Nitrofurantoin

What Furadantin Tablets are and what they are used for

Nitrofurantoin (the active substance in Furadantin Tablets) is an antibiotic.

It is used to treat and help prevent urinary tract infections (UTIs) of the lower urinary tract (bladder) caused by susceptible bacteria. Nitrofurantoin is not indicated 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 (causing itching, reddening of the skin, or difficulty breathing) to nitrofurantoin or any of the ingredients of Furadantin Tablets; or to other medicines containing nitrofurantoin;
• you have anuria, oliguria, or significant impairment of kidney function (ask your doctor if you are not sure);
• you have a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin;
• you are at term (38 to 42 weeks gestation), during labor or delivery, or when the onset of labor is imminent because there is a risk that it might affect the baby. Tell your doctor if you are not sure 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 are suffering from any illness causing severe weakness;
• you have anemia (a decrease in red blood cells causing pale skin, weakness, and breathlessness), a lack of vitamin B, or abnormal levels of salts in your blood (your doctor will be able to advise you);
• you have a history of allergic reactions.

The above conditions may increase the chance of developing a side effect that results in nerve damage, causing altered sensation and pins and needles.

• you lack an enzyme (body chemical) called glucose-6-phosphate dehydrogenase, which causes your red blood cells to be more easily damaged (your doctor will know);
• you have any disease of the lungs, liver, or nervous system. If you need to take Furadantin Tablets for a number of months, your doctor may want to regularly check how your lungs and liver are working.

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.

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

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

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

Taking Furadantin Tablets with food and drink

Furadantin Tablets should be taken at mealtimes with food or milk. This will help to avoid stomach upset 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 labor and delivery, or when the onset of labor is imminent. If you want to breastfeed, please consult your doctor first; breastfeeding is not recommended for infants less than one month of age or with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Driving and using machines

Furadantin Tablets may cause dizziness and drowsiness. Do not drive or operate machinery if you are affected until such symptoms go away.

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

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

How to take Furadantin Tablets

Follow your doctor's instructions exactly and complete the course of treatment even if you feel better. Check with your doctor or pharmacist if you are not sure. Do not forget to take your medicine. Tablets should be swallowed whole. Do not crush or chew.

Adults

The normal dosage depends on the type of infection you have, and instructions should be written on the label provided by the pharmacist. Consult your pharmacist or doctor if these instructions 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 provided by your doctor. Follow your doctor's instructions exactly.

Children younger than 1 month of age should not take Furadantin Tablets.

Medical checks

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

Furadantin Tablets may interfere with the results of some tests for glucose in the urine.

If you take more Furadantin Tablets than you should

Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any leftover tablets with you, as well as the container and label, so that the medical staff know what you have taken.

If you forget to take Furadantin Tablets

Do not worry. If you remember later on that day, take that day's dose as usual. If you miss a whole day's dose, take the 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 the treatment. Do not stop earlier than you are told, even if you feel better.

If you have any further questions on the use of 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 disappear when you stop taking Furadantin Tablets.

All medicines can cause allergic reactions, although serious allergic reactions are rare. If you notice any sudden wheeziness, difficulty breathing, swelling of the eyelids, face or lips, rash, or itching (especially affecting your whole body), stop taking your medicine and see a doctor immediately. If you experience any of the side effects detailed below, stop taking Furadantin Tablets and consult your doctor.

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

Jaundice

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

The nerves outside the spinal cord may be affected, causing changes to the sense of feeling and the use of muscles. In addition, headache, extreme changes of mood or mental state, confusion, weakness, and blurred vision may occur. These effects may be severe and, in some instances, irreversible.

Raised pressure in the skull

This may cause severe headaches.

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

• Feeling sick (nausea) and headache.
• Diarrhea.
• Loss of appetite, stomach ache, and being sick (vomiting).
• Dizziness, drowsiness.
• Blood cells have been affected in some patients. This may result in bruising, delayed clotting of the blood, sore throat, fever, anemia, and susceptibility to colds or persistent cold.
• A variety of skin rashes or reactions have occurred in some patients. These may appear as flaking skin, a red rash, or fever accompanied by rapid heart rate and a severe rash with blistering. 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 by germs that are not sensitive to Furadantin Tablets.

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

Remember

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

How to store Furadantin Tablets

Keep out of the reach and sight of children.

Store at 68°F to 77°F (20°C to 25°C). Store in the original, tight, 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 medicines no longer required. These measures will help to protect the environment.