Ciprofloxacin Pharmacare: detailed information

Patient Information Leaflet: Information for the User

Ciprofloxacin Pharmacare 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets

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

Keep this leaflet. You may need to read it again.
If you have any questions, consult 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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
1. What Ciprofloxacin Pharmacare is and what it is used for
2. What you need to know before taking Ciprofloxacin Pharmacare
3. How to take Ciprofloxacin Pharmacare
4. Possible side effects
5. How to store Ciprofloxacin Pharmacare
6. Contents of the pack and other information

1. What CIPROFLOXACIN PHARMACARE is and what it is used for

Ciprofloxacin Pharmacare contains the active substance ciprofloxacin. Ciprofloxacin Pharmacare 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 Pharmacare 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 (stomach and intestine) 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 also be used to manage patients with low white blood cell counts (neutropenia) who develop 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 Ciprofloxacin Pharmacare.

Children and adolescents
Ciprofloxacin Pharmacare 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

Ciprofloxacin Pharmacare 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 PHARMACARE

Do not take Ciprofloxacin Pharmacare:

if you are allergic to the active substance, 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 Pharmacare”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Ciprofloxacin Pharmacare.
You must not take quinolone/fluoroquinolone antibacterial medicines, including Ciprofloxacin Pharmacare, 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 Pharmacare
you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin
you have been diagnosed with 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 suffer from myasthenia gravis (a type of muscle weakness), as symptoms may worsen
you have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation)
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 or 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))
you have heart problems. Caution should be exercised when using this medicine if:
- you have been born with or have a family history of prolonged QT interval (seen on ECG, the electrical recording of the heart),
- you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood),
- you have a very slow heart rate (called bradycardia),
- you have a weak heart (heart failure),
- you have a history of heart attacks (myocardial infarction),
- you are a woman or elderly, or you are taking other medicines that may cause abnormal ECG changes (see section “Other medicines and Ciprofloxacin Pharmacare”).
you, or a family member, are known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of haemolytic 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 Pharmacare
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin Pharmacare. Your doctor will decide whether treatment 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 with the first dose, with the following symptoms: difficulty breathing, dizziness, nausea or fainting, vertigo when standing. In such a case, stop treatment with Ciprofloxacin Pharmacare and contact your doctor immediately.
Serious, prolonged, disabling, and potentially irreversible side effects Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin Pharmacare, have been associated with very rare but serious adverse 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, prickling, tickling, numbness or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell and hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.

If you experience any of these adverse effects after taking Ciprofloxacin Pharmacare, 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, or tendon inflammation or rupture, 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 Pharmacare. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder or knee), stop taking Ciprofloxacin Pharmacare, contact your doctor and rest the affected area. Avoid any unnecessary movement, as this 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 affecting the central nervous system. In such a case, stop treatment with Ciprofloxacin Pharmacare 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 treatment with Ciprofloxacin Pharmacare and inform your doctor immediately to prevent permanent nerve damage.
Psychiatric reactions may occur even when taking quinolone antibiotics for the first time, including Ciprofloxacin Pharmacare. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Pharmacare. In rare cases, depression and psychosis may progress to suicidal thoughts and self-harming behaviours such as suicide attempts or suicide (see section 4: Possible side effects). If you experience depression, psychosis, or thoughts or behaviours related to suicide, contact your doctor immediately.
Quinolone antibiotics may cause an increase above your normal levels of blood sugar (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 particularly important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
During treatment with antibiotics, including Ciprofloxacin Pharmacare, 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 Ciprofloxacin Pharmacare immediately 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 Ciprofloxacin Pharmacare, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin Pharmacare if you are having blood or urine tests.
If you have kidney problems, inform your doctor, as you may need a dosage adjustment.

Ciprofloxacin Pharmacare 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.

Ciprofloxacin Pharmacare 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 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.
If you experience sudden, severe abdominal, chest or back pain, which may be a sign of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroids.
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).

Other medicines and Ciprofloxacin Pharmacare
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Ciprofloxacin Pharmacare with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "Do not take Ciprofloxacin Pharmacare").
The following medicines interact with Ciprofloxacin Pharmacare in the body. Taking Ciprofloxacin Pharmacare 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 forms of cancer, psoriasis, rheumatoid arthritis)
metoclopramide (for nausea and vomiting)
theophylline (for respiratory problems)
tizanidine (for muscle spasticity in multiple sclerosis)
clozapine, olanzapine (antipsychotics)
ropinirole (for Parkinson’s disease)
phenytoin (for epilepsy)
ciclosporin (for skin problems, rheumatoid arthritis and organ transplants)
other medicines that may alter heart rhythm belonging to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide); tricyclic antidepressants; some antimicrobials (belonging to the macrolide group); some antipsychotics
zolpidem (for sleep disorders).

Ciprofloxacin Pharmacare may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathy or incontinence)
lidocaine (an antiarrhythmic)
sildenafil (for erectile dysfunction)
duloxetine (an antidepressant)
agomelatine (for the treatment of depression)

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

antacids (to prevent gastric hyperacidity)
omeprazole (for gastric acidity)
mineral supplements
sucralfate (for stomach ulcer)
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 Pharmacare approximately two hours before, or no sooner than four hours after, taking them.
Ciprofloxacin Pharmacare with food, drinks and alcohol
Unless otherwise instructed, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified drinks when taking the tablets, as they may interfere with the absorption of the active substance.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin Pharmacare during pregnancy.
Do not take Ciprofloxacin Pharmacare while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin Pharmacare may interfere with your level of alertness. Since neurological adverse events may occur, check how you react to Ciprofloxacin Pharmacare before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.
Ciprofloxacin Pharmacare contains sodium. Ciprofloxacin Pharmacare contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially sodium-free.

3. How to take CIPROFLOXACIN PHARMACARE

Your doctor will explain exactly how much Ciprofloxacin Pharmacare 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 last longer for severe infections.

Method of administration
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. Always take this medicine exactly as prescribed by your doctor. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacin Pharmacare.

a. Swallow the tablets with plenty of fluid.
b. If you are unable to swallow the tablets, inform your doctor.
c. Do not chew or crush the tablets, as they have an unpleasant taste.
d. Try to take the tablets at approximately the same time each day.
e. You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take Ciprofloxacin Pharmacare tablets with dairy products such as milk or yogurt, or with fruit juices fortified with minerals (e.g. calcium-fortified orange juice).

Remember to drink plenty of fluids during treatment with Ciprofloxacin Pharmacare.

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

If you forget to take Ciprofloxacin Pharmacare
If you forget to take Ciprofloxacin Pharmacare and:

there are 6 hours or more until your next scheduled dose, take the missed dose immediately. Then take your next dose as scheduled.
there are less than 6 hours until your next scheduled dose, do not take the missed dose. Take your 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 Ciprofloxacin Pharmacare
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.
The following section lists the most serious side effects you may notice on your own:
Stop taking Ciprofloxacin Pharmacare and contact your doctor immediately, who will assess an alternative antibiotic treatment, if you experience any of the following serious side effects:

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

Seizures (including epileptic fits) (see section 2 “Warnings and precautions”).

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

Severe and sudden allergic reaction with symptoms such as chest tightness, dizziness, feeling unwell or fainting, or dizziness when standing (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).

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

Unusual sensations of pain, burning, tingling, numbness or muscle weakness in the extremities (neuropathy) (see section 2 “Warnings and precautions”)
A reaction causing skin rash, fever, internal organ inflammation, blood abnormalities and systemic symptoms (DRESS: Drug Reaction with Eosinophilia and Systemic Symptoms, AGEP: Acute Generalized Exanthematous Pustulosis).

Other side effects observed during treatment with ciprofloxacin are listed below by frequency:

Common side effects (may affect up to 1 in 10 people)

Nausea, diarrhoea
Joint pain and inflammation in children.

Uncommon side effects (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, restlessness
Headache, dizziness, sleep disturbances, taste disturbances
Vomiting, abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn) or intestinal gas
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 substance present in the blood).

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

Inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section 2: Warnings and precautions)
Changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood clotting factor (platelets)
Allergic reaction, swelling (oedema), sudden swelling of the skin and mucous membranes (angioedema) (see section 2 “Warnings and precautions”)
Increased blood sugar (hyperglycaemia)
Decreased blood sugar (hypoglycaemia) (see section 2 “Warnings and precautions”)
Confusion, disorientation, anxious reaction, unusual dreams, depression (in rare cases leading to suicidal thoughts/ideation or suicide attempts and completed suicide) (see section 2: “Warnings and precautions”), 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)
Blood vessel dilation (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, inflammation of the urinary tract
Fluid retention, excessive sweating
Increased levels of the enzyme amylase.

Very rare side effects (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) (see section 2: “Warnings and precautions”); reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal
Allergic reaction called serum sickness-like reaction (see section 2: “Warnings and precautions”)
Mental disorders (psychotic reactions) (which potentially may lead to suicidal thoughts/ideation or suicide attempts and 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 including pseudotumour 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 (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”).

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

Loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2
Abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (called “prolongation of the QT interval”, seen on ECG, electrical activity of the heart)
Effect on blood clotting (in patients treated with vitamin K antagonists)
Feeling of extreme excitement (mania) or feeling of great optimism and hyperactivity (hypomania)
Syndrome associated with impaired water elimination and low sodium levels (SIADH).

Very rare cases of adverse drug reactions that are prolonged (lasting for 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, 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 ideation), changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.
Cases of aortic wall dilation and weakening or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of blood regurgitation from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may 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 PHARMACARE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack, following "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 you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CIPROFLOXACIN PHARMACARE contains

The active substance is ciprofloxacin.
Each 250 mg film-coated tablet of Ciprofloxacin Pharmacare contains 250 mg of ciprofloxacin.
Each 500 mg film-coated tablet of Ciprofloxacin Pharmacare contains 500 mg of ciprofloxacin.
Each 750 mg film-coated tablet of Ciprofloxacin Pharmacare contains 750 mg of ciprofloxacin.

The other excipients are:
microcrystalline cellulose, sodium starch glycolate (type A), crospovidone, maize starch, anhydrous colloidal silica, magnesium stearate, titanium dioxide, hypromellose, macrogol 4000.

Description of CIPROFLOXACIN PHARMACARE and contents of the pack

Film-coated tablet
Blister pack
250 mg film-coated tablet: 10 tablets
500 mg film-coated tablet: 6 tablets
750 mg film-coated tablet: 12 tablets

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan, Italy

Manufacturer
Special Product’s Line SpA
Via Fratta Rotonda vado Largo, 1
03012 Anagni (FR)
Italy