Nitrofurantoin 25mg/5ml Oral Suspension

• 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 4.

This product will be referred to as Nitrofurantoin Oral Suspension for ease hereafter.

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

• if you are allergic to Nitrofurantoin monohydrate , other nitrofurans or to 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 suffer from a blood disorder called porphyria
• if you are deficient in an enzyme called G6PD (glucose-6-phosphate dehydrogenase)
• if your child is under three months of age.

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

Talk to your doctor or pharmacist or nurse before taking Nitrofurantoin Oral Suspension:

• 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
• if you have disease of the lungs
  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.

The above conditions may increase the chance of developing a side effect which results in damage to the nerves, causes altered sense of feeling 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 Oral Suspension for a number of months, your doctor may want to regularly check how your lungs and liver are working.
• as this medicine may interfere with urine tests for glucose, causing the test to give a “false positive” result. That is, the test may say that glucose is present in the urine even if it is not. This medicine may also cause your urine to turn yellow or brown.
• 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.

If they are taken with Nitrofurantoin Oral Suspension their effect or the effect of Nitrofurantoin Oral Suspension 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)
• Typhoid vaccine
• 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.

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

Nitrofurantoin Oral Suspension should always be taken with food or milk. Taking this medicine with food or milk makes it work more effectively. This will help to avoid stomach upset and also to help the absorption.

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

• Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
• Less than 1mmol sodium (23mg) per dose, that is to say essentially ‘sodium- free’.

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

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.

• Your lungs may react to Nitrofurantoin Oral Suspension. 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 associated with pneumonia. Scaring due to damaged lung tissue may occur
• 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 fatigue, abdominal pain, joint pain and swelling. These could be signs of a condition known as hepatitis. In rare cases, it may cause liver failure which may be fatal.

Please note that while taking Nitrofurantoin Oral Suspension 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)
• Damage to bone marrow causing deficiency of the red blood cells (Anaemia)

Not known: frequency cannot be estimated from the available data

• Feeling sick (nausea) and headache.
• Diarrhoea
• 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, 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 Oral Suspension.
• 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 monohydrate . Each 5 mL contains 25 mg of nitrofurantoin monohydrate

The other ingredients are glycerol(E422), polysorbate 20, carbomer, saccharin sodium, methylhydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide, Lemon Essence F31874 ,Apricot Flavour F31191 and purified water.

Nitrofurantoin Oral Suspension is an opaque yellow liquid with a lemon/apricot characteristic odour.

This medicine is supplied in 300ml amber glass bottles.