SAMPER 250 mg Фильм-Коатированные Таблетки

Содержание инструкции

1. SAMPER 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets
   1. What SAMPER is and what it is used for
   2. What you need to know before taking SAMPER
   3. How to take SAMPER
   4. Possible side effects
   5. How to store SAMPER
   6. Contents of the pack and other information

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

ciprofloxacina
Generic medicine

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

1. What SAMPER is and what it is used for

SAMPER contains the active ingredient ciprofloxacin, an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing the bacteria that cause infections. It only works against particular strains of bacteria.

Adults
SAMPER is used in adults:

• for the treatment of respiratory tract infections;
• for the treatment of long-lasting or recurrent ear or sinus infections;
• for the treatment of urinary tract infections;
• for the treatment of testicular infections;
• for the treatment of infections of the genital organs in women;
• for the treatment of gastrointestinal and intra-abdominal infections;
• for the treatment of skin and soft tissue infections;
• for the treatment of 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(which causes meningitis);
• to prevent and cure infections caused by 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 SAMPER.

Children and adolescents
SAMPER is used in children and adolescents, under specialist supervision:

• to cure lung and bronchial infections in children and adolescents who suffer from cystic fibrosis;
• to cure complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis);
• to prevent and cure infections caused by inhalation of anthrax spores.

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

2. What you need to know before taking SAMPER

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

Do not take SAMPER

• if you are allergic (hypersensitive) to the active ingredient, to other quinolones or to any of the other ingredients of this medicine listed in section 6;
• if you are being treated with tizanidine, a muscle relaxant (see section “Other medicines and SAMPER”).

Warnings and precautions
Talk to your doctor or pharmacist before taking SAMPER.
You should not take antibacterial medicines based on quinolones/fluoroquinolones, including SAMPER, if you have previously
experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such
case, inform your doctor as soon as possible.
Tell your doctor:

• if you have heart problems. Particular caution should be exercised when using this type of medicine, if you were born with or have a family history of prolonged QT interval (displayed on an ECG, a recording of the heart's electrical activity), 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 attacks (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 section “Other medicines and SAMPER”).
• 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 SAMPER;
• if you suffer from myasthenia gravis (a type of muscle weakness);
• if you have suffered from heart rhythm disturbances (arrhythmias).
• 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 or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue diseases such as Marfan syndrome, 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 [an 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.
• Immediately inform your doctor if you notice a rapid onset of shortness of breath, especially when lying down in bed, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of rapid or irregular heartbeat).

While taking SAMPER
Immediately inform your doctor if during the intake of SAMPERone of the conditions
listed below occurs. The doctor will decide whether to interrupt the treatment with SAMPER.

• A severe and sudden allergic reaction(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 SAMPER and contactyour doctor immediately.
• Rarely, pain and swelling of the joints and inflammation or rupture of thetendonscan 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 taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and up to several months after the end of SAMPER 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 SAMPER, consult your doctor and rest the painful part. 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 SAMPER and contact your doctor immediately.
• Psychiatric reactionscan occur the first time you take SAMPER. If you suffer from depressionor psychosis, your symptoms may worsen during treatment with SAMPER. In rare cases, depression or psychotic reactions can evolve into behaviors aimed at causing harm to oneself. In this case, stop treatment with SAMPER and contact your doctor immediately.

Serious, prolonged, disabling and non-improving side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including SAMPER, have been associated with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling and may not improve. 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), sensory organ disorders 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 SAMPER, 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 from another class.

Other medicines and SAMPER
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Ciprofloxacin can increase the level of the following substances in the blood:

• Agomelatine,
• Zolpidem

Do not take SAMPER together with tizanidine, a muscle relaxant, as it may cause
side effects such as low blood pressure and drowsiness (see section 2 "What you need to know before
taking SAMPER").
Some medicines interact with SAMPER in the body. Taking SAMPER together with the medicines
indicated below can affect its therapeutic effect and increase the likelihood of side effects.
You must inform your doctor if you are taking other medicines that can alter the heart rhythm: medicines
that belong to the class of antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol,
dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (belonging to the macrolide group),
some antipsychotics.

Also inform your doctor if you are taking:

• Warfarin, vitamin K antagonists, or other oral anticoagulants (to thin the blood);
• probenecid (for gout);
• methotrexate (for certain types of cancer, for psoriasis or for rheumatoid arthritis);
• metoclopramide (for nausea and vomiting);
• theophylline (for respiratory problems);
• tizanidine (for muscle spasticity, i.e. a continuous muscle contraction, in multiple sclerosis);
• clozapine, olanzapine (antipsychotics);
• ropinirole (for Parkinson's disease);
• phenytoin (for epilepsy);
• medicines that belong to the class of antiarrhythmics e.g.: quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide);
• tricyclic antidepressants;
• some antimicrobials (belonging to the macrolide group);
• some antipsychotics;
• cyclosporine (anti-rejection);
• glibenclamide (for diabetes).

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

• pentoxifylline (for circulatory disorders);
• caffeine;
• lidocaine (an antiarrhythmic);
• sildenafil (for erectile dysfunction);
• duloxetine (an antidepressant).

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

• Antacids (to prevent stomach hyperacidity);
• omeprazole (for gastric acidity);
• mineral supplements;
• sucralfate (for stomach ulcer);
• a polymeric phosphate binder (e.g. sevelamer), used to reduce increased phosphorus in the blood;
• medicines or supplements containing calcium, magnesium, aluminum or iron.

If these preparations are essential, take SAMPER about two hours before taking them, or not before
four hours after.

SAMPER with food and drink
The tablets can be taken regardless of meals. Taking on an empty stomach
accelerates the absorption of the active ingredient.
However, do not take dairy products and derivatives (such as milk or yogurt) or beverages enriched with minerals (e.g. orange juice added 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 are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
It is preferable to avoid the use of SAMPER during pregnancy. Tell your doctor if you are planning a
pregnancy.

Breastfeeding
Do not take SAMPER during breastfeeding, as ciprofloxacin is excreted in breast milk and
may be harmful to your baby.

Driving and using machines
SAMPER can interfere with your state of attention. As adverse reactions
to the nervous system may occur, check your reactions to SAMPER before driving a vehicle or using machinery. If you are
in doubt, talk to your doctor.

3. How to take SAMPER

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The doctor will explain exactly how much SAMPER 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.
Always take the tablets following exactly the doctor's instructions. Consult your doctor or
pharmacist if you are not sure how many tablets to take and how to take SAMPER.
Method of administration

• a. Swallow the tablets with plenty of liquid. Do not chew the tablets because 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 nottake SAMPER 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 SAMPER.

If you take more SAMPER 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 the doctor.

If you forget to take SAMPER
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 SAMPER
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
antibiotic resistance.
If you have any doubts about using this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

• nausea, diarrhoea
• 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 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 produced by the liver 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 “Warnings and precautions”)
• changes in the number of blood cells (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease of a blood coagulation 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, (potentially culminating in suicidal ideas/thoughts or suicide attempts or completed suicide) (see section 2: “Warnings and precautions”), hallucinations (seeing or hearing things that do not exist)
• tingling, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremor, seizures (including epileptic fits) (see section “Warnings and precautions”), dizziness
• visual disturbances (e.g. diplopia)
• tinnitus (hearing noises or sounds in the ear), 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, yellowing of the skin), 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 coagulation factor (prothrombin), increased levels of the amylase enzyme, a sign of pancreatic distress.

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 “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 potentially culminating in suicidal ideas/thoughts or suicide attempts or completed suicide) (see section “Warnings and precautions”)
• migraine, coordination disorders, unsteady gait (walking disorders), disorders of smell (olfactory disorders), pressure on the brain (intracranial hypertension)
• distortions in color perception
• inflammation of the blood vessel walls (vasculitis)
• pancreatitis (inflammation of the pancreas)
• death of liver cells (hepatic necrosis), which very rarely can lead to life-threatening liver failure
• pinpoint hemorrhages under the skin (petechiae); various types of skin rashes (for example, Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
• muscle weakness, inflammation of the tendons, 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 “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 in the extremities
• abnormally increased heart rate, life-threatening irregular heartbeat, alteration of the heart rhythm (called “prolongation of the QT interval”, displayed on an ECG, a recording of the heart's electrical activity).
• acute generalized exanthematous pustulosis (AGEP)
• increased International Normalized Ratio (if you are treated with vitamin K antagonists)
• feeling of extreme excitement (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 excretion 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 prolonged (lasting months or years) or permanent adverse drug reactions, such as tendon inflammation, tendon rupture, joint pain, arm or leg pain, 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 alterations in hearing, vision, taste and smell, have been associated with the use of antibiotics of the quinolone and fluoroquinolone types, in some cases regardless of pre-existing risk factors. Cases of dilation and weakening of the aortic wall or tearing of the aortic wall (aneurysms and dissections), with possible ruptures that can be fatal, as well as cases of backflow of blood through 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, talk to 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 SAMPER

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after Scad. The expiry
date refers to the last day of the month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SAMPER contains
The active ingredient is ciprofloxacin hydrochloride monohydrate.

SAMPER 250 mg film-coated tablets
One film-coated tablet contains 250 mg of ciprofloxacin.

SAMPER 500 mg film-coated tablets
One film-coated tablet contains 500 mg of ciprofloxacin.

SAMPER 750 mg film-coated tablets
One film-coated tablet contains 750 mg of ciprofloxacin.
The other ingredients are:
microcrystalline cellulose (E460), sodium starch glycolate (type A), crospovidone (E1202), corn starch, colloidal anhydrous silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose 6 cp (E464), macrogol 4000.

Description of the appearance of SAMPER and contents of the pack
SAMPER 250 mg film-coated tablets are white in colour
SAMPER 500 mg film-coated tablets are white in colour
SAMPER 750 mg film-coated tablets are white in colour
Contents of the packs:
SAMPER 250 mg film-coated tablets: blister containing 10 tablets
SAMPER 500 mg film-coated tablets: blister containing 6 tablets
SAMPER 750 mg film-coated tablets: 12 tablets contained in 2 blisters
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AGIPS FARMACEUTICI S.r.l. - Via Amendola, 4 – RAPALLO (GE)

Manufacturer
LABORATORIO FARMACOLOGICO MILANESE S.r.l. - Via Monterosso, 273 – Caronno Pertusella (VA)

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

Therefore, 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.