Norfloxacin Stada 400 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Norfloxacin Stada 400 mg film-coated tablets EFG

Read all of 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Leaflet contents:

1. What Norfloxacin Stada is and what it is used for

2. What you need to know before taking Norfloxacin Stada

3. How to take Norfloxacin Stada

4. Possible side effects

5. How to store Norfloxacin Stada

6. Contents of the pack and other information

1. What Norfloxacino Stada is and what it is used for

Norfloxacino Stada contains the active substance norfloxacin.

Norfloxacin belongs to a group of antibiotics known as fluoroquinolones. Norfloxacin is a broad-spectrum antibiotic and acts against a wide range of infections.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important that you follow your doctor's instructions regarding dosage, administration, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Norfloxacin is indicated for the treatment of:

• Acute and chronic, complicated and uncomplicated infections of the upper and lower urinary tract (except complications of pyelonephritis: certain inflammatory complications of the kidneys caused by infection).

2. What you need to know before taking Norfloxacino Stada

DO NOT take Norfloxacino Stada:

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

• if you are hypersensitive (allergic) to any other antibiotic of the quinolone group (your doctor will know this).

• if you are hypersensitive (allergic) to the yellow-orange dye S (E110).

• if you have a history of tendon inflammation (tendinitis) and/or tendon rupture related to treatment with fluoroquinolones.

• if you are a child or adolescent under 18 years of age.

• if you are pregnant or breastfeeding.

• if you are taking tizanidine (see section 2: “Use of Norfloxacino Stada with other medicines”).

Warnings and precautions

Consult your doctor before starting Norfloxacino Stada, especially if you suffer from or have previously suffered from any of the following conditions or diseases:

• if you have been diagnosed with an enlarged or “bulge” in a large blood vessel (aortic aneurysm or peripheral large-vessel aneurysm).
• if you have previously experienced 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 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 inflammatory autoimmune 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)).

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including norfloxacin, if you have previously experienced a serious adverse reaction to a quinolone or fluoroquinolone. If this applies to you, inform your doctor as soon as possible.

If you experience sudden, severe pain in the abdomen, chest, or back, which may be symptoms of aortic dissection or aneurysm, go immediately to the emergency department. The risk may increase if you are receiving systemic corticosteroid treatment.

If you begin to experience sudden onset of shortness of breath, especially when lying down, or notice swelling in your ankles, feet, or abdomen, or develop palpitations (sensation of rapid or irregular heartbeat), inform your doctor immediately.

Quinolone antibiotics may cause blood sugar levels to rise above normal (hyperglycemia) or fall below normal, potentially leading to loss of consciousness (hypoglycemic coma) in severe cases (see section 4). This is particularly important for people with diabetes. If you have diabetes, you must carefully monitor your blood sugar levels.

Severe, disabling, long-lasting, and potentially irreversible adverse effects

Antibacterial medicines containing fluoroquinolones or quinolones, including norfloxacin, have been associated with very rare but serious adverse effects, some of which were long-lasting (persisting for months or years), disabling, or potentially irreversible. These include tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as reduced vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious sleep disturbances.

If you experience any of these adverse effects after taking norfloxacin, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue treatment, considering also the use of an antibiotic from another class.

Hypersensitivity reactions: Some patients have experienced severe allergic reactions, occasionally fatal, when treated with antibiotics of the quinolone group. Symptoms of an allergic reaction may include swelling of the skin of the face, limbs, tongue, or throat, and breathing difficulties. If you experience an allergic reaction:

• stop taking norfloxacin immediately.
• seek immediate medical attention for emergency treatment.

Liver disease:

Cases of liver failure (possible inability of the liver to perform its normal metabolic functions, potentially life-threatening) have been reported during treatment with norfloxacin (see section 4). If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, stop taking norfloxacin and consult your doctor immediately.

Tendon inflammation and/or tendon rupture:

Rarely, pain and swelling in joints and tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have received 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 or even several months after stopping norfloxacin. At the first sign of tendon pain or swelling (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking norfloxacin, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

Epilepsy or other central nervous system disorders:

• epilepsy or seizures (fits). These may worsen.
• mental disorders, such as hallucinations and/or confusion. These may worsen.
• central nervous system disorders, such as reduced blood flow to the brain or stroke.

If your symptoms worsen, stop treatment and consult your doctor immediately.

Peripheral neuropathy

Rarely, you may experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness, and/or weakness, particularly in the feet and legs or hands and arms. If this occurs, stop taking norfloxacin and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

Pseudomembranous colitis: Pseudomembranous colitis is an infection causing inflammation of the large intestine. This may result in severe and persistent diarrhea during or after treatment. If you have these symptoms:

• stop treatment with norfloxacin immediately and see your doctor.
• do not take medicines that slow down normal intestinal transit or inhibit peristalsis.

Your doctor will prescribe another medicine to treat your symptoms.

Heart problems

Caution is advised when using this type of medicine if you were born with or have a family history of prolonged QT interval (seen on ECG, a recording of the heart's electrical activity), have an electrolyte imbalance (especially low levels of potassium or magnesium in the blood), have a very slow heart rate (called 'bradycardia'), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), are female, are elderly, or are taking other medicines that cause abnormal changes in the ECG (see section "Use of Norfloxacino Stada with other medicines").

G6PD deficiency (glucose-6-phosphate dehydrogenase deficiency): You may develop a disorder of your red blood cells. This may occur if you lack sufficient amounts of the enzyme known as G6PD.

Myasthenia gravis (a disease causing muscle weakness): If you are taking norfloxacin, myasthenia gravis may appear or your symptoms may worsen. This can dangerously weaken your respiratory muscles, leading to respiratory failure. If your symptoms worsen, consult your doctor immediately.

Vision disturbances: If your vision worsens or if your eyes appear to be affected in any way, consult an eye specialist immediately (see section 4 "Possible adverse effects").

Photosensitivity: Photosensitivity may occur in patients treated with norfloxacin or other medicines of the quinolone group. You should avoid prolonged exposure to sunlight and intense solar radiation. You should also avoid using sunbeds (solariums) while taking norfloxacin.

Kidney disease: If you have renal impairment, norfloxacin may not work properly.

Crystalluria (crystals in your urine): If you take norfloxacin for a prolonged period, crystals may appear in your urine. To help prevent these symptoms:

• do not exceed the recommended dose of norfloxacin.
• drink plenty of fluids (e.g., water; never alcohol).

Use of Norfloxacino Stada with other medicines

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

DO NOT take norfloxacin if you are taking tizanidine (for muscle relaxation in multiple sclerosis).

The following medicines may interact with or be affected by norfloxacin:

• nitrofurantoin (an antibiotic).

• probenecid (used in the treatment of gout).

• theophylline (used to treat asthma and lung disease). The risk of side effects may increase when theophylline is taken with norfloxacin.

• caffeine (found in some pain medicines). You should not take medicines containing caffeine (e.g., some analgesics) while taking norfloxacin – consult your doctor.

• cyclosporine (used to prevent organ transplant rejection).

• warfarin (used to thin the blood).

• non-steroidal anti-inflammatory drugs (NSAIDs, used for pain and other conditions).

• fenbufen (a non-steroidal anti-inflammatory drug, NSAID, used to relieve pain).

You should inform your doctor if you are taking medicines that may alter your heart rhythm: medicines belonging to the antiarrhythmic group (e.g.: quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (macrolide group), and some antipsychotics.

Oral contraceptives: Be aware that oral contraceptive pills may have reduced effectiveness when taken with norfloxacin.

Products containing iron, antacids, magnesium, aluminium, or zinc: Products containing any of these substances (e.g., multivitamins, sucralfate) may reduce the concentration of norfloxacin in blood and urine.

Norfloxacin tablets should be taken 2 hours before or at least 4 hours after ingestion of such products.

Products containing calcium:

Products containing calcium may reduce the concentration of norfloxacin in blood and urine. For example, oral nutritional solutions and dairy products (milk or liquid dairy products such as yoghurt). Norfloxacin should be taken 1 hour before or at least 2 hours after ingestion of such products.

Taking Norfloxacino Stada with food, drinks, and alcohol

Norfloxacin should be taken on an empty stomach, 1 hour before or 2 hours after a meal or consumption of milk or other dairy products.

Do not drink alcohol while taking norfloxacin.

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.

This medicine may harm the unborn baby. Therefore, you must not take norfloxacin:

• if you are pregnant.
• if you think you may be pregnant.
• if you are trying to become pregnant.

If you become pregnant while taking norfloxacin, inform your doctor immediately.

You should use effective contraceptive methods while taking norfloxacin. If in doubt, consult your doctor.

Do not breastfeed while taking norfloxacin.

Driving and using machines

Norfloxacin may affect your reaction ability, especially:

• at the beginning of treatment.
• when increasing the dose.
• when changing medication.
• if you also drink alcohol.

Therefore, always exercise caution when driving or operating machinery. If you are affected, do not drive.

Norfloxacino Stada contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take Norfloxacino Stada

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

Your doctor may prescribe two doses per day. If so, it is best to take one dose in the morning and another at night. If you are required to take only one dose per day, take it always at the same time each day.

If you are taking antacids, multivitamins, or nutritional supplements, you must take norfloxacin at least 2 hours before or at least 4 hours after taking these products.

Swallow the norfloxacin tablets whole, without breaking, crushing, or chewing them. Swallow the tablets with liquid, for example, a glass of water. This should be taken at least 1 hour before or 2 hours after a meal or after consuming any dairy product.

Recommended dose:

Urinary tract infections

One 400 mg tablet twice daily. The duration of treatment depends on the type of infection you have.

• Uncomplicated acute cystitis (in women): treatment is usually 3 days.
• Urinary tract infections: treatment is generally 7 to 10 days.

Symptoms may improve quickly. Nevertheless, you must continue taking the medicine for the length of time recommended by your doctor.

• Complicated urinary tract infections: treatment is usually 2–3 weeks. Your doctor may extend the duration depending on the severity and location of the infection.

If you have kidney disease

Your doctor may check your kidney function by measuring creatinine clearance. If you have severe renal impairment (creatinine clearance = 30 ml/min × 1.73 m²), your doctor may reduce the dose to 400 mg once daily.

Elderly patients

If you are elderly and your kidney function is not impaired, the doses indicated above are suitable for you.

Use in children and adolescents

Children and adolescents who are still growing (under 18 years of age) must not take norfloxacin.

If you take more Norfloxacino Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine pack and leaflet to the healthcare professional.

You may be advised to take calcium-containing solutions. This will prevent your system from absorbing more norfloxacin.

If you forget to take Norfloxacino Stada

Do not worry. Simply take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop taking Norfloxacino Stada

Do not stop taking the medicine abruptly, even if your symptoms have improved quickly. You must continue taking the medicine for the length of time recommended by your doctor; otherwise, the infection may recur.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

Stop taking the medicine and consult your doctor immediately if you have:

• symptoms of angioedema (a potentially life-threatening reaction), such as:
  • swelling of the face, tongue, or throat
  • difficulty swallowing
  • hives and difficulty breathing
• a severe skin reaction
• yellowish discoloration of the whites of the eyes or skin, which may be a sign of liver inflammation (hepatitis) or liver failure.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

• • leucopenia (low number of white blood cells)
• neutropenia (low number of white blood cells called neutrophils)
• eosinophilia (high number of white blood cells called eosinophils)
• elevated liver enzymes (AST, ALT, alkaline phosphatase). These are blood tests indicating changes in liver function.
• headache
• dizziness
• vertigo
• somnolence
• abdominal pain and spasms
• nausea (feeling unwell)
• skin rash

Uncommon (may affect up to 1 in 100 people):

• thrombocytopenia (reduced number of platelets in the blood)

• reduced hematocrit (low number of red blood cells)

• crystalluria (crystals appearing in the urine)

• prolonged prothrombin time (when your blood takes longer to clot)

• haemolytic anaemia (decrease in red blood cells due to abnormal destruction, which may lead to pale skin, weakness, and difficulty breathing). This is sometimes associated with low levels of the enzyme glucose-6-phosphate dehydrogenase.

• hypersensitivity reactions (allergic reactions), such as:

  • anaphylaxis (serious allergic reaction, see section 2. "Warnings and precautions")
  • angioedema (serious allergic reaction causing swelling of the face, tongue, or throat, which may be life-threatening)
  • urticaria (hives)
  • interstitial nephritis (kidney inflammation)
  • petechiae (small red or purple spots on the body)
  • haemorrhagic bullae (bleeding blisters)
  • papules with vasculitis (small skin bumps with inflammation of blood vessels)

• fatigue

• mood changes

• paraesthesia (tingling, numbness)

• insomnia (difficulty sleeping)

• sleep disturbances

• depression (feeling sad)

• anxiety

• nervousness

• irritability

• euphoria (feeling of extreme happiness)

• disorientation

• hallucinations (seeing or hearing things that are not real)

• confusion

• polyneuropathy (when the nervous system does not function properly in arms and legs), including Guillain-Barré syndrome (characterized by weakness affecting the limbs, which may cause numbness and paralysis) (see section 2 “Warnings and precautions”)

• seizures (fits)

• psychiatric disorders, psychotic disorders and reactions (serious mental disorders)

• myasthenia gravis (a disease causing muscle weakness) may appear or worsen (see section 2. "Warnings and precautions")

• vision disorders

• increased lacrimation (tear production)

• tinnitus (ringing in the ears)

• palpitations (awareness of heartbeats)

• heartburn

• diarrhoea

• vomiting

• anorexia (loss of appetite)

• pancreatitis (inflammation of the pancreas)

• hepatitis (inflammation of the liver)

• increased serum bilirubin (a chemical in the blood)

• serious skin reactions:

  • exfoliative dermatitis (inflammation, pityriasis)
  • Lyell's syndrome (severe skin disease with intense redness, blisters, and peeling of the skin, resembling a burn)
  • erythema multiforme (Stevens-Johnson syndrome, a serious condition with blisters on the skin, mouth, eyes, and genitals)
  • photosensitivity (increased sensitivity to sunlight)
  • pruritus (itching)

• arthritis (inflamed joints)

• myalgia (muscle pain)

• arthralgia (joint pain)

• tendinitis (inflammation of tendons)

• tenosynovitis (inflammation of the tendon and tendon sheath)

• increased serum urea and creatinine (indicators of worsening kidney function)

• vaginal candidiasis (thrush)

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

• pseudomembranous colitis (inflammation of the intestine causing fever, abdominal pain or diarrhoea (see section 2 "Warnings and precautions")
• in some cases, inflammation of the Achilles tendon has been observed. This may lead to rupture of the Achilles tendon (see section 2. "Warnings and precautions").

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

• cholestatic hepatitis (liver inflammation where bile does not flow properly)
• liver necrosis (death of liver tissue)
• rhabdomyolysis (muscle disease caused by breakdown of muscle cells, which may lead to kidney problems)
• fever, sore throat, and persistent general feeling of illness due to reduced white blood cell count (agranulocytosis)

Not known (frequency cannot be estimated from available data):

• the orange-yellow dye (E 110) may cause allergic reactions.

• reduced sense of touch (hypoesthesia)

• liver failure, including fatal cases (see section 2. “Warnings and precautions”)

• abnormally fast heart rate, irregular heart rhythm that may be life-threatening, disturbance in heart rhythm (called “QT interval prolongation”, observed on ECG, the heart's electrical activity)

• Syndrome associated with impaired water excretion and low sodium levels (SIADH)

• Loss of consciousness due to severely low blood sugar levels (hypoglycaemic coma). See section 2.

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 pricking, tingling, pins and needles, burning, numbness or pain (neuropathy), depression, fatigue, sleep disturbances, memory impairment, and decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting of adverse effects

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

5. Storage of Norfloxacin Stada

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

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or in household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Norfloxacino Stada

• The active substance is norfloxacin.

Each film-coated tablet contains 400 mg of norfloxacin.

• The other components are:

Tablet core:

• povidone
• sodium carboxymethylstarch (type A) (from potato)
• microcrystalline cellulose
• colloidal anhydrous silica
• magnesium stearate
• purified water

Coating:

• hypromellose
• talc
• propylene glycol
• orange yellow S (E 110)
• titanium dioxide (E 171)

Appearance of the product and contents of the pack

Norfloxacino Stada are film-coated, round, orange tablets, with a scored line engraved on one side.

Norfloxacino Stada is available in aluminum PVC/PVDC blisters.

Pack sizes: 10, 14, 20 and 50 film-coated tablets. Hospital packs containing 500 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG,

Stadastrasse 2-18,

61118 Bad Vilbel,

Germany

or

Doppel Farmaceutici, S.R.L.

Via Volturno, 48 - Quinto de’ Stampi

20089 Rozzano (MI)

Italy

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Norfloxa Stadapharm 400 mg

Spain: Norfloxacino Stada 400 mg film-coated tablets EFG

Italy: Norfloxacina EG 400 mg Compresse Rivestite con film

Date of the most recent revision of this leaflet: February 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es