Package leaflet: Information for the patient

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

ciprofloxacin
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What SAMPER is and what it is used for
What you need to know before taking SAMPER
How to take SAMPER
Possible side effects
How to store SAMPER
Contents of the pack and other information

1. What SAMPER is and what it is used for

SAMPER contains the active substance ciprofloxacin, an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing the bacteria that cause infections. It is effective only against specific 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 genital organ infections 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 treat infections in patients with a very low white blood cell count (neutropenia);
to prevent infections in patients with a very low white blood cell count (neutropenia);
to prevent infections caused by the bacterium Neisseria meningitidis (which causes meningitis);
to prevent and treat infections caused by inhalation of anthrax spores.

If you have a severe infection, or one caused by more than one type of bacteria, your doctor may prescribe another antibiotic in addition to SAMPER.

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

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

SAMPER may also be used to treat other specific serious infections in children and adolescents, when considered necessary by the doctor.

2. What you need to know before taking SAMPER

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

Do not take SAMPER

if you are allergic (hypersensitive) to the active substance, 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.

Do not take quinolone/fluoroquinolone antibacterial medicines, including SAMPER, if you have previously experienced any serious adverse reaction during treatment with a quinolone or fluoroquinolone. In such a case, inform your doctor as soon as possible.

Inform your doctor:

if you have heart problems. Particular caution is required when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrocardiogram recording the heart's electrical activity), if you have an electrolyte imbalance in the blood (especially low levels of potassium or magnesium in the blood), if you have a very slow heart rate (called bradycardia), if you have a weak heart (heart failure), if you 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 may cause abnormal changes in the ECG (see section “Other medicines and SAMPER”);
if you have kidney problems, as your treatment may need to be adjusted;
if you suffer from epilepsy or other neurological disorders;
if you have previously experienced tendon problems during treatment with antibiotics such as SAMPER;
if you suffer from myasthenia gravis (a type of muscle weakness);
if you have experienced disturbances in heart rhythm (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, congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren’s syndrome [an autoimmune inflammatory disease], or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet’s syndrome, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]).
If you experience sudden pain in your abdomen, chest, or back, which may be a symptom of aortic aneurysm or dissection, go immediately to the emergency room. The risk may be higher if you are taking systemic corticosteroid medicines.
Inform your doctor immediately if you notice a sudden onset of shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or new episodes of palpitations (sensation of rapid or irregular heartbeat).

While taking SAMPER

Inform your doctor immediately if any of the following conditions occur during treatment with SAMPER. Your doctor will decide whether treatment with SAMPER should be discontinued.

A severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility that a severe and sudden allergic reaction may occur even after the first dose, with the following symptoms: chest tightness, dizziness, nausea or fainting, lightheadedness when standing. In such a case, stop taking SAMPER and contact your doctor immediately.
Rarely, joint pain and swelling, and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years of age), if you have had an organ transplant, if you have kidney problems, or if you are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment and up to several months after stopping treatment with SAMPER. At the first sign of tendon pain or inflammation (e.g. in the ankle, wrist, elbow, shoulder, or knee), stop taking SAMPER, consult your doctor, and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
If you suffer from epilepsy or other neurological disorders, such as cerebral ischaemia or stroke, you may experience adverse effects on the central nervous system. In such a case, stop taking SAMPER and contact your doctor immediately.
Psychiatric reactions may occur the first time you take SAMPER. If you suffer from depression or psychosis, your symptoms may worsen during treatment with SAMPER. In rare cases, depression or psychotic reactions may progress to self-harming behaviour. In such a case, stop taking SAMPER and contact your doctor immediately.
Rarely, symptoms of nerve damage (neuropathy) may occur, such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms. In such a case, stop taking SAMPER and contact your doctor immediately to avoid permanent nerve damage.
During treatment with antibiotics, including SAMPER, or even several weeks after stopping treatment, diarrhoea may develop. If it worsens or persists, or if you notice blood or mucus in your stool, stop taking SAMPER immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal motility and contact your doctor.
Inform your doctor or laboratory staff that you are taking SAMPER if you are due to have blood or urine tests.
SAMPER may cause liver damage. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or abdominal pain, stop taking SAMPER and contact your doctor immediately.
SAMPER may reduce the number of white blood cells, which may result in decreased resistance to infections. If you develop an infection with symptoms such as fever and marked deterioration in general condition, or fever with symptoms of localized infection such as sore throat, mouth or throat pain, or urinary problems, contact 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 this medicine.
Inform your doctor if you, or a family member, have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin (the active substance in SAMPER).
While taking SAMPER, your skin may become more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as from sunbeds.
If your vision deteriorates or your eyes are otherwise affected, consult an ophthalmologist immediately.

Serious, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including SAMPER, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, and may not improve. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, abnormal sensations such as pricking, tingling, itching, numbness, or burning (paraesthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If any of these side effects occur after taking SAMPER, consult your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider using an antibiotic from another class.

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

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 following medicines may affect their therapeutic effect and increase the likelihood of side effects.
You must inform your doctor if you are taking other medicines that may alter heart rhythm: medicines belonging to the antiarrhythmic class (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, psoriasis, or rheumatoid arthritis);
metoclopramide (for nausea and vomiting);
theophylline (for respiratory problems);
tizanidine (for muscle spasticity, i.e. continuous muscle contraction, in multiple sclerosis);
clozapine, olanzapine (antipsychotics);
ropinirole (for Parkinson’s disease);
phenytoin (for epilepsy);
medicines belonging to the antiarrhythmic group, e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide;
tricyclic antidepressants;
some antimicrobials (belonging to the macrolide group);
some antipsychotics;
ciclosporin (immunosuppressant);
glibenclamide (for diabetes).

SAMPER may increase blood levels of the following medicines:

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

Certain medicines reduce the effect of SAMPER. Inform your doctor if you are taking 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 elevated blood phosphate levels;
medicines or supplements containing calcium, magnesium, aluminium, or iron.

If these preparations are essential, take SAMPER approximately two hours before or no sooner than four hours after taking them.

SAMPER with food and drinks
The tablets can be taken regardless of meals. Taking them on an empty stomach accelerates the absorption of the active substance.
However, do not take dairy products and their derivatives (such as milk or yoghurt) or drinks fortified with minerals (e.g. orange juice enriched with calcium) when taking the tablets, as they may interfere with the absorption of the active substance.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is preferable to avoid using SAMPER during pregnancy. Inform your doctor if you are planning a pregnancy.
Breastfeeding
Do not take SAMPER while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.

Driving and using machines
SAMPER may affect your level of alertness. Since neurological adverse events may occur, check how you react to SAMPER before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take SAMPER

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Your doctor will explain exactly how much SAMPER you should take, how often, and for how long.
This will depend on the type and severity of your infection.
Inform your doctor if you have kidney problems, as your dose may need to be adjusted.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.
Always take the tablets exactly as directed by your doctor. Consult your doctor or pharmacist
if you are unsure about how many tablets to take or how to take SAMPER.

Method of administration
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 approximately the same time each day.
c. You may take the tablets with meals or between meals. Calcium taken during meals does not significantly affect absorption. However, do not take SAMPER tablets with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (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, contact your doctor immediately. If possible, take the tablets or the pack with you to show the doctor.

If you forget to take SAMPER
Take the missed dose as soon as possible and then continue as prescribed. However, if it is almost time for the next dose, do not take the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a forgotten dose. Make sure you complete the full course of treatment.

If you stop taking SAMPER
It is important that you complete the full course of treatment, even if you start to feel better after a few days.
If you stop taking this medicine too early, the infection may not be completely cured and symptoms may return or worsen. You may also develop resistance to the antibiotic.

If you have any questions about the use of this product, consult your doctor or pharmacist.

4. Possible side effects

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

Common side effects (may affect from 1 to 10 people in 100)

nausea, diarrhoea
joint pain in children

Uncommon side effects (may affect from 1 to 10 people in 1,000)

fungal superinfections
high concentration of eosinophils, a type of white blood cells
loss of appetite (anorexia)
hyperactivity, agitation
headache, dizziness, sleep disturbances, 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, 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 and present in the blood)

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

inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section “Warnings and precautions”)
changes in blood cell counts (leucopenia, leucocytosis, neutropenia, anaemia), increase or decrease in a blood clotting factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may potentially lead to suicidal thoughts/ideation 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, reduced skin sensitivity, tremor, seizures (including epileptic fits) (see section “Warnings and precautions”), dizziness
visual disturbances (e.g. diplopia)
tinnitus (ringing or noises in the ear), hearing loss, decreased hearing
rapid heartbeat (tachycardia)
dilation of blood vessels (vasodilation), low blood pressure, fainting
shortness of breath, including symptoms of asthma
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 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 enzyme amylase, a sign of pancreatic distress

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

a specific type of reduction in red blood cells (haemolytic anaemia); a dangerous reduction in a type of white blood cells (agranulocytosis); a reduction in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal; bone marrow depression, which may also be fatal (see section “Warnings and precautions”)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal – serum sickness) (see section “Warnings and precautions”)
mental disorders (psychotic reactions which may potentially lead to suicidal thoughts/ideation or suicide attempts or completed suicide) (see section “Warnings and precautions”)
migraine, coordination disorders, unsteady gait (gait disturbances), disturbances of smell (olfactory disturbances), increased pressure in the brain (intracranial hypertension)
distortions in colour perception
inflammation of blood vessel walls (vasculitis)
pancreatitis (inflammation of the pancreas)
liver cell death (hepatic necrosis), which very rarely may lead to life-threatening liver failure
pinpoint bleeding under the skin (petechiae); various types of skin rashes (e.g. Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal)
muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section “Warnings and precautions”); worsening of symptoms of myasthenia gravis (see section “Warnings and precautions”)

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

nervous system disorders such as pain, burning, tingling, numbness and/or weakness of the extremities
abnormally increased heart rate, life-threatening irregular heartbeat, changes in heart rhythm (known as “QT interval prolongation”, seen on ECG, a recording of the heart’s electrical activity)
acute generalised exanthematous pustulosis (AGEP)
increase in the International Normalised Ratio (if you are being 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 drop in blood sugar levels (hypoglycaemic coma). See section 2.

Very rare cases of adverse drug reactions that are prolonged (lasting for months or years) or permanent, such as tendon inflammation, tendon rupture, joint pain, pain in arms or legs, difficulty walking, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, impaired memory and concentration, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression and suicidal ideation), and changes in hearing, vision, taste and smell, have been associated with the use of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Cases of dilation and weakening of the aortic wall or aortic wall tear (aneurysms and dissections), with possible rupture that may be fatal, as well as cases of regurgitation of blood from heart valves, have been reported in patients treated with fluoroquinolones. See also section 2.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via 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 the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What SAMPER contains
The active substance 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 components are:
microcrystalline cellulose (E460), sodium starch glycolate (type A), crospovidone (E1202), maize starch, anhydrous colloidal silica, magnesium stearate (E572), titanium dioxide (E171), hypromellose 6 cp (E464), macrogol 4000.

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

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

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

Health advice/education
Antibiotics are used to treat bacterial infections. They are not effective against viral infections. If your doctor has prescribed antibiotics, it is because you specifically need them for your current illness. However, despite antibiotic treatment, certain bacteria may survive or multiply. This phenomenon is known as resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. If you do not follow the prescribed:

dosage
frequency of administration
duration of treatment

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

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

Samper