Leaflet: information for the user

NorfloxacinoDari Pharma400 mg coated tablets EFG

Norfloxacino

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Norfloxacino Dari Pharma and what it is used for

2. What you need to know before starting to take Norfloxacino Dari Pharma

3. How to take Norfloxacino Dari Pharma

4. Possible side effects

5. Conservation of Norfloxacino Dari Pharma

6. Contents of the pack and additional information

Norfloxacino Dari Pharma is a medication used to treat various infections produced by gram-positive and gram-negative microorganisms.

Norfloxacino Dari Pharma is indicated for the treatment of upper and lower urinary tract infections, including cystitis (inflammation of the urinary bladder), pyelitis (inflammation of the renal pelvis), and cystopyelitis (inflammation of the urinary bladder and renal pelvis) caused by bacteria sensitive to norfloxacin.

Do not take NorfloxacinoDari Pharma:

• If you are allergic to the active ingredient, to any other quinolone, such as pipemidic acid, or to any of the other components of this medication (listed in section 6)

Warnings and precautions

Before starting to take this medication

You should not take antibacterial medications that contain fluoroquinolones or quinolones, including Norfloxacino Dari Pharma, if you have experienced a severe adverse reaction to a quinolone or fluoroquinolone in the past. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor or pharmacist before starting to take Norfloxacino Dari Pharma.

• If you have a history of seizures or factors that may trigger their occurrence.

• If you have cardiovascular disease or risk factors that may prolong the QT interval, especially women or elderly patients

• If you have been diagnosed with an enlarged or "bulge" of a large blood vessel (aortic aneurysm or large peripheral artery aneurysm).

• If you have had a previous episode of aortic dissection (tear in the aortic wall).

• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).

• If you have a family history of aortic dissections or aneurysms, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, known atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

During treatment with this medication

• If you experience severe and sudden pain in the abdomen, chest, or back, which may be symptoms of aortic dissections or aneurysms, seek immediate medical attention. The risk may be increased if you are receiving systemic corticosteroid treatment.
• If you start experiencing sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the onset of palpitations (sensation of rapid or irregular heartbeat), you should inform your doctor immediately.

• Consult an ophthalmologist immediately if you experience any visual disturbances or eye problems.
• Avoid exposure to the sun or ultraviolet rays during treatment due to possible risks of photosensitivity.

In rare cases, the following may occur:joint pain and swelling, and inflammation or rupture of tendons. The risk is higher if you are an elderly person (over 60 years old), have received an organ transplant, have kidney problems, or are receiving corticosteroid treatment. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Norfloxacino Dari Pharma. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Norfloxacino Dari Pharma, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

In rare cases, you may experience symptoms ofnerve damage (neuropathy)such as pain, burning, tingling, numbness, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking Norfloxacino Dari Pharma and inform your doctor immediately to prevent the development of a potentially irreversible condition.

Severe, prolonged, and potentially irreversible adverse effects

Fluoroquinolone or quinolone-containing antibacterial medications, including Norfloxacino Dari Pharma, have been associated with rare but severe adverse effects, some of which were persistent for months or years, incapacitating, or potentially irreversible. This includes tendon pain, muscle pain, and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pinching, tingling, itching, numbness, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking Norfloxacino Dari Pharma, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, also considering the use of an antibiotic from a different class.

Other medications and Norfloxacino Dari Pharma

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Inform your doctor if you are taking ciclosporin (used to prevent organ transplant rejection); medications that can alter heart rhythm: antiarrhythmic medications (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, difetilide, ibutilide), tricyclic antidepressants, some antibiotics (macrolides), and some antipsychotics.

Do not administer this medication with:

-Probenecid(reduces the elimination of norfloxacin in urine).

-Theophyllineused for respiratory problems andciclosporinaused to prevent organ transplant rejection, may increase the risk of adverse reactions to these medications if taken together with norfloxacin).

-Oral anticoagulants(norfloxacin may increase the action of warfarin or its derivatives, which may alter blood coagulation).

-Antacids, sucralfate, and preparations containing zinc and iron(reduce the absorption of norfloxacin. Therefore, Norfloxacino Dari Pharma should only be taken 3 or 4 hours before or 2 hours after administration of these preparations).

-Nitrofurantoin(since antagonism has been demonstrated with norfloxacin).

Taking Norfloxacino Dari Pharma with food and beverages:

Avoid drinking alcohol while taking this medication.

Milk and yogurt reduce the absorption of norfloxacin. Therefore, Norfloxacino Dari Pharma should be taken 1 hour before or 2 hours after these foods.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Consult your doctor or pharmacist before taking a medication.

The safety of Norfloxacino Dari Pharma during pregnancy has not been established. Norfloxacino Dari Pharma should only be used during pregnancy when the doctor considers that the potential benefits justify the risk to the fetus.

Lactation

Consult your doctor or pharmacist before taking a medication.

Norfloxacino Dari Pharma is excreted in breast milk, so it is not recommended to take this medication during lactation.

Driving and operating machinery

No effects on the ability to drive and operate machinery have been described.

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medication.

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated polyoxethylene ricinoleate oil.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment beforehand, as the expected results will not be obtained.

The tablets should be swallowed whole, with a little water, in the morning or during meals.

Adults:

•For the treatment of urinary tract infections, the usual dose is 1 tablet (400 mg of norfloxacin) twice a day (every 12 hours), which means a maximum daily dose of 2 tablets (800 mg of norfloxacin). The treatment duration will be 7 to 10 days, although symptoms may have disappeared before.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The most frequent adverse reactions are: nausea, loss of appetite, diarrhea, headache, dizziness, and allergic reactions (hives, rashes, and/or itching on the skin).

In older adults, fatigue, drowsiness, and confusion may appear.

Rarely, decreases in the number of certain blood cells and/or elevations in certain liver or kidney function parameters have been observed.

Rarely, tendonitis or tendon rupture may occur.

Cardiac Disorders

Unknown frequency: Abnormally fast heart rhythm, life-threatening irregular heart rhythm, alteration of heart rhythm (called QT interval prolongation, recorded on electrocardiogram, heart electrical activity).

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, prickling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, memory decline, and hearing, vision, taste, and smell decline in some cases, regardless of the presence of pre-existing risk factors.

Cases of aortic wall enlargement and weakening or tearing (aneurysms and dissections) have been reported, which could lead to rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store at room temperature

Do not use this medication after the expiration date that appears on the packaging after CAD.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at your local SIGRE drop-off point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Norfloxacin CompositionDari Pharma400 mg

The active ingredient is norfloxacin. Each coated tablet contains 400 mg of norfloxacin.

The other components are: Lactose monohydrate, hydroxypropylcellulose (E463), hydrogenated ricin oil polyoxyethylene, povidone, crospovidone, hydrated colloidal silica, magnesium stearate. Coating: Hydroxypropylmethylcellulose (hypromellose), titanium dioxide (E171), macrogol 400.

Product appearance and packaging contents

Coated tablets with a film coating.

This medicine is presented in packaging with 14 tablets or in a clinical pack of 500 tablets.

Marketing authorization holder and manufacturer

Marketing Authorization Holder:

Dari Pharma, S.L.

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Manufacturer:

Laboratorios LESVI, S.L.

Avda. Barcelona, 69;

Sant Joan Despí - Barcelona

Spain

Last review date of this leaflet: November 2020

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es