CIPROFLOXACINA 250 mg Фильм-Coated Таблетки

Содержание инструкции

1. Ciprofloxacina Alter 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What Ciprofloxacina Alter is and what it is used for
   2. What you need to know before taking Ciprofloxacina Alter
   3. How to take Ciprofloxacina Alter
   4. Possible side effects
   5. How to store Ciprofloxacina Alter
   6. Contents of the pack and other information

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

Ciprofloxacina

Generic medicine
Read this leaflet carefully before 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, as 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 Ciprofloxacina Alter is and what it is used for
• 2. What you need to know before you take Ciprofloxacina Alter
• 3. How to take Ciprofloxacina Alter
• 4. Possible side effects
• 5. How to store Ciprofloxacina Alter
• 6. Contents of the pack and other information

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

Ciprofloxacina Alter is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing the bacteria that cause infections. It only works against specific strains of bacteria.
Adults
Ciprofloxacina Alter 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 cure 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 severe infection, or one caused by more than one type of bacteria, you may be prescribed another
antibiotic treatment in addition to Ciprofloxacina Alter.
Children and adolescents
Ciprofloxacina Alter is used in children and adolescents, under specialist supervision, to
treat the following bacterial infections:

• lung and bronchial infections in children and adolescents suffering from cystic fibrosis
• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
• exposure to inhalation of anthrax spores

Ciprofloxacina Alter 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 Ciprofloxacina Alter

Do not take Ciprofloxacina Alter if:

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

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

• 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 and mitral regurgitation);
• if you have a family history of aortic aneurysm, aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue diseases 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, Behcet'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 and aortic dissection, go to the emergency room immediately. The risk may be greater if you are taking systemic corticosteroids.

soccorso. The risk may be greater if you are taking systemic corticosteroids
systemic.

• 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 rapid or irregular heartbeat).

Quinolone antibiotics can cause an increase above your normal levels of
blood sugar (hyperglycemia) or a decrease below your normal levels of
blood sugar, which in severe cases can potentially lead to loss of
consciousness (hypoglycemic coma) (see section 4). This is important for people who
have diabetes. If you have diabetes, your blood sugar levels should be closely
monitored.

Before taking Ciprofloxacina Alter
Do not take antibacterial medicines based on quinolones/fluoroquinolones, including
Ciprofloxacina Alter, 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.
Tell your doctor if:

• you have had kidney problems, as treatment may need to be adjusted
• you suffer from epilepsy or other neurological disorders
• you have had tendon problems during previous treatment with antibiotics such as Ciprofloxacina Alter
• if you are diabetic because there may be a risk of hypoglycemia when using ciprofloxacin
• you suffer from myasthenia gravis (a type of muscle weakness)
• you have suffered from heart rhythm disturbances (arrhythmias)
• tell 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 anemia with ciprofloxacin
• if your vision becomes impaired or if your eyes seem affected, consult an ophthalmologist immediately.

Heart problems
You must be particularly careful when using this medicine if you were born with or have
a family history of prolonged QT interval (displayed on an ECG, an electrical recording of the heart), have a salt imbalance in the blood (especially a low level of
potassium or magnesium in the blood), have a very slow heart rate (called bradycardia), have
a weak heart (heart failure), have a history of heart attack (myocardial
infarction), if you are a woman or an elderly patient or if you are taking other medicines that
can cause abnormal changes on the ECG (see section “Other medicines and
Ciprofloxacina Alter”).

When taking Ciprofloxacina Alter
Immediately inform your doctor if during the intake of Ciprofloxacina Alterone of the
conditions listed below occurs. The doctor will decide whether to stop treatment
with Ciprofloxacina Alter:

• If your vision should decrease or if your eyes should be impaired in any other way, consult an ophthalmologist immediately.
• A severe and sudden allergic reaction(anaphylactic/anaphylactic shock, angioedema). There is a remote possibility of a severe and sudden allergic reaction even with the first dose, with the following symptoms: chest tightness, dizziness, nausea or fainting, dizziness when standing up. In this case,stop treatment with Ciprofloxacina Alter and contact yourdoctor immediately.
• Rarely, pain and swelling in the joints andinflammation or rupture of the tendonscan occur. The risk is greater 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. Inflammation and rupture of the tendons can occur within the first 48 hours of treatment and up to several months after the end of therapy with Ciprofloxacina Alter. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop treatment with Ciprofloxacina Alter, consult your doctor and keep the painful part at rest. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
• If you suffer from epilepsyor other neurological disorders, such as cerebral ischemia or stroke, you may experience adverse effects on the central nervous system. In this case, stop treatment with Ciprofloxacina Alter and contact your doctor immediately.
• Psychiatric reactionscan occur the first time you take Ciprofloxacina Alter. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacina Alter. In this case, stop treatment with Ciprofloxacina Alter and contact your doctor immediately.
• Rarely, symptoms of nerve damage (neuropathy) such aspain, burning, tingling, numbness and/or weakness especially in the feet and legsor in the hands and armscan occur. In this case, stop treatment with Ciprofloxacina Alter and informyour doctor immediately to prevent nerve damage from becomingpermanent.
• During treatment with antibiotics, including Ciprofloxacina Alter, or even weeks later, diarrheacan develop. If it worsens or persists, or if you notice blood or mucus in your stool, you should stop taking Ciprofloxacina Alter immediately, as it may be a life-threatening form. Do not take medicines that block or reduce bowel movements and contact your doctor.
• Inform your doctor or laboratory personnel that you are taking Ciprofloxacina Alter if you need to have blood or urine tests.
• Ciprofloxacina Alter can cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or abdominal tenderness, stop taking Ciprofloxacina Alter and contact your doctor immediately.
• Ciprofloxacina Alter can cause a reduction in the number of white blood cells, which can lead to reduced resistance to infections. If you experience an infection with symptoms such as fever and marked deterioration of general conditions, or fever with symptoms of localized infection, such as sore throat or sore throat or mouth problems, you should 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 you suffer from kidney problems, tell your doctor as you may need a
dosage adjustment
During the intake of Ciprofloxacina Alter the skin becomes more sensitive to sunlight or
ultraviolet (UV) radiation.Avoid exposure to intense sunlight and artificial UV radiation, such as
that of tanning beds.

Serious, prolonged, disabling and non-improving side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including Ciprofloxacina Alter, have
been associated with very rare but serious side effects, some of which are prolonged (lasting
months or years), disabling or non-improving. These include pain in the tendons, muscles and joints of arms and legs, difficulty walking, abnormal sensations
such as tingling, tingling, itching, numbness or burning (paresthesia), disorders of the sensory organs such as alteration of vision, taste, smell and hearing, depression,
memory impairment, severe fatigue and severe sleep disturbances.

If you experience any of these side effects after taking Ciprofloxacina
Alter, contact your doctor immediately before continuing treatment. The doctor
will decide together with you whether to continue treatment and will also consider
the use of an antibiotic from another class.
Other medicines and Ciprofloxacina Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including over-the-counter medicines.

Do not take Ciprofloxacina Alter together with tizanidine,as this may cause side
effects such as low blood pressure and drowsiness.
The following medicines interact with Ciprofloxacina Alter in the body. Taking
Ciprofloxacina Alter together with these medicines can affect their therapeutic effect.
It can also increase the likelihood of side effects.
You must tell your doctor if you are taking or have recently taken 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 group of macrolides), some
antipsychotics.

Tell your doctor if you are taking:

• Vitamin K antagonists (e.g. warfarin) or other oral anticoagulants (to thin the blood)
• probenecid (for gout)
• metoclopramide (for nausea)
• methotrexate (for certain types of cancer, psoriasis or rheumatoid arthritis)
• theophylline (for breathing problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• olanzapine (an antipsychotic)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)
• cyclosporine (to prevent organ rejection)
• glibenclamide (for diabetes)
• duloxetine (for depression)
• lidocaine (a local anesthetic)
• 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 group of macrolides), some antipsychotics.

Ciprofloxacina Alter 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 (used to treat erectile dysfunction),
• Agomelatine,
• Zolpidem.

Certain medicines reducethe effect of Ciprofloxacina Alter. Tell your doctor if you take or
intend to take:

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

If these preparations are essential, take Ciprofloxacina Alter about two hours before their
intake, or not before four hours after.

Ciprofloxacina Alter with food and drink
Unless you are taking Ciprofloxacina Alter with 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, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this
medicine.
It is preferable to avoid the use of Ciprofloxacina Alter during pregnancy.
Do not take Ciprofloxacina Alter while breastfeeding, because ciprofloxacin is
excreted in breast milk and may be harmful to your baby .
Driving and operating machinery
Ciprofloxacina Alter may interfere with your state of attention. Because neurological adverse events may occur, check your reactions to Ciprofloxacina Alter before driving a
vehicle or operating machinery. If you are in doubt, talk to your doctor.

3. How to take Ciprofloxacina Alter

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The doctor will explain to you exactly how much Ciprofloxacina Alter you need to take, how often and for how long.
This will depend on the type of infection you have and its severity.
Tell your doctor if you have kidney problems, as a dosage adjustment may be necessary.
Usually the treatment lasts from 5 to 21 days, but may last longer for severe infections. Consult your doctor or pharmacist if you are not sure how many tablets to take and how to take Ciprofloxacina Alter.

• 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 about the same time each day.
• c. You can take the tablets with meals or in between. Calcium taken during meals does not significantly affect absorption. However, do not take Ciprofloxacina Alter 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 Ciprofloxacina Alter.

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

If you forget to take Ciprofloxacina Alter

• Take the 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 the treatment with Ciprofloxacina Alter

• It is important that you complete the treatment cycleeven 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 reappear or worsen. You may also develop resistance to the antibiotic .

If you have any further questions on 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.

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

• nausea, diarrhea
• joint pain in children.

Uncommon side effects(may affect up to 1 in 1,000 people):

• superinfections caused by fungi
• high concentration of eosinophils, a type of white blood cells
• loss of appetite (anorexia)
• hyperactivity, agitation
• headache, feeling of instability, 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, malaise (asthenia), fever
• increased alkaline phosphatase in the blood (a certain substance present in the blood).

Rare side effects(may affect up to 1 in 10,000 people):

• inflammation of the intestine (colitis) associated with the use of antibiotics (in very rare cases it can be fatal) (see section 2 ‘Warnings and precautions’)
• alterations in the number of blood cells (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in a blood coagulation factor (platelets, thrombocytopenia, thrombocytosis)
• 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 in rare cases can evolve into thoughts of suicide or suicide attempts or suicide), hallucinations
• tingling, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremor, convulsions (see section 2: Warnings and precautions), dizziness
• visual disturbances (diplopia)
• 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 2: Warnings and precautions)
• muscle pain, joint inflammation, increased muscle tone, cramps
• kidney failure, blood or crystals in the urine (see section 2: Warnings and precautions), inflammation of the urinary tract
• fluid retention, excessive sweating
• abnormal levels of a coagulation factor (prothrombin), increased levels of the amylase enzyme

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

• 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 2: Warnings and precautions)
• severe allergic reaction ( anaphylactic reaction to anaphylactic shock, which can be fatal - serum sickness) (see section 2: Warnings and precautions)
• mental disorders (psychotic reactions) (see section 2: Warnings and precautions)
• migraine, coordination disorders, unsteady gait (walking disorders), smell disorders (olfactory disorders), pressure on the brain (increased intracranial pressure including pseudotumor cerebri)
• distortions in color perception
• inflammation of the blood vessel walls (vasculitis)
• 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 (for example, 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 2: Warnings and precautions); worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

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

• disorders associated with the nervous system, such as pain, burning, tingling, numbness and/or weakness of the extremities
• pustular rash generally caused by drugs (acute generalized exanthematous pustulosis, AGEP)
• alteration of the heart rhythm (called prolongation of the QT interval, shown on the ECG, heart electrical activity) abnormally fast heart rhythm life-threatening irregular heartbeat
• increased risk of bleeding (in patients treated with anticoagulants)
• feeling very excited (mania) or feeling of great optimism and hyperactivity (hypomania), hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
• syndrome associated with impaired water elimination and low sodium levels (SIADH)
• loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma). See section 2.

Very rare cases of adverse drug reactions, prolonged (lasting months or years) or
permanent, such as tendon inflammation, tendon rupture, joint pain, pain to
arms or legs, difficulty walking, abnormal sensations such as prickling, tingling,
itching, burning, numbness or pain (neuropathy), fatigue, impairment of
memory and concentration, effects on mental health (which may include sleep disorders,
anxiety, panic attacks, depression and suicidal thoughts), as well as alterations in hearing,
vision, taste and smell, have been associated with the use of antibiotics of the type of
quinolones and fluoroquinolones, in some cases regardless 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 experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side
effects you can help provide more information on the safety of this
medicine.

5. How to store Ciprofloxacina Alter

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister or the carton after
"Exp.". The expiry date refers to the last day of that 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. Contents of the pack and other information

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

• The active ingredient is:ciprofloxacin hydrochloride: 277.55 mg (equivalent to ciprofloxacin 250 mg)
• The other ingredients are:Core: crospovidone, microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate. Coating: hypromellose, titanium dioxide (E 171), glycerol triacetate.

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

• The active ingredient is:ciprofloxacin hydrochloride: 555.10 mg (equivalent to ciprofloxacin 500 mg)
• The other ingredients are:Core: crospovidone, microcrystalline cellulose, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate. Coating: hypromellose, titanium dioxide (E 171), glycerol triacetate.

Description of the appearance of Ciprofloxacina Alter and contents of the pack
Ciprofloxacina Alter 250 mg film-coated tablets
Film-coated tablets, white, lenticular shaped with a fracture line on one side.
Pack of 10 tablets

Ciprofloxacina Alter 500 mg film-coated tablets
Film-coated tablets, white, capsule-shaped, with a fracture line on one side.
Pack of 6 tabletsThe fracture line on the tablet is intended to facilitate breaking the tablet for easier swallowing and not for dividing it into equal doses.

Marketing Authorisation Holder
Laboratori Alter S.r.l.
Via Egadi, 7 - 20144 Milano

Manufacturer
Laboratorios Alter SA, CIMateo Inurria, 30- 28036 Madrid, Spain