Flontalexin

Package leaflet: Information for the user

Flontalexin 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets

Ciprofloxacin
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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Flontalexin is and what it is used for
2. What you need to know before taking Flontalexin
3. How to take Flontalexin
4. Possible side effects
5. How to store Flontalexin
6. Contents of the pack and other information

1. What Flontalexin is and what it is used for
Flontalexin is an antibiotic belonging to the fluoroquinolone family. The active substance is
ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections.
It is effective only against specific bacterial strains.

Adults
Flontalexin 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 infections in women
• gastrointestinal and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• to treat infections in patients with very low white blood cell counts (neutropenia)
• to prevent infections in patients with very low white blood cell counts (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 another antibiotic in addition to Flontalexin.

Children and adolescents
Flontalexin 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

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

2. What you should know before taking Flontalexin

Do not take Flontalexin

• if you are allergic to ciprofloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6); if you are taking tizanidine (see section “Other medicines and Flontalexin”)

Warnings and precautions
Talk to your doctor before taking Flontalexin.

• if you have been diagnosed with heart valve insufficiency (aortic or mitral regurgitation);
• if you have a family history of aortic aneurysm or aortic dissection, or congenital heart valve disease, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an autoimmune inflammatory disease], or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).

Before taking this medicine
Do not take quinolone/fluoroquinolone antibacterial medicines, including FLONTALEXIN, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such cases, inform your doctor as soon as possible.
Take special care with Flontalexin
Inform your doctor:

• if you have kidney problems, as your treatment may need adjustment;
• if you suffer from epilepsy or other neurological disorders;
• if you have had tendon problems during previous treatment with antibiotics such as Flontalexin;
• if you suffer from myasthenia gravis (a type of muscle weakness);
• if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart);
• if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood);
• if you have a very slow heart rate (called bradycardia);
• if you have heart failure or a history of heart attack (myocardial infarction);
• 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 a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you have vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or known atherosclerosis);
• if you are female or elderly;
• if you are taking other medicines that may cause abnormal changes on ECG (see section “Other medicines and Flontalexin”);
• 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 kidney problems, as you may need a dosage adjustment.

If you experience sudden and severe pain in the abdomen, chest, or back, 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 corticosteroid medicines.
Inform your doctor immediately if you notice sudden shortness of breath, especially when lying down, swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).

• 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 dizziness upon standing. In such cases, stop treatment with Flontalexin and contact your doctor immediately.
• Joint pain and swelling and tendon inflammation (tendinitis). Rarely, joint pain and swelling and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping Flontalexin. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Flontalexin, consult your doctor, and rest the affected area. Avoid unnecessary movement, as the risk of tendon rupture may increase.
• Undesirable effects on the central nervous system, especially if you suffer from epilepsy or other neurological disorders such as cerebral ischemia or stroke; in such cases, stop treatment with Flontalexin and contact your doctor immediately.
• Psychiatric reactions, even after the first dose of Flontalexin. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Flontalexin. In rare cases, depression or psychotic reactions may progress to suicidal thoughts/ideation, which may result in suicide attempts or suicide. If psychiatric reactions occur, stop treatment with Flontalexin and contact your doctor immediately.
• Symptoms of nerve damage, 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 cases, stop treatment with FLONTALEXIN and inform your doctor immediately to prevent permanent nerve damage.
• Diarrhoea: During treatment with antibiotics, including Flontalexin, or even several weeks after, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking Flontalexin immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal motility and contact your doctor.
• Symptoms of liver damage, such as loss of appetite, yellowing of the skin, dark urine, itching, or abdominal pain, as Flontalexin may cause liver damage. Stop taking Flontalexin and contact your doctor immediately.
• Symptoms of infection, 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, as Flontalexin may cause a reduction in white blood cell count, leading to decreased resistance to infections. If you experience symptoms of infection, 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.
• Vision problems, for example, if your vision deteriorates or your eyes are otherwise affected. Consult an ophthalmologist immediately.
• Serious, prolonged, disabling, and potentially irreversible adverse effects. Fluoroquinolone/quinolone antibacterial medicines, including Flontalexin, 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 the arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, 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 FLONTALEXIN, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider using an antibiotic from another class.
Inform your doctor or laboratory staff that you are taking Flontalexin if you need blood or urine tests.
While taking Flontalexin, your skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to strong sunlight and artificial UV light, such as sunbeds.
Other medicines and Flontalexin
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Flontalexin with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section "Do not take Flontalexin").
The following medicines interact with Flontalexin in the body. Taking Flontalexin together with these medicines may affect their therapeutic effect and increase the likelihood of adverse effects.
In particular, 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, certain antimicrobials (belonging to the macrolide group), certain antipsychotics.
• 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)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson’s disease)
• phenytoin (for epilepsy)
• metoclopramide (for nausea and vomiting)
• ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
• glibenclamide (for diabetes)
• medicines known to prolong the QT interval

Flontalexin 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)

Certain medicines reduce the effect of Flontalexin.

• antacids
• mineral supplements
• sucralfate (for ulcers and gastritis)
• a polymeric phosphate binder (e.g., sevelamer)
• medicines or supplements containing calcium, magnesium, aluminium, or iron
• omeprazole (for ulcers and stomach problems due to excess acidity) If your doctor considers these medicines essential, take Flontalexin approximately two hours before or no sooner than four hours after taking them.

Flontalexin with food and drinks
Unless you are taking Flontalexin with meals, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified beverages when taking the tablets, as they may interfere with the absorption of the active ingredient.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Avoid using Flontalexin during pregnancy.
Do not take Flontalexin while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Flontalexin may affect your level of alertness. Since neurological adverse events may occur, check how you react to Flontalexin before driving or operating machinery. If in doubt, discuss with your doctor.

3. How to take Flontalexin

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you exactly how much Flontalexin to take, how often, and for how long. This will depend on the type and severity of the infection you have.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.

• Swallow the tablets with plenty of liquid. Do not chew the tablets as they have an unpleasant taste.
• Try to take the tablets at approximately the same time each day.
• You may take the tablets with meals or between meals. Calcium taken during meals does not significantly affect absorption. However, do not take Flontalexin tablets with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).

Drink plenty of fluids during treatment with Flontalexin.
Use in patients with renal problems
Inform your doctor if you have kidney problems, as dose adjustment may be necessary.
If you take more Flontalexin 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 Flontalexin
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 the missed dose. Make sure you complete the full course of treatment.
If you stop taking Flontalexin
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 how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• nausea, diarrhoea
• joint pain in children

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

• fungal superinfections
• high concentration of eosinophils, a type of white blood cells
• loss of appetite (anorexia)
• hyperactivity, agitation
• headache, dizziness, feeling of instability, 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 substance present in the blood)

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

• inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section “Warnings and precautions”)
• 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)
• confusion, disorientation, anxiety reaction, unusual dreams, depression (which may lead to suicidal thoughts/ideation, suicide attempt and suicide), hallucinations
• tingling, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremor, seizures (including epilepsy) (see section “Warnings and precautions”), vertigo
• visual disturbances (e.g. double vision)
• 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 “Warnings and precautions”)
• muscle pain, joint inflammation, increased muscle tone, cramps
• kidney failure, blood or crystals in urine (see section “Warnings and precautions”), inflammation of the urinary tract
• Fluid retention, excessive sweating
• abnormal levels of a clotting factor (prothrombin), increased levels of amylase enzyme

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

• blood disorders: a specific type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis); reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal (see section “Warnings and Precautions”)
• severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section “Warnings and precautions”)
• mental disorders (psychotic reactions which may lead to suicidal thoughts/ideation, suicide attempt and suicide) (see section “Warnings and precautions”)
• unilateral headache, coordination problems, unsteady gait (gait disturbances), smell disorders (olfactory disturbances), pressure on the brain (intracranial hypertension)
• distortion in colour perception
• inflammation of blood vessel walls (vasculitis)
• inflammation of the pancreas (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, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section “Warnings and precautions”); worsening of symptoms of myasthenia gravis (see section 2: Pay special attention with FLONTALEXIN)

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

• disorders affecting the nervous system, such as pain, burning, tingling, numbness and/or weakness of the extremities

• abnormal increase in heart rate, life-threatening irregular heartbeat, changes in heart rhythm (known as QT interval prolongation, seen on ECG, the heart's electrical activity)

• a skin rash with formation of superficial pustules (acute generalised exanthematous pustulosis)

• effects on blood coagulation (in patients treated with vitamin K antagonists as oral anticoagulants)

• Syndrome associated with impaired water excretion and low sodium levels (SIADH)

• Very rare cases of adverse drug reactions that are prolonged (lasting for months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking,
  tingling, tickling, burning, numbness or pain (neuropathy), fatigue,
  memory and concentration impairment, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal ideation), 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 be fatal, as well as cases of backflow of blood 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
https://www.aifa.gov.it/content/segnalazione-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Flontalexin

Keep this medicine out of the sight and reach of children.
Do not use Flontalexin after the expiry date stated on the blister or carton after "Exp.". The expiry date refers to the last day of the 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 Flontalexin contains

• The active substance is: ciprofloxacin hydrochloride monohydrate:

One 250 mg coated tablet contains 291 mg of ciprofloxacin hydrochloride monohydrate,
equivalent to 250 mg of ciprofloxacin.
One 500 mg coated tablet contains 582 mg of ciprofloxacin hydrochloride monohydrate,
equivalent to 500 mg of ciprofloxacin.
One 750 mg coated tablet contains 873 mg of ciprofloxacin hydrochloride monohydrate,
equivalent to 750 mg of ciprofloxacin.
The other components are: povidone, microcrystalline cellulose (E460), crospovidone (E1202),
anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), macrogol, titanium dioxide (E171).

Description of the appearance of Flontalexin and pack contents
Flontalexin 250 mg coated tablets – pack of 10 tablets
Flontalexin 500 mg coated tablets – pack of 6 tablets
Flontalexin 750 mg coated tablets – pack of 12 tablets

Marketing Authorization Holder and Manufacturer
I.B.N. Savio S.r.l. - Via del Mare, 36 Pomezia (RM)
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A., Aprilia (LT) facility, via di Fossignano 2
or
Special Product’s Line S.p.A. - Via Fratta Rotonda Vado Largo, 1 – Anagni (FR)

Advice/health education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
If your doctor has prescribed antibiotics, it is because you specifically need them for your current illness.

Despite antibiotic treatment, certain bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. If you do not follow:

• dosage
• frequency of administration
• duration of treatment

you may even promote the development of bacterial resistance, delay recovery, or reduce the effectiveness of antibiotics.

Therefore, to preserve the effectiveness of this medicine:
1 – Use antibiotics only when prescribed.
2 – Follow your doctor's instructions exactly.
3 – Do not reuse an antibiotic without a medical prescription, even if you are treating a similar illness.
4 – Never give your antibiotics to another person; they may not be suitable for their illness.
5 – At the end of treatment, return any unused medicines to a pharmacy so they can be properly disposed of.