Nitrofurantoin

What Furadantin Tablets are and what they are used for

Nitrofurantoin (the active ingredient in Furadantin Tablets) is an antibiotic. In Australia, it is prescribed for certain urinary tract infections under a doctor’s guidance.

It is used to treat and help prevent lower urinary tract infections (UTIs) of the bladder caused by susceptible bacteria. Nitrofurantoin is not used for kidney infections such as pyelonephritis.

Before you take Furadantin Tablets

Do not take Furadantin Tablets and talk to your doctor if:

• you are allergic to nitrofurantoin, any of the ingredients in Furadantin Tablets, or any other medicines containing nitrofurantoin. Signs of an allergic reaction can include itching, skin redness, or trouble breathing;
• you have anuria, oliguria, or significantly reduced kidney function (ask your doctor if you are not sure);
• you have previously had cholestatic jaundice or liver problems linked to nitrofurantoin;
• you are at term (38 to 42 weeks gestation), in labour or giving birth, or labour is about to start, as there is a risk it could affect the baby. Tell your doctor if you are unsure about any of the above.

Take special care with Furadantin Tablets and speak to your doctor or pharmacist before taking the tablets if:

• you have diabetes;
• you have any illness that causes severe weakness;
• you have anaemia (a low number of red blood cells, which can cause pale skin, weakness and shortness of breath), a lack of vitamin B, or abnormal salt levels in your blood (your doctor will be able to advise you);
• you have a history of allergic reactions.

The conditions above may increase the chance of a side effect that affects the nerves and causes altered sensation or pins and needles.

• you have a deficiency of an enzyme called glucose-6-phosphate dehydrogenase, which can make your red blood cells more likely to be damaged (your doctor will know);
• you have any disease affecting the lungs, liver or nervous system. If you need to take Furadantin Tablets for several months, your doctor may want to check your lungs and liver regularly.

Taking other medicines

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

1. Antacids for indigestion that contain magnesium trisilicate;
2. Medicines for gout (for example, probenecid or sulfinpyrazone).

If you are unsure about any medicines, ask your doctor or pharmacist.

Furadantin Tablets may affect the results of some urine glucose tests (for example, Benedict's or Fehling's copper reduction tests).

Taking Furadantin Tablets with food and drink

Furadantin Tablets should be taken with food or milk, preferably at mealtimes. This may help prevent an upset stomach and may improve absorption.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine. Furadantin Tablets are not recommended at term (38 to 42 weeks gestation), during labour and delivery, or when labour is about to start. If you want to breastfeed, speak to your doctor first. Breastfeeding is not recommended for infants under 1 month of age or for infants with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Driving and using machines

Furadantin Tablets may cause dizziness and drowsiness. Do not drive or use machines if you are affected, until these symptoms have gone away.

Important information about some of the ingredients in Furadantin^® Tablets

This medicine contains lactose and sucrose (sugars). If your doctor has told you that you are intolerant to some sugars and need to avoid them, contact your doctor before taking this medicine.

How to take Furadantin Tablets

Follow your doctor's instructions exactly and complete the full course of treatment, even if you feel better. Check with your doctor or pharmacist if you are not sure. Try not to miss any doses. Swallow the tablets whole. Do not crush or chew them.

Adults

The usual dose depends on the type of infection you have, and the directions should be written on the label supplied by your pharmacist. Ask your pharmacist or doctor if the directions are not clear. The usual doses are:

• For treatment of infections: 50 mg or 100 mg four times a day for 7 days (as prescribed).
• For prevention of further infections: 50 mg or 100 mg at bedtime (as prescribed).

Children 1 month of age and older

The dose depends on the child's weight and will be decided by your doctor. Follow your doctor's instructions exactly.

Children under 1 month of age should not take Furadantin Tablets.

Medical checks

Your doctor will monitor you carefully for any effects on the liver, lungs, blood or nervous system.

Furadantin Tablets may affect the results of some urine glucose tests.

If you take more Furadantin Tablets than you should

Contact your doctor or pharmacist straight away, or go to the emergency department of your nearest hospital. Always take any leftover tablets with you, along with the container and label, so medical staff know what you have taken.

If you forget to take Furadantin Tablets

Do not worry. If you remember later the same day, take that day's dose as usual. If you miss a whole day's dose, take your normal dose the next day. Do not take a double dose to make up for a forgotten tablet. If you are not sure, ask your doctor or pharmacist.

If you stop taking Furadantin Tablets

Your doctor will tell you how long to take this medicine for. Do not stop taking it early, even if you feel better.

If you have any further questions about using this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Furadantin Tablets can cause side effects, although not everybody gets them. Most are mild and go away when you stop taking Furadantin Tablets.

All medicines can cause allergic reactions, although serious allergic reactions are rare. If you notice sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, a rash, or itching, especially over your whole body, stop taking the medicine and see a doctor straight away. If you get any of the side effects listed below, stop taking Furadantin Tablets and speak to your doctor.

Your lungs may react to Furadantin Tablets. This may happen quickly, within a week of starting treatment, or very slowly, especially in older patients. It may cause fever, chills, cough and shortness of breath.

Jaundice

Inflammation of the liver may cause yellowing of the skin or the whites of the eyes.

The nerves outside the spinal cord may be affected, causing changes in sensation and muscle use. Headache, marked changes in mood or mental state, confusion, weakness and blurred vision may also occur. These effects may be severe and, in some cases, irreversible.

Raised pressure in the skull

This may cause severe headaches.

Please note that while taking Furadantin Tablets, your urine may turn dark yellow or brown. This is normal and is not a reason to stop taking the medicine. Other side effects include:

• Feeling sick (nausea) and headache.
• Diarrhoea.
• Loss of appetite, stomach ache and being sick (vomiting).
• Dizziness, drowsiness.
• In some patients, blood cells have been affected. This may lead to bruising, delayed blood clotting, sore throat, fever, anaemia, and a tendency to catch colds or have a cold that does not go away.
• Some patients have had a range of skin rashes or reactions. These may include peeling skin, a red rash, or fever with a fast heartbeat and a severe blistering rash. Other reactions may include inflammation of the salivary glands (causing facial pain), inflammation of the pancreas (causing severe abdominal pain), and joint pain.
• Short-term hair loss.
• Urinary infection caused by germs that are not sensitive to Furadantin Tablets.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Remember

This medicine has been prescribed for you only. Only a doctor can prescribe it for you. Never give it to anyone else. It could harm them, even if their symptoms seem the same as yours.

How to store Furadantin Tablets

Keep out of the sight and reach of children.

Store at 20°C to 25°C (68°F to 77°F). Keep in the original, tightly closed, light-resistant container to protect from light and moisture.

Do not use Furadantin Tablets after the expiry date stated on the carton (EXP). 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 any medicines you no longer need. These measures help protect the environment.