Nitrofurantoin 100 mg Tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section

1. What Nitrofurantoin Tablets are and what they are used for
2. What you need to know before you take Nitrofurantoin Tablets
3. How to take Nitrofurantoin Tablets
4. Possible side effects
5. How to store Nitrofurantoin Tablets
6. Contents of the pack and other information

• if you are allergic to Nitrofurantoin, other medicines containing nitrofurantoin or any of the other ingredients of this medicine (listed in Section 6)
• if you have a disease of the kidneys which is severely affecting the way they work (ask your doctor if you are not sure)
• if you are in the final stages of pregnancy (labour or delivery) as there is a risk that it might affect the baby
• if you have porphyria (blood disorder)
• if you are a patient with G6PD (glucose-6-phosphate dehydrogenase) deficiency
• if your child is under three months of age
• if you are breast-feeding a baby with suspected or known deficiency in an enzyme called G6PD (glucose-6-phosphate dehydrogenase).

Tell your doctor if you are not sure about any of the above.

Talk to your doctor, pharmacist or nurse before taking Nitrofurantoin Tablets:

• if you have diabetes
• if you are suffering from any illness causing severe weakness
• if you have anaemia (a decrease in red blood cells causing pale skin, weakness and breathlessness) or a lack of vitamin B or abnormal levels of salts in your blood (your doctor will be able to advise you)
• if you have a history of allergic reactions
• if you have any problems with your kidneys.

The above conditions may increase the chance of developing a side effect which results in damage to the nerves, causes altered sense of feeling, like pins and needles.

• if you lack an enzyme (body chemical) called glucose-6-phosphate dehydrogenase, which causes your red blood cells to be more easily damaged (this is more common in black people and people of Mediterranean, Middle Eastern or Asian origin. Your doctor will know)
• if you have any disease of the lungs, liver or nervous system. If you need to take Nitrofurantoin Tablets for a number of months, your doctor may want to regularly check how your lungs and liver are working

This medicine can also cause lung disease in patients with no previous medical history affecting their lungs. Lung disease can occur in patients on short-term or long-term treatment. Talk to your doctor if you experience trouble breathing, shortness of breath, a lingering cough, coughing up blood or mucus, or pain or discomfort when breathing. These may be symptoms of side effects affecting the lungs.

• if you have false positive results on testing your urine for glucose
• if your urine is dark yellow or brown coloured.
• if you experience fatigue, yellowing of the skin or eyes, itching, skin rashes, joint pain, abdominal discomfort, nausea, vomiting, loss of appetite, dark urine, and pale or gray-colored stools. It may be symptoms of liver disorder.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

If they are taken with Nitrofurantoin Tablets their effect or the effect of Nitrofurantoin Tablets may be changed.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• Antacids for indigestion (e.g. magnesium trisilicate)
• Medicines for gout (e.g. probenecid or sulfinpyrazone)
• Medicines which slow the passage of food through the stomach (e.g. atropine, hyoscine)
• Medicines for raised pressure in the eye (glaucoma), such as carbonic anhydrase inhibitors (e.g. acetazolamide)
• Medicines which make the urine less acidic (e.g. potassium citrate mixture)
• Medicines for infections, known as quinolones
• Typhoid vaccine, which is given for the prevention of typhoid.

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

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

Nitrofurantoin Tablets should always be taken with food or milk. Taking this medicine with food or milk makes it work more effectively.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

As far as is known, Nitrofurantoin Tablets may be used in pregnancy. However, it should not be used during labour or delivery because there is a possibility that use at this stage may affect the baby. If you want to breast-feed, please consult your doctor first.

Nitrofurantoin Tablets may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.

This medicine contains lactose (sugars). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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

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

Tablets should be swallowed whole. The score line is not intended for breaking the tablet.

Nitrofurantoin Tablets should always be taken with food or milk. Taking this medicine with food or milk makes it work more effectively.

Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left-over tablets with you, as well as the container and label, so that the medical staff knows what you have taken. You may experience symptoms of stomach ache, nausea and vomiting.

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 on the next day. Do not take a double dose to make up for a forgotten dose. If you are not sure ask your doctor or pharmacist.

Your doctor will tell you how long to take the treatment. Do not stop earlier than you are told, even if you feel better.

• Problems with your lungs. This can happen quickly, within one week after the start of treatment, or very slowly, especially in the elderly and can lead to fever, shivering, coughing and shortness of breath associated with pneumonia and/or tissue damage.
• Jaundice (inflammation of the liver causing 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, blurred vision may occur. These effects may be severe and in some instances permanent
• Raised pressure in the skull (causing severe headaches)
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely
• Blue or purple coloration of the skin due to low oxygen levels. A condition known as cyanosis
• Symptoms of fever, flu, abdominal pain, diarrhea, blood in your stool and weakness. These could be signs of a condition known as cutaneous vasculitis
• Symptoms of jaundice, fatigue, abdominal pain, joint pain and swelling. These could be signs of a condition known as autoimmune hepatitis.

Please note that while taking Nitrofurantoin Tablets your urine may become dark yellow or brown coloured. This is quite normal and not a reason to stop taking the medicine.

Rare (may affect up to 1 in 1,000 people)

• Loss of consciousness (collapse)

Not known (frequency cannot be estimated from the available data)

• Feeling sick (nausea) and headache
• Loose stools
• Loss of appetite, stomach ache, and being sick (vomiting)
• Diarrhea
• Dizziness, drowsiness
• Blood cells have been affected in some patients. This may result in bruising, delayed clotting of the blood, sore throat, fever, anaemia, and a 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 severe rash with blistering.

Other reactions may include inflammation of salivary glands (causing facial pains), inflammation of the pancreas gland (causing severe abdominal pain) and joint pains

• Short-term hair loss
• Urinary infection by germs which are not sensitive to Nitrofurantoin Tablets.
• Inflammation of small blood vessel walls, causing skin lesions
• Liver inflammation due to turn of immune system against liver cells
• Inflammation of kidney tissue surrounding tubules, causing renal impairment

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the MHRA yellow card scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is Nitrofurantoin. Nitrofurantoin Tablets are available in two strengths, containing either 50 mg or 100 mg Nitrofurantoin.

Nitrofurantoin Tablets are available in PVC – Aluminium blisters containing 20, 28, 30, 50 or 100 tablets.

The other ingredients are maize starch, lactose monohydrate, magnesium stearate and polyvidone

50 mg Tablet

Yellow, round, biconvex tablets with a single score line on one side, approximately 8.0 mm ± 0.2 mm in diameter.

The score line is not intended for breaking the tablet.

100 mg Tablet

Yellow, round, biplane with bevelled edge tablets with a single score line on one side and debossed “I” on the other side, approximately 10.0 mm ± 0.2 mm in diameter.

The score line is not intended for breaking the tablet.