Ciprofloxacin Alter: detailed information

Package leaflet: Information for the patient

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

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Ciprofloxacina Alter is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only against certain strains of bacteria.

Adults
Ciprofloxacina Alter is used in adults to treat the following bacterial infections:

respiratory tract infections
prolonged or recurrent ear or paranasal sinus infections
urinary tract infections
testicular infections
genital 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 count (neutropenia)
prevention of infections in patients with very low white blood cell count (neutropenia)
prevention of infections caused by the bacterium Neisseria meningitidis
exposure to inhalation of anthrax spores

If you have a severe infection or one caused by more than one type of bacteria, your doctor may prescribe another antibiotic treatment in addition to Ciprofloxacina Alter.

Children and adolescents
Ciprofloxacina Alter 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 Alter 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 Alter

Do not take Ciprofloxacin Alter if:

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

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

if you have been diagnosed with an enlargement or “bulging” of a major 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 have been diagnosed with insufficiency of one of the heart valves (aortic or mitral regurgitation)
if 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, vascular Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's syndrome, high blood pressure, known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart])
if you experience sudden abdominal, chest, or back pain, which may be a symptom of aortic aneurysm or dissection, seek immediate emergency care. 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).

Quinolone antibiotics may cause an increase above your normal levels of sugar in the blood (hyperglycaemia) or a decrease below your normal levels of sugar in the blood, which in severe cases could 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.
Before taking Ciprofloxacin Alter
Do not take quinolone/fluoroquinolone antibacterial medicines, including Ciprofloxacin Alter, if you have previously had any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
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 a previous treatment with antibiotics such as Ciprofloxacin Alter
you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin
you suffer from severe myasthenia (a type of muscle weakness)
you have experienced heart rhythm disturbances (arrhythmias)
inform your doctor if you or a family member is known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin
if your vision becomes impaired or if your eyes appear otherwise affected, consult an ophthalmologist immediately.

Heart problems
You should exercise particular caution when using this type of medicine 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 can cause abnormal changes on the ECG (see section “Other medicines and Ciprofloxacin Alter”).
While taking Ciprofloxacin Alter
Inform your doctor immediately if while taking Ciprofloxacin Alter any of the following conditions occur. Your doctor will decide whether treatment with Ciprofloxacin Alter should be discontinued:

If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
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 with the first dose, with symptoms such as chest tightness, dizziness, nausea or fainting, or lightheadedness when standing up. In such a case, stop treatment with Ciprofloxacin Alter and contact your doctor immediately.
Rarely, pain and swelling in the joints and inflammation or rupture of tendons 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 Alter. At the first signs of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Ciprofloxacin Alter, 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 undesirable effects on the central nervous system. In such a case, stop treatment with Ciprofloxacin Alter and contact your doctor immediately.
Psychiatric reactions may occur the first time you take Ciprofloxacin Alter. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin Alter. In such a case, stop treatment with Ciprofloxacin Alter and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) may occur, such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or in the hands and arms. In such a case, stop treatment with Ciprofloxacin Alter and inform your doctor immediately to prevent nerve damage from becoming permanent.
During treatment with antibiotics, including Ciprofloxacin Alter, 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 Alter 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 Alter if you need to have blood or urine tests.
Ciprofloxacin Alter 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 Alter and contact your doctor immediately.
Ciprofloxacin Alter 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, mouth or throat pain, 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 have kidney problems, inform your doctor, as you may need a dosage adjustment.
While taking Ciprofloxacin Alter, your skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as from sunbeds.
Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin Alter, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not improve. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, numbness, or burning (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 side effects after taking Ciprofloxacin Alter, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will also consider using an antibiotic from another class.
Other medicines and Ciprofloxacin Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Do not take Ciprofloxacin Alter with tizanidine, as this may cause undesirable effects such as low blood pressure and drowsiness.
The following medicines interact with Ciprofloxacin Alter in the body. Taking Ciprofloxacin Alter together with these medicines may affect their therapeutic effect. It may also increase the likelihood of side effects.
You must inform your doctor if you are taking or have recently taken 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.
Inform your doctor if you are taking:

Vitamin K antagonists (e.g. warfarin) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
metoclopramide (for nausea)
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
theophylline (for respiratory problems)
tizanidina (for muscle spasticity in multiple sclerosis)
olanzapine (an antipsychotic)
clozapine (an antipsychotic)
ropinirole (for Parkinson's disease)
phenytoin (for epilepsy)
ciclosporin (to prevent organ rejection)
glibenclamide (for diabetes)
duloxetine (for depression)
lidocaine (a local anaesthetic)
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 Alter may increase the blood levels of the following medicines:

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

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

antacids
omeprazole (for ulcers)
mineral supplements
sucralfate
a polymer phosphate binder (e.g. sevelamer or lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium, or iron

If these preparations are essential, take Ciprofloxacin Alter approximately two hours before or no sooner than four hours after taking them.
Ciprofloxacin Alter with food and drink
Unless you are taking Ciprofloxacin Alter with meals, 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 to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is preferable to avoid using Ciprofloxacin Alter during pregnancy.
Do not take Ciprofloxacin Alter while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin Alter may affect your level of alertness. Since neurological adverse events may occur, check how you react to Ciprofloxacin Alter before driving a vehicle or operating machinery. If you are in doubt, discuss this with your doctor.

3. How to take Ciprofloxacina Alter

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much Ciprofloxacina Alter you should take, how often, and for how long.
This will depend on the type and severity of your infection.
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. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take Ciprofloxacina Alter.

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 Ciprofloxacina Alter 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 Ciprofloxacina Alter.

If you take more Ciprofloxacina Alter than you should
If you take more than the prescribed dose, consult your doctor immediately.

If you forget to take Ciprofloxacina Alter

Take the missed dose as soon as possible, then continue as directed. However, if it is almost time for the 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 treatment with Ciprofloxacina Alter

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 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
increased levels of 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 the use of antibiotics (in very rare cases may be fatal) (see section 2 'Warnings and precautions')
changes in the number of blood cells (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood coagulation factor (platelets, thrombocytopenia, thrombocythemia)
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 in rare cases may progress to suicidal thoughts or suicide attempts or suicide), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremor, seizures (see section 2: Warnings and precautions), dizziness
visual disturbances (diplopia)
tinnitus, hearing loss, decreased hearing
rapid heartbeat (tachycardia)
dilation of blood vessels (vasodilation), low blood pressure, fainting
shortness of breath, including asthma-like symptoms
liver disorders, jaundice (cholestatic jaundice), hepatitis
sensitivity to light (see section 2: Warnings and precautions)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in the urine (see section 2: Warnings and precautions), inflammation of the urinary tract
fluid retention, excessive sweating
abnormal levels of a coagulation factor (prothrombin), increased levels of the enzyme amylase

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

a particular type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis); a reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow suppression, which may also be fatal (see section 2: Warnings and precautions)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2: Warnings and precautions)
psychiatric disorders (psychotic reactions) (see section 2: Warnings and precautions)
migraine, coordination disorders, unsteady gait (gait disturbances), disturbances of smell (olfactory disturbances), pressure on the brain (intracranial hypertension including pseudotumor cerebri)
distortions in colour perception
inflammation of the walls of blood vessels (vasculitis)
pancreatitis
death of liver cells (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, inflammation of tendons, tendon rupture – especially of the large tendon located 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)

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

disorders associated with the nervous system, such as pain, burning, tingling, numbness and/or weakness of the extremities
pustular rash generally caused by medicines (acute generalized exanthematous pustulosis, AGEP)
changes in heart rhythm (called QT interval prolongation, seen on ECG, electrical activity of the heart), abnormally fast heartbeat, life-threatening irregular heartbeat
increased risk of bleeding (in patients treated with anticoagulants)
feeling highly excited (mania) or sensation of great optimism and hyperactivity (hypomania), hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
syndrome associated with impaired water excretion and low sodium levels (SIADH)
loss of consciousness due to severe decrease 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), as well as changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors. Cases of dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may result in death, 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 Alter

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.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ciprofloxacina Alter contains
Ciprofloxacina Alter 250 mg film-coated tablets
One film-coated tablet contains:

Active substance: ciprofloxacin hydrochloride: 277.55 mg (equivalent to 250 mg ciprofloxacin)
Other components: Core: crospovidone, microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate. Coating: hypromellose, titanium dioxide (E 171), glycerol triacetate.

Ciprofloxacina Alter 500 mg film-coated tablets
One film-coated tablet contains:

Active substance: ciprofloxacin hydrochloride: 555.10 mg (equivalent to 500 mg ciprofloxacin)
Other components: Core: crospovidone, microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate. Coating: hypromellose, titanium dioxide (E 171), glycerol triacetate.

Description of the appearance of Ciprofloxacina Alter and package contents
Ciprofloxacina Alter 250 mg film-coated tablets
Film-coated, white, biconvex lens-shaped tablets with a break line on one side.
Pack size: 10 tablets.

Ciprofloxacina Alter 500 mg film-coated tablets
Film-coated, white, capsule-shaped tablets with a break line on one side.
Pack size: 6 tablets.

The break line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.

Marketing Authorization Holder
Laboratori Alter S.r.l.
Via Egadi, 7 - 20144 Milan, Italy

Manufacturer
Laboratorios Alter SA, CI Mateo Inurria, 30 - 28036 Madrid, Spain