Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Nitrofurantoin (the active substance in Nitrofurantoin Capsules) is an antibiotic.
It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.
Do not take Nitrofurantoin Capsules: • if you are allergic to nitrofurantoin, other medicines containing nitrofurantoin or to any of the 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
• 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.
Warnings and precautions Talk to your doctor or pharmacist before taking Nitrofurantoin Capsules:
• 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, causing altered sense of feeling such as 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 East 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 Capsules 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.
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.
Talk to your doctor 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.
Other medicines and Nitrofurantoin Capsules Tell your doctor or pharmacist if you are taking, have recently or might take any other medicines, including medicines obtained without a prescription.
If they are taken with Nitrofurnatoin Capsules their effect or the effect of Nitrofurantoin Capsules 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 anydrase inhibitors (e.g. acetazolamide)
• Medicines which make the urine less acidic (e.g. potassium citrate mixture)
• Medicines for infections, known as quinoloes
• 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 Capsules with food and drink Nitrofurantoin Capsules should be taken at meal times with food or milk. This will help to avoid stomach upset and also help absorption of the medicine.
Pregnancy, breast-feeding and fertility 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 Capsules 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.
Driving and using machines Nitrofurantoin Capsules may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.
Nitrofurantoin Capsules contains One 50 mg capsule contains 103.50 mg lactose.
One 100 mg capsule contains 207 mg lactose.
This should be taken into account in patients with lactose intolerance.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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 the treatment of infections: Either one 50 mg capsule or one 100 mg capsule four times a day for seven days
• For prevention of further infections: Either one 50 mg capsule or one 100 mg capsule at bedtime
• For prevention of infections during surgery: One 50 mg capsule four times a day on the day of the opeation and three days thereafter.
Use in children and infants aged over three months of age: The dose depends on the weight of the child and will be provided by your doctor. Follow your doctor instructions exactly. For children > 3 months and under 6 years of age or under 25 kg body weight, other, more suitable formulations should be used.
Children below 3 months of age should not take Nitrofurantoin Capsules.
Medical Checks: Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system.
Nitrofurantoin Capsules may interfere with results of some tests for glucose in the urine.
How to take this medicine: This medicine should be taken with food or milk. Taking this medicine with food or milk makes it work more effectively.
If you take more Nitrofurantoin Capsules you should: Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left over capsules with you, as well as the container and label, so that the medical staff know what you have taken.
If you forget to take Nitrofurantoin Capsules: 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 capsule. If you are not sure ask your doctor or pharmacist.
If you stop taking Nitrofurantoin Capsules: 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of them are mild and disappear when you stop taking Nitrofurantoin Capsules.
All medicines can cause allergic reaction although serious allergic reactions are rare. If you notice any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately.
If you experience any of the side effects detailed below stop taking Nitrofurantoin Capsules and consult your doctor. • 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.
• 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, weakness, blurred vision may occur. These effects may be severe and is 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.
• Symptoms of fever, flu, abdominal pain, diarrhoea, 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.
Other side effects include: Rare (may affect up to 1 in 1,000 people)
• Loss of consciousness (collapse)
• Blue or purple coloration of the skin due to low oxygen levels. A condition known as cyanosis.
• Severe reduction in blood cells which can cause weakness, bruising or make infections more likely. A condition known as aplastic anaemia.
Not known (frequency cannot be estimated from the available data)
• Feeling sick (nausea) and headache
• Diarrhoea
• Loss of appetite, stomachache, 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 Capsules
• 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
• Jaundice (inflammation of the liver causing yellowing of the skin or whites of the eyes).
• Confusion
• Depression
• Very happy (euphoria)
• Psychotic reactions
• Urine may become coloured dark yellow or brown coloured. This is quite normal and not a reason to stop taking the medicine.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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.
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
Do not use Nitrofurantoin Capsules after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be dispossed via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the enviroment.
What Nitrofurantoin Capsules contains The active substance is Nitrofurantoin in macrocrystalline form.
Nitrofurantoin Capsules are available in two strengths, containing either 50 mg or 100 mg nitrofurantoin.
The other ingredients are
50 mg capsules:
maize starch, lactose monohydrate, talc, titanium dioxide, yellow iron oxide, gelatin
100 mg capsules:
maize starch, lactose monohydrate, talc, titanium dioxide, yellow iron oxide, gelatin
What Nitrofurantoin Capsules looks like and contents of the pack Nitrofurantoin 50 mg capsule is hard gelatin capsule with yellow cap and white body with dimensions:
Length approximately 16 mm and diameter approximately 6 mm.
Nitrofurantoin 100 mg capsule is hard gelatin capsule with yellow cap and body with dimensions:
Length approximately 19 mm and diameter approximately 7 mm.
The capsules are available in PVC/aluminium blister packs of 30.
Marketing Authorisation Holder Glenmark Pharmaceuticals Europe Limited
Laxmi House
2-B Draycott Avenue
Kenton
Middlesex
HA3 0BU
United Kingdom
Manufacturer IASIS Pharmaceuticals Hellas ABEE
137 Filis Ave
Kamatero Attiki
13451
Greece
IASIS Pharmaceuticals Hellas S.A. – KOROPI
Archimidous Street
Koropi Attikis
19 400
Greece
This leaflet was last revised in June 2023
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Nitrofurantoin 50 mg Capsules comes as capsule containing 50mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Nitrofurantoin 50 mg Capsules is nitrofurantoin.
Medicines with the same active substance, strength and form include: Nitrofurantoin 50 mg Hard Capsules, Nitrofurantoin 50 mg capsules, Nitrofurantoin 50 mg hard capsules. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Nitrofurantoin 50 mg Capsules, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures. It is indicated in adults, children and infants over 3 months old.
Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible strains of Escherichia coli, enterococci, staphylococci, Citrobacter, Klebsiella and Enterobacter.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
Adults
Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for seven days.
Severe chronic recurrence (UTIs): 100 mg four times daily for seven days.
Long term suppression: 50-100 mg once a day.
Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.
Paediatric population
Children and Infants over three months of age
Acute Urinary Tract Infections: 3mg/kg day in four divided doses for seven days.
Suppressive - 1mg/kg, once a day.
For children under the age of 6 years or under 25 kg body weight consideration should be given to the use of nitrofurantoin oral suspension.
Elderly
Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy (see section 4.8).
Renal impairment
Nitrofurantoin is contraindicated in patients with renal dysfunction and in patients with an eGFR of less than 45 ml/minute (see sections 4.3 & 4.4).
Method of administration
For oral use
This medicine should always be taken with food or milk. Taking Nitrofurantoin with a meal improves absorption and is important for optimal efficacy.
● Hypersensitivity to the active substance, other nitrofurans or to any of the excipients listed in section 6.1.
● Patients suffering from renal dysfunction with an eGFR below 45 ml/minute.
● G6PD deficiency (see also Section 4.6).
● Acute porphyria.
● In infants under three months of age as well as pregnant patients at term (during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the newborn infant due to immature erythrocyte enzyme systems.
Hepatotoxicity
Hepatic reactions, including hepatitis, autoimmune hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury. If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken.
Pulmonary adverse reactions
Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately. Signs of pulmonary damage include difficulty and or pain when breathing, shortness of breath and coughing up blood or mucus.
Chronic pulmonary reactions
Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary conditions of patients receiving long-term therapy is warranted (especially in the elderly).
Acute pulmonary reactions
Pulmonary reactions may be acute and usually occur within the first week of treatment. Increased vigilance for respiratory symptoms in patients who have just started therapy is warranted (especially in the elderly).
Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally nonfunctioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.
Nitrofurantoin may be used with caution as short-course therapy only for the treatment of uncomplicated lower urinary tract infection in individual cases with an eGFR between 30-44 ml/min to treat resistant pathogens, when the benefits are expected to outweigh the risks.
Since pre-existing conditions may mask adverse reactions, Nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic dysfunction, neurological disorders, and allergic diathesis.
Peripheral neuropathy and susceptibility to peripheral neuropathy which may become severe or irreversible has occurred and may be life threatening.
Therefore, treatment should be stopped at the first signs of neural involvement (paraesthesia).
Nitrofurantoin should be used in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.
Patient should be monitored closely for signs of hepatitis (particularly in long term use). Urine may be coloured yellow or brown after taking Nitrofurantoin.
Patients on Nitrofurantoin are susceptible to false positive urinary glucose (if tested for reducing substances).
Nitrofurantoin should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate dehydrogenase deficiency.
Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.
Capsule contain lactose
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
1. Increased absorption with food or agents delaying gastric emptying.
2. Decreased absorption with magnesium trisilicate.
3. Decreased renal excretion of Nitrofurantoin by probenecid and sulfinpyrazone.
4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and urine alkalisation.
5. Anti-bacterial antagonism by quinolone anti-infectives.
6. Interference with some tests for glucose in urine.
7. As Nitrofurantoin belongs to the group of Antibacterials, it will have the following interactions:
●Typhoid Vaccine (oral): Antibacterials inactivate oral typhoid vaccine.
Pregnancy
Animal studies with Nitrofurantoin have shown no teratogenic effects.
Nitrofurantoin has been in extensive clinical use since 1952, and its suitability in human pregnancy has been well documented. However, as with all other drugs, the maternal side effects may adversely affect course of pregnancy. The drug should be used at the lowest dose as appropriate for a specific indication, only after careful assessment.
Nitrofurantoin is however contraindicated in infants under three months of age and in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infants' immature red cells.
Breast-feeding
Breast feeding an infant known or suspected to have an erythrocyte enzyme deficiency (including G6PD deficiency), must be temporarily avoided, since Nitrofurantoin is detected in trace amounts in breast milk.
Nitrofurantoin may cause dizziness and drowsiness and the patient should not drive or operate machinery if affected this way.
A tabulated list of undesirable effects is outlined below:
The undesirable effects are listed according to organ systems and following frequencies:
Rare (≥1/10,000 to <1/1,000)
Not known (cannot be estimated from the available data)
System organ class
Frequency
Adverse reaction
Infections and infestations
Not known
Superinfections by fungi or resistant organisms such as Pseudomonas. However, these are limited to the genitourinary tract
Blood and lymphatic system disorders
Rare
Not known
Aplastic anaemia
Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, glucose¬6- phosphatedehydrogenase deficiency anaemia, megaloblastic anaemia and eosinophilia
Immune system disorders
Not known
Allergic skin reactions, angioneurotic oedema and anaphylaxis, Cutaneous vasculitis
Psychiatric disorders
Not known
Depression, euphoria, confusion, psychotic reactions
Nervous system disorders
Not known
Peripheral neuropathy including optic neuritis (sensory as well as motor involvement), nystagmus, vertigo, dizziness, headache and drowsiness.
Benign intracranial hypertension
Cardiac
Rare
Collapse and cyanosis
Respiratory, thoracic and mediastinal disorders
Not known
Acute pulmonary reactions, Subacute pulmonary reactions*
Chronic pulmonary reactions Cough, Dyspnoea, Pulmonary fibrosis; possible association with lupus-erythematous-like syndrome.
Gastrointestinal disorders
Not known
Sialadenitis, Pancreatitis, Nausea, Anorexia, Emesis, Abdominal pain and Diarrhoea.
Hepatobiliary disorders
Not known
Cholestatic jaundice, Chronic active hepatitis**, Hepatic necrosis, Autoimmune hepatitis
Skin and subcutaneous tissue disorders
Not known
Transient alopecia Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson Syndrome), maculopapular, erythematous or eczematous eruptions, urticaria, rash, and pruritus. Lupus-like syndrome associated with pulmonary reaction.
Drug Rash With Eosinophilia And Systemic Symptoms (DRESS syndrome), cutaneous vasculitis
Renal and urinary disorders
Not known
Yellow or brown discolouration of urine, Interstitial nephritis
General disorders and administration site conditions
Not known
Asthenia, fever, chills, drug fever and arthralgia
Investigations
Not known
False positive urinary glucose
* Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x-ray, and eosinophilia. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form.
Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients. Changes in ECG have occurred, associated with pulmonary reactions.
** Fatal events have been reported
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
Symptoms and signs of overdose include gastric irritation, nausea and vomiting.
Management
There is no known specific antidote. However, Nitrofurantoin can be haemodialysed in cases of recent ingestion. Standard treatment is by induction of emesis or by gastric lavage. Monitoring of full blood count, liver function, and pulmonary function tests are recommended. A high fluid intake should be maintained to promote urinary excretion of the drug.
Ask anything about Nitrofurantoin 50 mg Capsules. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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