UTINOR 400MG TABLETS

Active substance: NORFLOXACIN

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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.

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 Parkinson’s 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 mother’s 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.

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 3 days
• 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 12 weeks.

XXXXX/XXXXXX-X

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

For Position Only

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 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-Barré’ 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 25°C, 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 400 mg 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 EN11 9BU, UK
PIL.NRX.11.UK.3390
9829

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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