Package leaflet: Information for the user

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

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Ciprofloxacin Aurobindo 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 Aurobindo is used in adults to treat the following bacterial infections:

respiratory tract infections
long-lasting or recurrent ear or paranasal sinus infections
complicated urinary tract infections
kidney inflammation
bacterial infection causing inflammation of the prostate
genital tract infections in men and women
intra-abdominal infections
skin and soft tissue infections
bone and joint infections
prevention of invasive Neisseria meningitidis infections
exposure to inhaled anthrax

Ciprofloxacin may be used to treat patients with a low number of white blood cells (neutropenia) who have a 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 Ciprofloxacin Aurobindo.
Children and adolescents
Ciprofloxacin Aurobindo 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 (acute pyelonephritis)
exposure to inhaled anthrax

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

2. What you need to know before taking Ciprofloxacin Aurobindo

Do not take Ciprofloxacin Aurobindo:

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: Ciprofloxacin Aurobindo and other medicines)

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

you should not take antibacterial medicines containing fluoroquinolones/quinolones, including Ciprofloxacin Aurobindo, if you have previously experienced a serious adverse reaction while taking a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible
if you have kidney problems, as your treatment may need to be adjusted
if you suffer from epilepsy or other neurological disorders
if you have had tendon problems during previous treatment with antibiotics such as Ciprofloxacin Aurobindo
if you are diabetic, because you may be at risk of hypoglycaemia with ciprofloxacin
if you suffer from severe myasthenia gravis (a type of muscle weakness), as symptoms may worsen
if you have heart problems. Caution is required when using ciprofloxacin if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called bradycardia), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), if you are female or elderly, or if you are taking other medicines that may cause abnormal changes in the ECG (see section 2: Other medicines and Ciprofloxacin Aurobindo).
if you or a family member suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency, because you may be at risk of anaemia with ciprofloxacin.
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).
if you or a family member have a 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 suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, high blood pressure or known atherosclerosis).

If you experience sudden pain in the abdomen, chest or back, go immediately to the emergency room.
For the treatment of certain genital tract infections, your doctor may prescribe additional antibiotics along with ciprofloxacin. If symptoms do not improve after 3 days of treatment, consult your doctor.
While taking Ciprofloxacin Aurobindo
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin Aurobindo. Your doctor will decide whether treatment should be discontinued.

A severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility that a severe and sudden allergic reaction may occur even after the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, dizziness upon standing. In this case, stop treatment with Ciprofloxacin Aurobindo and contact your doctor immediately.
Joint pain and swelling, as well as tendon inflammation or rupture, may rarely occur. The risk increases 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 discontinuation of therapy with Ciprofloxacin Aurobindo. At the first sign of tendon pain or inflammation (e.g. ankle, wrist, elbow, shoulder or knee), stop taking Ciprofloxacin Aurobindo, contact your doctor and rest the affected area. Avoid any unnecessary exercise, 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 on the central nervous system. In case of seizures, contact your doctor immediately.
Psychiatric reactions may occur the first time you take Ciprofloxacin Aurobindo. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Aurobindo. In rare cases, depression or psychosis may progress to suicidal thoughts, suicide attempts or suicide. If this occurs, contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms, may occur. In this case, stop taking Ciprofloxacin Aurobindo and contact your doctor immediately to prevent the development of potentially irreversible conditions.
Hypoglycaemia has been very frequently reported in diabetic patients, particularly in the elderly population. If this occurs, contact your doctor immediately.
If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
During treatment with antibiotics, including Ciprofloxacin Aurobindo, 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 Aurobindo and contact your doctor immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements.
Inform your doctor or laboratory staff that you are taking Ciprofloxacin Aurobindo if you need to have blood or urine tests.
If you have kidney problems, inform your doctor, as the dose may need to be adjusted.
Ciprofloxacin Aurobindo 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 Aurobindo 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 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 Aurobindo, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as from sunbeds.

Severe, prolonged, disabling and potentially irreversible adverse effects
Antibacterial medicines containing fluoroquinolones/quinolones, including Ciprofloxacin Aurobindo, have been associated with very rare but serious adverse effects, some of which are long-lasting (lasting for months or years), disabling or potentially irreversible. These include tendon, muscle and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pins and needles, tingling, itching, numbness or burning (paraesthesia), sensory disturbances including impaired vision, taste, smell and hearing, depression, memory disturbances, marked fatigue and severe sleep disturbances.
If you experience any of these adverse effects after taking Ciprofloxacin Aurobindo, contact your doctor immediately before continuing treatment. You and your doctor will decide together whether to continue treatment, considering also the possibility of switching to an antibiotic from another class.
Other medicines and Ciprofloxacin Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Do not take Ciprofloxacin Aurobindo together with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: “Do not take Ciprofloxacin Aurobindo”).
The following medicines interact with Ciprofloxacin Aurobindo in the body. Taking Ciprofloxacin Aurobindo 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 agonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anticoagulants (to thin the blood)
theophylline (for respiratory problems)
phenytoin (for epilepsy)
probenecid (for gout)
ropinirole (for Parkinson’s disease)
methotrexate (for certain forms of cancer, psoriasis, rheumatoid arthritis)
tizanidine (for muscle spasticity in multiple sclerosis)
olanzapine (an antipsychotic)
clozapine (antipsychotics)
metoclopramide (for nausea and vomiting)
ciclosporin (for skin diseases, 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.
zolpidem (for sleep disorders).

Ciprofloxacin Aurobindo may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathic damage or incontinence)
lidocaine (for heart problems or anaesthetic use)
sildenafil (e.g. for erectile dysfunction)
agomelatine (for depression).

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

antacids (to prevent stomach hyperacidity)
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 Aurobindo approximately two hours before or no sooner than four hours after taking them.
Ciprofloxacin Aurobindo with food and drinks
Unless otherwise instructed, 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
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 Aurobindo during pregnancy.
Do not take Ciprofloxacin Aurobindo while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin Aurobindo may reduce your level of alertness. Since neurological adverse events may occur, check how you react to Ciprofloxacin Aurobindo before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Ciprofloxacin Aurobindo

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Inform your doctor if you have kidney problems, as a dose adjustment may be necessary.
The treatment usually lasts from 5 to 21 days, but may last 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 Aurobindo.

a. Swallow the tablets with plenty of liquid. 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 Aurobindo tablets with dairy products such as milk or yoghurt, or with fruit juices fortified with minerals (e.g. calcium-fortified orange juice).

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

If you take more Ciprofloxacin Aurobindo than you should
If you take more than the prescribed dose, seek medical help immediately. If possible, bring the tablets or the pack with you to show the doctor.

If you forget to take Ciprofloxacin Aurobindo
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 Aurobindo
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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

The following section lists the most serious side effects that you may notice on your own:

Stop taking Ciprofloxacin Aurobindo and contact your doctor immediately, who will consider 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 (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)

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

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

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

Common (may affect up to 1 in 10 people):

nausea, diarrhoea
joint pain and joint inflammation in children

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

fungal superinfections
elevated levels of eosinophils, a type of white blood cell
loss of appetite (anorexia)
hyperactivity or restlessness
headache, dizziness, sleep disturbances, taste disturbances
vomiting, abdominal pain, digestive problems such as stomach discomfort (indigestion/heartburn) or 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, weakness (asthenia) or fever
increased alkaline phosphatase in the blood (a substance present in the blood)

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

muscle pain, joint inflammation, increased muscle tone and cramps
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), acute swelling of the skin and mucous membranes (angioedema) (see section 2: Warnings and precautions)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially lead to suicidal thoughts, suicide attempts or suicide) (see section 2: Warnings and precautions), or hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor, seizures or dizziness
visual disturbances including double vision (see section 2: Warnings and precautions)
tinnitus, hearing loss, decreased hearing
rapid heartbeat (tachycardia)
dilation of blood vessels (vasodilation), low blood pressure or fainting
shortness of breath, including asthma-like symptoms
liver disorders, jaundice (cholestatic jaundice) or hepatitis
sensitivity to light (see section 2: Warnings and precautions)
kidney failure, blood or crystals in the urine, inflammation of the urinary tract
fluid retention or 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) (see section 2: Warnings and precautions); reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow suppression, which may also be fatal
an allergic reaction called serum sickness-like reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2: Warnings and precautions)
psychiatric disorders (psychotic reactions) (see section 2: Warnings and precautions)
migraine, coordination problems, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), increased pressure in the brain (intracranial hypertension)
colour vision disturbances
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
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)

abnormally rapid heartbeat, potentially fatal heart rhythm irregularities, changes in heart rhythm (called 'QT interval prolongation', observed on electrocardiogram, electrical activity of the heart)
effects on blood clotting (in patients treated with certain anticoagulant medicines called vitamin K antagonists)
feeling of extreme excitement (mania) or feeling of extreme optimism and hyperactivity (hypomania)
syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Other side effects include:

Increased blood sugar levels (hyperglycaemia) or reduced blood sugar levels leading to coma (hypoglycaemic coma). This is important for people with diabetes.

Very rare cases of adverse reactions that are long-term (up to months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pins and needles, tingling, itching, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory problems, as well as impairment of hearing, vision, taste and smell, have been associated with the administration of quinolone and fluoroquinolone antibiotics, in some cases independent of pre-existing risk factors.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: 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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister 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 Ciprofloxacin Aurobindo contains

The active substance is ciprofloxacin (as hydrochloride). Each film-coated tablet contains 250 mg of ciprofloxacin (as hydrochloride). Each film-coated tablet contains 500 mg of ciprofloxacin (as hydrochloride). Each film-coated tablet contains 750 mg of ciprofloxacin (as hydrochloride).
The other components are:
Tablet core: Microcrystalline cellulose, sodium starch glycolate (type A), povidone (K30), anhydrous colloidal silica, magnesium stearate.
Coating: Hypromellose, titanium dioxide (E171), macrogol 400.

Description of the appearance of Ciprofloxacin Aurobindo and package contents
Film-coated tablet.
Ciprofloxacin Aurobindo 250 mg film-coated tablets
White to almost white, round film-coated tablets (diameter 11.1 mm), with a score line on one side and engraved with “F” and “23” with a score line on the other side. The tablet can be divided into two equal doses.
Ciprofloxacin Aurobindo 500 mg film-coated tablets
White to almost white, capsule-shaped film-coated tablets, with a score line on one side and engraved with “F22” on the other side. The tablet can be divided into two equal doses. Size: 18.2 mm x 8.1 mm.
Ciprofloxacin Aurobindo 750 mg film-coated tablets
White to almost white, capsule-shaped film-coated tablets, engraved with “C” on one side and “93” on the other side. Size: 22.3 mm x 8.2 mm.
Ciprofloxacin Aurobindo film-coated tablets are available in blister packs.
Pack sizes:
250 mg: 8, 10 and 16 film-coated tablets
500 mg: 6, 8 and 16 film-coated tablets
750 mg: 8, 12 and 16 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l., via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000 - Malta
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD,
HA4 6QD – United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Ciprofloxacin Aurobindo
Portugal: Ciprofloxacin Aurovitas

Medical information / Indications
Antibiotics are used to treat bacterial infections and are ineffective against viral infections.
If your doctor has prescribed antibiotics, it is because you specifically need them for your current illness.
Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is called resistance: certain antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. If you do not follow the points listed below, you may even help bacteria become resistant, thereby delaying recovery or reducing the effectiveness of antibiotics:

dosage
timing
duration of treatment

Therefore, to ensure the effectiveness of this medicine:

Use antibiotics only when prescribed by a doctor.
Follow the instructions carefully.
Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar condition.
Never give your antibiotics to another person: they may not be suitable for their condition.
After completing treatment, return any unused medicines to the pharmacist for proper disposal.