Ciprofloxacin Tecnigen: detailed information

Package leaflet: Information for the user

Ciprofloxacin TecniGen 250 mg film-coated tablets

Ciprofloxacin
Generic medicine
Please 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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Ciprofloxacina TecniGen 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 strains of bacteria.
Adults
Ciprofloxacina TecniGen is used in adults to treat the following bacterial infections:

respiratory tract infections;
long-lasting or recurrent ear or paranasal sinus infections;
urinary tract infections;
testicular infections;
genital infections in women;
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);
to prevent infections caused by the bacterium Neisseria meningitidis;
exposure to inhaled anthrax spores.

If you have a severe infection, or one caused by more than one type of bacteria, your doctor may
prescribe another antibiotic treatment in addition to Ciprofloxacina TecniGen.
Children and adolescents
Ciprofloxacina TecniGen is used in children and adolescents, under specialist supervision,
to treat the following bacterial infections:

lung and bronchial infections in children and adolescents with cystic fibrosis;
complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis);
exposure to inhaled anthrax spores.

Ciprofloxacina TecniGen may also be used to treat other specific severe infections in children
and adolescents, when considered necessary by the physician.

2. What you need to know before taking Ciprofloxacin TecniGen

Do not take Ciprofloxacin TecniGen

if you are allergic to ciprofloxacin, to other quinolones, 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 TecniGen”).

Warnings and precautions
Talk to your doctor before taking Ciprofloxacin TecniGen.
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including
Ciprofloxacin TecniGen, if you have previously experienced any serious adverse reaction during
treatment with a quinolone or fluoroquinolone. In such cases, inform your doctor as soon as possible.
Be especially careful with Ciprofloxacin TecniGen and inform your doctor:

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 had tendon problems during previous treatment with antibiotics such as Ciprofloxacin TecniGen;
if you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin;
if you have myasthenia gravis (a type of muscle weakness);
if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart);
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) or a history of heart attack (myocardial infarction);
if you are female or elderly;
if you are taking other medicines that may cause abnormal changes on the ECG (see section “Other medicines and Ciprofloxacin TecniGen”);
if you or a family member know you have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin;
if you have kidney problems, as you may require a dosage adjustment.
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 vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease], or endocarditis [inflammation of the heart]). For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there are no symptoms of improvement after 3 days of treatment, consult your doctor.

Serious, prolonged, disabling, and potentially irreversible adverse effects
Antibacterial medicines belonging to the fluoroquinolone/quinolone class, including Ciprofloxacin TecniGen,
have been associated with very rare but serious adverse effects, some of which are prolonged (lasting months or years), disabling, or may not resolve. These include pain in tendons, muscles, and joints of arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness, or burning (paresthesia), sensory organ disorders such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these adverse effects after taking Ciprofloxacin TecniGen, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and will consider the use of an antibiotic from another class.
Immediately inform your doctor if any of the following conditions occur during treatment with Ciprofloxacin TecniGen. Your doctor will decide whether treatment with Ciprofloxacin TecniGen should be discontinued:

severe and sudden allergic reaction (anaphylactic reaction/anaphylactic shock, angioedema). There is a remote possibility of a severe and sudden allergic reaction even after the first dose, with the following symptoms: chest tightness, dizziness, nausea or fainting, lightheadedness when standing. In such cases, discontinue treatment with Ciprofloxacin TecniGen and contact your doctor immediately.
pain and swelling in joints and tendon inflammation (tendinitis) , rarely pain and swelling in joints and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years of age), if you have received an organ transplant, if you have kidney problems, or if you are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of
treatment and up to several months after completion of therapy with Ciprofloxacin
TecniGen. At the first signs of pain or inflammation in a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), discontinue treatment with Ciprofloxacin TecniGen, consult your doctor, and keep the affected area at rest. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
if you experience sudden and severe pain in the 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).
adverse effects on the central nervous system , especially if you suffer from epilepsy or other neurological disorders such as cerebral ischemia or stroke. In such cases, discontinue treatment with Ciprofloxacin TecniGen and contact your doctor immediately.
psychiatric reactions , even after the first dose of Ciprofloxacin TecniGen. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin TecniGen. In rare cases, depression or psychotic reactions may progress to suicidal thoughts/ideation, which may lead to suicide attempts or suicide. In case of psychiatric reactions, discontinue treatment with Ciprofloxacin TecniGen and contact your doctor immediately.
symptoms of neurological damage , rarely 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 occur. In such cases, discontinue treatment with Ciprofloxacin TecniGen and inform your doctor immediately to prevent permanent nerve damage.
Quinolone antibiotics may cause blood sugar levels to rise above normal (hyperglycaemia) or fall below normal, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4.4). This is particularly important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
diarrhoea . Diarrhoea may develop during treatment with antibiotics, including Ciprofloxacin TecniGen, or even several weeks afterwards. If it worsens or persists, or if you notice blood or mucus in your stools, discontinue Ciprofloxacin TecniGen immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements and contact your doctor.
symptoms of liver damage such as loss of appetite, yellowing of the skin, dark urine, itching, or abdominal pain, as Ciprofloxacin TecniGen may cause liver damage. Discontinue taking Ciprofloxacin TecniGen and contact your doctor immediately.
symptoms of infection such as fever and marked deterioration in general condition, or fever with symptoms of localized infection such as sore throat or mouth pain or urinary problems, as Ciprofloxacin TecniGen may cause a reduction in white blood cell count, leading to decreased resistance to infections. If you experience symptoms of infection, consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about the medicine.
vision problems , for example, if your vision deteriorates or your eyes are otherwise affected. Consult an ophthalmologist immediately.

Inform your doctor or laboratory staff that you are taking Ciprofloxacin TecniGen if you need to have blood or urine tests.
During treatment with Ciprofloxacin TecniGen, your skin becomes 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.
Other medicines and Ciprofloxacin TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Ciprofloxacin TecniGen together with tizanidine , as it may cause adverse effects such as low blood pressure and drowsiness (see section “Do not take Ciprofloxacin TecniGen”).
The following medicines interact with Ciprofloxacin TecniGen in the body. Taking Ciprofloxacin TecniGen together with these medicines may affect their therapeutic effect and increase the likelihood of adverse effects.
In particular, inform your doctor if you are taking:

other medicines that may alter heart rhythm: 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;
vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood);
probenecid (for gout);
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis);
theophylline (for respiratory 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 conditions, rheumatoid arthritis, and organ transplants);
glibenclamide (for diabetes);
medicines known to prolong the QT interval.

Ciprofloxacin TecniGen may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders);
caffeine;
duloxetine (for depression, diabetic neuropathy, or incontinence);
lidocaine (for heart conditions or anaesthetic use);
sildenafil (for erectile dysfunction);
agomelatine;
zolpidem.

Certain medicines reduce the effect of Ciprofloxacin TecniGen:

antacids;
mineral supplements;
sucralfate (for ulcers and gastritis);
a polymeric phosphate binder (e.g., sevelamer or lanthanum carbonate);
medicines or supplements containing calcium, magnesium, aluminium, or iron;
omeprazole (for ulcers and stomach problems caused by excess acid).

If your doctor considers these medicines essential, take Ciprofloxacin TecniGen approximately two hours before or no sooner than four hours after taking them.
Ciprofloxacin TecniGen with food and drinks
Unless you are taking Ciprofloxacin TecniGen with meals, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified beverages 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, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ciprofloxacin TecniGen may be used during pregnancy only if the benefit to the mother outweighs the risk to the unborn child and only under strict medical supervision. Inform your doctor if you are planning a pregnancy.
Do not take Ciprofloxacin TecniGen while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin TecniGen may affect your level of alertness. Since neurological adverse events may occur, check how you react to Ciprofloxacin TecniGen before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take Ciprofloxacina TecniGen

Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much Ciprofloxacina TecniGen you should take, how
often, and for how long. This will depend on the type and severity of the infection you have.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.

Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.
Try to take the tablets at approximately the same time each day.
You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take Ciprofloxacina TecniGen tablets with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (e.g. calcium-fortified orange juice).
Drink plenty of fluids during treatment with Ciprofloxacina TecniGen.

Use in patients with renal problems
Inform your doctor if you have kidney problems, as dose adjustment may be necessary.
If you take more Ciprofloxacina TecniGen than you should
If you take more than the prescribed dose, consult your doctor immediately. If possible, take the tablets or the pack with you to show the doctor.
If you forget to take Ciprofloxacina TecniGen
Take the missed dose as soon as possible, 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 Ciprofloxacina TecniGen
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 doubts about how to use this medicine, 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 (may affect up to 1 in 10 people)

nausea, diarrhoea
joint pain in children

Uncommon (may affect up to 1 in 100 people)

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
increased levels 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 certain substance present in the blood)

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

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 (leukopenia, leukocytosis, 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)
decreased blood sugar (hypoglycaemia) (see section “Warnings and precautions”)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may lead to suicidal thoughts/ideation, suicide attempt and suicide), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, seizures (including epilepsy) (see section “Warnings and precautions”), vertigo
visual disturbances (e.g. double vision)
tinnitus, hearing loss, decreased hearing
rapid heartbeat (tachycardia)
dilation of blood vessels (vasodilation), low blood pressure, fainting
shortness of breath, including asthma-like symptoms
liver disorders, jaundice (cholestatic jaundice), 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
increased levels of amylase enzyme

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

blood disorders: a specific type of reduction in red blood cells (haemolytic anaemia), a dangerous reduction in a type of white blood cells (agranulocytosis), 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”)
psychiatric disorders (psychotic reactions which may lead to suicidal thoughts/ideation, suicide attempt and suicide) (see section “Warnings and precautions”)
migraine, coordination disorders, unsteady gait (gait disturbances), disturbances in smell (olfactory disturbances), pressure in the brain (intracranial hypertension including pseudotumour cerebri)
distortion in colour perception
inflammation of blood vessel walls (vasculitis)
inflammation of the pancreas (pancreatitis)
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), worsening of symptoms of myasthenia gravis (see section “Warnings and precautions”)

Frequency not known (frequency 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 “prolongation of the QT interval”, seen on ECG, electrical activity of the heart)
a skin rash with formation of superficial pustules (acute generalised exanthematous pustulosis)
effects on blood clotting (in patients treated with vitamin K antagonists as oral anticoagulants)
sensations of overexcitement (mania) or feelings of great optimism and hyperactivity (hypomania)
Hypersensitivity reactions 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 (hypoglycaemic coma). See section 2.

Very rare cases of prolonged (lasting for months or years) or permanent adverse drug reactions, 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), depression, fatigue, sleep disturbances, memory impairment, 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 rupture (aneurysms and dissections), with possible fatal rupture, as well as cases of backflow 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 effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 Ciprofloxacin TecniGen

Keep this medicine out of the sight and reach of children.
Do not use Ciprofloxacin TecniGen after the expiry date stated on the blister or carton after "Exp.". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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 Ciprofloxacina TecniGen contains

The active substance is ciprofloxacin hydrochloride monohydrate. One film-coated tablet contains 291 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 250 mg of ciprofloxacin.
The other components are: maize starch, microcrystalline cellulose (E460), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), macrogol 4000, titanium dioxide (E171).

Description of the appearance of Ciprofloxacina TecniGen and package contents
Film-coated tablets – pack of 10 tablets
Marketing Authorization Holder
Tecnigen S.r.l. - via Galileo Galilei 40, 20092 - Cinisello Balsamo (MI)
Manufacturer
Genetic S.p.A. – Contrada Canfora – Industrial Area – 84084 Fisciano (Salerno)
Package leaflet: information for the user
Ciprofloxacina TecniGen 500 mg film-coated tablets
Ciprofloxacin
Generic Medicine
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ciprofloxacina TecniGen is and what it is used for
What you need to know before taking Ciprofloxacina TecniGen
How to take Ciprofloxacina TecniGen
Possible side effects
How to store Ciprofloxacina TecniGen
Package contents and other information

1. What Ciprofloxacin TecniGen is and what it is used for

Ciprofloxacin TecniGen 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 strains of bacteria.
Adults
Ciprofloxacin TecniGen is used in adults to treat the following bacterial infections:

respiratory tract infections
long-lasting or recurrent ear or paranasal sinus infections
urinary tract infections
infections of the testicles
genital infections in women
gastrointestinal and intra-abdominal infections
skin and soft tissue infections
bone and joint infections
to treat infections in patients with very low white blood cell counts (neutropenia)
to prevent infections in patients with very low white blood cell counts (neutropenia)
to prevent infections caused by the bacterium Neisseria meningitidis
exposure to inhalation of anthrax spores

If you have a severe infection, or one caused by more than one type of bacteria, your doctor may
prescribe another antibiotic treatment in addition to Ciprofloxacin TecniGen.
Children and adolescents
Ciprofloxacin TecniGen is used in children and adolescents, under specialist supervision,
to treat the following bacterial infections:

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

Ciprofloxacin TecniGen may also be used to treat other specific severe infections in children and
adolescents, when considered necessary by the physician.

2. What you should know before taking Ciprofloxacin TecniGen

Do not take Ciprofloxacin TecniGen

if you are allergic to ciprofloxacin, to other quinolones, 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 TecniGen”).

Warnings and precautions
Talk to your doctor before taking Ciprofloxacin TecniGen.
Before taking this medicine
You must not take antibacterial medicines containing quinolones/fluoroquinolones, including
Ciprofloxacin TecniGen, 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.
Be especially cautious with Ciprofloxacin TecniGen and inform your doctor:

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 had tendon problems during previous treatment with antibiotics such as Ciprofloxacin TecniGen;
if you are diabetic, because there may be a risk of hypoglycemia when using ciprofloxacin;
if you have myasthenia gravis (a type of muscle weakness);
if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart);
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) or a history of heart attack (myocardial infarction);
if you are a woman or an elderly person;
if you are taking other medicines that may cause abnormal changes on the ECG (see section “Other medicines and Ciprofloxacin TecniGen”);
if you, or a family member, know of having glucose-6-phosphate dehydrogenase (G6PD) deficiency, because you may be at risk of developing anemia with ciprofloxacin;
if you have kidney problems, as you may need a dosage adjustment.
if you have been diagnosed with 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 disorders such as Marfan syndrome, 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, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).

For the treatment of certain genital tract infections, your doctor may prescribe another
antibiotic in addition to ciprofloxacin. If there are no symptoms of improvement after 3
days of treatment, consult your doctor.
Severe, prolonged, disabling, and potentially irreversible side effects
Antibacterial medicines containing fluoroquinolones/quinolones, including Ciprofloxacin TecniGen,
have been associated with very rare but serious adverse effects, some of which are prolonged (lasting months or years), disabling, or may not improve. These include pain in the tendons, muscles, and joints of the arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, itching, numbness, or burning (paresthesia), sensory organ disturbances such as changes in vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and severe sleep disturbances.
If you experience any of these adverse effects after taking Ciprofloxacin
TecniGen, consult your doctor immediately before continuing treatment. Your doctor
will decide together with you whether to continue treatment and will also consider
using an antibiotic from another class.
Inform your doctor immediately if any of the following conditions occur during treatment with Ciprofloxacin TecniGen. Your doctor will decide whether to discontinue
treatment with Ciprofloxacin TecniGen:

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, dizziness upon standing. In such a case, stop treatment with Ciprofloxacin TecniGen and contact your doctor immediately.
pain and swelling in joints and tendon inflammation (tendinitis) , rarely pain and swelling in joints and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years old), if you have received 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 the end of therapy with Ciprofloxacin
TecniGen. At the first signs of pain or inflammation in a tendon (e.g., in the
ankle, wrist, elbow, shoulder, or knee), stop treatment with
Ciprofloxacin TecniGen, consult your doctor, and rest the affected area. Avoid
unnecessary movements, as the risk of tendon rupture may increase.
if you experience sudden and severe pain in the abdomen, chest, or back, which may be a symptom of aneurysm or aortic 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 rapid 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).
adverse effects on the central nervous system , especially if you suffer from epilepsy or other neurological disorders, such as cerebral ischemia or stroke. In such a case, stop treatment with Ciprofloxacin TecniGen and contact your doctor immediately.
psychiatric reactions , even after the first dose of Ciprofloxacin TecniGen. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin TecniGen. In rare cases, depression or psychotic reactions may progress to suicidal thoughts/ideation, which may lead to suicide attempts or suicide. In case of psychiatric reactions, stop treatment with Ciprofloxacin TecniGen and contact your doctor immediately.
symptoms of nerve damage , rarely 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 occur. In such a case, stop treatment with Ciprofloxacin TecniGen and inform your doctor immediately to prevent permanent nerve damage.
Quinolone antibiotics may 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 may potentially lead to loss of consciousness (hypoglycemic coma) (see section 4.4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
diarrhea . During treatment with antibiotics, including Ciprofloxacin TecniGen, or even several weeks after, diarrhea may develop. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking Ciprofloxacin TecniGen immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements and contact your doctor.
symptoms of liver damage such as loss of appetite, yellowing of the skin, dark urine, itching, or abdominal pain, as Ciprofloxacin TecniGen may cause liver damage. Stop taking Ciprofloxacin TecniGen and contact your doctor immediately.
symptoms of infection such as fever and marked deterioration in general condition, or fever with symptoms of localized infection, such as sore throat or mouth pain or urinary problems, as Ciprofloxacin TecniGen may cause a
reduction in the number of white blood cells, leading to decreased resistance to
infections. If you experience symptoms of infection, consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells
(agranulocytosis). It is important that you inform your doctor about this medicine.
vision problems , for example, if your vision deteriorates or if your eyes are otherwise affected. Consult an ophthalmologist immediately.

Inform your doctor or laboratory staff that you are taking Ciprofloxacin TecniGen if
you need to have blood or urine tests.
During treatment with Ciprofloxacin TecniGen, your skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.
If your vision deteriorates or if your eyes are otherwise affected, consult an ophthalmologist immediately.
Other medicines and Ciprofloxacin TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Ciprofloxacin TecniGen together with tizanidine , as it may cause adverse effects such as low blood pressure and drowsiness (see section “Do not take
Ciprofloxacin TecniGen”).
The following medicines interact with Ciprofloxacin TecniGen in the body. Taking
Ciprofloxacin TecniGen together with these medicines may affect their therapeutic effect
and increase the likelihood of adverse effects.
In particular, inform your doctor if you are taking :

other medicines that may alter heart rhythm: 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.
vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
theophylline (for respiratory 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)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
glibenclamide (for diabetes)
medicines known to prolong the QT interval

Ciprofloxacin TecniGen may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathy, or incontinence)
lidocaine (for heart problems or anesthetic use)
sildenafil (for erectile problems)
agomelatine
zolpidem

Certain medicines reduce the effect of Ciprofloxacin TecniGen:

antacids
mineral supplements
sucralfate (for ulcers and gastritis)
a polymeric phosphate binder (e.g., sevelamer or lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium, or iron
omeprazole (for ulcers and stomach problems caused by excess acid)

If your doctor considers these medicines essential, take
Ciprofloxacin TecniGen approximately two hours before taking them, or not earlier than four hours
after.
Ciprofloxacin TecniGen with food and drinks
Unless you are taking Ciprofloxacin TecniGen with meals, do not eat or drink dairy products
(such as milk or yogurt) or calcium-fortified drinks when taking the tablets, as
they may interfere with the absorption of the active ingredient.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Ciprofloxacin TecniGen may be used during pregnancy only if the benefit to the mother
outweighs the risk to the unborn child and only under strict medical supervision. Inform your doctor if
you are planning a pregnancy.
Do not take Ciprofloxacin TecniGen while breastfeeding, as ciprofloxacin
is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin TecniGen may affect your level of attention. Since neurological adverse events may occur, check your response to Ciprofloxacin TecniGen
before driving a vehicle or operating machinery. If in doubt, discuss this with your doctor.

3. How to take Ciprofloxacina TecniGen

Take this medicine exactly as instructed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much Ciprofloxacina TecniGen you should take,
how often, and for how long. This will depend on the type and severity of your
infection.
Treatment usually lasts between 5 and 21 days, but may last longer for severe
infections.

Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.
Try to take the tablets at approximately the same time each day.
You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take Ciprofloxacina TecniGen tablets with dairy products such as milk or yogurt, or with fruit juices fortified with minerals (e.g. calcium-fortified orange juice).
Drink plenty of fluids during treatment with Ciprofloxacina TecniGen.

Use in patients with renal problems
Inform your doctor if you have kidney problems, as a dosage adjustment may be
necessary.
If you take more Ciprofloxacina TecniGen than you should
If you take more than the prescribed dose, consult your doctor immediately. If possible, bring
the tablets or the pack with you to show the doctor.
If you forget to take Ciprofloxacina TecniGen
Take the missed dose as soon as possible and then continue as prescribed. However, if it is almost time for the next dose, skip the missed dose and continue with your regular 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 Ciprofloxacina TecniGen
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 antibiotic resistance.
If you have any doubts about how to use this medicine, consult 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 worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Common (may affect up to 1 in 10 people)

nausea, diarrhoea
joint pain in children

Uncommon (may affect up to 1 in 100 people)

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), flatulence
increased levels 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 certain substance present in the blood)

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

inflammation of the bowel (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section “Warnings and precautions”)
changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increase or decrease in a blood coagulation factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section “Warnings and precautions”)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may lead to suicidal thoughts/ideation, suicide attempt and suicide), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, seizures (including epilepsy) (see section “Warnings and precautions”), vertigo
visual disturbances (e.g. double vision)
tinnitus, hearing loss, decreased hearing
rapid heartbeat (tachycardia)
dilation of blood vessels (vasodilation), low blood pressure, fainting
shortness of breath, including asthma-like symptoms
liver disorders, jaundice (cholestatic jaundice), 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
increased levels of amylase enzyme

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

blood disorders: a specific type of decrease in red blood cells (haemolytic anaemia), a dangerous decrease in a type of white blood cells (agranulocytosis), 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”)
severe allergic reaction (anaphylactic reaction or anaphylactic shock, which may be fatal)
serum sickness (see section “Warnings and precautions”)
psychiatric disorders (psychotic reactions which may lead to suicidal thoughts/ideation, suicide attempt and suicide) (see section “Warnings and precautions”)
migraine, coordination disorders, unsteady gait (gait disturbances), smell disorders (olfactory disturbances), pressure on the brain (intracranial hypertension including pseudotumour cerebri)
colour vision distortion
inflammation of blood vessel walls (vasculitis)
inflammation of the pancreas (pancreatitis)
death of liver cells (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), worsening of symptoms of myasthenia gravis (see section “Warnings and precautions”)

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

nervous system disorders such as pain, burning, tingling, numbness and/or weakness of the extremities;
abnormal increase in heart rate, life-threatening irregular heartbeat, changes in heart rhythm (known as “QT interval prolongation”, seen on ECG, electrical activity of the heart);
a skin rash with formation of superficial pustules (acute generalised exanthematous pustulosis);
effects on blood coagulation (in patients treated with vitamin K antagonists as oral anticoagulants);
sensations of over-excitement (mania) or sensations of great optimism and hyperactivity (hypomania);
hypersensitivity reactions called DRESS (drug reaction with eosinophilia and systemic symptoms);
Syndrome associated with impaired water elimination and low sodium levels (SIADH);
Loss of consciousness due to severe decrease in blood sugar levels (hypoglycaemic coma). See section 2.

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 blood regurgitation 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, talk to your doctor or pharmacist. You can 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 Ciprofloxacin TecniGen

Keep this medicine out of the sight and reach of children.
Do not use Ciprofloxacin TecniGen after the expiry date stated on the blister or carton after "Exp.". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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 Ciprofloxacin TecniGen contains

The active substance is ciprofloxacin hydrochloride monohydrate. One film-coated tablet contains 582 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 500 mg of ciprofloxacin.
The other components are: maize starch, microcrystalline cellulose (E460), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), macrogol 4000, titanium dioxide (E171).

Description of the appearance of Ciprofloxacin TecniGen and package contents
Film-coated tablets – pack containing 6 tablets
Marketing Authorization Holder
Tecnigen S.r.l. - via Galileo Galilei 40, 20092 - Cinisello Balsamo (MI)
Manufacturer
Genetic SpA – Contrada Canfora – Industrial Area – 84084 Fisciano (Salerno)
Package leaflet: information for the user

Ciprofloxacin TecniGen 750 mg film-coated tablets

Ciprofloxacin
Generic Medicine
Please read 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Ciprofloxacina TecniGen 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 strains of bacteria.
Adults
Ciprofloxacina TecniGen is used in adults to treat the following bacterial infections:

respiratory tract infections
long-lasting or recurrent ear or paranasal sinus infections
urinary tract infections
testicular infections
genital infections in women
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)
to prevent infections caused by the bacterium Neisseria meningitidis
exposure to inhalation of anthrax spores

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

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

2. What you need to know before taking Ciprofloxacin TecniGen

Do not take Ciprofloxacin TecniGen

if you are allergic to ciprofloxacin, to other quinolones, 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 TecniGen”).

Warnings and precautions
Talk to your doctor before taking Ciprofloxacin TecniGen.
Before taking this medicine
You must not take quinolone/fluoroquinolone antibacterial medicines, including
Ciprofloxacin TecniGen, 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.
Be especially careful with Ciprofloxacin TecniGen and inform your doctor:

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 had tendon problems during previous treatment with antibiotics such as Ciprofloxacin TecniGen;
if you are diabetic, as there may be a risk of hypoglycaemia when using ciprofloxacin;
if you have myasthenia gravis (a type of muscle weakness);
if you were born with or have a family history of prolonged QT interval (seen on ECG, an electrical recording of the heart);
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 heart failure or a history of heart attack (myocardial infarction);
if you are a woman or elderly;
if you are taking other medicines that may cause abnormal changes on the ECG (see section “Other medicines and Ciprofloxacin TecniGen”);
if you or a family member know you have glucose-6-phosphate dehydrogenase (G6PD) deficiency, as you may be at risk of developing anaemia with ciprofloxacin;
if you have kidney problems, as you may need a dosage adjustment.
if you have been diagnosed with 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 disorders such as Marfan syndrome, 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, known high blood pressure or atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart]).

For the treatment of certain genital tract infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there are no signs of improvement after 3 days of treatment, consult your doctor.
Severe, prolonged, disabling, and potentially irreversible side effects
Fluoroquinolone/quinolone antibacterial medicines, including Ciprofloxacin TecniGen, have been associated with very rare but serious side effects, some of which may be prolonged (lasting months or years), disabling, or may not resolve. These include tendon, muscle, and joint pain in the arms and legs, difficulty walking, abnormal sensations such as tingling, prickling, tickling, 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 you experience any of these side effects after taking Ciprofloxacin TecniGen, contact your doctor immediately before continuing treatment. Your doctor will decide together with you whether to continue treatment and may consider using an antibiotic from another class.
Inform your doctor immediately if during treatment with Ciprofloxacin TecniGen any of the following conditions occur. Your doctor will decide whether to discontinue treatment with Ciprofloxacin TecniGen:

severe and sudden allergic reaction (an 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 case, stop treatment with Ciprofloxacin TecniGen and contact your doctor immediately.
pain and swelling in joints and tendon inflammation (tendinitis) , rarely pain and swelling in joints and inflammation or rupture of tendons may occur. The risk is higher if you are elderly (over 60 years of age), have had an organ transplant, have kidney problems, or 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 Ciprofloxacin TecniGen. At the first signs of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop treatment with Ciprofloxacin TecniGen, contact your doctor, and rest the affected area. Avoid any unnecessary movement, as the risk of tendon rupture may increase.
if you experience sudden and severe abdominal, chest, or back pain, 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).
side effects affecting the central nervous system , especially if you suffer from epilepsy or other neurological disorders such as cerebral ischaemia or stroke. In such case, stop treatment with Ciprofloxacin TecniGen and contact your doctor immediately.
psychiatric reactions , even after the first dose of Ciprofloxacin TecniGen. If you suffer from depression or psychosis, your symptoms may worsen during treatment with Ciprofloxacin TecniGen. In rare cases, depression or psychotic reactions may progress to suicidal thoughts/ideation, which may lead to suicide attempts or suicide. In case of psychiatric reactions, stop treatment with Ciprofloxacin TecniGen and contact your doctor immediately.
symptoms of nerve damage , rarely 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 occur. In such case, stop treatment with Ciprofloxacin TecniGen and inform your doctor immediately to prevent permanent nerve damage.
Quinolone antibiotics may cause an increase above your normal levels of sugar in the blood (hyperglycaemia) or a decrease below your normal levels of sugar in the blood, which in severe cases may potentially lead to loss of consciousness (hypoglycaemic coma) (see section 4.4). This is important for people with diabetes. If you have diabetes, your blood sugar levels must be closely monitored.
diarrhoea . Diarrhoea may develop during treatment with antibiotics, including Ciprofloxacin TecniGen, or even several weeks after treatment. If it worsens or persists, or if you notice blood or mucus in your stools, stop taking Ciprofloxacin TecniGen immediately, as this may be a life-threatening condition. Do not take medicines that block or reduce intestinal movements and contact your doctor.
symptoms of liver damage such as loss of appetite, yellowing of the skin, dark urine, itching, or abdominal pain, as Ciprofloxacin TecniGen may cause liver damage.
Stop taking Ciprofloxacin TecniGen and contact your doctor immediately.
symptoms of infection such as fever and marked deterioration in general condition, or fever with symptoms of localized infection such as sore throat or pain in the throat or mouth or urinary problems, as Ciprofloxacin TecniGen may cause a reduction in white blood cell count, leading to decreased resistance to infections. If you experience symptoms of infection, consult your doctor immediately. A blood test will be performed to check for a possible reduction in white blood cells (agranulocytosis). It is important that you inform your doctor about this medicine.
vision problems , for example, if your vision deteriorates or if your eyes are otherwise affected in any way. Consult an ophthalmologist immediately.

Inform your doctor or laboratory staff that you are taking Ciprofloxacin TecniGen if you need to have blood or urine tests.
During treatment with Ciprofloxacin TecniGen, your skin becomes more sensitive to sunlight or ultraviolet (UV) light. Avoid exposure to intense sunlight and artificial UV light, such as sunbeds.
If your vision deteriorates or if your eyes are otherwise affected, consult an ophthalmologist immediately.
Other medicines and Ciprofloxacin TecniGen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Ciprofloxacin TecniGen with tizanidine , as it may cause side effects such as low blood pressure and drowsiness (see section “Do not take Ciprofloxacin TecniGen”).
The following medicines interact with Ciprofloxacin TecniGen in the body. Taking Ciprofloxacin TecniGen together with these medicines may affect their therapeutic effect and increase the likelihood of side effects.
In particular, inform your doctor if you are taking:

other medicines that may alter heart rhythm: 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.
vitamin K antagonists (e.g., warfarin, acenocoumarol, phenprocoumon, or fluindione) or other oral anticoagulants (to thin the blood)
probenecid (for gout)
methotrexate (for certain types of cancer, psoriasis, or rheumatoid arthritis)
theophylline (for respiratory 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)
ciclosporin (for skin conditions, rheumatoid arthritis, and organ transplants)
glibenclamide (for diabetes)
medicines known to prolong the QT interval

Ciprofloxacin TecniGen may increase blood levels of the following medicines:

pentoxifylline (for circulatory disorders)
caffeine
duloxetine (for depression, diabetic neuropathy, or incontinence)
lidocaine (for heart problems or anaesthetic use)
sildenafil (for erectile dysfunction)
agomelatine
zolpidem

Certain medicines reduce the effect of Ciprofloxacin TecniGen:

antacids
mineral supplements
sucralfate (for ulcers and gastritis)
a polymeric phosphate binder (e.g., sevelamer or lanthanum carbonate)
medicines or supplements containing calcium, magnesium, aluminium, or iron
omeprazole (for ulcers and conditions caused by stomach hyperacidity)

If your doctor considers these medicines essential, take Ciprofloxacin TecniGen approximately two hours before or no less than four hours after taking them.
Ciprofloxacin TecniGen with food and drinks
Unless you are taking Ciprofloxacin TecniGen with meals, do not eat or drink dairy products (such as milk or yoghurt) or calcium-fortified drinks when taking the tablets, as they may interfere with the absorption of the active ingredient.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ciprofloxacin TecniGen may be used during pregnancy only if the benefit to the mother outweighs the risk to the unborn child and only under strict medical supervision. Inform your doctor if you are planning a pregnancy.
Do not take Ciprofloxacin TecniGen while breastfeeding, as ciprofloxacin is excreted in breast milk and may be harmful to your baby.
Driving and using machines
Ciprofloxacin TecniGen may interfere with your level of alertness. Since neurological adverse events may occur, assess your response to Ciprofloxacin TecniGen before driving or operating machinery. If in doubt, discuss this with your doctor.

3. How to take Ciprofloxacina TecniGen

Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will explain exactly how much Ciprofloxacina TecniGen you should take, how often,
and for how long. This will depend on the type and severity of your infection.
Treatment usually lasts from 5 to 21 days, but may last longer for severe infections.

Swallow the tablets with plenty of liquid. Do not chew the tablets as they have an unpleasant taste.
Try to take the tablets at approximately the same time each day.
You may take the tablets with meals or between meals. Calcium consumed during meals does not significantly affect absorption. However, do not take Ciprofloxacina TecniGen tablets with dairy products such as milk or yoghurt, or with fruit juices fortified with minerals (e.g. calcium-fortified orange juice).
Drink plenty of fluids during treatment with Ciprofloxacina TecniGen.

Use in patients with renal problems
Inform your doctor if you have kidney problems, as dose adjustment may be necessary.
If you take more Ciprofloxacina TecniGen than you should
If you take more than the prescribed dose, contact your doctor immediately. If possible, bring the tablets or the pack with you to show the doctor.
If you forget to take Ciprofloxacina TecniGen
Take the missed dose as soon as possible, then continue taking the medicine as prescribed. However, if it is almost time for your next dose, skip the missed dose and continue with your regular 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 treatment with Ciprofloxacina TecniGen
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 antibiotic resistance.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Common (may affect up to 1 in 10 people)

nausea, diarrhoea
joint pain in children

Uncommon (may affect up to 1 in 100 people)

fungal superinfections
high concentration of eosinophils, a type of white blood cell
loss of appetite (anorexia)
hyperactivity, agitation
headache, dizziness, sleep disturbances, taste disturbances
vomiting, abdominal pain, digestive problems (stomach discomfort, indigestion/heartburn), flatulence
increased levels 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 certain substance present in the blood)

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

inflammation of the intestine (colitis) associated with antibiotic use (in very rare cases may be fatal) (see section “Warnings and precautions”)
changes in the number of blood cells (leukopenia, leukocytosis, neutropenia, anaemia), increase or decrease in a blood coagulation factor (platelets)
allergic reaction, swelling (oedema), acute swelling of the skin and mucous membranes (angioedema)
increased blood sugar (hyperglycaemia)
decreased blood sugar (hypoglycaemia) (see section “Warnings and precautions”)
confusion, disorientation, anxious reaction, unusual dreams, depression (which may lead to suicidal thoughts/ideation, suicide attempt and suicide), hallucinations
tingling, unusual sensitivity to sensory stimuli, reduced skin sensitivity, tremors, seizures (including epilepsy) (see section “Warnings and precautions”), vertigo
visual disturbances (e.g. double vision)
tinnitus, hearing loss, decreased hearing
rapid heartbeat (tachycardia)
dilation of blood vessels (vasodilation), low blood pressure, fainting
shortness of breath, including asthma-like symptoms
liver disorders, jaundice (cholestatic jaundice), hepatitis
sensitivity to light (see section “Warnings and precautions”)
muscle pain, joint inflammation, increased muscle tone, cramps
renal failure, blood or crystals in urine (see section “Warnings and precautions”), inflammation of the urinary tract
fluid retention, excessive sweating
increased levels of amylase enzyme

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

blood disorders: a specific type of reduction in red blood cells (haemolytic anaemia), a dangerous reduction in a type of white blood cells (agranulocytosis), 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”)
psychiatric disorders (psychotic reactions which may lead to suicidal thoughts/ideation, suicide attempt and suicide) (see section “Warnings and precautions”)
migraine, coordination disorders, unsteady gait (gait disturbances), smell disorders (olfactory disturbances), pressure on the brain (intracranial hypertension including pseudotumor cerebri)
distortion in colour perception
inflammation of blood vessel walls (vasculitis)
inflammation of the pancreas (pancreatitis)
death of liver cells (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 located at the back of the ankle (Achilles tendon), worsening of symptoms of myasthenia gravis (see section “Warnings and precautions”)

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

nervous system disorders such as pain, burning, tingling, numbness and/or weakness of the extremities
abnormal increase in heart rate, life-threatening irregular heartbeat, changes in heart rhythm (called “prolongation of the QT interval”, seen on ECG, electrical activity of the heart)
a skin rash with formation of superficial pustules (acute generalised exanthematous pustulosis)
effects on blood clotting (in patients treated with vitamin K antagonists as oral anticoagulants)
feelings of overexcitement (mania) or feelings of great optimism and hyperactivity (hypomania)
Hypersensitivity reactions known as DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)
Syndrome associated with impaired water excretion and low sodium levels (SIADH)
Loss of consciousness due to severe drop in blood sugar levels (hypoglycaemic 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, abnormal sensations such as pricking, tingling, tickling, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, 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 aortic wall dilation and weakening 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 effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 Ciprofloxacin TecniGen

Keep this medicine out of sight and reach of children.
Do not use Ciprofloxacin TecniGen after the expiry date stated on the blister or carton after "Exp.". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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 Ciprofloxacina TecniGen contains

The active substance is ciprofloxacin hydrochloride monohydrate. One film-coated tablet contains 873 mg of ciprofloxacin hydrochloride monohydrate, equivalent to 750 mg of ciprofloxacin.
The other components are: maize starch, microcrystalline cellulose (E460), crospovidone (E1202), anhydrous colloidal silica, magnesium stearate (E572), hypromellose (E464), macrogol 4000, titanium dioxide (E171).

Description of the appearance of Ciprofloxacina TecniGen and the contents of the pack
Film-coated tablets – pack containing 12 tablets
Marketing Authorization Holder
Tecnigen S.r.l. - via Galileo Galilei 40, 20092 - Cinisello Balsamo (MI)
Manufacturer
Genetic SpA – Contrada Canfora – Industrial Area – 84084 Fisciano (Salerno)