FLONTALEXIN 250 mg Коированная Таблетка

Содержание инструкции

1. Flontalexin 250 mg coated tablets
2. Flontalexin 750 mg coated tablets
   1. What you need to know before taking Flontalexin
   2. How to take Flontalexin
   3. Possible side effects
   4. How to store Flontalexin
   5. Package contents and other information

Flontalexin 250 mg coated tablets

Flontalexin 500 mg coated tablets

Flontalexin 750 mg coated tablets

Ciprofloxacin

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 ingredient is
ciprofloxacin. Ciprofloxacin works by killing the bacteria that cause infections.
It only works against certain types of bacteria.

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

• respiratory tract infections
• long-lasting or recurrent ear or sinus infections
• urinary tract infections
• testicular infections
• infections of the female genital organs
• gastrointestinal and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• to treat infections in patients with a very low number of white blood cells (neutropenia)
• to prevent infections in patients with a very low number of white blood cells (neutropenia)
• to prevent infections caused by the bacterium Neisseria meningitidis
• exposure to inhalation of anthrax spores

If you have a serious infection, or one caused by more than one type of bacteria, you may be prescribed
another antibiotic treatment 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 suffering from cystic fibrosis
• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
• exposure to inhalation of anthrax spores

Flontalexin can also be used to treat other specific serious infections in children and
adolescents, if deemed necessary by the doctor.

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

Before taking this medicine
Do not take antibacterial medicines based on quinolones/fluoroquinolones, including
FLONTALEXIN, if you have had any serious adverse reaction in the past during
treatment with a quinolone or fluoroquinolone. In this case, inform your doctor as soon as possible.

Be particularly careful with Flontalexin
tell your doctor:

• if you have had kidney problems, as the treatment may need to be adjusted;
• if you suffer from epilepsy or other neurological disorders;
• if you have had tendon problems during a 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 (displayed on ECG, an electrical recording of the heart);
• if you have a salt imbalance in the blood (especially a low level of potassium or magnesium in the blood);
• if you have a very slow heartbeat (called bradycardia);
• if you have a weak heart (heart failure) or a history of heart attack (myocardial infarction);
• 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 a family history of aortic aneurysm, aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue diseases such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure or known atherosclerosis);
• if you are a woman or an elderly person;
• if you are taking other medicines that can cause abnormal changes on the ECG (see section “Other medicines and Flontalexin”);
• if you, or a family member, are known to have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anemia with ciprofloxacin;
• if you suffer from kidney problems, as you may need a dosage adjustment.

If you experience severe and sudden abdominal, chest or back pain, which may be
a symptom of aneurysm and aortic dissection, go to the emergency room immediately. The
risk may be greater if you are taking systemic corticosteroids. Immediately inform your doctor if you notice a rapid onset of shortness of breath,
especially when lying down, or swelling of the ankles, feet or abdomen,
or new episodes of palpitations (feeling of a rapid or irregular heartbeat).

• severe and sudden allergic reaction(an anaphylactic/anaphylactic shock, angioedema). There is a remote possibility that a severe and sudden allergic reaction may occur even with the first dose, with the following symptoms: tightness in the chest, dizziness, nausea or fainting, dizziness when standing up. In this case,stop treatment with Flontalexin and contact your doctor immediately.
• pain and swelling in the joints andinflammation of the tendons (tendinitis).Pain and swelling in the joints and inflammation or rupture of the tendons can rarely occur. The risk is greater if you are elderly (over 60 years of age), have received an organ transplant, have kidney problems or are being treated with corticosteroids. Inflammation and rupture of the tendons can occur within the first 48 hours of treatment and up to several months after stopping Flontalexin therapy. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop treatment with Flontalexin, see your doctor and rest the painful part. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
• adverse effects on the central nervous system, especially if you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke; In this case, stop treatment with Flontalexin and contact your doctor immediately.
• psychiatric reactions, even after the first time you take Flontalexin if you suffer from depression or psychosis, your symptoms may worsen during treatment with Flontalexin. In rare cases, depression or psychotic reactions can evolve into suicidal thoughts/ideation that can culminate in suicide attempt or suicide. In case of psychiatric reactions, stop treatment with Flontalexin and contact your doctor immediately.
• symptoms of neurological damage, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, particularly in the feet and legs or hands and arms, can rarely occur. In this case, stop treatment with FLONTALEXIN and inform your doctor immediately to prevent nerve damage from becoming permanent
• diarrhea,during treatment with antibiotics, including Flontalexin, or even several weeks later, diarrhea can develop. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking Flontalexin immediately, as it may be a life-threatening form. Do not take medicines that block or reduce bowel movements and contact your doctor.
• symptoms of liver damage, such as loss of appetite, yellowing of the skin, dark urine, itching or abdominal tenderness, as Flontalexin can cause liver damage. Stop taking Flontalexin and contact your doctor immediately.
• symptoms of infection,such as fever and marked deterioration of general condition, or fever with symptoms of localized infection, such as sore throat or sore throat or mouth or urinary problems, as Flontalexin can cause a reduction in the number of white blood cells which can lead to decreased resistance to infections. If you experience symptoms of infection, consult your doctor immediately. You will be given a blood test to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about the medicine.
• visual problems,for example if your vision should decrease or if your eyes should be compromised in any other way. Consult an ophthalmologist immediately.
• Serious, prolonged, disabling and potentially irreversible adverse effects.Antibacterial medicines based on fluoroquinolones/quinolones, including Flontalexin, have been associated with very rare but serious adverse effects, some of which are prolonged (lasting months or years), disabling or potentially irreversible. These include pain in tendons, muscles and joints of arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, tickling, numbness or burning (paresthesia), sensory organ disorders such as alteration of vision, taste, smell and hearing, depression, impaired memory, severe fatigue and severe sleep disturbances.

If you experience any of these adverse effects after taking FLONTALEXIN, contact your
doctor immediately before continuing treatment. The doctor will decide
together with you whether to continue the treatment and will also consider the use of an
antibiotic of another class.
Inform your doctor or laboratory personnel that you are taking Flontalexin if you need to have
blood or urine tests.
During the intake of Flontalexin, the skin becomes more sensitive to sunlight or ultraviolet
(UV) light. Avoid exposure to intense sunlight and artificial UV light, such as that of
tanning beds.

Other medicines and Flontalexin
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines

Do not take Flontalexin together with tizanidine, as it can 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 can affect their therapeutic effect and increase
the likelihood of adverse effects.

In particular, tell your doctor if you are taking:

• other medicines that can alter the heart rhythm: medicines that belong to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group), some antipsychotics.
• vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumone or fluindione) or other oral anticoagulants (to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, for psoriasis or rheumatoid arthritis)
• theophylline (for breathing problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)
• metoclopramide (for nausea and vomiting)
• cyclosporine (for skin problems, rheumatoid arthritis and in organ transplants)
• glibenclamide (for diabetes)
• medicines known to prolong the QT interval

Flontalexin can increasethe levels of the following medicines in the blood:

• pentoxifylline (for circulatory disorders)
• caffeine
• duloxetine (for depression, diabetic neuropathy or incontinence)
• lidocaine (for heart problems or for anesthetic use)
• sildenafil (for erectile dysfunction)

Certain medicines reducethe effect of Flontalexin.

• antacids
• mineral supplements
• sucralfate (for ulcers and gastritis)
• a polymeric phosphate binder (e.g. sevelamer)
• medicines or supplements containing calcium, magnesium, aluminum or iron
• omeprazole (for ulcers and problems caused by excess stomach acid) If the doctor considers that these medicines are essential, take Flontalexin about two hours before taking them, or not before four hours after.

Flontalexin with food and drink
Unless you are taking Flontalexin during meals, do not eat or drink dairy products (such as milk or
yogurt) or beverages supplemented with calcium when taking the tablets, as they may
interfere with the absorption of the active ingredient.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Avoid using Flontalexin during pregnancy.
Do not take Flontalexin during breastfeeding, as ciprofloxacin is excreted into
breast milk and may be harmful to your baby.

Driving and operating machinery
Flontalexin can interfere with your state of attention. As adverse events
neurological may occur, check your reactions to Flontalexin before driving a vehicle or
operating machinery. If in doubt, talk to your doctor.

3. How to take Flontalexin

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
Your doctor will explain exactly how much Flontalexin you need to take, how often and
for how long. This will depend on the type of infection you have and its severity.
Usually the treatment 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 because they have an unpleasant taste.
• Try to take the tablets at about the same time each day.
• You can take the tablets with meals or in between. Calcium taken during meals does not significantly affect absorption. However, do nottake Flontalexin tablets with dairy products such as milk or yogurt or with fruit juices fortified with minerals (e.g. calcium-fortified orange juice).

Drink plenty of fluids during treatment with Flontalexin.

Use in patients with kidney problems
Tell your doctor if you have kidney problems, as a dosage 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 with
you the tablets or the package to show to the doctor.

If you forget to take Flontalexin
Take the normal 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 as usual. Do not
take a double dose to make up for a missed dose. Make sure to
complete the treatment cycle.

If you stop taking Flontalexin
It is important that you complete the treatment cycle even if you start to feel better after
a few days. If you stop taking this medicine too soon, the infection may
not be completely cured and the symptoms of the infection may recur or
worsen. You may also develop antibiotic resistance.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the side effects gets worse, or if you notice any not listed

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

• nausea, diarrhea
• joint pain in children

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

• superinfections caused by fungi
• high concentration of eosinophils, a type of white blood cells
• loss of appetite (anorexia)
• hyperactivity, agitation
• headache, dizziness, feeling unstable, sleep disorders, taste disturbances
• vomiting, abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn), intestinal gas
• increase in certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching, hives
• joint pain in adults
• reduced kidney function
• muscle and bone pain, feeling unwell (asthenia), fever
• increased alkaline phosphatase in the blood (a certain substance present in the blood)

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

• inflammation of the intestine (colitis) associated with the use of antibiotics (in very rare cases it can be fatal) (see section “Warnings and precautions”)
• changes in the number of blood cells (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in a blood clotting factor (platelets)
• allergic reaction, swelling (edema), acute swelling of the skin and mucous membranes (angioedema)
• increased blood sugar (hyperglycemia)
• confusion, disorientation, anxious reaction, unusual dreams, depression (which can culminate in thoughts/suicidal ideation, suicide attempt and suicide), hallucinations
• tingling, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremor, convulsions (including epilepsy) (see section “Warnings and precautions”), vertigo
• visual disturbances (e.g. double vision)
• tinnitus, hearing loss, decreased hearing
• fast heartbeat (tachycardia)
• dilation of blood vessels (vasodilation), low blood pressure, fainting
• shortness of breath, including asthma 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 the 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 the amylase enzyme

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

• blood disorders: a particular type of decrease in red blood cells (hemolytic anemia); a dangerous decrease in a type of white blood cells (agranulocytosis); a decrease in red blood cells, white blood cells and platelets (pancytopenia), which can be fatal; bone marrow depression, which can also be fatal (see section “Warnings and Precautions”)
• severe allergic reaction (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) (see section “Warnings and precautions”)
• mental disorders (psychotic reactions which can culminate in thoughts/suicidal ideation, suicide attempt and suicide) (see section “Warnings and precautions”)
• one-sided headache, coordination disorders, unsteady gait (walking disorders), disorders of smell (olfactory disorders), pressure on the brain (intracranial hypertension)
• distortion in color perception
• inflammation of the blood vessel walls (vasculitis)
• Inflammation of the pancreas (pancreatitis)
• death of liver cells (hepatic necrosis), which very rarely can lead to liver failure life-threatening
• pinpoint hemorrhages 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 located in the back of the ankle (Achilles tendon) (see section “Warnings and precautions”); worsening of symptoms of myasthenia gravis (see section 2: Pay particular attention with FLONTALEXIN)

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

• disorders associated with the nervous system, such as pain, burning, tingling, numbness and/or weakness in the extremities
• abnormally increased heart rate, life-threatening irregular heartbeat, alteration of heart rhythm (called prolongation of the QT interval, displayed on the ECG, heart electrical activity)
• a skin rash with the formation of superficial pustules (acute generalized pustulotic exanthem)
• influence on blood coagulation (in patients treated with vitamin K antagonists such as oral anticoagulants)
• 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 inflammation of the tendons, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as prickling,

tingling, itching, burning, numbness or pain (neuropathy), fatigue,
impaired memory and concentration, effects on mental health (which
may include sleep disorders, anxiety, panic attacks, depression and suicidal ideation) as well as alteration of hearing, vision, taste and smell, have
been associated with the use of antibiotics of the quinolone and fluoroquinolone type, in some cases
independently of pre-existing risk factors

• Cases of dilation and weakening of the aortic wall or rupture of the aortic wall (aneurysms and dissections), with possible ruptures that can cause death, as well as cases of backflow of blood from the heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https:// www.aifa.gov.it/content/segnalazionireazioni-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 which is stated on the blister or the carton after
“Exp.”. The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredient is: ciprofloxacin hydrochloride monohydrate:

A 250 mg coated tablet contains 291 mg of ciprofloxacin hydrochloride monohydrate,
equivalent to 250 mg of ciprofloxacin.
A 500 mg coated tablet contains 582 mg of ciprofloxacin hydrochloride monohydrate,
equivalent to 500 mg of ciprofloxacin.
A 750 mg coated tablet contains 873 mg of ciprofloxacin hydrochloride monohydrate,
equivalent to 750 mg of ciprofloxacin.
The other ingredients 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 contents of the pack
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 authorisation holder and manufacturer
I.B.N. Savio S.r.l. - Via del Mare, 36 Pomezia (RM)
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A Officina di Aprilia (LT), 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, you need them specifically for your current
illness.
Despite antibiotics, certain bacteria can survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Misuse of antibiotics increases resistance. You can even promote the development
of resistance in bacteria and delay healing or reduce the effectiveness of antibiotics if you do not
adhere to:

• dosage
• frequency of administration
• duration of treatment

Consequently, to safeguard the effectiveness of this medicine:

• 1 – Use antibiotics only when prescribed.
• 2 – Follow your doctor's instructions strictly.
• 3 – Do not reuse an antibiotic without a prescription, even if you want to treat a similar illness.
• 4 – Never give your antibiotic to another person; it may not be suitable for their illness.
• 5 – At the end of treatment, return all unused medicines to the pharmacy to ensure they are disposed of correctly