Ullax: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

ULLAX 750 mg film-coated tablets

Ciprofloxacin
EQUIVALENT 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 personally. Do not give it to others, even if their symptoms are the same as yours, as it could be dangerous.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ULLAX IS AND WHAT IT IS USED FOR

ULLAX 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
ULLAX 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 infections in women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
to treat infections in patients with a very low white blood cell count (neutropenia)
to prevent infections in patients with a very low white blood cell count (neutropenia)
exposure to inhaled 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 ULLAX.
Children and adolescents
ULLAX 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

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING ULLAX

Do not take ULLAX if:

you are allergic (hypersensitive) to the active substance, to other quinolones, or to any of the excipients of ULLAX (see section 6)
you are taking tizanidine (see section 2: Taking ULLAX with other medicines)

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing quinolones/fluoroquinolones, including ULLAX, if in the past
you have experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In
such case, inform your doctor as soon as possible.
Talk to your doctor or pharmacist before taking or using ULLAX
In particular if:

you have kidney problems, as your dose may need to be adjusted to avoid an increase in adverse drug reactions caused by accumulation of ciprofloxacin
you suffer from epilepsy or other neurological disorders
you have had tendon problems during previous treatment with antibiotics such as ULLAX
you suffer from myasthenia gravis (a type of muscle weakness)
you have experienced heart rhythm disturbances (arrhythmias)
Inform your doctor if you, or a family member, suffer from glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin.
If you have been diagnosed with 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 have been diagnosed with insufficiency of one of the heart valves (aortic and 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, or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
If you experience sudden pain in the abdomen, chest, or back, which may be a symptom of aortic aneurysm or dissection, seek immediate medical attention at the emergency room. 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).

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.
Heart problems
Special caution is required when using this medicine if you were born with or have a family history of prolonged
QT interval (seen on ECG, the electrical recording of the heart), if you have an electrolyte imbalance in the
blood (especially low levels of potassium or magnesium), if you have a very slow heartbeat (called bradycardia),
if you have a weak heart (heart failure), a history of heart attacks (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
ULLAX with other medicines”).
While taking ULLAX
Inform your doctor immediately if any of the following conditions occur during treatment with ULLAX.
Your doctor will decide whether to discontinue treatment with ULLAX.

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, malaise or fainting, dizziness upon standing. In such a case, stop taking ULLAX and contact your doctor immediately.

When taking this medicine
Rarely, joint pain and swelling, 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 ULLAX. At the first sign of tendon pain or
inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking ULLAX, consult your doctor, and
keep the affected area at rest. Avoid unnecessary movement, as the risk of tendon rupture may increase.

If you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke, you may experience undesirable effects on the central nervous system. In such a case, stop taking ULLAX and contact your doctor immediately.
Psychiatric reactions may occur the first time you take ULLAX. If you suffer from depression or psychosis, your symptoms may worsen during treatment with ULLAX. In such a case, stop taking ULLAX 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 taking ULLAX and inform your doctor immediately to prevent permanent nerve damage.
Quinolone antibiotics may cause an increase above normal levels of blood sugar (hyperglycaemia) or a decrease below 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.
During treatment with antibiotics, including ULLAX, 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 ULLAX 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 ULLAX if you are due to have blood or urine tests.
If you have kidney problems, inform your doctor, as you may need a dose adjustment.
ULLAX 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 ULLAX and contact your doctor immediately.
ULLAX 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 general condition, or fever with symptoms of localized infection such as sore throat, pain in the throat or mouth, or urinary problems, 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 the medicine.
If your vision deteriorates or if your eyes are otherwise affected, consult an ophthalmologist immediately.

Serious, prolonged, disabling, and potentially irreversible adverse effects
Fluoroquinolone/quinolone antibacterial medicines, including ULLAX, 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
pricking, tingling, 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 disorders.
If you experience any of these adverse effects after taking ULLAX, consult 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.
During treatment with ULLAX, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid
exposure to strong sunlight and artificial UV light, such as sunbeds.
Other medicines and ULLAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those without a prescription.
You must inform your doctor if you are taking 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.
Do not take ULLAX together with tizanidine, as it may cause adverse effects such as low blood pressure and
drowsiness (see section 2: "Do not take ULLAX").
The following medicines interact with ULLAX in the body. Taking ULLAX together with these medicines may
affect their therapeutic effect and increase the likelihood of adverse effects.
Inform your doctor if you are taking:

Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
theophylline (for respiratory problems)
tizanidine (for muscle spasticity in multiple sclerosis)
olanzapine (an antipsychotic)
clozapine (an antipsychotic)
ropinirole (for Parkinson’s disease)
phenytoin (for epilepsy)
metoclopramide (for nausea and vomiting)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
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.

ULLAX 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 (for erectile dysfunction or high blood pressure)
agomelatine
zolpidem

Certain medicines reduce the effect of ULLAX. 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 ULLAX approximately two hours before or no sooner than four hours
after taking them.
Taking ULLAX with food and drink
Unless otherwise directed, 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 ULLAX during pregnancy. Inform your doctor if you are planning a pregnancy.
Do not take ULLAX while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your
baby.
Driving and using machines
ULLAX may affect your level of alertness. Since neurological adverse events may occur, check how you react
to ULLAX before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. HOW TO TAKE ULLAX

Your doctor will explain exactly how much ULLAX 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. Always take the tablets exactly as instructed by your doctor. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take ULLAX.
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 taken during meals does not significantly affect absorption. However, do not take ULLAX tablets with dairy products such as milk or yogurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with ULLAX.

If you take more ULLAX than you should

If you take more than the prescribed dose, consult your doctor immediately. If possible, bring the tablets or the pack with you to show the doctor.

If you forget to take ULLAX

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 ULLAX

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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ULLAX can cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Common adverse reactions (may affect from 1 to 10 people in 100):

nausea, diarrhea
joint pain in children

Uncommon adverse reactions (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), intestinal gas
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 adverse reactions (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: Take special care with ULLAX)
changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in a blood coagulation factor (platelets)
allergic reaction, swelling (edema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycemia)
decreased blood sugar (hypoglycemia) (see section 2: Warnings and precautions)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially lead to suicidal ideation/thoughts, suicide attempt, or completed suicide) (see section 2: Take special care with ULLAX), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, seizures (see section 2: Take special care with ULLAX), dizziness
visual disturbances (e.g., 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: Take special care with ULLAX)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in urine (see section 2: Take special care with ULLAX), inflammation of the urinary tract
fluid retention, excessive sweating
abnormal levels of a coagulation factor (prothrombin), increased levels of the enzyme amylase

Very rare adverse reactions (may affect less than 1 person in 10,000):

a specific type of reduction in red blood cells (hemolytic anemia); 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: Take special care with ULLAX)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2: Take special care with ULLAX)
mental disorders (psychotic reactions which may potentially lead to suicidal ideation/thoughts, suicide attempt, or completed suicide) (see section 2: Take special care with ULLAX)
migraine, coordination disorders, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), increased pressure in the brain (intracranial hypertension including pseudotumor cerebri)
distortions in color 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: Take special care with ULLAX); worsening of symptoms of myasthenia gravis (see section 2: Take special care with ULLAX)

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

nervous system disorders, such as pain, burning, tingling, numbness and/or weakness of the extremities
Loss of consciousness due to a severe drop in blood sugar levels (hypoglycemic coma). See section 2.
heart problems: abnormally increased heart rate, life-threatening irregular heartbeat, changes in heart rhythm (called “prolongation of the QT interval”, documented by ECG, electrical activity of the heart)
Acute generalized exanthematous pustulosis (AGEP) Increased international normalized ratio (in patients treated with vitamin K antagonists)
feeling of extreme excitement (mania) or feeling of extreme 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)

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), depression, fatigue, sleep disturbances, memory impairment, 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.

Cases of dilation and weakening of the aortic wall 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 adverse reactions

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

5. HOW TO STORE ULLAX

Keep this medicine out of the sight and reach of children.
Do not use ULLAX after the expiry date stated on the blister or carton after “Exp.”. The expiry date refers to the last day of the month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What ULLAX contains
The active substance is ciprofloxacin hydrochloride monohydrate.
Each film-coated tablet contains 873 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 750 mg of
ciprofloxacin.
The excipients are:
Maize starch, microcrystalline cellulose (E460), crospovidone (E1202), anhydrous colloidal silica, magnesium
stearate (E572), hypromellose (E464), macrogol 4000, titanium dioxide (E171).
Description of the appearance of ULLAX and packaging contents
Film-coated tablets - Pack size: 12 tablets
Marketing Authorization Holder
S.F. GROUP srl
Via Tiburtina, No. 1143 - 00156 Rome
Manufacturer
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)
This patient information leaflet was last approved on

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

ULLAX 500 mg film-coated tablets

Ciprofloxacin
EQUIVALENT MEDICINE

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

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not give it to others, 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 ULLAX is and what it is used for
What you need to know before taking ULLAX
How to take ULLAX
Possible side effects
How to store ULLAX
Package contents and other information

1. WHAT ULLAX IS AND WHAT IT IS USED FOR

ULLAX 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
ULLAX 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
infections of the testicles
genital organ infections in women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
to treat infections in patients with a very low white blood cell count (neutropenia)
to prevent infections in patients with a very low white blood cell count (neutropenia)
to prevent infections caused by the bacterium Neisseria meningitidis
exposure to inhalation of anthrax spores

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

ULLAX 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 ULLAX

Do not take ULLAX if:

you are allergic (hypersensitive) to the active substance, to other quinolones, or to any of the excipients of ULLAX (see section 6)
you are taking tizanidine (see section 2: Taking ULLAX with other medicines)

Warnings and precautions
Before taking this medicine
Do not take antibacterial medicines containing quinolones/fluoroquinolones, including ULLAX, if in the past
you have experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In
such a case, inform your doctor as soon as possible.
Talk to your doctor or pharmacist before taking or using ULLAX
In particular if:

you have had kidney problems, as your dose may need to be adjusted to avoid an increase in adverse drug reactions caused by accumulation of ciprofloxacin
you suffer from epilepsy or other neurological disorders
you have had tendon problems during a previous treatment with antibiotics such as ULLAX
you suffer from myasthenia gravis (a type of muscle weakness)
you have experienced disturbances in heart rhythm (arrhythmias)
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.
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 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, or 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 aneurysm or aortic dissection, seek immediate emergency care. 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).

Heart problems
Particular caution is required when using this medicine if you have a personal or family history of prolonged
QT interval (seen on ECG, the electrical recording of the heart), if you have an electrolyte imbalance in the
blood (especially low levels of potassium or magnesium), 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 ULLAX with other medicines”).
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 ULLAX
Inform your doctor immediately if any of the following conditions occur during treatment with ULLAX. Your
doctor will decide whether treatment with ULLAX 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 symptoms such as chest tightness, dizziness, malaise, or fainting, or dizziness upon standing. In such a case, stop taking ULLAX and contact your doctor immediately.

When taking this medicine
Rarely, joint pain and swelling, 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 therapy with ULLAX. At the first sign of tendon pain or
inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking ULLAX, consult your doctor, and
keep the affected area at rest. Avoid unnecessary movement, as the risk of tendon rupture may increase.

If you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke, you may experience undesirable effects on the central nervous system. In such a case, stop taking ULLAX and contact your doctor immediately.
Psychiatric reactions may occur the first time you take ULLAX. If you suffer from depression or psychosis, your symptoms may worsen during treatment with ULLAX. In such a case, stop taking ULLAX 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 taking ULLAX and inform your doctor immediately to avoid permanent nerve damage.
Quinolone antibiotics may cause blood sugar levels to rise above normal (hyperglycaemia) or fall below normal (hypoglycaemia), 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.
During treatment with antibiotics, including ULLAX, 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 ULLAX 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 ULLAX if you need to have blood or urine tests.
If you suffer from kidney problems, inform your doctor, as you may need a dosage adjustment.
ULLAX 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 ULLAX and contact your doctor immediately.
ULLAX 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, throat or mouth pain, or urinary problems, 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 the medicine.

If your vision deteriorates or if your eyes are otherwise affected in any way, consult an ophthalmologist immediately.
Severe, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including ULLAX, 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 arms and legs, difficulty walking, abnormal sensations such as
pricking, tingling, tickling, numbness, or burning (paraesthesia), sensory organ disturbances such as changes
in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disorders.
If you experience any of these side effects after taking ULLAX, consult 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.
During treatment with ULLAX, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid
exposure to strong sunlight and artificial UV light, such as sunbeds.
Other medicines and ULLAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those without a prescription.
You must inform your doctor if you are taking 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), or some antipsychotics.
Do not take ULLAX with tizanidine, as it may cause side effects such as low blood pressure and drowsiness
(see section 2: "Do not take ULLAX").
The following medicines interact with ULLAX in the body. Taking ULLAX together with these medicines may
affect their therapeutic effect and increase the likelihood of side effects.
Inform your doctor if you are taking:

Vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
theophylline (for respiratory problems)
tizanidine (for muscle spasticity in multiple sclerosis)
olanzapine (an antipsychotic)
clozapine (an antipsychotic)
ropinirole (for Parkinson’s disease)
phenytoin (for epilepsy)
metoclopramide (for nausea and vomiting)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
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.

ULLAX may increase 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 (for erectile dysfunction or high blood pressure)
agomelatine
zolpidem

Certain medicines reduce the effect of ULLAX. Inform your doctor if you are taking or plan 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 ULLAX approximately two hours before or no sooner than four hours after taking them.
Taking ULLAX with food and drinks
Unless otherwise directed, do not consume 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 and breastfeeding
It is preferable to avoid using ULLAX during pregnancy. Inform your doctor if you are planning a pregnancy.
Do not take ULLAX while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your
baby.
Driving and using machines
ULLAX may affect your level of alertness. Since neurological adverse events may occur, check how you react to
ULLAX before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. HOW TO TAKE ULLAX

Your doctor will explain exactly how much ULLAX 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 a dosage adjustment may be necessary.
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 ULLAX.
d. Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.
e. Try to take the tablets at approximately the same time each day.
f. You may take the tablets with meals or between meals. Calcium taken during meals does not significantly affect absorption. However, do not take ULLAX tablets with dairy products such as milk or yogurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).
Remember to drink plenty of fluids during treatment with ULLAX.

If you take more ULLAX than you should

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

If you forget to take ULLAX

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 treatment as usual. 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 ULLAX

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 doubts about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, ULLAX may cause adverse effects, although not everyone experiences them.
If any of the adverse effects worsen, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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

nausea, diarrhoea
joint pain in children

Uncommon adverse 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 blood substances (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 adverse 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: Take special care with ULLAX)
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: Warnings and precautions)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially lead to suicidal ideation/thoughts, suicide attempt or completed suicide) (see section 2: Take special care with ULLAX), hallucinations
tingling, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, seizures (see section 2: Take special care with ULLAX), dizziness
visual disturbances (e.g. diplopia)
tinnitus, hearing loss, decreased hearing
rapid heartbeat (tachycardia)
dilation of blood vessels (vasodilation), low blood pressure, fainting
breathlessness, including symptoms of asthma
liver disorders, jaundice (cholestatic jaundice), hepatitis
sensitivity to light (see section 2: Take special care with ULLAX)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in urine (see section 2: Take special care with ULLAX), inflammation of the urinary tract
fluid retention, excessive sweating
abnormal levels of a coagulation factor (prothrombin), increased levels of amylase enzyme

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

a specific 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: Take special care with ULLAX)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2: Take special care with ULLAX)
mental disorders (psychotic reactions which may potentially lead to suicidal ideation/thoughts, suicide attempt or completed suicide) (see section 2: Take special care with ULLAX)
migraine, coordination disorders, unsteady gait (gait disturbances), smell disorders (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: Take special care with ULLAX); worsening of symptoms of myasthenia gravis (see section 2: Take special care with ULLAX)

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

nervous system-related disorders such as pain, burning, tingling, numbness and/or weakness of the extremities
Loss of consciousness due to a severe decrease in blood sugar levels (hypoglycaemic coma). See section 2.
heart problems: abnormal increase in heart rate, life-threatening irregular heartbeat, changes in heart rhythm (known as “prolongation of the QT interval”, documented by ECG, electrical activity of the heart)
acute generalized exanthematous pustulosis (AGEP)
International Normalized Ratio (INR) increased (in patients treated with vitamin K antagonists)
feeling of extreme excitement (mania) or feeling of extreme 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)

Very rare cases of prolonged (lasting 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), depression, fatigue, sleep disturbances, memory impairment, 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.

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 regurgitation of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

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

5. HOW TO STORE ULLAX

Keep the medicine out of the sight and reach of children.
Do not use ULLAX after the expiry date stated on the blister or carton after "Exp.". The expiry date refers to the last day of the month.
Medicines must not be disposed of 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 PACKAGE AND OTHER INFORMATION

What ULLAX contains
The active substance is ciprofloxacin hydrochloride monohydrate.
Each film-coated tablet contains 582 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 500 mg of
ciprofloxacin.
The excipients are:
Maize starch, microcrystalline cellulose (E460), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), macrogol 4000, titanium dioxide (E171).
Description of the appearance of ULLAX and pack sizes
Film-coated tablets – pack size: 6 tablets
Marketing Authorisation Holder
S.F. GROUP srl
Via Tiburtina, n° 1143 - 00156 Rome
Manufacturer
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)
This patient information leaflet was last approved on

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

ULLAX 250 mg film-coated tablets

Ciprofloxacin
EQUIVALENT 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 personally. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ULLAX IS AND WHAT IT IS USED FOR

respiratory tract infections
long-lasting or recurrent ear or paranasal sinus infections
urinary tract infections
infections of the testicles
genital infections in women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
to treat infections in patients with a very low white blood cell count (neutropenia)
to prevent infections in patients with a very low white blood cell count (neutropenia)
to prevent infections caused by the bacterium Neisseria meningitidis
after exposure to inhaled anthrax spores

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 ULLAX.
Children and adolescents
ULLAX 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)
after exposure to inhaled anthrax spores

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING ULLAX

Do not take ULLAX if:

you are allergic (hypersensitive) to the active substance, to other quinolones, or to any of the excipients of ULLAX (see section 6)
you are taking tizanidine (see section 2: Taking ULLAX with other medicines)

Warnings and precautions
Before taking this medicine, do not take quinolone/fluoroquinolone antibacterial medicines, including ULLAX, if you have previously experienced any severe adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.
Talk to your doctor or pharmacist before taking or using ULLAX, especially if:

you have kidney problems, as your dose may need to be adjusted to avoid an increase in drug-related adverse reactions due to accumulation of ciprofloxacin
you suffer from epilepsy or other neurological disorders
you have had tendon problems during previous treatment with antibiotics such as ULLAX
you suffer from myasthenia gravis (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 developing 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 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, or 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, 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).

Heart problems
Particular caution is required when using this medicine if you have congenital or familial history of prolonged QT interval (seen on ECG, the electrical recording of the heart), have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium), have a very slow heart rate (bradycardia), have a weak heart (heart failure), have a history of heart attacks (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 ULLAX with other medicines”).
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 ULLAX
Inform your doctor immediately if any of the following conditions occur during treatment with ULLAX. Your doctor will decide whether treatment with ULLAX should be discontinued.

A severe and sudden allergic reaction (anaphylactic reaction/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, malaise, or fainting, or dizziness upon standing. In such a case, stop taking ULLAX and contact your doctor immediately.

When taking this medicine
Rarely, joint pain and swelling, tendon inflammation, or tendon 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 ULLAX. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking ULLAX, consult your doctor, and rest the affected area. Avoid unnecessary movements, as the risk of tendon rupture may increase.

If you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke, you may experience adverse effects on the central nervous system. In such a case, stop taking ULLAX and contact your doctor immediately.
Psychiatric reactions may occur the first time you take ULLAX. If you suffer from depression or psychosis, your symptoms may worsen during treatment with ULLAX. In such a case, stop taking ULLAX 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 taking ULLAX and inform your doctor immediately to prevent permanent nerve damage.

Quinolone antibiotics may cause blood sugar levels to rise above normal (hyperglycaemia) or fall below normal (hypoglycaemia), 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 ULLAX, or even several weeks afterwards, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking ULLAX 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 ULLAX if you need to have blood or urine tests.
If you suffer from kidney problems, inform your doctor, as you may require a dose adjustment.
ULLAX 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 ULLAX and contact your doctor immediately.
ULLAX 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, throat or mouth pain, or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about the medicine.
If your vision deteriorates or your eyes are otherwise affected in any way, consult an ophthalmologist immediately.

During treatment with ULLAX, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.
Serious, prolonged, disabling, and potentially irreversible adverse effects
Fluoroquinolone/quinolone antibacterial medicines, including ULLAX, 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 (paresthesia), 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 ULLAX, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
Other medicines and ULLAX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
You must inform your doctor if you are taking 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), or some antipsychotics.
Do not take ULLAX together with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section 2: "Do not take ULLAX").
The following medicines interact with ULLAX in the body. Taking ULLAX together with these medicines may affect their therapeutic effect and increase the likelihood of adverse effects.
Inform your doctor if you are taking:

vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
theophylline (for respiratory problems)
tizanidine (for muscle spasticity in multiple sclerosis)
olanzapine (an antipsychotic)
clozapine (an antipsychotic)
ropinirole (for Parkinson’s disease)
phenytoin (for epilepsy)
metoclopramide (for nausea and vomiting)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
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), or some antipsychotics.

ULLAX may increase 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 (for erectile dysfunction or high blood pressure)
agomelatine
zolpidem

Certain medicines reduce the effect of ULLAX. 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 ULLAX approximately two hours before or no sooner than four hours after taking them.
Taking ULLAX with food and drinks
Unless otherwise directed, 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 ULLAX during pregnancy. Inform your doctor if you are planning a pregnancy.
Do not take ULLAX during breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
ULLAX may affect your level of alertness. Since neurological adverse events may occur, assess your response to ULLAX before driving or operating machinery. If in doubt, discuss this with your doctor.

3. HOW TO TAKE ULLAX

Your doctor will explain exactly how much ULLAX 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 a dose adjustment may be necessary.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Always take the tablets exactly as instructed by your doctor. Consult your doctor or pharmacist if you are unsure about how many tablets to take or how to take ULLAX.
g. Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.
h. Try to take the tablets at approximately the same time each day.
i. You may take the tablets with meals or between meals. Calcium taken during meals does not significantly affect absorption. However, do not take ULLAX 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 ULLAX.

If you take more ULLAX than you should

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

If you forget to take ULLAX

Take the missed dose as soon as possible, 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 ULLAX

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 product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, ULLAX can cause adverse effects, although not everyone experiences them.
If any of the adverse effects worsen, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

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

nausea, diarrhoea
joint pain in children

Uncommon adverse 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), intestinal gas
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 adverse 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: Special warnings and precautions with ULLAX)
changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increase or decrease in a blood clotting factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section 2: Warnings and precautions)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially lead to suicidal ideation/thoughts, attempted suicide or completed suicide) (see section 2: Special warnings and precautions with ULLAX), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, seizures (see section 2: Special warnings and precautions with ULLAX), dizziness
visual disturbances (e.g. 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: Special warnings and precautions with ULLAX)
muscle pain, joint inflammation, increased muscle tone, cramps
kidney failure, blood or crystals in urine (see section 2: Special warnings and precautions with ULLAX), inflammation of the urinary tract
fluid retention, excessive sweating
abnormal levels of a clotting factor (prothrombin), increased levels of the enzyme amylase

Very rare adverse effects (may affect fewer than 1 person in 10,000):

a specific 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: Special warnings and precautions with ULLAX)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section 2: Special warnings and precautions with ULLAX)
psychiatric disorders (psychotic reactions which may potentially lead to suicidal ideation/thoughts, attempted suicide or completed suicide) (see section 2: Special warnings and precautions with ULLAX)
migraine, coordination disorders, unsteady gait (walking disturbances), smell disorders (olfactory disturbances), pressure on 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
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 – particularly of the large tendon at the back of the ankle (Achilles tendon) (see section 2: Special warnings and precautions with ULLAX); worsening of symptoms of myasthenia gravis (see section 2: Special warnings and precautions with ULLAX)

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. Loss of consciousness due to a severe drop in blood sugar levels (hypoglycaemic coma). See section 2.
heart problems: abnormal increase in heart rate, life-threatening irregular heartbeat, changes in heart rhythm (called “prolongation of the QT interval”, documented by ECG, electrical activity of the heart)
Acute Generalized Exanthematous Pustulosis (AGEP)
Increased International Normalized Ratio (INR) (in patients treated with vitamin K antagonists)
feeling of extreme excitement (mania) or feeling of extreme 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)

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

5. HOW TO STORE ULLAX

Keep this medicine out of the sight and reach of children.
Do not use ULLAX after the expiry date stated on the blister or carton after “Exp.”. The expiry date refers to the last day of that month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What ULLAX contains
The active substance is ciprofloxacin hydrochloride monohydrate.
Each film-coated tablet contains 291 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 250 mg of
ciprofloxacin.
The excipients are:
Maize starch, microcrystalline cellulose (E460), crospovidone (E1202), anhydrous colloidal silica, magnesium
stearate (E572), hypromellose (E464), macrogol 4000, titanium dioxide (E171).
Description of the appearance of ULLAX and packaging contents
Film-coated tablets – pack of 10 tablets
Marketing Authorization Holder
Manufacturer
Genetic SPA Contrada Canfora – 84084 Fisciano (Sa)
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