Norfloxacin 400 mg film-coated tablet Taj Pharma

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NORFLOXACIN FILM COATED TABLETS 400 MG Package leaflet: Information for the patient Norfloxacin 400 mg film-coated tablet.

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 further questions, ask your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

What is in this leaflet 1. What Norfloxacin is and what it is used for 2. Before you are given Norfloxacin 3. How you will be given Norfloxacin 4. Possible side effects 5. How Norfloxacin is stored 6. Further Information

1. What Norfloxacin is and what it is used for Norfloxacin belongs to the so-called fluoroquinolones, a group of antibacterial medicines.

Norfloxacin is used for the treatment of infections caused by bacteria that are sensitive to norfloxacin, such as infections of the urinary system.

2. Before you are given Norfloxacin Do not take Norfloxacin if:  you are allergic (hypersensitive) to norfloxacin or any of the other ingredients of Norfloxacin (listed in Section 6)  have had a history of tendon problems from using this type of medicine before  you are pregnant or think you could be pregnant (see Pregnancy and breastfeeding’ section below)  you are breast-feeding  you have had a reaction to a similar medicine in the past  the patient is a child or young person who is still growing.

Do not take Norfloxacin if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Norfloxacin.

Warnings and precautions Talk to your doctor or pharmacist before taking Norfloxacin.

You should contact your doctor if:  you experience serious allergic reactions (an anaphylactic reaction) while starting or maintaining treatment with Norfloxacin(see section 4 ‘uncommon serious side effects: allergic reaction’).In such cases, therapy with Norfloxacin must be discontinued immediately and appropriate emergency action must be started, for example antihistamines, glucocorticosteroids, sympathomimetics and ventilation if

necessary.  you experience symptoms of inflammation of tendons and tendon ruptures during the treatment.  you have ever had fits (convulsions or stroke)  you have ever had an illness that causes fits (convulsions), such as epilepsy  you have impaired kidney function. Your doctor may have to adjust the dose.  you have an illness called myasthenia gravis which causes muscle weakness  you or anyone in your family has anaemia caused by an illness called glucose-6phosphate dehydrogenase deficiency (also called G-6-PD deficiency)  you experience diarrhoea, especially if you have severe, persistent and/or bloody diarrhoea.  If your eyesight becomes impaired or if your eyes seem to be otherwise affected whilst taking Norfloxacin, consult an eye specialist immediately (see sections Driving and using machines and 4. Possible side effects).  you have been diagnosed with an enlargement or "bulge" of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).  you have experienced a previous episode of aortic dissection (a tear in the aorta wall).  you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis,

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Behcet’s disease, high blood pressure, or known atherosclerosis).

If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.

Heart problems Caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Other medicines and Norfloxacin).

When using norfloxacin, exposure to the sun or ultraviolet light should be avoided on the account of the possibility of the development of sensitivity to light.

Drink sufficient amounts during the treatment in order to prevent crystallisation of norfloxacin in the urine.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Norfloxacin.

Other medicines and Norfloxacin You must tell your doctor if you are taking other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine,

hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Norfloxacin can affect the way some other medicines work. Also some other medicines can affect the way Norfloxacin works.

Some medicines can reduce the amount of Norfloxacin that gets into the body.

If you take Norfloxacin, leave a gap of two hours before and at least four hours after taking one of these medicines:  antacids - used for indigestion or heartburn (this restriction does not apply to H2-receptor antagonist-type antacids).  sucralfate - used for stomach ulcers or an inflamed stomach (gastritis)  medicines containing calcium, magnesium, aluminium, iron, or zinc including multivitamins and minerals.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Norfloxacin.

It is also particularly important to tell your doctor or pharmacist if you take:  theophylline – used for breathing problems  medicines used to thin the blood, such as warfarin, phenprocoumon or acenocoumarol

 fenbufen - used for joint pain  glibenclamide  didanosine - used for HIV or AIDS  ciclosporin or mycophenolic acid - used after transplants and for some other illnesses  probenecid - used for gout  nitrofurantoin - used for urinary tract infections, such as blatter infection  caffeine If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Norfloxacin.

Norfloxacin with food and drink Take Norfloxacin with a glass of water. Take Norfloxacin at least one hour before or two hours after food or milk.

Pregnancy and breast-feeding Do not take Norfloxacin if you are pregnant or think you might become pregnant. This is because it may affect the baby.

Do not breast-feed if you are taking Norfloxacin. This is because small amounts may pass into the mother’s milk. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines Do not drive or use machines because Norfloxacin may adversely affect your reactivity, especially if you suffer from side effects such as dizziness, headache, fatigue or nausea. Reduced reactivity may occur to a greater degree at the start of treatment,

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when the dose is increased, when switching medication and in conjunction with alcohol.

You may experience a sudden, transient loss of vision, or you might faint for a short period. If you are affected in this way do not drive or operate machinery.

Therefore, make sure you know how you react to [nationally completed name] before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

It is not necessary to adjust the dose.

3. How you will be given Norfloxacin

If you forget to take Norfloxacin If you forget to take a tablet, skip the missed dose. Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

Always take Norfloxacin exactly as your doctor told you. Check with your doctor or pharmacist if you are not sure.

Drink sufficient amounts during the treatment in order to prevent crystallisation of norfloxacin in the urine.

Taking this medicine Take at least one hour before or two hours after food, milk or multivitamins. Swallow the tablets whole with a full glass of water in the morning and in the evening. If you have only one tablet per day this should always be taken at the same time of day.

The recommended dose is  for less serious infections - one tablet twice a day for 3 days  for more serious infection - one tablet twice a day for 7 to 10 days  for severe infections one tablet twice a day for 2 to 3 weeks The dose depends on your illness and how bad it is.

People with kidney disease: It can be necessary to adjust the dose.

Elderly:

Children: This medicine is not recommended for children and growing adolescents.

If you take more Norfloxacin than you should If you take more Norfloxacin than you should, talk to your doctor straight away.

If you stop taking Norfloxacin Keep taking these tablets until the course is finished. Keep taking them, even if you start to feel better after a few days.

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

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

Serious side effects If any of the following happens, stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital: Uncommon: may affect up to 1 in 100 people  fits (convulsions)

 severe pain in the abdomen and back (signs of inflamed pancreas) Rare serious side effects: may affect up to 1 in 1,000 people  inflammation of the bowels, called colitis (or antibiotic-associated colitis), causing severe longlasting watery diarrhoea with stomach cramps and fever.  allergic reaction – the signs may include swelling of your face, lips, tongue and throat (This may make it difficult to breathe or swallow),  a serious skin reaction that causes blisters and bleeding called ‘Stevens-Johnson’ syndrome  yellowing of the skin and eyes, unusual tiredness or fever, dark coloured urine (signs of inflamed liver and liver damage)  kidney disorder Very rare serious side effects: may affect up to 1 in 10,000 people  low white blood cells which may cause frequent infections, fever, severe chills, sore throat or mouth Not known: frequency cannot be estimated from the available data  Abnormal fast heart rhythm, lifethreatening irregular heart rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)  purple skin patches, itching, burning  transient loss of vision Other possible side effects: Tell your doctor if any of the following side effects bother you:

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Common: may affect up to 1 in 10 people  changes in blood tests that check for liver problems  feeling sick (nausea)  abnormal kidney function test results Uncommon: may affect up to 1 in 100 people  low or high levels of a specific type of white blood cells  short of breath, labored breathing  bleed for a long time after a cut or bruise very easily  tiredness, insomnia, not sleeping very well  mood swings, depression, feeling nervous (anxiety)  pins and needles  headache, dizziness, lightheadedness, drowsiness  bitter, weird or funny taste  stomach pain and cramps  heartburn, dry mouth, flatulence, stomach discomfort after meal, constipation  loss of appetite, vomiting  changes in your eyesight, overflow of tears  rash, itching  thrush (vaginal) Rare: may affect up to 1 in 1,000 people  rupture of the Achilles’ tendon  being pale and tired. This may be due to anaemia especially in patients with something called ‘glucose-6-phosphate dehydrogenase deficiency’ due to a red cell loss  swelling mainly of the face and throat  feeling restless (irritability), feeling disorientated, confusion, loss of contact

with reality (psychosis), problems of behavior and personality , seeing things that are not really there (hallucination)  uncontrolled shaking  an illness called ‘Gullain-Barré’ syndrome.

This makes you weak and can make it difficult to breath.  making worse the illness called ‘myasthenia gravis’ (this illness causes muscle weakness)  ringing in the ears  severe upper stomach pain due to inflamed pancreas  red or purple, flat, pinhead spots under the skin; red blisters and papules; dermatitis; skin reactions to sunlight  pain and swelling of joints and muscles Very rare: may affect up to 1 in 10,000 people  loss of hearing  pain and swelling of tendons, often around your ankles. This is more common if you are an older person, or are taking steroid medicines such as prednisolone, dexamethasone or hydrocortisone. Try to rest the painful areas until a doctor is seen.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

By reporting side effects you can help provide more information on the safety of this medicine.

date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

No special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Further information What Norfloxacin contains - The active substances is norfloxacin. Each film-coated tablet contains 400 mg norfloxacin.

- The other ingredients are: Tablet core Povidone, sodium starch glycolate (type A), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, purified water Coating: hypromellose, talc, titanium dioxide (E 171), propylene glycol What Norfloxacin looks like and contents of the pack Round, slightly biconvex, white film-coated tablet with one side scored.

Al/PVC/PVDC-blister: 6, 10, 14, 20 and 50 film-coated tablets Not all pack sizes may be marketed.

5. How Norfloxacin is stored Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry

Manufactured in India by:

Norfl oxa cin 40 0 mg fil m-coate d tablet Taj Phar ma : Use s, Side Effe cts, Interacti ons, Pi ctures, Warnings , Nor floxacin D osage & Rx I nfo | Nor floxa cin U ses, Side E ffe cts , N orfloxaci n 400 mg fil m-coated ta blet: Indi cations, Side Effects , Warning s, Nor floxaci n - Drug Infor mation - Taj Phar ma, N orfloxaci n dose Taj pharma ceutical s Nor floxacin intera ctions , Taj Phar mace utical Nor floxaci n contraindications, N orfl oxa cin pri ce, Nor floxaci n , Taj Pharma Nor floxa cin 4 00 mg film-coated tablet - Taj P harma . Stay conne cted to all updated on N orfloxaci n Taj Phar mace uticals Taj pharma ceuti cals Hyderaba d. P atient Infor mation Leaflet s, PIL.

TAJ PHARMACEUTICALS LTD. Mumbai, India At: 615, GIDC, Kerala, Bavla, Dist.

Ahmedabad 438225, Gujarat, INDIA This leaflet was last revised in August 2019