Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Nitrofurantoin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for Nitrofurantoin is an antibiotic. It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.
e Nitrofurantoin Do not take Nitrofurantoin if:
The above conditions may increase the chance of developing side effects which result in damage to the nerves, causing an altered sense of feeling or pins and needles.
However, Nitrofurantoin should not be used during labour or delivery because there is a possibility that taking this medicine at this stage may affect the baby. Breast-feeding If you want to breast-feed, please consult your doctor first. Driving and using machines Nitrofurantoin may cause dizziness and drowsiness. If you experience any of these side effects, you should not drive or operate machinery. Nitrofurantoin contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Nitrofurantoin Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults: The normal dose depends on the type of infection you have, and instructions should be written on the label provided by the pharmacist. Consult your doctor or pharmacist if these instructions are not clear. The usual doses are:
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose. If you stop taking Nitrofurantoin: Do not stop taking Nitrofurantoin without talking to your doctor. Your doctor will tell you how long to take this medicine for. Do not stop sooner than you have been told, even if you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Possible side effects
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. All medicines can cause allergic reactions, 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 see a doctor immediately. If you notice any of the following side effects consult your doctor immediately: Problems with your lungs. This may develop 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. Scarring due to damaged lung tissue may occur. If you experience any of the side effects detailed below stop taking Nitrofurantoin and consult your doctor.
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search 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. 5.
Nitrofurantoin
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton after 'EXP'. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment. 6.
What Nitrofurantoin Capsules contain The active substance is nitrofurantoin. Nitrofurantoin Capsules are available in two strengths, containing either 50mg or 100mg of nitrofurantoin. The other ingredients are: lactose monohydrate, pregelatinised starch, talc. The capsule shell contains gelatin, quinoline yellow (E104), iron oxide yellow (E172) and titanium dioxide (E171). The printing ink contains shellac, propylene glycol, potassium hydroxide and black iron oxide (E172). What Nitrofurantoin Capsules look like and contents of the pack
The 50mg capsule is a yellow and white capsule with "EM28" printed on it in black ink. It also has a black band printed around it. The 100mg capsule is a yellow capsule with "EM29" printed on it in black ink. It also has a black band printed around it. Nitrofurantoin Capsules are available in blister packs of 20 and 30 capsules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Tillomed Laboratories Ltd 220 Butterfield Great Marlings Luton, LU2 8DL United Kingdom This leaflet was last revised in 01/2026 Till-Ver.1
Nitrofurantoin 100mg Capsules, Hard comes as capsule containing 100mg. 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 100mg Capsules, Hard is nitrofurantoin.
Medicines with the same active substance, strength and form include: Nitrofurantoin 100 mg Capsules, Nitrofurantoin 100 mg Hard Capsules, Nitrofurantoin 100 mg capsules. In total there are 9 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Nitrofurantoin 100mg Capsules, Hard, 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.
Nitrofurantoin is indicated for the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections when due to susceptible micro-organisms (see section 4.4 and 5.1).
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Posology
Adults
Acute Uncomplicated Urinary Tract Infections (UTIs): 50mg 4 times daily for 7 days.
Severe chronic recurrence (UTIs): 100mg 4 times daily for 7 days.
Long term suppression: 50-100mg once a day.
Prophylaxis: 50mg 4 times daily for the duration of procedure and for 3 days thereafter.
Paediatric population
Nitrofurantoin should not be used in children under three months of age (see section 4.3 and 4.6).
Acute Urinary Tract Infections: 3mg/kg day in four divided doses for 7 days.
Suppressive - 1mg/kg, once a day.
For children under 25 kg body weight consideration should be given to the use of Nitrofurantoin 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 capsules with a meal improves absorption and is important for optimal efficacy.
• Hypersensitivity to nitrofurantoin, 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.
Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally non-functioning 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 (paraesthesiae).
Nitrofurantoin should be used with caution in patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.
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 can often occur in elderly patients. Close monitoring of the lung disease of patients receiving long-term therapy is indicated (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).
Patients 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.
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.
Nitrofurantoin 50mg Capsules contains 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:
• Oestrogens: In common with other antibiotics, nitrofurantoin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of oestrogen-containing contraceptive products. Therefore, patients should be warned appropriately and extra contraceptive precautions taken.
• Typhoid Vaccine (oral): Antibacterials inactivate the oral typhoid vaccine.
Pregnancy
Animal studies with nitrofurantoin have shown no teratogenic effects however study in rats has shown reproductive toxicity (see section 5.3). 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 the 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.
Fertility
No data available.
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 (derived from clinical studies and post-marketing surveillance with nitrofurantoin) is outlined below.
The undesirable effects are listed according to organ systems and following frequencies:
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1000 to <1/100), Rare (≥1/10,000 to <1/1000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
System organ class
MedDRA
Very common
(≥1/10)
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1000 to <1/100)
Rare
(≥1/10,000 to <1/1000)
Very rare
(<1/10,000)
Not known
(cannot be estimated from the available data)
Blood and lymphatic system disorders
Aplastic anaemia
Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, glucose¬6-phosphatedehydrogenase deficiency anaemia, megaloblastic anaemia and eosinophilia
Cardiac disorders
Collapse and cyanosis
Congenital, familial and genetic disorders
Acute porphyria
Immune system disorders
Allergic skin reactions, angioneurotic oedema and anaphylaxis
Infections and infestations
Superinfections by fungi or resistant organisms such as Pseudomonas. However, these are limited to the genitourinary tract
Psychiatric disorders
Psychotic reactions, depression, euphoria, confusion
Nervous system disorders
Benign intracranial hypertension, peripheral neuropathy including optic neuritis (sensory as well as motor involvement), nystagmus, vertigo, dizziness, headache and drowsiness
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis; possible association with lupus-erythematous-like syndrome, acute pulmonary reactions, * subacute pulmonary reactions, * chronic pulmonary reactions, *cough, dyspnoea
Gastrointestinal disorders
Sialadenitis, pancreatitis, anorexia, emesis, abdominal pain, diarrhoea and nausea
Hepatobiliary disorders
Chronic active hepatitis (fatalities have been reported), hepatic necrosis, autoimmune hepatitis, cholestatic jaundice
Skin and subcutaneous tissue disorders
Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), lupus-like syndrome associated with pulmonary reaction, exfoliative dermatitis and erythema multiforme (including Stevens-Johnson Syndrome), maculopapular, erythematous or eczematous eruptions, cutaneous vasculitis, urticaria, rash, and pruritus, transient alopecia
Renal and urinary disorders
Yellow or brown discolouration of urine, interstitial nephritis
General disorders and administration site conditions
Asthenia, fever, chills, drug fever and arthralgia
Investigations
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.
Treatment should be stopped at the first sign of hepatotoxicity.
Fatalities have been reported. Cholestatic jaundice is generally associated with short-term therapy (usually up to two weeks). Chronic active hepatitis, occasionally leading to hepatic necrosis is generally associated with long-term therapy (usually after six months). The onset may be insidious.
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 100mg Capsules, Hard. 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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