UTINOR 400MG TABLETS
Active substance: NORFLOXACIN
View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER
UTINOR 400 mg Tablets
(norfloxacin) Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may want to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Utinor is and what it is used for 2. Before you take Utinor 3. How to take Utinor 4. Possible side effects 5. How to store Utinor 6. Further information
1.What Utinor is and what it is used for
What Utinor is Utinor contains a medicine called norfloxacin. This is an antibiotic which works against a large number of bacteria. What Utinor is used for Utinor is used for infections of the urinary system. It works by killing bacteria that can cause infections of your urinary system.
2.Before you take Utinor
Do not use Utinor if: you are allergic (hypersensitive) to norfloxacin or any of the other ingredients of Utinor (listed in Section 6) you are pregnant or think you could be pregnant (see Pregnancy and breast-feeding section below) 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 Utinor if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Utinor. Take special care with Utinor Check with your doctor or pharmacist before taking your medicine if: you have ever had fits (convulsions) you have ever had an illness that causes fits, such as epilepsy 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-6-phosphate dehydrogenase deficiency (also called G-6-PD deficiency) you were born with or have a 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). If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Utinor. Diarrhoea Diarrhoea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting the treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two more months after having taken the last dose of the antibiotic. If this occurs, you should speak to your doctor as soon as possible. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Utinor can affect the way some other medicines work. Also some other medicines can affect the way Utinor works. Some medicines can reduce the amount of Utinor that gets into the body. Leave a gap of at least two hours after taking Utinor before taking any of these medicines: antacids - used for indigestion or heartburn sucralfate - used for stomach ulcers or an inflamed stomach (gastritis) didanosine - used for HIV or AIDS medicines containing 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 Utinor. It is also particularly important to tell your doctor or pharmacist if you take: theophylline - used for asthma and also found in some cough and cold medicines medicines used to thin the blood, such as warfarin fenbufen - used for joint pain Non-steroidal anti-inflammatory drugs ( NSAIDS)- used for pain and other illnesses ciclosporin - used after transplants and for some other illnesses probenecid - used for gout and arthritis caused by gout nitrofurantoin - used for water-works infection caffeine - found in some cough and cold medicines and also in some drinks for example tea, coffee and cola drinks clozapine used to treat schizophrenia ropinirole used to treat Parkinsons disease tizanadine used to treat muscle spasms glibenclamide - used for diabetes cisapride - used for indigestion, heartburn, feeling sick or being sick medicines used for mental illness called neuroleptics ( such as phenothiazine) medicines used for lots of types of illness called corticosteroids, such as prednisolone, dexamethasone and hydrocortisone. 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. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Utinor. Taking Utinor with food and drink Take Utinor with a glass of water. Take Utinor at least one hour before or two hours after food or milk. Utinor and the sun Keep out of the sun as much as possible while taking Utinor. This is because the medicine may cause an allergic reaction in some patients when they go in the sun. Pregnancy and breast-feeding Do not take Utinor 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 Utinor. This is because small amounts may pass into the mothers milk. Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding. Driving and using machines You may feel dizzy while taking Utinor. If this happens do not drive or use any tools or machines.
For Position Only
3.How to take Utinor
Always take Utinor exactly as your doctor told you. You should check with your doctor or pharmacist if you are not sure. REMEMBER, this medicine is for you. Do not share it with anyone else. It may not suit them. Taking this medicine Take at least one hour before or two hours after food or milk Swallow the tablets whole with a full glass of water. How much to take The dose depends on your illness and how bad it is. The usual dose is: for less serious infections - one tablet twice a day for 3days for more serious infection - one tablet twice a day for 7 to 10 days If the infection comes back, your treatment can be for up to 12weeks. If you take more Utinor than you should If you take more Utinor than you should, talk to your doctor straight away.
XXXXX/XXXXXX-X
If you forget to take Utinor 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.
If you stop taking Utinor 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 product, ask your doctor or pharmacist.
4.Possible side effects
Like all medicines Utinor can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Stop taking and tell your doctor straight away if you notice any of the following serious side effects, you may need urgent medical treatment. Allergic reaction the signs may include swelling of your face, lips, tongue and throat. This may make it difficult to breathe or swallow. Skin rashes with itching and lumps under the skin (nettle rash). Other side effects include: Heart and circulation 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)Changes in blood flow to some parts of your body, such as the skin, head or leg caused by inflammation of the blood vessels (vasculitis). Skin and hair a serious skin reaction that causes blisters and bleeding called Stevens-Johnson syndrome dermatitis skin reactions to sunlight Nervous system headache dizziness pins and needles diminished sensibility partial loss of sensation fits (convulsions) shaking movements (tremors) confusion an illness called Gullain-Barr syndrome. This makes you weak and can make it difficult to breath. Eyes or ears ringing in the ears hearing loss overflow of tears changes in your eyesight Infections thrush (vaginal) Stomach and gut changes in taste sickness, stomach cramps, indigestion or diarrhoea loss of appetite severe pain in your guts, high temperature, fever, diarrhoea (which may contain blood), vomiting and yellow colour to skin (all caused by inflammation of the colon, liver or pancreas) Blood low white blood cells which may cause frequent infections, fever, severe chills, sore throat or mouth increased white blood cells bleed for a long time after a cut or bruise very easily changes in blood tests that check for liver problems 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. Joints and muscles making worse the illness called myasthenia gravis (this illness causes muscle weakness). inflammation of the tendons, tendon rupture swelling of joints causing pain and stiffness swelling of the muscles causing aches or pains 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. involuntary muscle twitches Urinary poor or no kidney function high temperature or pain in your lower back or side. This may be due to inflammation of the kidneys. pain on passing urine Mental illness not sleeping very well depression feeling nervous (anxiety) feeling restless (irritability) loss of contact with reality (pychosis) feeling disorientated seeing things that are not really there (hallucination) feeling confused If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.How to store Utinor
Keep your tablets out of the reach of children. Your tablets should be kept below 25C, in a dry place out of direct sunlight. Do not put your tablets in another container, as they might get mixed up. If you have any tablets left over when your doctor tells you to stop taking them, return them to the pharmacist. Do not take them after the expiry date that is clearly marked on the pack. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.Further Information
What Utinor contains: The active ingredient in your tablets is norfloxacin. Each tablet contains 400mg of norfloxacin. The other ingredients in Utinor are Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Hydroxypropylcellulose, Hypromellose, Titanium Dioxide, Carnauba Wax. What Utinor looks like and the contents of the pack Utinor tablets are off-white oval shaped tablets marked MSD 705. Utinor Tablets are available in blister packs of 2, 6, 7 and 14 tablets, and bottles of 50. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The marketing Authorisation Holder is Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK Utinor tablets are made by Merck Manufacturing Division, Merck Sharp & Dohme (Italia) SpA, Via Emilia 21, 27100 Pavia, Italy This leaflet was last revised in September 2012 This leaflet gives you some of the most important patient information about Utinor. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information. Merck Sharp & Dohme Limited 2012. All rights reserved.
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN119BU, UK PIL.NRX.11.UK.3390
9829
UTINOR 400 mg Tablets
(norfloxacin) Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may want to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Utinor is and what it is used for 2. Before you take Utinor 3. How to take Utinor 4. Possible side effects 5. How to store Utinor 6. Further information
1.What Utinor is and what it is used for
What Utinor is Utinor contains a medicine called norfloxacin. This is an antibiotic which works against a large number of bacteria. What Utinor is used for Utinor is used for infections of the urinary system. It works by killing bacteria that can cause infections of your urinary system.
2.Before you take Utinor
Do not use Utinor if: you are allergic (hypersensitive) to norfloxacin or any of the other ingredients of Utinor (listed in Section 6) you are pregnant or think you could be pregnant (see Pregnancy and breast-feeding section below) 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 Utinor if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Utinor. Take special care with Utinor Check with your doctor or pharmacist before taking your medicine if: you have ever had fits (convulsions) you have ever had an illness that causes fits, such as epilepsy 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-6-phosphate dehydrogenase deficiency (also called G-6-PD deficiency) you were born with or have a 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). If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Utinor. Diarrhoea Diarrhoea is a common problem caused by antibiotics, which usually ends when the antibiotic is discontinued. Sometimes after starting the treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two more months after having taken the last dose of the antibiotic. If this occurs, you should speak to your doctor as soon as possible. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Utinor can affect the way some other medicines work. Also some other medicines can affect the way Utinor works. Some medicines can reduce the amount of Utinor that gets into the body. Leave a gap of at least two hours after taking Utinor before taking any of these medicines: antacids - used for indigestion or heartburn sucralfate - used for stomach ulcers or an inflamed stomach (gastritis) didanosine - used for HIV or AIDS medicines containing 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 Utinor. It is also particularly important to tell your doctor or pharmacist if you take: theophylline - used for asthma and also found in some cough and cold medicines medicines used to thin the blood, such as warfarin fenbufen - used for joint pain Non-steroidal anti-inflammatory drugs ( NSAIDS)- used for pain and other illnesses ciclosporin - used after transplants and for some other illnesses probenecid - used for gout and arthritis caused by gout nitrofurantoin - used for water-works infection caffeine - found in some cough and cold medicines and also in some drinks for example tea, coffee and cola drinks clozapine used to treat schizophrenia ropinirole used to treat Parkinsons disease tizanadine used to treat muscle spasms glibenclamide - used for diabetes cisapride - used for indigestion, heartburn, feeling sick or being sick medicines used for mental illness called neuroleptics ( such as phenothiazine) medicines used for lots of types of illness called corticosteroids, such as prednisolone, dexamethasone and hydrocortisone. 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. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Utinor. Taking Utinor with food and drink Take Utinor with a glass of water. Take Utinor at least one hour before or two hours after food or milk. Utinor and the sun Keep out of the sun as much as possible while taking Utinor. This is because the medicine may cause an allergic reaction in some patients when they go in the sun. Pregnancy and breast-feeding Do not take Utinor 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 Utinor. This is because small amounts may pass into the mothers milk. Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding. Driving and using machines You may feel dizzy while taking Utinor. If this happens do not drive or use any tools or machines.
For Position Only
3.How to take Utinor
Always take Utinor exactly as your doctor told you. You should check with your doctor or pharmacist if you are not sure. REMEMBER, this medicine is for you. Do not share it with anyone else. It may not suit them. Taking this medicine Take at least one hour before or two hours after food or milk Swallow the tablets whole with a full glass of water. How much to take The dose depends on your illness and how bad it is. The usual dose is: for less serious infections - one tablet twice a day for 3days for more serious infection - one tablet twice a day for 7 to 10 days If the infection comes back, your treatment can be for up to 12weeks. If you take more Utinor than you should If you take more Utinor than you should, talk to your doctor straight away.
XXXXX/XXXXXX-X
If you forget to take Utinor 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.
If you stop taking Utinor 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 product, ask your doctor or pharmacist.
4.Possible side effects
Like all medicines Utinor can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Stop taking and tell your doctor straight away if you notice any of the following serious side effects, you may need urgent medical treatment. Allergic reaction the signs may include swelling of your face, lips, tongue and throat. This may make it difficult to breathe or swallow. Skin rashes with itching and lumps under the skin (nettle rash). Other side effects include: Heart and circulation 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)Changes in blood flow to some parts of your body, such as the skin, head or leg caused by inflammation of the blood vessels (vasculitis). Skin and hair a serious skin reaction that causes blisters and bleeding called Stevens-Johnson syndrome dermatitis skin reactions to sunlight Nervous system headache dizziness pins and needles diminished sensibility partial loss of sensation fits (convulsions) shaking movements (tremors) confusion an illness called Gullain-Barr syndrome. This makes you weak and can make it difficult to breath. Eyes or ears ringing in the ears hearing loss overflow of tears changes in your eyesight Infections thrush (vaginal) Stomach and gut changes in taste sickness, stomach cramps, indigestion or diarrhoea loss of appetite severe pain in your guts, high temperature, fever, diarrhoea (which may contain blood), vomiting and yellow colour to skin (all caused by inflammation of the colon, liver or pancreas) Blood low white blood cells which may cause frequent infections, fever, severe chills, sore throat or mouth increased white blood cells bleed for a long time after a cut or bruise very easily changes in blood tests that check for liver problems 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. Joints and muscles making worse the illness called myasthenia gravis (this illness causes muscle weakness). inflammation of the tendons, tendon rupture swelling of joints causing pain and stiffness swelling of the muscles causing aches or pains 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. involuntary muscle twitches Urinary poor or no kidney function high temperature or pain in your lower back or side. This may be due to inflammation of the kidneys. pain on passing urine Mental illness not sleeping very well depression feeling nervous (anxiety) feeling restless (irritability) loss of contact with reality (pychosis) feeling disorientated seeing things that are not really there (hallucination) feeling confused If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5.How to store Utinor
Keep your tablets out of the reach of children. Your tablets should be kept below 25C, in a dry place out of direct sunlight. Do not put your tablets in another container, as they might get mixed up. If you have any tablets left over when your doctor tells you to stop taking them, return them to the pharmacist. Do not take them after the expiry date that is clearly marked on the pack. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6.Further Information
What Utinor contains: The active ingredient in your tablets is norfloxacin. Each tablet contains 400mg of norfloxacin. The other ingredients in Utinor are Croscarmellose Sodium, Magnesium Stearate, Microcrystalline Cellulose, Hydroxypropylcellulose, Hypromellose, Titanium Dioxide, Carnauba Wax. What Utinor looks like and the contents of the pack Utinor tablets are off-white oval shaped tablets marked MSD 705. Utinor Tablets are available in blister packs of 2, 6, 7 and 14 tablets, and bottles of 50. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer The marketing Authorisation Holder is Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, UK Utinor tablets are made by Merck Manufacturing Division, Merck Sharp & Dohme (Italia) SpA, Via Emilia 21, 27100 Pavia, Italy This leaflet was last revised in September 2012 This leaflet gives you some of the most important patient information about Utinor. If you have any questions after you have read it, ask your doctor or pharmacist, who will give you further information. Merck Sharp & Dohme Limited 2012. All rights reserved.
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN119BU, UK PIL.NRX.11.UK.3390
9829
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
