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NITROFURANTOIN 50 mg AND 100 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

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. 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 Nitrofurantoin is and what it is used for

2.    Before you take Nitrofurantoin

3.    How to take Nitrofurantoin

4.    Possible side effects

5.    How to store Nitrofurantoin

6.    Further information

OWHAT NITROFURANTOIN IS AND WHAT IT IS USED FOR

Nitrofurantoin is a broad-spectrum antibacterial agent.

Nitrofurantoin is used to treat and prevent many types of bacteria associated with infections in the urinary tract. Examples of these infections are cystitis, pyelitis, and infections of the genito-urinary tract that may occur after an operation.

BEFORE YOU TAKE NITROFURANTOIN

DO NOT take Nitrofurantoin if you:

•    are allergic (hypersensitive) to nitrofurantoin (or other nitrofurans) or any of the other ingredients of this medicine

•    have kidney problems

•    are giving birth

•    are suffering from porphyria, which is a deficiency of certain enzymes in the body

•    have glucose-6-phosphate dehydrogenase deficiency (an inherited failure to metabolise glucose)

•    Nitrofurantoin should not be given to infants under three months old.

Take special care with Nitrofurantoin

Talk to your doctor before you start to take this

medicine if you:

•    have diabetes

•    have anaemia (a reduction in red blood cells which can make the skin pale and cause weakness or breathlessness)

•    have an imbalance of salts in the body

•    have vitamin B or folate deficiency

•    have peripheral neuropathy (damage to the nerves)

•    have lung problems

•    have liver problems

•    have allergies

•    have any neurological disorders (disorders of the nervous system)

•    have any serious illness

•    are elderly

•    are breast-feeding.

Nitrofurantoin may interfere with some tests for glucose (sugar) in the urine. Make sure you have told the doctor you are taking this medicine if you have a urine test.

Your doctor may want to monitor you if you are being treated for a long time with Nitrofurantoin.

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.

It is especially important that you tell your doctor if you are taking any of the following:

•    any medicines that delay stomach emptying, some examples of these include

•    narcotic pain relievers (e.g. morphine phosphate, codeine phosphate)

•    anticholinergic/antimuscarinic medicines (e.g. oxybutynin, tolterodine)

•    tricyclic antidepressants (e.g. amitriptyline, clomipramine)

•    calcium channel blockers (e.g. verapamil, nifedipine)

•    proton pump inhibitors (e.g. omeprazole, lansoprazole)

•    probenecid or sulphinpyrazone, used for the treatment of gout

•    carbonic anhydrase inhibitors e.g. acetazolamide, used to treat high fluid pressure in the eye

•    antacids containing magnesium trisilicate

•    medicines which make the urine less acidic e.g. potassium citrate mixture, used for relief of discomfort in mild urinary-tract infections

•    medicines used in the treatment of infections (antibiotics) known as quinolones.

Important information about some of the ingredients of Nitrofurantoin

•    Patients who are intolerant to lactose should note that Nitrofurantoin tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, talkto your doctor before taking this medicine.

Taking Nitrofurantoin with food and drink

•    Certain types of food may cause higher levels of Nitrofurantoin in the blood because they delay stomach emptying. Examples of types of food which may have this effect are:

•    foods with a high fat content

•    foods high in soluble fibre such as oats, pulses (e.g. beans and lentils), and some raw fruits and vegetables.

Ask your doctor for advice about this.

Pregnancy and breast-feeding

•    Do not take Nitrofurantoin while you are giving birth.

•    If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor for advice before taking this medicine.

Driving and using machines

Nitrofurantoin is not expected to affect your ability to drive or operate machinery.

Q HOW TO TAKE NITROFURANTOIN

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

It is important to complete the course of tablets to prevent the infection returning, unless your doctor advises otherwise.

The tablets are best taken with food and should be swallowed preferably with a drink of water. Taking Nitrofurantoin with food or milk may help to reduce any stomach problems you may experience.The usual dose is:

Adults (including the elderly)

•    For treatment of infections:

Either 50 mg or 100 mg four times a day for seven days.

•    For prevention of further infections:

Either 50 mg or 100 mg once a day.

•    For prevention of infections during surgical procedures:

A 50 mg tablet four times a day on the day of the procedure and three days thereafter.

Children and infants over 3 months old

The daily dosage depends on the weight of the child. Your doctor will calculate the appropriate dose. Follow your doctor's instructions exactly.

For children under 25 kg body weight, your doctor may consider giving Nitrofurantoin as a suspension.

Infants under 3 months old

Nitrofurantoin should not be given to infants under three months old.

If you take more Nitrofurantoin than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause stomach problems, feeling sick and being sick. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Nitrofurantoin

If you forget to take a tablet, take one as soon as you remember, unless it is more than two hours after the missed dose; if so, ignore the missed dose and wait until it is time to take the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Nitrofurantoin

Do not stop taking your medicine without talking to your doctor first even if you feel better. It is important to complete the course of tablets, unless your doctor advises otherwise.

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

Q POSSIBLE SIDE EFFECTS

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

Serious side effects may occur, but they are rare. They generally occur in the elderly, or in those who have received continuous therapy for long periods (six months or longer).

It is expected that many of these reactions will get better on stopping treatment, however, some of these serious side effects may persist, even after stopping the treatment.

Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if any of the following happen:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash, itching or hives)

•    flaking skin or a severe rash with blistering. These are very serious but rare side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately if any of the following happen:

•    lung problems causing shortness of breath, fever, chills, chest pain and cough and rarely, collapse or blue discolouration of skin.There may also be changes to your ECG if you are having this measured.

•    asthma attacks, symptoms may include coughing, shortness of breath, chest tightness, or wheezing

•    collapse

•    blue discolouration of skin

•    inflammation of the liver causing jaundice (yellowing of the skin and whites of the eyes) which has sometimes lead to death

•    effects on the nerves that supply the eyes or limbs, infrequently causing loss of feeling or control of movement of a limb or blurred vision

•    loss of balance, headache, drowsiness, dizziness, vertigo, weakness, depression, increased feeling of wellbeing, confusion or other mental disturbances

•    anaemia, symptoms may include paleness of the skin, tiredness, lethargy, feeling faint, becoming easily breathless

•    sore throat, fever, skin bruising or more prone to colds, which may be signs of other effects on the blood.

If you experience any of these effects, your doctor will stop your treatment immediately.

The following side effects have also been reported:

•    muscle and joint pain

•    severe abdominal pain (due to inflammation of the pancreas)

•    facial pain (due to the inflammation of the salivary glands)

•    feeling sick, being sick, loss of appetite, diarrhoea, stomach pain

•    short-term hair loss

•    raised pressure in the skull, symptoms may include severe headache which is not relieved by anything, vision disturbance, disorientation, loss of memory or concentration, being sick, dizziness and pins and needles in the hands

•    increased risk of urinary infection by germs which are not affected by Nitrofurantoin. Symptoms of these infections may include a burning sensation on passing urine, needing to pass urine more frequently than usual or having the sensation of needing to pass urine but being unable to do so, or having cloudy foul smelling urine.

Your urine may become coloured dark yellow or brown; this is normal and is not a reason to stop taking the medicine.

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.

Q HOWTO STORE NITROFURANTOIN

Keep out of the reach and sight of children.

Do not store above 25°C. Protect the tablets from light. Store in the original package.

Do not use Nitrofurantoin after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month. 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.

Q FURTHER INFORMATION

What Nitrofurantoin tablets contain:

•    The active ingredient is nitrofurantoin.

•    The other ingredients are maize starch, lactose, alginic acid and magnesium stearate (E572).

What Nitrofurantoin tablets look like and contents of the pack:

•    The 50 mg tablets are yellow, round, flat, bevel-edged tablets.They are engraved '7N2' on one side and a score line on the reverse.

•    The 100 mg tablets are yellow, round, flat, bevel-edged tablets.They are engraved '7N3' on one side and a score line on the reverse.

•    The product is available in pack sizes of 28, 50, 100, 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture isTEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: November 2009

PL 00289/0769-70

TTWTI