Norfloxacin-Ratiopharm 400 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Norfloxacin-ratiopharm® 400 mg tablets Norfloxacin
Read all of this leaflet carefully before you start taking this medicine.
- 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 you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Norfloxacin-ratiopharm® 400 mg is and what it is used for
2. What you need to know before you take Norfloxacin-ratiopharm® 400 mg
3. How to take Norfloxacin-ratiopharm® 400 mg
4. Possible side effects
5. How to store Norfloxacin-ratiopharm® 400 mg
6. Contents of the pack and other information 1. WHAT Norfloxacin-ratiopharm® 400 mg IS AND WHAT IT IS USED FOR
Norfloxacin, the active ingredient contained in Norfloxacin-ratiopharm® 400 mg, belongs to a group of antibiotics called quinolones which work by killing bacteria that cause infections.
Norfloxacin-ratiopharm® 400 mg tablets are indicated for the treatment of bacterial infections of the urinary tract e. g. cystitis, pyelitis, chronic prostatitis and uncomplicated pyelonephritis.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Norfloxacin-ratiopharm® 400 mg
Do not take Norfloxacin-ratiopharm® 400 mg
- 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 are breast-feeding
- if you have had pain, inflammation or rupture of tendons after taking quinolone antibiotics (see “Take special care with Norfloxacin-ratiopharm® 400 mg” 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 before taking Norfloxacin-ratiopharm® 400 mg
- if you have a history of convulsions, or any condition which predisposes you to have convulsions
- if you suffer from psychiatric disorders, hallucinations and/or confusion
- if you suffer from a condition called myasthenia gravis 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 deficiency, G-6-PD deficiency)
Pain or inflammation 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 Norfloxacin-ratiopharm® 400 mg, contact your doctor and rest the affected limb.
Providing you do not have a problem with your heart or kidney, 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 cause an allergic reaction to sunlight in some patients.
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-ratiopharm® 400 mg and contact your doctor 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”).
Patients with kidney problems
If you suffer from severe renal impairment your doctor may prescribe you a lower dosage of this medicine.
Vision disorders
If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.
Other medicines and Norfloxacin-ratiopharm® 400 mg
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including medicines obtained without a prescription.
There are some other medicines which may interfere with Norfloxacin-ratiopharm® 400 mg, 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
You must tell your doctor if you are taking other medicines that can alter you 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.
Taking Norfloxacin-ratiopharm® 400 mg with food and, drink
Take Norfloxacin-ratiopharm® 400 mg 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 Norfloxacin-ratiopharm® 400 mg. Norfloxacin-ratiopharm® 400 mg should be taken either 2 hours before or at least 4 hours after such products.
Pregnancy, breast-feeding and fertility
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
Your reactivity may be altered so that your ability to drive or operate 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-ratiopharm® 400 mg
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose in adults is 1 film-coated tablet (400 mg norfloxacin) twice daily.
Dosage in patients with impaired renal function:
If you suffer from severe renal impairment, your doctor may adjust your dosage according to your laboratory values. 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.
The tablets should preferably be taken in the morning and evening.
If you take only a single daily dose, do this always 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, a 3 day course of Norfloxacin-ratiopharm® 400 mg with the recommended dose has frequently proved sufficient.
In the treatment of urinary tract infections, adults will generally need to use Norfloxacin-ratiopharm® 400 mg for 7-10 days.
In case of chronic inflammation of the prostate a duration of treatment for 4 weeks has proved itself.
The symptoms of urinary tract infection, such as a burning sensation experienced during micturation, pain, and fever, will generally disappear within 1-2 days. However, the treatment course with Norfloxacin-ratiopharm® 400 mg should be continued up to 12 weeks in chronic relapsing urinary tract infections. If adequate suppression is obtained within the first 4 weeks of therapy, the dose may be reduced to 400 mg norfloxacin (1 film-coated tablet) daily.
If you take more Norfloxacin-ratiopharm® 400 mg than you should
If you have taken a double dose, it is sufficient, if you contact your doctor when side effects occur. Continue taking Norfloxacin-ratiopharm® 400 mg regularly as prescribed.
If you have taken more than a double dose by mistake, contact your doctor immediately, so that your doctor can initiate the appropriate measures.
If you forget to take Norfloxacin-ratiopharm® 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-ratiopharm® 400 ms
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 medicine, ask your doctor or pharmacist.
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 symptoms or side effects, stop the treatment and seek medical advice immediately:
Some people may be allergic to norfloxacin, the active ingredient of Norfloxacin-ratiopharm® 400 mg. Thus, allergic reactions occur rarely. Usually, if you are allergic to norfloxacin, a reaction will occur soon after you start taking the tablets. An allergic reaction may include any of the following symptoms: 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. Allergic reactions can, very rarely, be life-threatening (see “Take special care with Norfloxacin-ratiopharm® 400 mg"). Norfloxacin-ratiopharm® 400 mg may rarely cause inflammation of the tendon, 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 Norfloxacin-ratiopharm® 400 mg").
Whilst taking inflammation of the liver with jaundice 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.
Rarely the appearance of heavy diarrhoea is possible. If you develop 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, you must stop taking this medicine.
Other possible side effects:
Common ( may affect up to 1 in 10 people)
- Myolysis of the muscles with muscle pain, weakness (rhabdomyolysis, a breakdown of muscle tissue).
Uncommon (may affect up to 1 in 100 people)
- Blood disorders (reduced number of white blood cells “leucocytes" [leucopenia] or “neutrophiles” [neutropenia], increased number of certain white blood cells “eosinophiles” [eosinophilia], reduced number of blood platelets [thrombocytopenia], reduced volume of the red blood cells in the blood [hematocrit], prolongation of prothrombin time [reduced blood clotting ability]) which may cause sore throat and mouth, increased frequency of infections, 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 1,000 people)
-Skin reactions including bad reaction to sunlight (see “Take special care with Norfloxacin-ratiopharm® 400 mg”), itching and nettle rash and severe skin reactions causing blisters and bleeding (exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome), swelling of the face, lips, tongue and/or throat
- 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, and possible worsening of a condition called myasthenia gravis which causes muscle weakness (see “Take special care with Norfloxacin-ratiopharm® 400 mg”).
- Visual disturbance, increased production of tears.
- Ringing in the ears.
- Bleeding into the skin with inflammation of blood vessels.
- Vomiting, loss of appetite, inflammation of the liver and the pancreas.
- Muscle and/or joint pains, inflammation of the joints, inflammation of the tendon, inflammation of the membrane that lines a joint capsule.
- In some cases, inflammation of the Achilles tendon has been observed during treatment with a medicine of the fluoroquinolone group, including norfloxacin, which may result in a ruptured Achilles tendon. If you experience signs of inflammation of the Achilles tendon seek medical advice immediately and rest the affected limb.
- Inflammation of the kidneys
- Thrush (Vaginal)
Not known (frequency cannot be estimated from the available data)
- Allergic reactions (Hypersensitivity)
- Increased rhythm of the heart, abnormal fast heart rhythm, life threatening irregular heart rhythm, alteration of the heart rhythm (called prolongation of QT intervall, seen on ECG, electrical recording of the heart)
- Jaundice
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-ratiopharm® 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 after EXP. 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. FURTHER INFORMATION
What Norfloxacin-ratiopharm® 400 mg contains The active substance is norfloxacin.
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-ratiopharm® 400 ms looks like and contents of the pack Round, white film-coated tablets.
Norfloxacin-ratiopharm® 400 mg is available in blister packs of 2, 6, 7, 10, 14, 20, 30 and 50 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
www .ratiopharm .de
Manufacturer Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren
This leaflet was last revised in December 2015
PL 15773/0001