NORFLOXACINA 400 mg Hard Capsules

Зміст інструкції

1. NORFLOXACINA ABC 400 mg hard capsules

NORFLOXACINA ABC 400 mg hard capsules

Norfloxacina

Generic medicine
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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

What is Norfloxacina ABC and what it is used for
Norfloxacina ABC contains the active ingredient norfloxacin which belongs to a group of medicines
called antibacterials, used for the treatment of infections caused by pathogenic microorganisms
with multiple resistances.
This medicine is indicated for the treatment of infections of the upper and lower urinary tract (cystitis,
pyelitis, cystopyelitis, pyelonephritis).
This medicine, taken at normal doses, allows for the successful treatment of infections caused by microorganisms
resistant to other antibiotics.

What you need to know before taking Norfloxacina ABC
Before taking this medicine
Do not take antibacterial medicines based on quinolones/fluoroquinolones, including Norfloxacina ABC,
if you have had any serious adverse reaction in the past during treatment with a quinolone or
fluoroquinolone. In this case, inform your doctor as soon as possible.

Do not take Norfloxacina ABC

• if you are allergic to norfloxacin, to other similar substances (quinolone medicines) or to any of the other ingredients of this medicine (listed in section 6);
• if you have had inflammation of the tendons (tendinopathy), especially after taking medicines similar to this one (fluoroquinolones);
• if you are pregnant and if you are breastfeeding (see section “Pregnancy and breastfeeding”);
• if the patient is a child in the pre-pubertal age or if he/she is an adolescent with incomplete skeletal development (see section “Children and adolescents”);
• if you suffer from seizures or epilepsy, if you are predisposed to having seizures (see section “Possible side effects”).

Warnings and precautions
Talk to your doctor before taking Norfloxacina ABC:

• 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 suffer from kidney problems (renal insufficiency) and have a urinary tract infection, you can take this medicine but inform your doctor anyway (see section “Use in patients with kidney problems”). It is recommended to drink plenty of fluids to avoid complications (crystalluria);
• if your vision should decrease or if your eyes should be compromised in any way, consult an ophthalmologist immediately;
• if you have previously experienced episodes of aortic dissection (a tear in the wall of the aorta);
• if you have been diagnosed with insufficiency of one of the heart valves (aortic and mitral regurgitation);
• if you have a family history of aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [an autoimmune inflammatory disease], or vascular disorders Takayasu arteritis, giant cell arteritis, Behçet's syndrome, high blood pressure or known atherosclerosis, rheumatoid arthritis [an autoimmune inflammatory disease] or endocarditis [inflammation of the heart])

During the taking of Norfloxacina ABC:

• if you experience severe and sudden abdominal, chest or back pain, which may be a symptom of aneurysm and aortic dissection, go to the emergency room immediately. The risk may be greater if you are taking systemic corticosteroids.
• immediately inform your doctor if you notice a rapid onset of shortness of breath, especially when lying down, or swelling of the ankles, feet or abdomen, or new episodes of palpitations (feeling of rapid or irregular heartbeat).

During treatment with this medicine, you may experience skin problems after exposure to light,
such as irritation (photosensitivity), therefore avoid excessive exposure to light. If you experience
these problems, stop treatment with Norfloxacina ABC.

When taking this medicine
Rarely, pain and swelling in the joints and inflammation or rupture of the tendons can occur. The
risk is greater if you are elderly (over 60 years of age), if you have received an organ transplant, if
you have kidney problems or if you are being treated with corticosteroids. Inflammation and rupture of the tendons can
occur within the first 48 hours of treatment and up to several months after the end of therapy with
Norfloxacina ABC. At the first signs of pain or inflammation in a tendon (for example in the ankle, wrist, elbow, shoulder or knee), stop treatment with Norfloxacina ABC, consult
your doctor and keep the painful part at rest. Avoid any unnecessary movement, as the risk of
tendon rupture may increase.
Rarely, symptoms of nerve damage (neuropathy) such as pain, burning, tingling, numbness and/or weakness, especially in the feet and legs or hands and arms, can occur. In this case,
stop treatment with Norfloxacina ABC and inform your doctor immediately, to prevent
nerve damage from becoming permanent.

Take this medicine with caution and inform your doctor if you have heart problems, especially if you have
conditions that predispose you to heart problems (prolongation of the QT interval), for example:

• if you have a congenital disease (long QT syndrome);
• if your blood salt levels are altered (electrolyte imbalance), for example a decrease in potassium (hypokalemia) and magnesium (hypomagnesemia);
• if you have heart problems (heart failure, myocardial infarction, bradycardia)
• if you are an elderly person or a woman.

Children and adolescents
This medicine is contraindicated in children before puberty and in adolescents with incomplete
skeletal development.

Serious, prolonged, disabling and non-improving side effects
Antibacterial medicines based on fluoroquinolones/quinolones, including Norfloxacina ABC, have been associated
with very rare but serious side effects, some of which are prolonged (lasting months or years), disabling or
non-improving. These include pain in the tendons, muscles and joints of arms or
legs, difficulty walking, abnormal sensations such as tingling, tingling, itching, numbness or
burning (paresthesia), sensory organ disorders such as changes in vision, taste, smell and
hearing, depression, memory impairment, severe fatigue and severe sleep disturbances.
If you experience any of these side effects after taking Norfloxacina ABC, contact
your doctor immediately before continuing treatment. The doctor will decide together with you whether to continue
treatment and will also consider the use of an antibiotic from another class.

Other medicines and Norfloxacina ABC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Take Norfloxacina ABC with caution and inform your doctor if you are taking the following medicines, because
specific checks may be necessary:

• medicines used to treat high uric acid levels (probenecid);
• medicines used for urinary tract infections (nitrofurantoin);
• medicines used to treat asthma (theophylline), your doctor will check the levels of the medicines in the blood and if necessary adjust the dose;
• cyclosporine, a medicine used after a transplant to prevent rejection or for the treatment of immune system disorders, the doctor will check the levels of the medicines in the blood and if necessary adjust the dose;
• medicines used to thin the blood (oral anticoagulants such as warfarin and its derivatives), as specific checks are necessary (prothrombin time coagulation tests);
• zinc and iron-containing vitamin supplements, antacids, medicines used to treat stomach problems (reflux, ulcers), such as sucralfate. Take these medicines at least two hours after Norfloxacina ABC and not at the same time;
• non-steroidal anti-inflammatory drugs (fenbufen), as this may cause seizures;
• medicines used to treat heart rhythm disturbances (antiarrhythmics such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), medicines used to treat depression (tricyclic antidepressants), medicines used to treat some mental disorders (antipsychotics), as these cause heart problems (prolongation of the QT interval).

Norfloxacina ABC with drinks
Be careful with coffee consumption during treatment with Norfloxacina ABC, as caffeine
may cause an increase in the levels of this medicine in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant or breastfeeding.

Driving and using machines
This medicine can cause side effects such as dizziness and drowsiness that can alter your ability to
drive vehicles and operate machinery.
If you experience these effects, avoid driving vehicles or operating machinery.

Norfloxacina ABC contains sodium
Norfloxacina ABC capsules contain less than 1 mmol (23 mg) of sodium per dose, which is
essentially ‘sodium-free’.

How to take Norfloxacina ABC
Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.
Take the capsules one hour before or two hours after meals with a glass of water.

Treatment of urinary tract infections
The recommended dose for adults is 400 mg twice a day for 7-10 days.
In the case of cystitis in women (acute uncomplicated cystitis), the treatment period is 3-7 days.
It is recommended to perform urine tests to know the effectiveness of this medicine, however you can
take Norfloxacina ABC even before the results of the tests.

Use in patients with kidney problems
If you have kidney problems (renal insufficiency) the recommended dose is one 400 mg capsule per day.
If you have severe kidney problems, a marked alteration of Norfloxacina ABC levels may occur
in the urine.

If you take more Norfloxacina ABC than you should
In case of overdose of this medicine, take plenty of fluids.
If you accidentally ingest/take an excessive dose of Norfloxacina ABC, warn
your doctor immediately or go to the nearest hospital.

If you forget to take Norfloxacina ABC
Do not take a double dose to make up for a missed dose.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• stomach and intestinal disorders such as nausea, abdominal pain, indigestion (dyspepsia), constipation, flatulence, stomach pain (gastralgia).
• mental disorders (neuropsychiatric problems) such as headache, dizziness, fatigue, drowsiness, depression, insomnia;
• skin reactions such as skin irritation (rash).

Rare(may affect up to 1 in 1000 people)

• seizures, even if you have previously taken this medicine but have never suffered from this problem.

Unknown frequency(frequency cannot be estimated from available data):

• increased levels of white blood cells (eosinophilia);
• increased levels of enzymes produced by the liver (transaminases) and alkaline phosphatase;
• reduction in the number of white blood cells (leukopenia, neutropenia), reduction in platelet levels (thrombocytopenia);
• allergic reactions (hypersensitivity), including severe ones (anaphylaxis);
• kidney problems (interstitial nephritis);
• swelling of the face, lips, mouth, tongue or throat due to fluid accumulation (angioedema);
• inflammation of blood vessels (vasculitis);

• skin irritation (urticaria);
• inflammation of the joints (arthritis), muscle (myalgia) and joint (arthralgia) pain;
• skin sensitivity to light (photosensitivity);
• severe skin disorders (Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, erythema multiforme);
• itching;
• inflammation of the intestine (pseudomembranous colitis);
• mental confusion;
• other serious allergic reactions, such as swelling of the tongue, larynx (glottis), difficulty breathing (dyspnea), lowering of blood pressure (arterial hypotension) up to insufficient blood circulation in the main organs (dangerous shock);
• altered heartbeat (ventricular arrhythmia and torsade de pointes, reported predominantly in patients with known risk factors for QT prolongation (prolonged QT on electrocardiogram); loss of appetite (anorexia), dry mouth, diarrhea, fever, vomiting, skin irritation (erythema), anxiety, agitation, irritability, euphoria, disorientation, hallucinations, ringing in the ears, tearing of the eyes (epiphora).
• vision disorders (including diplopia), hearing disorders such as ringing in the ears, decreased hearing (hypoacusia) and taste alterations;
• increased levels of nitrogen and creatinine in the blood (azotemia and creatinemia);
• decrease in the number of cells present in the blood (hematocrit).
• inflammation of the pancreas (pancreatitis).

Cases of dilation and weakening of the aortic wall or rupture of the aortic wall (aneurysms and
dissections), with possible ruptures that can cause death, as well as cases of backflow of blood from the
heart valves, have been reported in patients treated with fluoroquinolones. See also paragraph 2.
Very rare cases of adverse drug reactions, prolonged (lasting for months or years) or permanent, such as
inflammation of the tendons, tendon rupture, joint pain, arm or leg pain, difficulty
walking, abnormal sensations such as tingling, prickling, itching, burning, numbness or pain
(neuropathy), fatigue, impaired memory and concentration, effects on mental health
(which may include sleep disorders, anxiety, panic attacks, depression and suicidal thoughts),
alteration of hearing, vision, taste and smell, have been associated with the use of antibiotics of the type of
quinolones and fluoroquinolones, in some cases regardless of pre-existing risk factors.

Reporting suspected adverse reactions
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the website:
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.

How to store Norfloxacina ABC
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the packaging after “Expiry”.
The expiry date refers to the last day of that month, for a product in intact packaging and
correctly stored.
This medicine should be stored at room temperature.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

Contents of the pack and other information
What NorfloxacinaABC contains
The active ingredient is norfloxacin. Each capsule contains 400 mg of norfloxacin.

The other ingredients are: hydration water, sodium lauryl sulfate, starch, titanium dioxide (E171), yellow iron oxide (E172), gelatin.

Description of NorfloxacinaABC and contents of the pack
Pack of 14 capsules.

Marketing Authorisation Holder
ABC Farmaceutici S.p.a. - Corso Vittorio Emanuele II, 72 - 10121 Turin - Italy.

Manufacturer
ABC Farmaceutici S.p.a. Canton Moretti, 29 – 10015 San Bernardo d’Ivrea - Turin - Italy.