Ciprofloxacin PensA: detailed information

Package leaflet: Information for the patient

CIPROFLOXACIN PENSA 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets

Ciprofloxacin
Generic medicine
Please read all of this leaflet carefully before you take this medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

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

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

Adults
Ciprofloxacin Pensa 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
testicular infections
genital organ infections in women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
treatment of infections in patients with very low white blood cell counts (neutropenia)
prevention of infections in patients with very low white blood cell counts (neutropenia)
exposure to inhalation of anthrax spores

For Ciprofloxacin Pensa 250 mg and 500 mg film-coated tablets:

prevention of infections caused by the bacterium Neisseria meningitidis

If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe an additional antibiotic treatment alongside Ciprofloxacin Pensa.

Children and adolescents
Ciprofloxacin Pensa 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

Ciprofloxacin Pensa 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 Pensa

Quinolone antibiotics can cause an increase above your normal levels of sugar in the blood (hyperglycaemia) or a decrease below your normal levels of blood sugar, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.

Do not take Ciprofloxacin Pensa if:

you are allergic (hypersensitive) to the active substance, to other quinolones, or to any of the excipients of this medicine (listed in section 6)
you are taking tizanidine (see section 2 “Other medicines and Ciprofloxacin Pensa”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Ciprofloxacin Pensa
You must not take antibacterial medicines containing quinolones/fluoroquinolones, including Ciprofloxacin Pensa, 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 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 previous treatment with antibiotics such as Ciprofloxacin Pensa;
you suffer from myasthenia gravis (a type of muscle weakness);
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 been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation);
you have a family history of aortic aneurysm, aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an autoimmune inflammatory disease], or if you have vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet’s syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).

Special caution is required when using Ciprofloxacin Pensa if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), if you have a very slow heart rate (called bradycardia), if you have a weak heart (heart failure), if you 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 “Taking with other medicines”).

Inform your doctor if you, or a family member, are known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin.

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there are no signs of improvement after 3 days of treatment, consult your doctor.

While taking Ciprofloxacin Pensa
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin Pensa. Your doctor will decide whether treatment with Ciprofloxacin Pensa should be discontinued.

A severe and sudden allergic reaction (an 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, dizziness, nausea or fainting, dizziness upon standing. In this case, stop treatment with Ciprofloxacin Pensa and contact your doctor immediately.
Rarely, joint pain and swelling, or tendon inflammation or rupture, may occur. The risk is higher if you are elderly (over 60 years of age), if you have received an organ transplant, if you have kidney problems, or if you 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 Pensa. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Ciprofloxacin Pensa, consult your doctor, and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
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 this case, stop treatment with Ciprofloxacin Pensa and contact your doctor immediately.
Psychiatric reactions may occur after taking Ciprofloxacin Pensa. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Pensa. In this case, stop treatment with Ciprofloxacin Pensa 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 this case, stop treatment with Ciprofloxacin Pensa and inform your doctor immediately to prevent permanent nerve damage.
During treatment with antibiotics, including Ciprofloxacin Pensa, 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 Pensa immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal motility and contact your doctor.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin Pensa if you are undergoing blood or urine tests.
If you suffer from kidney problems, inform your doctor, as you may need a dosage adjustment.
Ciprofloxacin Pensa 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 Pensa and contact your doctor immediately.
Ciprofloxacin Pensa 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 your general condition, or fever with symptoms 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.
During treatment with Ciprofloxacin Pensa, 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.
If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
if you experience sudden, severe pain in the abdomen, chest, or back, which may be a sign 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 sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).

Serious, prolonged, disabling, and potentially irreversible adverse effects
Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin Pensa, have been associated with very rare but serious adverse effects, some of which may be prolonged (lasting months or years), disabling, or irreversible. These include tendon, muscle, and joint pain in the 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 adverse effects after taking Ciprofloxacin Pensa, 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.

Other medicines and Ciprofloxacin Pensa
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

Do not take Ciprofloxacin Pensa with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciprofloxacin Pensa").

The following medicines interact with Ciprofloxacin Pensa in the body. Taking Ciprofloxacin Pensa 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)
glibenclamide (for diabetes)
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 Pensa may increase blood levels of the following medicines:

agomelatine
zolpidem
pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathy, or incontinence)
lidocaine (for heart problems or anaesthetic use)
sildenafil (for erectile dysfunction)

Certain medicines reduce the effect of Ciprofloxacin Pensa. 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 Pensa approximately two hours before or no sooner than four hours after taking them.

Ciprofloxacin Pensa with food and drink
Unless you are taking Ciprofloxacin Pensa 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 substance.

Pregnancy and breastfeeding
It is preferable to avoid using Ciprofloxacin Pensa during pregnancy. Inform your doctor if you are planning a pregnancy.

Do not take Ciprofloxacin Pensa during breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.

Driving and using machines
Ciprofloxacin Pensa may interfere with your level of alertness. Since neurological adverse events may occur, check your response to Ciprofloxacin Pensa before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take Ciprofloxacin Pensa

Take this medicine exactly as instructed by your doctor.
Your doctor will explain precisely how much Ciprofloxacin Pensa you should take, how often,
and for how long. This will depend on the type of infection you have and its severity.
Inform your doctor if you have kidney problems, as your dosage may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Always take the tablets exactly as directed by your doctor.
Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacin Pensa.

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 Pensa tablets with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with Ciprofloxacin Pensa.

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

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

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

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

4. Possible side effects

Like all medicines, Ciprofloxacin Pensa can cause side effects, although not everybody gets them.
If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Cases of dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may lead to death, as well as cases of backflow of blood from heart valves (regurgitation), have been reported in patients treated with fluoroquinolones. See also section 2.

Common side effects (may affect from 1 to 10 people in 100):

nausea, diarrhoea
joint pain in children

Uncommon side effects (may affect from 1 to 10 people in 1,000):

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

Rare side effects (may affect from 1 to 10 people in 10,000):

inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2)
changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood coagulation factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section 2)
confusion, disorientation, anxious reaction, unusual dreams, depression, which in rare cases may lead to suicidal ideation/thoughts, attempted suicide or completed suicide (see section 2), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor, seizures (see section 2), dizziness
visual disturbances (e.g. diplopia)
tinnitus, hearing loss, decreased hearing
fast heartbeat (tachycardia)
dilation of blood vessels (vasodilatation), low blood pressure, fainting
shortness of breath, including asthma-like symptoms
liver disorders, jaundice (cholestatic jaundice), hepatitis
light sensitivity (see section 2)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in urine (see section 2), inflammation of the urinary tract
fluid retention, excessive sweating
abnormal levels of a coagulation factor (prothrombin), increased levels of amylase enzyme

Very rare side effects (may affect less than 1 person in 10,000):

a particular type of decrease in red blood cells (haemolytic anaemia); a dangerous decrease in a type of white blood cells (agranulocytosis); a decrease 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)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2)
mental disorders (psychotic reactions) (see section 2)
migraine, coordination disorders, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), pressure in the brain (intracranial hypertension including 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); worsening of symptoms of myasthenia gravis (see section 2)

Frequency not known (cannot be estimated from the available data)

disorders related to the nervous system, such as pain, burning, tingling, numbness and/or weakness of the extremities (peripheral neuropathy and polyneuropathy)
abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as QT interval prolongation, seen on ECG, electrical activity of the heart)
Acute Generalized Exanthematous Pustulosis (AGEP)
Increased International Normalized Ratio (INR) (affecting blood coagulation in patients treated with vitamin K antagonists)
Feeling of euphoria (mania) or feeling of great optimism and hyperactivity (hypomania)
Hypersensitivity reaction known as 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 drop in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of prolonged (lasting for months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, impaired memory and concentration, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal thoughts), 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.

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 Ciprofloxacin Pensa

Keep this medicine out of 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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacin Pensa contains
CIPROFLOXACIN PENSA 250 mg tablets
One film-coated tablet contains:
Active substance: ciprofloxacin hydrochloride monohydrate 291 mg, equivalent to 250 mg of
ciprofloxacin.
Excipients: microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize
starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose
(E464), macrogol 4000.
CIPROFLOXACIN PENSA 500 mg tablets
One film-coated tablet contains:
Active substance: ciprofloxacin hydrochloride monohydrate 582 mg, equivalent to 500 mg of
ciprofloxacin.
Excipients: microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize
starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose
(E464), macrogol 4000.
CIPROFLOXACIN PENSA 750 mg tablets
One film-coated tablet contains:
Active substance: ciprofloxacin hydrochloride monohydrate 873 mg, equivalent to 750 mg of
ciprofloxacin.
Excipients: microcrystalline cellulose (E460), pregelatinized starch, crospovidone (E1202), maize
starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose
(E464), macrogol 4000.

Description of the appearance of Ciprofloxacin Pensa and contents of the pack
Film-coated tablets
250 mg film-coated tablets - 10 tablets
500 mg film-coated tablets - 6 tablets
750 mg film-coated tablets - 12 tablets

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy
Manufacturer and final controller
Special Product’s Line S.p.A
Via Fratta Rotonda Vado Largo, 103012, Anagni (FR)

Health advice/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 they are specifically needed for your current illness.
Despite antibiotic treatment, certain bacteria may survive or multiply. This phenomenon is known as
resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You may even promote the development of
bacterial resistance and delay recovery or reduce the effectiveness of antibiotics if you do not adhere to:

dosage
frequency of administration
duration of treatment

Therefore, to preserve the effectiveness of this medicine:

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