CUSPIS 250 mg Фильм-Coated Таблетки

Содержание инструкции

1. CUSPIS 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets
   1. WHAT CUSPIS IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING CUSPIS
   3. HOW TO TAKE CUSPIS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE CUSPIS
   6. PACKAGE CONTENTS AND OTHER INFORMATION

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

Ciprofloxacin
Generic medicine
Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may 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 CUSPIS is and what it is used for
• 2. What you need to know before you take CUSPIS
• 3. How to take CUSPIS
• 4. Possible side effects
• 5. How to store CUSPIS
• 6. Contents of the pack and other information

1. WHAT CUSPIS IS AND WHAT IT IS USED FOR

Cuspis contains the active ingredient ciprofloxacin. Cuspis is an antibiotic belonging to the family of
fluoroquinolones. Ciprofloxacin works by killing the bacteria that cause infections. It only works against
specific strains of bacteria.

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

• respiratory tract infections
• long-lasting or recurrent ear or sinus infections
• urinary tract infections
• infections of the genital organs in men and women
• gastrointestinal and intra-abdominal infections
• skin and soft tissue infections
• bone and joint infections
• - to prevent infections caused by the bacterium Neisseria meningitidis
• exposure to inhalation of anthrax spores

Ciprofloxacin can be used to manage patients with a low number of white blood cells (neutropenia)
who develop a fever suspected to be due to bacterial infection.
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 CUSPIS.

Children and adolescents
CUSPIS 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

CUSPIS 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 CUSPIS

Do not take CUSPIS:

• If you are allergic to the active ingredient, to other quinolones or to any of the excipients of this medicine (listed in paragraph 6)
• If you are taking tizanidine (see paragraph 2: Other medicines and Cuspis)

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

Tell your doctor before taking CUSPIS

• If you have had kidney problems, as 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 CUSPIS
• If you are diabetic because there may be a risk of hypoglycemia when using ciprofloxacin
• If you suffer from myasthenia gravis (a type of muscle weakness) because the symptoms may worsen
• 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 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, 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]).
• If you have heart problems. Particular caution should be exercised when using Cuspis 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 an electrolyte 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 in the ECG (see
paragraph 2 “Other medicines and Cuspis).

• Tell your doctor if you, or a family member, are known to have a glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anemia with ciprofloxacin.

For the treatment of some infections of the genital tract, your doctor may prescribe you another antibiotic in
addition to ciprofloxacin. If there are no signs of improvement after 3 days of treatment, consult your
doctor.

While taking CUSPIS
Immediately inform your doctor if during taking CUSPISyou experience any of the conditions listed
below. The doctor will decide whether to stop treatment with CUSPIS.

• A severe and sudden allergic reaction(an anaphylactic/anaphylactic shock reaction, angioedema). There is a remote possibility of experiencing a severe and sudden allergic reaction 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 CUSPIS and contact your doctor immediately.
• Serious, prolonged, disabling and potentially irreversible adverse effects. Antibacterial medicines based on fluoroquinolones/quinolones, including CUSPIS, 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 the tendons, muscles and joints of arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness or burning (paresthesia), disorders of the sense organs 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 CUSPIS, 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.
• Pain and swelling in the joints and inflammation or rupture of the tendons may 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. Tendon inflammation and rupture can occur within the first 48 hours of treatment and up to several months after the end of CUSPIS 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 CUSPIS, consult your doctor and rest the painful part. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
• 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 corticosteroid drugs.
• 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).
• 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 case of seizures, stop treatment with CUSPIS and contact your doctor immediately.
• 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 rarely occur. In this case, stop treatment with CUSPIS and inform your doctor immediately to prevent nerve damage from becoming permanent.
• Psychiatric reactions can occur even when taking quinolone antibiotics, including CUSPIS, for the first time. If you suffer from depression or psychosis, your symptoms may worsen during treatment with CUSPIS. In rare cases, depression and psychosis can evolve into thoughts of suicide and self-harming behaviors such as suicide attempts or suicide (see paragraph 4: Possible side effects). If you experience depression, psychosis, thoughts or behaviors related to suicide, contact your doctor immediately.
• 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 a loss of consciousness (hypoglycemic coma) (see paragraph 4). This is important for people who suffer from diabetes. If you have diabetes, blood sugar levels should be carefully monitored.
• During treatment with antibiotics, including CUSPIS, or even several weeks later, diarrhea may develop. If it worsens or persists, or if you notice blood or mucus in your stool, you should stop taking CUSPIS and contact your doctor immediately, as it may be a life-threatening form. Do not take medicines that block or reduce bowel movements.
• If your vision should decrease or your eyes should be compromised in any other way, consult an ophthalmologist immediately.
• During the taking of CUSPIS the skin becomes more sensitive to sunlight or ultraviolet (UV) radiation. Avoid exposure to intense sunlight and artificial UV light, such as that of tanning beds.
• Inform your doctor or laboratory personnel that you are taking CUSPIS if you need to have blood or urine tests.
• If you suffer from kidney problems, tell your doctor as you may need a dosage adjustment.
• CUSPIS can cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or abdominal tenderness, contact your doctor immediately.
• CUSPIS can cause a reduction in the number of white blood cells, which can lead to a lower resistance to infections. If you experience an infection with symptoms such as fever and marked deterioration of general condition, or fever with symptoms of localized infection, such as sore throat or sore throat or urinary problems, you should 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.

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

Do not take CUSPIS together with tizanidine, as it can cause adverse effects such as low blood
pressure and drowsiness (see paragraph 2: “Do not take CUSPIS).
The following medicines interact with CUSPIS in the body. Taking CUSPIS together with these
medicines can affect their therapeutic effect and increase the likelihood of adverse effects.

Tell your doctor if you are taking:

• 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 for 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)
• metoclopramide (for nausea and vomiting)
• cyclosporine (for skin problems, rheumatoid arthritis and in organ transplants)
• other drugs that can alter the heart rhythm: drugs that belong to the group of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (which belong to the macrolide group), some antipsychotics
• zolpidem (for sleep disorders)

CUSPIS 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 (e.g. for erectile dysfunction)
• agomelatine (for depression)

Certain medicines reducethe effect of CUSPIS. Tell your doctor if you take 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, aluminum or iron

If these preparations are essential, take CUSPIS about two hours before their administration, or no earlier than
four hours after.

CUSPIS with food and drink
Unless you take CUSPIS 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 or breastfeeding, if you think you may be pregnant or are planning a pregnancy, ask
your doctor or pharmacist for advice before taking this medicine.
It is preferable to avoid the use of CUSPIS during pregnancy.
Do not take CUSPIS during breastfeeding, as ciprofloxacin is excreted in breast milk and can
be harmful to your baby.

Driving and operating machinery
CUSPIS can interfere with your state of attention. As adverse effects on the nervous system may occur,
check your reactions to CUSPIS before driving a vehicle or operating machinery. If in doubt, talk to
your doctor.

3. HOW TO TAKE CUSPIS

Your doctor will explain exactly how much CUSPIS 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, treatment lasts from 5 to 21 days, but may last longer for severe infections. Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are not sure how many tablets to take and how to take CUSPIS.

• a. Swallow the tablets with plenty of liquid.
• b. If you are unable to swallow the tablets, tell your doctor.
• c. Do not chew or crush the tablets because they have an unpleasant taste.
• d. Try to take the tablets at about the same time each day.
• e. You can take the tablets with or between meals. Calcium taken during meals does not significantly affect absorption. However, do nottake CUSPIS tablets with dairy products such as milk or yogurt or with fruit juices supplemented with minerals (e.g. calcium-fortified orange juice).

Remember to drink plenty of fluids during treatment with this medicine.

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

If you forget to take CUSPIS
If you forget to take Cuspis and:

• If 6 hours or moreremain until your next scheduled dose, take the forgotten dose immediately. Then take your next dose as scheduled.
• If less than 6 hoursremain until your next scheduled dose, do not take the forgotten dose. Take your next dose as scheduled.

Do not take a double dose to make up for a missed dose. Make sure to complete the course of
treatment.

If you stop taking CUSPIS
It is important that you complete the course of treatmenteven if you begin 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 return or worsen. You may also develop
antibiotic resistance.
If you have any questions about using 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.
The following paragraph lists the most serious side effects that you may observe on your own:

Stop taking Cuspis and contact your doctor immediatelywho will assess another antibiotic treatment, if you notice any of the following serious side effects:

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

• convulsions (see section 2: Warnings and precautions)

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

• severe and sudden allergic reaction with symptoms such as a feeling of tightness in the chest, dizziness, feeling unwell or fainting, or feeling dizzy when standing up (anaphylactic reaction/anaphylactic shock) (see section 2: Warnings and precautions)
• muscle weakness, tendon inflammation that can lead to tendon rupture - especially of the large tendon located at the back of the ankle (Achilles tendon) (see section 2: Warnings and precautions)
• A life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes and other mucous membranes such as the genitals, and which may progress to widespread blisters or skin peeling (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis)

Not known(frequency cannot be estimated from available data):

• unusual sensation of pain, burning, tingling, numbness or muscle weakness in the extremities (neuropathy) (see section 2: Warnings and precautions)
• A reaction that causes skin rashes, fever, inflammation of internal organs, changes in blood counts and symptoms affecting the whole body (DRESS: drug reaction with eosinophilia and systemic symptoms, AGEP: Acute Generalized Exanthematous Pustulosis)

Other side effectsthat have been observed during treatment with Cuspis are listed below
according to their frequency:

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

• nausea, diarrhea
• joint pain and joint inflammation in children

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

• joint pain in adults
• superinfections with fungi
• high concentration of eosinophils, a type of white blood cells
• decreased appetite
• hyperactivity, agitation
• headache, dizziness, sleep disorders, taste disturbances
• vomiting, abdominal pain, digestive problems (such as stomach upset, indigestion/heartburn) or flatulence
• increased levels of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching, hives
• reduced kidney function
• muscle and bone pain, feeling unwell (asthenia) or fever
• increased alkaline phosphatase in the blood (a certain substance present in the blood)

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

• muscle pain, joint inflammation, increased muscle tone and cramps
• 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)
• 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) (see section 2: Warnings and precautions)
• 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 develop into thoughts of suicide or suicide attempts or suicide) (see section 2: Warnings and precautions), or hallucinations
• tingling, unusual sensitivity to stimuli, decreased skin sensitivity, tremors, lightheadedness
• visual disturbances including double vision (see section 2: Warnings and precautions)
• 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) or hepatitis
• sensitivity to light (see section 2: Warnings and precautions)
• kidney failure, blood or crystals in the urine, inflammation of the urinary tract
• fluid retention or excessive sweating
• increased levels of the enzyme amylase

Very rare(may affect up to 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) (see section 2: Warnings and precautions); a decrease in red blood cells, white blood cells and platelets (pancytopenia), which can be fatal; bone marrow depression, which can also be fatal; allergic reaction called serum sickness-like reaction (see section 2: Warnings and precautions)
• mental disorders (psychotic reactions which in rare cases can develop into thoughts of suicide or suicide attempts or suicide) (see section 2: Warnings and precautions)
• migraine, coordination disorders, unsteady gait (walking disorders), disorders of smell (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 (necrosis), which very rarely can lead to life-threatening liver failure (see section 2: Warnings and precautions)
• pinpoint hemorrhages under the skin (petechiae); various types of skin rashes or rash
• worsening of symptoms of myasthenia gravis (see section 2: Warnings and precautions)

Not known(frequency cannot be estimated from available data):
syndrome associated with impaired water excretion and low sodium levels (SIADH)
feeling of intense excitement (mania) or feeling of great optimism and hyperactivity (hypomania)
abnormal heart rate acceleration, life-threatening irregular heartbeat, alteration of heart rhythm (called “QT prolongation”, displayed on ECG, heart electrical activity).
influence on blood coagulation (in patients treated with vitamin K antagonists)
loss of consciousness due to a severe decrease in blood sugar levels (hypoglycemic coma).
See section 2.
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, unusual 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) and alteration of hearing, vision, taste and smell, have been associated with the use of antibiotics of the quinolone and fluoroquinolone type, 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 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/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE CUSPIS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the blister and 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
any medicine you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What CUSPIS contains
The active ingredient is ciprofloxacin
CUSPIS 250 mg film-coated tablets
Each film-coated tablet contains 250 mg of ciprofloxacin (as monohydrate hydrochloride)
The excipients are:
Tablet core: corn starch, pregelatinized starch, microcrystalline cellulose, crospovidone,
anhydrous colloidal silica, magnesium stearate.
Film coating: hypromellose, macrogol, titanium dioxide (E 171).
CUSPIS 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of ciprofloxacin (as monohydrate hydrochloride)
The excipients are:
Tablet core: corn starch, pregelatinized starch, microcrystalline cellulose, crospovidone,
anhydrous colloidal silica, magnesium stearate.
Film coating: hypromellose, macrogol, titanium dioxide (E 171).
CUSPIS 750 mg film-coated tablets
Each film-coated tablet contains 750 mg of ciprofloxacin (as monohydrate hydrochloride)
The excipients are:
Tablet core: corn starch, pregelatinized starch, microcrystalline cellulose, crospovidone,
anhydrous colloidal silica, magnesium stearate.
Film coating: hypromellose, macrogol, titanium dioxide (E 171).

Description of the appearance of CUSPIS and contents of the pack
Film-coated tablets.
CUSPIS 250 mg film-coated tablets - 10 tablets
CUSPIS 500 mg film-coated tablets – 6 tablets
CUSPIS 750 mg film-coated tablets – 12 tablets
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
LANOVA FARMACEUTICI S.R.L.
Via Conca D’oro, 212
00141 Rome - Italy

Manufacturer
Special Product’s Line S.p.A., Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo 1 – 03012 Anagni

• Frosinone

CUSPIS 500 mg and CUSPIS 750 mg
LACHIFARMA S.R.L. – Laboratorio Chimico Farmaceutico Salentino
S.S. 16, Zona Industriale – 73010 Zollino (Lecce)

Advice/health education
Antibiotics are used to treat bacterial infections. They are not effective for 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.