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 (the active substance in Nitrofurantoin hard capsules) is an antibiotic. It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract. You must talk to a doctor if you do not feel better or if you feel worse.
e Nitrofurantoin Do not take Nitrofurantoin:
Black Version: 01 Date & Time: 26.09.2023 & 4:00 PM Submission: N19027_u15c
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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.
Other medicines and Nitrofurantoin Capsules Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If they are taken with Nitrofurantoin 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:
Nitrofurantoin Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults: The normal dosage depends on the type of infection you have and appropriate 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:
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Package leaflet: Information for the user
If you take more Nitrofurantoin Capsules than you should: Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any leftover capsules with you, as well as the container and label, so that the medical staff knows what you or the child has 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.
Half Fold: 275 mm
If you stop taking Nitrofurantoin Capsules: Your doctor will tell you how long to take the treatment. Do not stop earlier than you have been told, even if you start to 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 Capsules. 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, lips or tongue, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately. If you experience any of the
detailed below stop taking Nitrofurantoin Capsules and consult your doctor. •
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Your lungs may react to Nitrofurantoin Capsules. 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)
Please note that while taking Nitrofurantoin Capsules your urine may become dark yellow or brown coloured. This is quite normal and not a reason to stop taking the medicine. Other side effects include: Rare (may affect up to 1 in 1,000 people)
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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 (causing severe abdominal pain) and joint pains Short-term hair loss Urinary infection by germs or fungi 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
Reporting of side effects 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 national reporting system listed in the Yellow Card Scheme at: 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.
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. This medicine does not require any special storage conditions. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Nitrofurantoin contains
The other ingredients are: Capsules content: Cellulose Microcrystalline (Grade 101), croscarmellose Sodium, magnesium stearate Capsules shell: Iron oxide yellow (E172), titanium Dioxide (E171), gelatin Printing Ink: Shellac, black iron oxide (E172), Potassium hydroxide (E525)
What Nitrofurantoin looks like and contents of the pack Hard Capsule. Nitrofurantoin 50 mg hard capsules Hard gelatin capsules of size '4' with white opaque body imprinted with '50' and yellow opaque cap imprinted with 'NMC' with black ink, filled with yellow to light yellow granular powder. Nitrofurantoin 100 mg hard capsules Hard gelatin capsules of size '2' with yellow opaque body imprinted with '100' and yellow opaque cap imprinted with 'NMC' with black ink, filled with yellow to light yellow granular powder. Nitrofurantoin hard capsules are available in Clear PVC Aluminium foil blister. Pack sizes: 30 hard capsules Marketing Authorisation Holder Milpharm Limited Ares Block, Odyssey Business Park West End Road Ruislip, HA4 6QD United Kingdom Manufacturer APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta or Milpharm Limited Ares Block, Odyssey Business Park West End Road Ruislip, HA4 6QD United Kingdom or Generis Farmaceutica, S.A. Rua João de Deus, n. o 19, Venda Nova, 2700-487 Amadora, Portugal This leaflet was last revised in 09/2023.
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Method of administration Nitrofurantoin Capsules should always be taken with food or milk. Taking this medicine with food or milk makes it work more effectively.
Nitrofurantoin 100 mg hard capsules 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 100 mg hard capsules 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 100 mg hard 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.
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 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 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.
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 (paraesthesia).
Nitrofurantoin should be used in caution with 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 may occur commonly in elderly patients. Close monitoring of the pulmonary condition 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).
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.
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.
Excipient
This medicine contains less than 1 mmol sodium (23 mg) per each hard capsule, that is to say essentially 'sodium-free'.
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.
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 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
Aplastic anaemia
Not known
Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, glucose-6- phosphatedehydrogenase deficiency anaemia, megaloblastic anaemia and eosinophilia
Immune system disorders
Not known
Anaphylaxis, angioneurotic oedema and allergic skin reactions
Psychiatric disorders
Not known
Depression, euphoria, confusion, psychotic reactions
Nervous system disorders
Not known
Benign intracranial hypertension, peripheral neuropathy including optic neuritis (sensory as well as motor involvement), nystagmus, vertigo, dizziness, headache and drowsiness.
Cardiac
Rare
Collapse and cyanosis
Respiratory, thoracic and mediastinal disorders
Not known
Pulmonary fibrosis; possible association with lupus erythematous-like syndrome. acute pulmonary reactions, * subacute pulmonary reactions, * chronic pulmonary reactions, * cough, dyspnoea
Gastrointestinal disorders
Not known
Sialadenitis, pancreatitis, nausea, anorexia, emesis, abdominal pain and diarrhoea.
Hepatobiliary disorders
Not known
Chronic active hepatitis (fatalities have been reported), hepatic necrosis, autoimmune hepatitis, cholestatic jaundice
Skin and subcutaneous tissue disorders
Not known
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
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.
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 100 mg hard 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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