofloxacina Sandoz.

Children and adolescents
Ciprofloxacina Sandoz is used in children and adolescents, under specialist supervision, to treat the following bacterial infections:

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

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

2. What you should know before taking Ciprofloxacin Sandoz

Do not take Ciprofloxacin Sandoz if:

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

Warnings and precautions
Talk to your doctor before taking Ciprofloxacin Sandoz if:

you have kidney problems, as your treatment may need to be adjusted
you suffer from epilepsy or other neurological disorders
you have had tendon problems during a previous treatment with antibiotics such as Ciprofloxacin Sandoz
you are diabetic, as you may be at risk of hypoglycaemia with ciprofloxacin
you suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen
you have heart problems. You should use caution when taking ciprofloxacin if you were born with (or have a family history of) QT interval prolongation (detected by ECG, the graphical representation of heart activity), you have electrolyte imbalances in the blood (particularly low blood levels of potassium or magnesium), you have a very slow heart rate (a condition called “bradycardia”), you have a weak heart (heart failure), you have a history of heart attack (myocardial infarction), you are female or elderly, or you are taking other medicines that cause abnormal changes in the ECG (see section 2, “Other medicines and Ciprofloxacin Sandoz”).
you or a family member suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin.
you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel).
you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta).
you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, known high blood pressure, or atherosclerosis). If you experience sudden pain in the abdomen, chest, or back, go immediately to the emergency room.

For the treatment of certain genital 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.
Quinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycaemia) or a decrease below normal levels, which in severe cases could 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.
WHILE TAKING CIPROFLOXACIN SANDOZ
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin Sandoz. Your doctor will decide whether treatment with Ciprofloxacin Sandoz should be discontinued.

A severe and sudden allergic reaction (an anaphylactic reaction/anaphylactic shock, angioedema). There is a rare possibility of a severe and sudden allergic reaction even with the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, dizziness when standing up. In such cases, stop taking Ciprofloxacin Sandoz and contact your doctor immediately.
Occasionally, joint pain, swelling, and tendinitis may occur, especially if you are elderly or taking corticosteroids. Inflammation and tendon ruptures may occur within the first 48 hours of treatment or up to several months after stopping treatment with Ciprofloxacin Sandoz. At the first sign of pain or inflammation, stop taking Ciprofloxacin Sandoz and rest the affected area. Avoid unnecessary physical activity, as it may increase the risk of tendon rupture.
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 such cases, stop taking Ciprofloxacin Sandoz and contact your doctor immediately.
Psychiatric reactions may occur the first time you take Ciprofloxacin Sandoz. In rare cases, depression or psychosis may lead to suicidal thoughts, suicide attempts, or completed suicide. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Sandoz. If this occurs, stop taking Ciprofloxacin Sandoz and contact your doctor immediately.
You may experience symptoms of neuropathy, such as pain, burning, tingling, numbness, and/or weakness. In such cases, stop taking Ciprofloxacin Sandoz and contact your doctor immediately.
Hypoglycaemia has been reported more frequently in diabetic patients, especially in elderly individuals. If this occurs, contact your doctor immediately.
During treatment with antibiotics, including Ciprofloxacin Sandoz, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking Ciprofloxacin Sandoz immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements and contact your doctor.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin Sandoz if you are undergoing blood or urine tests.
If you have kidney problems, inform your doctor, as your dose may need to be adjusted.
Ciprofloxacin Sandoz 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 Sandoz and contact your doctor immediately.
Ciprofloxacin Sandoz may cause a reduction in the number of white blood cells, which may result in decreased resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with symptoms of localized infection such as sore throat or mouth pain or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.
If you experience visual disturbances or suspect eye damage while taking Ciprofloxacin Sandoz, consult an ophthalmologist immediately.
While taking Ciprofloxacin Sandoz, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as tanning beds.

OTHER MEDICINES AND CIPROFLOXACIN SANDOZ
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Ciprofloxacin Sandoz with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciprofloxacin Sandoz").
The following medicines interact with Ciprofloxacin Sandoz in the body. Taking Ciprofloxacin Sandoz 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 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 transplantation)
other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics.

Ciprofloxacin Sandoz may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, nerve damage due to diabetes, or incontinence)
lidocaine (for heart conditions or use in anaesthesia)
sildenafil (for erectile dysfunction)
agomelatine
zolpidem

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

antacids
omeprazole
mineral supplements
sucralfate
a polymeric phosphate binder (e.g. sevelamer or lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium, or iron. If these preparations are essential, take Ciprofloxacin Sandoz approximately two hours before or at least four hours after taking them.

Ciprofloxacin Sandoz with food and drink
Unless you are taking Ciprofloxacin Sandoz with meals, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified beverages when taking 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 Sandoz during pregnancy.
Do not take Ciprofloxacin Sandoz while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin Sandoz may affect your level of alertness. As neurological adverse events may occur, check how you react to Ciprofloxacin Sandoz before driving or operating machinery. If in doubt, discuss with your doctor.

3. How to take Ciprofloxacin Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much Ciprofloxacin Sandoz you should take, how often, and for
how long. This will depend on the type and severity of the infection you have.
Inform your doctor if you have kidney problems, as your dosage may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may be longer for severe infections. Always take
this medicine exactly as directed by your doctor. Consult your doctor or pharmacist
if you are unsure about how many tablets to take or how to take Ciprofloxacin Sandoz.
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 consumed during meals does not
significantly affect absorption. However, do not take Ciprofloxacin Sandoz tablets with dairy products such as milk or yogurt, or with fruit juices fortified with minerals (e.g. orange juice fortified with calcium).
Remember to drink plenty of fluids during treatment with this medicine.
Ciprofloxacin Sandoz 250 mg/500 mg/750 mg film-coated tablets
The tablet may be divided into equal doses.
If you take more Ciprofloxacin Sandoz than you should
If you take more than the prescribed dose, consult your doctor immediately. If possible, bring the
tablets or the pack to show your doctor.
If you forget to take Ciprofloxacin Sandoz
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 Sandoz
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 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 gets 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
elevated levels of eosinophils, a type of white blood cells
loss of appetite
hyperactivity, restlessness
headache, dizziness, sleep disorders, taste disturbances
vomiting, abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn), flatulence
increased levels of certain substances in the blood (transaminases and/or bilirubin)
rash, itching, urticaria
joint pain in adults
reduced kidney function
muscle and bone pain, malaise (asthenia), fever
increased alkaline phosphatase in the blood (a 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 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)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section 2 “Warnings and precautions”)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially lead to
suicidal 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 blurred or double vision
tinnitus, hearing loss, decreased hearing
fast 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 urine (see section 2: Warnings and precautions), inflammation of the
urinary tract
fluid retention, 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 reduction in a type of
white blood cells (agranulocytosis); 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)
mental disorders (psychotic reactions which may potentially lead to suicidal thoughts, suicide attempts or
completed suicide) (see section 2: Warnings and precautions)
migraine, coordination disorders, unsteady gait (gait disturbances), disturbances in smell (olfactory
disturbances), pressure in the brain (intracranial hypertension and pseudotumor cerebri)
distortions in colour perception
inflammation of blood vessel walls (vasculitis)
pancreatitis
liver cell death (hepatic necrosis), which very rarely may lead to life-threatening liver failure
pinpoint bleeding under the skin (petechiae); various types of skin rashes (e.g. Stevens-Johnson syndrome
or toxic epidermal necrolysis, potentially fatal)
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 and polyneuropathy)
abnormally fast heartbeat, irregular heartbeat (potentially fatal), a disturbance in heart rhythm (called
“QT interval prolongation” and detected by ECG, the graphical recording of heart activity)
pustular rash
effects on blood clotting (in patients treated with vitamin K antagonists)
feeling of intense excitement (mania) or feeling of extreme optimism and hyperactivity (hypomania)
severe 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 severe decrease in blood sugar levels (hypoglycaemic coma). See section 2.

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

5. How to store Ciprofloxacina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or 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 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 Ciprofloxacin Sandoz 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).
Each film-coated tablet contains 750 mg of ciprofloxacin (as monohydrochloride monohydrate).
The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch, povidone, colloidal anhydrous silica, stearic acid, magnesium stearate, sodium croscarmellose, hypromellose, macrogol 6000, talc, titanium dioxide (E 171).

Description of the appearance of Ciprofloxacin Sandoz and contents of the pack
CIPROFLOXACIN Sandoz 250 mg: white, spherical, film-coated tablets, engraved on one side with the raised inscription "cip 250".
CIPROFLOXACIN Sandoz 500 mg: white, oblong, film-coated tablets, engraved on both sides, with the raised inscription "cip 500" on one side.
CIPROFLOXACIN Sandoz 750 mg: white, oblong, film-coated tablets, engraved on both sides, with the raised inscription "cip 750" on one side.

CIPROFLOXACIN Sandoz 250 mg film-coated tablets
6, 8, 10, 12, 16, 20 and 100 film-coated tablets in PVC/aluminum or PP/aluminum blisters.
Hospital packs containing 30, 50 (10 x 5) and 160 film-coated tablets.

CIPROFLOXACIN Sandoz 500 mg film-coated tablets
3, 6, 10, 12, 16, 20, 50 (10 x 5) and 100 film-coated tablets in PVC/aluminum or PP/aluminum blisters.
Hospital packs containing 30, 100, 120 and 160 film-coated tablets.

CIPROFLOXACIN Sandoz 750 mg film-coated tablets
10, 12, 16, 20 and 100 film-coated tablets in PVC/aluminum or PP/aluminum blisters.
Hospital packs containing 30, 50 (10 x 5) and 160 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio (VA), Italy

Responsible manufacturers for batch release:
S.C. Sandoz S.R.L.
7A Livezeni Street
540472 Targu Mures
Romania
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben
Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Ciprofloxacin Sandoz 250 mg film-coated tablets
Netherlands: Ciprofloxacine 250 mg, filmomhulde tabletten
Hungary: Ciprofloxacin 1a Pharma 250 mg filmtabletta
Italy: CIPROFLOXACINA SANDOZ
Portugal: CIPROFLOXACINA SANDOZ
Slovenia: Ciprofloksacin Lek 250 mg filmsko obložene tablete

Ciprofloxacin Sandoz 500 mg film-coated tablets
Netherlands: Ciprofloxacine 500 mg, filmomhulde tabletten
Estonia: Ciprofloxacin Sandoz 500mg
Hungary: Ciprofloxacin 1A Pharma 500 mg filmtabletta
Italy: CIPROFLOXACINA SANDOZ
Latvia: Ciprofloxacin Sandoz 500 mg apvalkotas tabletes
Lithuania: Ciprofloxacin Sandoz 500 mg plevele dengtos tabletės
Portugal: CIPROFLOXACINA SANDOZ
Slovak Republic: Ciprofloxacín Sandoz 500 mg filmom obalené tablety
Slovenia: Ciprofloksacin Lek 500 mg filmsko obložene tablete

Ciprofloxacin Sandoz 750 mg film-coated tablets
Netherlands: Ciprofloxacine 750 mg, filmomhulde tabletten
Italy: CIPROFLOXACINA SANDOZ
Portugal: CIPROFLOXACINA SANDOZ
Slovenia: Ciprofloksacin Lek 750 mg filmsko obložene tablete

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

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:

Use antibiotics only when prescribed by a doctor.
Strictly follow your doctor's instructions.
Do not reuse an antibiotic without a medical prescription, even if you are treating a similar illness.
Never give your antibiotics to another person; they may not be suitable for their condition.
At the end of treatment, return any unused medicines to a pharmacy so they can be properly disposed of.