NORFLOXACIN DARI PHARMA 400 mg FILM-COATED TABLETS

2. What you need to know before you take Norfloxacin Dari Pharma

Do not take Norfloxacin Dari Pharma:

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

Warnings and precautions

Before you start taking this medicine

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

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

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

• If you suffer from heart disorders or risk factors that prolong the QT interval, especially women or elderly patients

• If you have been diagnosed with an aneurysm of a large blood vessel (aortic aneurysm or peripheral large vessel 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 the heart valves).

• If you have a family history of aortic dissection or aneurysm, 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, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

During treatment with this medicine

• If you experience severe and sudden abdominal, chest, or back pain, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency room. The risk may increase if you are receiving systemic corticosteroid treatment.
• If you start to experience sudden onset of shortness of breath, especially when lying down, or if you notice swelling in the ankles, feet, or abdomen, or the appearance of heart palpitations (feeling of rapid or irregular heartbeat), you should inform your doctor immediately.

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

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

In rare cases, you may experience symptoms of nerve 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 Norfloxacin Dari Pharma and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Severe, long-lasting, and potentially irreversible side effects

Antibacterial medicines that contain fluoroquinolones or quinolones, including Norfloxacin Dari Pharma, have been associated with very rare but severe side effects, some of which were long-lasting (persisting for months or years) or irreversible. These include tendon pain, muscle pain, joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, tingling, prickling, burning, numbness, or pain (paresthesia), sensory disorders such as decreased vision, taste, smell, or hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these side effects after taking Norfloxacin Dari Pharma, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not, considering the use of an antibiotic from another class.

Other medicines and Norfloxacin Dari Pharma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

It is not recommended to administer this medicine with:

• Probenecid (decreases the elimination of norfloxacin in urine).
• Theophylline used for respiratory problems and cyclosporin used to prevent organ transplant rejection may cause a possible increase in adverse reactions to these drugs if administered together with norfloxacin.
• Oral anticoagulants (norfloxacin may increase the action of warfarin or its derivatives, which could alter blood coagulation).
• Antacids, sucralfate, and preparations containing zinc and iron (reduce the absorption of norfloxacin. Therefore, Norfloxacin Dari Pharma should only be taken 3 or 4 hours before or 2 hours after the administration of these preparations).
• Nitrofurantoin (since antagonism with norfloxacin has been demonstrated).

Taking Norfloxacin Dari Pharma with food and drinks:

Avoid drinking alcohol while taking this medicine.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Consult your doctor or pharmacist before taking a medicine.

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

Breastfeeding

Consult your doctor or pharmacist before taking a medicine.

Norfloxacin Dari Pharma is excreted in breast milk, so it is not recommended to take this medicine during breastfeeding.

Driving and using machines

No effects on the ability to drive and use machines have been described.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine may cause stomach upset and diarrhea because it contains hydrogenated polyoxyethylene castor oil.

3. How to take Norfloxacin Dari Pharma

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment before, as the expected results will not be achieved.

The tablets should be swallowed whole, with a little water, on an empty stomach or during meals.

Adults:

• For the treatment of urinary 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, even if symptoms have disappeared before.

• In women with acute uncomplicated cystitis, the 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 is 3 days.

Patient with renal insufficiency:

• In patients with a creatinine clearance of less than 30 ml/minute, the recommended dose is 1 tablet (400 mg of norfloxacin) once a day.

• If renal insufficiency is advanced, your doctor will assess the convenience of treatment on a case-by-case basis.

Use in children:

Norfloxacin should not be used in children due to the possible appearance of joint diseases (arthropathies).

If you think the action of norfloxacin is too strong or too weak, tell your doctor or pharmacist.

If you take more Norfloxacin Dari Pharma 400 mg than you should:

If you have taken more norfloxacin than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 915 62 04 20, indicating the medicine and the amount taken.

If you forget to take Norfloxacin Dari Pharma:

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

In elderly people, fatigue, somnolence, and confusion may appear.

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

Rarely, tendonitis or tendon rupture may occur.

Cardiac disorders

Frequency not known: Abnormally rapid heart rate, life-threatening irregular heart rhythm, alteration of heart rhythm (called QT interval prolongation, recorded on an electrocardiogram, electrical activity of the heart).

The administration of antibiotics that contain 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, pain in the limbs, difficulty walking, abnormal sensations such as pinching, tingling, prickling, burning, numbness, or pain (neuropathy), depression, fatigue, sleep disorders, decreased memory, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting of side effects:

If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Norfloxacin Dari Pharma 400 mg

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

Store at room temperature

Do not use this medicine after the expiry date stated on the packaging after EXP.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Norfloxacin Dari Pharma 400 mg

The active substance is norfloxacin. Each film-coated tablet contains 400 mg of norfloxacin.

The other ingredients are: lactose monohydrate, hydroxypropylcellulose (E463), hydrogenated polyoxyethylene castor oil, povidone, crospovidone, colloidal silica, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), macrogol 400.

Appearance and packaging of the product

Film-coated tablets.

This medicine is available in packs of 14 tablets or 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

Date of last revision of this leaflet: November 2020

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