PACKAGE LEAFLET: INFORMATION FOR THE USER

Norfloxacin 400 mg Tablets

What is in this leaflet:

1.    What Norfloxacin 400 mg is and what it is used for

2.    What you need to know before you take Norfloxacin 400 mg

3.    How to take Norfloxacin 400 mg

4.    Possible side effects

5.    How to store Norfloxacin 400 mg

6.    Contents of the pack and other information

1.    What Norfloxacin 400 mg is and what it is used for

Norfloxacin the active ingredient contained in Norfloxacin 400 mg belongs to a group of antibiotics called quinolones which work by killing bacteria that cause infections.

This medicine is indicated for the treatment of bacterial infections of the urinary tract e. g. cystitis, pyelitis and chronic prostatitis.

2.    What you need to know before you take Norfloxacin 400 mg Do not take this medicine

•    if you are allergic to norfloxacin, other quinolone antibiotics or any of this medicine (listed

in section 6)

•    if you are pregnant or think you could be pregnant

•    if you have had pain, inflammation or rupture of tendons after taking quinolone antibiotics (see “Take special care with this medicine” and “4. Possible side effects”)

•    if you have not reached puberty or are a teenager who is still growing

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Norfloxacin 400 mg

•    if you have a history of convulsions (symptoms include body twitching, jerking limbs, fits), or a disorder that increases the risk of having convulsions

•    if you suffer from psychiatric disorders, hallucinations and/or confusion

•    if you suffer from a condition called myasthenia gravis (an auto-immune disease) which causes muscle weakness

•    if you or any member of your family suffers from a deficiency disorder where patients become anaemic after taking certain drugs (glucose-6-phosphate dehydrogenase, G-6-PD deficiency) (symptoms of anaemia include paleness and tiredness)

•    If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately

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 Taking other medicines).

Pain, inflammation or rupture of tendons, particularly around the ankles may occur with this class of antibiotics, especially if you are older or if you are taking corticosteroids at the same time. If you experience tendon pain or signs of inflammation of the Achilles tendon stop taking your medicine and contact your doctor and rest the affected limb.

Providing you do not have a problem with your heart or kidneys, you should drink plenty of liquid whilst taking this medicine. This medicine may cause a problem with your kidneys called “crystalluria” which results in tiny crystals forming in the urine. These crystals cannot be seen by the naked eye. Drinking plenty of liquid can help prevent this occurring.

You should avoid excessive sunlight while taking this medicine as the drug may make your skin more sensitive to sunlight or UV light.

If you develop severe and persistent diarrhoea whilst you are taking your tablets or after stopping your tablets you should consult your doctor.

You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness. If this happens, stop taking Norfloxacin tablets and contact your doctor immediately.

Patients with kidney problems

If you suffer from severe renal impairment your doctor may prescribe you a lower dosage of this medicine.

Other medicines and Norfloxacin 400 mg

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

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.

There are some other medicines which may interfere with this medicine, particularly:

•    nitrofurantoin, a medicine used in the treatment of infections

•    probenecid, a medicine used in the treatment of gout and gouty arthritis

•    theophylline, found in certain medicines used to treat asthma and some cough/decongestant medicines

•    caffeine-containing medications (e.g. certain analgesics)

•    ciclosporin, a medicine used to dampen the body’s immune response

•    warfarin or other blood-thinning medicines

•    multivitamins or products containing iron, magnesium, calcium or zinc

•    antacids or sucralfate

•    fenbufen, a medicine for rheumatism

•    clozapine - used to treat schizophrenia

•    ropinirole - used to treat Parkinson’s disease

•    tizanadine -used to treat muscle spasms

•    glibenclamide - used for diabetes

•    Non-steroidal anti-inflammatory drugs ( NSAIDS)- used for pain and other illnesses

Norfloxacin 400 mg with food ,drink and alcohol

Take your medicine at least one hour before or two hours after a meal or milk products such as yoghurt.

Multivitamins, products containing iron or zinc, antacids or sucralfate should not be taken at the same time as this medicine. This medicine should be taken either 2 hours before or at least 4 hours after such products.

Pregnancy, breast-feeding and fertility

If you are pregnant, planning a family or breast-feeding, tell your doctor before taking this medicine, as it is not recommended for use under these conditions.

Driving and using machines

Your reactivity may be altered so that your ability to drive or operate machinery is impaired, especially at the start of treatment, on increasing the dosage or when switching medication and in conjunction with alcohol.

3. How to take Norfloxacin 400 mg

Always take your medicine exactly as your doctor or Pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose in adults is 1 film-coated tablet (400 mg norfloxacin) twice daily.

Dosage in patients with kidney problems

If you suffer from severe renal impairment, your doctor may adjust your dosage. The recommended dose is 1 film-coated tablet (400 mg norfloxacin) once daily.

Swallow the tablets with a glass of water at least one hour before or two hours after a meal or drink of milk.

Preferably the tablets should be taken in the morning and evening.

If you only take a single daily dose, always take this at the same time of day.

The duration of treatment depends on the type and severity of infection. For women with acute, uncomplicated inflammation of the bladder, the usual duration of treatment is a 3 day course of this medicine with the recommended dose.

In the treatment of urinary tract infections, adults will generally need to use this medicine for 7-10 days.

In chronic inflammation of the prostate the usual duration of treatment is 4 weeks.

The symptoms of urinary tract infection, such as a burning sensation experienced during passing water, pain, and fever, will generally disappear within 1-2 days. However, the treatment course with this medicine should be continued for up to 12 weeks in chronic relapsing urinary tract infections. If the infection is adequately controlled within the first 4 weeks of treatment, the dose may be reduced to 400 mg norfloxacin (1 film-coated tablet) daily.

If you take more Norfloxacin 400 mg than you should

If you have taken a double dose, you only need to contact your doctor if side effects occur. Continue taking your medicine regularly as prescribed.

If you have taken more than a double dose by mistake, contact your doctor immediately.

If you forget to take Norfloxacin 400 mg

Do not take a double dose to make up for a forgotten tablet, just carry on with the next one as normal.

If you stop taking Norfloxacin 400 mg

It is important that you complete the course of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

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

4. Possible side effects

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

If you experience any of the following rare symptoms or side effects, stop the treatment and seek medical advice immediately:

•    An allergic reaction soon after you start taking the tablets - including:

swelling of the face, lips, tongue and/or throat (with difficulty in breathing or swallowing), itching, nettle rash, and severe skin reactions causing blisters and bleeding (exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome). Allergic reactions can, very rarely, be life-threatening.

•    Inflammation of the membrane that lines a joint capsule and very rarely rupture of the tendon e.g. Achilles tendon. If you experience tendon pain or signs of inflammation of the Achilles tendon, stop taking this medicine, seek medical advice immediately and rest the affected limb (see “Take special care with this medicine”).

Inflammation of the liver with jaundice (yellowing of the skin or whites of the eyes) commonly occurs. Stop treatment and contact your doctor if you experience signs and symptoms of liver problems such as loss of appetite, jaundice, dark urine, itching or sensitivity to pressure in the abdominal cavity.

If you develop the rare side effect of severe and persistent diarrhoea whilst you are taking your tablets or after stopping your tablets you should consult your doctor.

In rare cases seizures occur. If fits occur, stop taking this medicine.

Other possible side effects:

Common, (may affect upto 1 in 10 people):

•    Breakdown of the the muscle tissue with muscle pain, weakness (rhabdomyolysis) Uncommon, (may affect up to 1 in 100people):

•    Reduced number of white blood cells “leucocytes“ [leucopenia] or “neutrophiles” [neutropenia], increased number of certain white blood cells “eosinophiles” [eosinophilia], which may cause sore throat and mouth, increased frequency of infections

•    Reduced number of blood platelets [thrombocytopenia], reduced volume of the red blood cells in the blood [hematocrit], reduced blood clotting ability, which may cause prolonged bleeding after injury

•    Headache, dizziness and drowsiness

•    Abdominal pain and cramps, heartburn, diarrhoea and sickness

•    Increased liver enzymes

•    Rash

•    Effects on the kidney which cause pain and discomfort when passing water (crystalluria) Rare (may affect up to 1 in 1,000people)

•    Skin reactions to sunlight (see “Take special care with this medicine”)

•    Anaemia (paleness and tiredness), sometimes associated with Glucose-6-phosphate-dehydrogenase deficiency, due to a red cell loss

•    Tiredness, changes of mood, a tingling sensation, sleeplessness, sleep disturbances, depression, feeling of anxiety, restlessness, irritability, exaggerated sense of well being, disorientation, hallucinations, confusion

•    Disorders of the nerves including Guillain-Barre syndrome, psychic disturbances and psychotic reactions

•    Worsening of a condition called myasthenia gravis which causes muscle weakness (see “Take special care with this medicine”)

•    Visual disturbance, increased production of tears

•    Ringing in the ears

•    Bleeding into the skin with inflammation of blood vessels

•    Vomiting (being sick), loss of appetite, inflammation of the pancreas (symptoms include abdominal pain, fever, being sick)

•    Muscle and/or joint pains, inflammation of the joints

•    Inflammation of the kidneys (symptoms may include blood in the urine, decreased urine)

•    Vaginal thrush (itching, soreness or burning of the vagina)

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

Heart problems

•Abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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

5.    How to store Norfloxacin 400 mg

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

Do not use this medicine after the expiry date which is stated on the label and the carton.

The expiry date refers to the last day of that month.

Store in the original package.

Keep the blister in the outer carton.

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.    Contents of the pack and other information What Norfloxacin 400 mg contains

These tablets contain 400 mg norfloxacin as the active substance.

The other ingredients are povidone, sodium starch glycolate, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate, purified water, hypromellose, talc, titanium dioxide, propylene glycol.

What Norfloxacin 400 mg looks like and contents of the pack

Round, white film-coated tablets.

This medicine is available in blister packs of 6, 10, 14, 20 and 50 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Ratiopharm GmbH, Graf-Arco-Str.3, D-89079 Ulm, Germany. www.ratiopharm.de

Manufacturer:

Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren.

This leaflet was last revised in. January 2016 PL 15773/0002