Ciprofloxacin Galenica Senese

Package leaflet: Information for the user

CIPROFLOXACIN GALENICA SENESE 200mg/100ml infusion solution, 400mg/200ml infusion solution

ciprofloxacin (lactate)
Read all of 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 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:

1. What CIPROFLOXACIN GALENICA SENESE is and what it is used for.
2. What you need to know before taking CIPROFLOXACIN GALENICA SENESE.
3. How to use CIPROFLOXACIN GALENICA SENESE.
4. Possible side effects.
5. How to store CIPROFLOXACIN GALENICA SENESE.
6. Contents of the pack and other information.

1. What is CIPROFLOXACINA GALENICA SENESE and what is it used for?

CIPROFLOXACINA GALENICA SENESE is an antibiotic belonging to the
fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing the bacteria
that cause infections. It is effective only against specific types (strains) of bacteria.
Adults
CIPROFLOXACINA GALENICA SENESE is used in adults to treat the following bacterial infections:

• respiratory tract infections;
• long-lasting or recurrent ear infections or infections of the air-filled cavities within the facial bones (paranasal sinuses);
• urinary tract infections;
• testicular infections;
• genital infections in women;
• stomach and intestinal (gastrointestinal) and intra-abdominal infections;
• skin and soft tissue infections;
• 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);
• exposure to inhaled anthrax microorganisms (spores). If you have a severe infection, or an infection caused by more than one type of bacteria, your doctor may prescribe another antibiotic treatment in addition to CIPROFLOXACINA GALENICA SENESE.

Children and adolescents
CIPROFLOXACINA GALENICA SENESE is used in children and adolescents, under the supervision of a specialist doctor, to treat the following bacterial infections:

• lung (pulmonary) and bronchial (bronchial) infections in children and adolescents suffering from a serious congenital disease called "cystic fibrosis";
• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis);
• exposure to inhaled anthrax microorganisms (spores). CIPROFLOXACINA GALENICA SENESE may also be used to treat other specific severe infections in children and adolescents, if deemed necessary by the doctor.

2. What you should know before taking CIPROFLOXACIN GALENICA SENESE

Do not take CIPROFLOXACIN GALENICA SENESE

• if you are allergic to ciprofloxacin or to any of the other ingredients of this medicine (listed in section 6);
• if you are taking tizanidine (see section “Other medicines and CIPROFLOXACIN GALENICA SENESE”).

Warnings and precautions
Talk to your doctor or pharmacist before taking CIPROFLOXACIN GALENICA SENESE:

• if you have kidney problems, as your treatment may need to be adjusted;
• if you suffer from epilepsy or other disorders of the nervous system (neurological disorders);
• if you have previously experienced tendon problems during treatment with antibiotics such as CIPROFLOXACIN GALENICA SENESE;
• if you suffer from a type of muscle weakness (myasthenia gravis);
• if you have heart (cardiac) problems;
• if you have been diagnosed with an enlargement or “bulging” of a large blood vessel (aortic aneurysm or peripheral aneurysm of a large blood vessel);
• if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta);
• if you have a family history of aortic aneurysm, aortic dissection, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, vascular Ehlers-Danlos syndrome, or if you suffer from vascular diseases such as Takayasu arteritis, giant cell arteritis, Behcet's syndrome, high blood pressure, or known atherosclerosis).

If you experience sudden pain in the abdomen, chest, or back, go immediately to the emergency room.

During treatment with CIPROFLOXACIN GALENICA SENESE, pay attention if:

• you were born with or have a family history of prolonged QT interval (a heart rhythm disorder) shown on an electrocardiogram (ECG), an electrical recording of the heart;
• you have an imbalance of salts in your blood (especially low levels of potassium or magnesium in the blood);
• you have a very slow heart rate (bradycardia);
• you have a weak heart (heart failure);
• you have a history of heart attack (myocardial infarction);
• you are a woman or an elderly patient, or if you are taking other medicines that may cause abnormal changes in the electrocardiogram (ECG) (see section “Other medicines and CIPROFLOXACIN GALENICA SENESE”).

Inform your doctor immediately if any of the following conditions occur during treatment with CIPROFLOXACIN GALENICA SENESE:

• if you experience a severe and sudden allergic reaction (anaphylactic reaction/shock, angioedema). There is a remote possibility that a severe and sudden allergic reaction may occur even after the first dose, with symptoms such as chest tightness (chest pain), dizziness, nausea or fainting, or vertigo when standing. In this case, inform your doctor immediately, as treatment with CIPROFLOXACIN GALENICA SENESE must be stopped;
• if you have joint pain and swelling and tendon inflammation (tendinitis), especially if you are elderly and are also taking corticosteroid medicines. Inflammation and rupture of tendons may occur within 48 hours of starting treatment or up to several months after stopping treatment with ciprofloxacin. At the first sign of pain or inflammation, treatment with CIPROFLOXACIN GALENICA SENESE must be stopped. Rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture;
• if you have a disease called epilepsy or 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 CIPROFLOXACIN GALENICA SENESE and contact your doctor immediately;
• if psychiatric reactions occur after the first dose of CIPROFLOXACIN GALENICA SENESE. If you suffer from depression or psychosis, your symptoms may worsen during treatment with CIPROFLOXACIN GALENICA SENESE. In this case, stop treatment and contact your doctor immediately;
• if you experience symptoms of neuropathy, such as pain, burning, tingling, numbness, and/or weakness. In this case, stop treatment with CIPROFLOXACIN GALENICA SENESE and contact your doctor immediately;
• if you develop diarrhoea during treatment with antibiotics, including CIPROFLOXACIN GALENICA SENESE, even weeks after stopping them. If it worsens or persists, or if you notice blood or mucus in your stools, inform your doctor immediately. Treatment with CIPROFLOXACIN GALENICA SENESE must be stopped immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal motility;
• if you are scheduled for blood or urine tests, inform your doctor or laboratory staff that you are taking CIPROFLOXACIN GALENICA SENESE;
• if you have kidney (renal) problems, inform your doctor, as you may need a dosage adjustment;
• if you notice symptoms such as loss of appetite, jaundice (yellowing of the skin and whites of the eyes), dark urine, itching, or abdominal pain, stop taking CIPROFLOXACIN GALENICA SENESE and contact your doctor immediately, as the medicine may cause liver damage;
• if you develop an infection with symptoms such as fever and marked deterioration in your general condition, or fever with symptoms of localized infection such as sore throat, pain in the throat or mouth, or urinary problems. Contact your doctor immediately, as the medicine may cause a reduction in white blood cell count, leading to decreased resistance to infections. Your doctor may recommend a blood test to check for this reduction (agranulocytosis);
• if you or a family member has glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of anaemia with ciprofloxacin;
• if you experience changes in vision or any eye-related symptoms, you should consult an ophthalmologist immediately.

During treatment with CIPROFLOXACIN GALENICA SENESE, your skin may become more sensitive to sunlight or ultraviolet (UV) light. During treatment, avoid exposure to strong sunlight and artificial UV light, such as sunbeds.

Other medicines and CIPROFLOXACIN GALENICA SENESE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

You must inform your doctor if you are taking other medicines that may affect your heart rhythm (cardiac), such as medicines belonging to the antiarrhythmic class (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobials (belonging to the macrolide class), or certain antipsychotics.

Do not take CIPROFLOXACIN GALENICA SENESE together with tizanidine, as it may cause adverse effects such as low blood pressure and drowsiness (see section: "Do not take CIPROFLOXACIN GALENICA SENESE").

The following medicines interact with CIPROFLOXACIN GALENICA SENESE in the body. Taking CIPROFLOXACIN GALENICA SENESE together with these medicines may affect their therapeutic effect and increase the likelihood of adverse effects. Inform your doctor if you are taking any of the following medicines:

• vitamin K antagonists (e.g. warfarin, acenocoumarol, phenprocoumon or fluindione) or other oral anticoagulants (to thin the blood);
• probenecid (for gout, an inflammation of the joints causing swelling and pain);
• methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis);
• theophylline (for respiratory problems);
• tizanidine (for muscle spasticity in multiple sclerosis);
• olanzapine and clozapine (antipsychotics for mental disorders);
• ropinirole (for the treatment of Parkinson’s disease);
• phenytoin (for epilepsy);
• metoclopramide (an antiemetic);
• ciclosporin A (for skin conditions, rheumatoid arthritis, and organ transplants);
• omeprazole (a medicine used to treat gastric ulcers belonging to the class of “proton pump inhibitors”);
• glibenclamide (a hypoglycaemic agent);
• duloxetine (an antidepressant);
• sildenafil (for the treatment of impotence);
• lidocaine (for heart problems or anaesthetic use);
• other medicines that may alter heart rhythm, such as medicines belonging to the antiarrhythmic group (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobials (belonging to the macrolide group), or certain antipsychotics.

CIPROFLOXACIN GALENICA SENESE may increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders);
• caffeine;
• agomelatine (for depression);
• zolpidem (for insomnia).

CIPROFLOXACIN GALENICA SENESE with food and drink
Food and drink do not affect treatment with CIPROFLOXACIN GALENICA SENESE.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
It is preferable to avoid using CIPROFLOXACIN GALENICA SENESE during pregnancy. Inform your doctor if you are planning a pregnancy.

Breastfeeding
Do not take CIPROFLOXACIN GALENICA SENESE while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.

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

CIPROFLOXACIN GALENICA SENESE contains sodium. The sodium content is 900 mg (15.4 mmol) per 100 ml bag and 1800 mg (30.8 mmol) per 200 ml bag.
This should be taken into account in patients with reduced kidney function or those on a low-sodium diet.

3. How to take CIPROFLOXACIN GALENICA SENESE

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 precisely how much CIPROFLOXACIN GALENICA SENESE 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 dosage may need to be adjusted.
The usual duration of treatment is 5 to 21 days, but it may last longer for severe infections.
Your doctor will administer each dose as a slow intravenous infusion into your bloodstream. For
children, the infusion should last 60 minutes. In adult patients, the infusion duration is 60 minutes for
CIPROFLOXACIN GALENICA SENESE 400 mg and 30 minutes for CIPROFLOXACIN GALENICA SENESE 200 mg.
Administering the infusion slowly helps prevent the occurrence of immediate adverse effects.
Remember to drink plenty of fluids during treatment with CIPROFLOXACIN GALENICA SENESE.

If you take more CIPROFLOXACIN GALENICA SENESE than you should
In case of accidental ingestion/overdose of CIPROFLOXACIN GALENICA SENESE, inform your
doctor immediately or go to the nearest hospital.
Symptoms of overdose may include: dizziness, tremor, headache, fatigue, seizures, hallucinations,
confusion, abdominal discomfort, liver and kidney problems (impaired renal and hepatic function,
crystalluria, reversible renal toxicity), and blood in the urine (haematuria).

If you forget to take CIPROFLOXACIN GALENICA SENESE
Do not take a double dose to make up for the missed dose.

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

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

4. Possible side effects

Like all medicines, CIPROFLOXACIN GALENICA SENESE may cause side effects,
although not everyone experiences them.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

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

• nausea, diarrhoea, vomiting;
• joint pain in children;
• local reaction at the injection site, skin rash;
• temporary increase in certain substances in the blood (transaminases).

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, increase or decrease in a blood clotting factor (platelets);
• loss of appetite (anorexia);
• hyperactivity, agitation, confusion, disorientation, hallucinations;
• headache, dizziness (vertigo), sleep disturbances, taste disturbances, tingling,

unusual sensitivity to sensory stimuli, seizures (see section "Warnings and precautions"), dizziness;

• visual disturbances;
• hearing loss;
• rapid heartbeat (tachycardia);
• dilation of blood vessels (vasodilation), low blood pressure;
• abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn), intestinal gas;
• liver disorders, increased levels of a substance in the blood (bilirubin), yellowing of the skin and whites of the eyes (jaundice/cholestatic jaundice);
• itching, urticaria;
• joint pain in adults;
• reduced kidney function, kidney failure;
• muscle and bone pain, malaise (asthenia), fever, fluid retention;
• increased alkaline phosphatase in the blood (a certain substance 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 rare cases may be fatal) (see section "Warnings and precautions");
• changes in the number of blood cells (leukopenia, leukocytosis, neutropenia, anaemia), a decrease in red blood cells, white blood cells and platelets (pancytopenia), which may be fatal, bone marrow suppression, which may also be fatal (see section "Warnings and precautions");
• allergic reaction, allergic swelling (edema), acute swelling of the skin and mucous membranes (angioedema), severe allergic reaction (anaphylactic shock) which may be life-threatening (see section "Warnings and precautions");
• increased blood sugar (hyperglycaemia);
• anxiety reaction, unusual dreams, depression (which in rare cases may progress to suicidal thoughts, suicide attempts or suicide), mental disorders (psychotic reactions which in rare cases may progress to suicidal thoughts, suicide attempts or suicide) (see section "Warnings and precautions");
• decreased skin sensitivity, tremor, migraine, disturbances of smell (olfactory disturbances);
• hearing disorder known as "tinnitus", hearing loss;
• fainting, inflammation of blood vessels (vasculitis);
• shortness of breath, including asthma-like symptoms;
• inflammation of the pancreas (pancreatitis);
• liver inflammation (hepatitis), death of liver cells (hepatic necrosis), which very rarely may lead to life-threatening liver failure;
• sensitivity to light (see section "Warnings and precautions"), pinpoint bleeding under the skin (petechiae);
• muscle pain, joint inflammation, increased muscle tone, cramps, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see section "Warnings and precautions");
• blood or crystals in the urine (see section "Warnings and precautions"), inflammation of the urinary tract;
• excessive sweating;
• abnormal levels of a clotting factor (prothrombin), increased levels of the enzyme amylase.

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

• a specific type of reduction in red blood cells (haemolytic anaemia) or a dangerous reduction in a type of white blood cells (agranulocytosis);
• severe allergic reaction (anaphylactic reaction, anaphylactic shock, serum sickness) which may be fatal (see section "Warnings and precautions");
• coordination disorders, unsteady gait (gait disturbances), increased pressure in the brain (intracranial hypertension);
• distortions in colour perception;
• various types of skin rashes (e.g., Stevens-Johnson syndrome or toxic epidermal necrolysis, potentially fatal);
• muscle weakness, tendon inflammation, worsening of symptoms of severe myasthenia (see section 2 "Warnings and precautions").

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

• nervous system disorders such as pain, burning, tingling, numbness and/or weakness of the extremities;
• abnormally fast heart rate, life-threatening irregular heart rhythm, changes in heart rhythm (known as QT interval prolongation, visible on ECG (electrical activity of the heart));
• pustular skin rashes;
• effects on blood clotting (in patients treated with vitamin K antagonists).
• feeling of intense excitement (mania) or feeling of extreme optimism and hyperactivity (hypomania), hypersensitivity reaction called DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms).

Very rare cases of prolonged (up to months or years) or permanent adverse drug reactions, such as
tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pins and needles, tingling, pricking, burning, numbness or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disturbances, anxiety, panic attacks, depression, and suicidal ideation), as well as hearing, vision, taste and smell impairment, have been associated with the administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of pre-existing risk factors.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store CIPROFLOXACIN GALENICA SENESE

Do not store above 25°C. Do not refrigerate or freeze.
Keep in the original packaging to protect the medicine from light.
Since the infusion solution is light-sensitive, remove bags from the outer packaging only
immediately before use. When exposed to daylight, the solution maintains full efficacy
throughout the administration period. Do not use this medicine if the solution is not clear.
Check the integrity of the packaging before use, as this ensures the sterility of the product.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp.". The
expiry date refers to the last day of the month indicated. The expiry date applies to the
product in undamaged packaging and stored correctly.
Do not dispose of medicines 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 CIPROFLOXACIN GALENICA SENESE contains
Each 100 mL bag of infusion solution contains:

• the active substance: ciprofloxacin 200 mg;
• the other components: lactic acid, sodium chloride, hydrochloric acid, water for injections.

Each 200 mL bag of infusion solution contains:

• the active substance: ciprofloxacin 400 mg;
• the other components: lactic acid, sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of CIPROFLOXACIN GALENICA SENESE and contents of the pack
Infusion solution
The medicinal product is supplied in polypropylene infusion bags.
Packs
CIPROFLOXACIN GALENICA SENESE 200 mg/100 ml solution for infusion – 10 bags
CIPROFLOXACIN GALENICA SENESE 400 mg/200 ml solution for infusion – 10 bags
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
INDUSTRIA FARMACEUTICA GALENICA SENESE S.R.L.
VIA CASSIA NORD, 351
53014 MONTERONI D'ARBIA, SIENA
ITALY
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 called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You may even promote the development of bacterial resistance, delay recovery, or reduce the effectiveness of antibiotics if you do not adhere to:

• dosage
• frequency of administration
• duration of treatment

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 wish to treat a similar illness.
4 – Never give your antibiotic to another person; it may not be suitable for their condition.
5 – At the end of treatment, return all unused medicines to a pharmacy, to ensure they are properly disposed of.

The following information is intended for healthcare professionals only

CIPROFLOXACIN GALENICA SENESE must be administered by intravenous infusion. In children, the infusion duration is 60 minutes. In adult patients, the infusion duration is 60 minutes for CIPROFLOXACIN GALENICA SENESE 400 mg and 30 minutes for CIPROFLOXACIN GALENICA SENESE 200 mg. Slow infusion into a large vein reduces both patient discomfort and the risk of venous irritation. The infusion solution may be administered alone or in combination with other compatible infusion solutions. CIPROFLOXACIN GALENICA SENESE is compatible with Ringer's solution, Ringer's lactate solution, 5% and 10% glucose solutions, and 5% and 10% fructose solutions.

The infusion solution must always be administered separately unless compatibility with other solutions or infusion drugs has been demonstrated. Physical signs of incompatibility include, for example, precipitation, cloudiness, and discoloration.

Incompatibility occurs with all drugs or infusion solutions that are physically or chemically unstable at the pH of the solution itself (e.g., penicillins and heparin solutions), particularly those buffered at alkaline pH (the pH of ciprofloxacin infusion solutions ranges from 3.5 to 4.6).

After initial intravenous administration, treatment may be continued orally.