Active ingredient
- nitrofurantoin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 25258/0317 .
Nitrofurantoin 50 mg, 100 mg Capsules
Package leaflet: Information for the user
Nitrofurantoin 50 mg Capsules
Nitrofurantoin 100 mg Capsules
Nitrofurantoin in macrocrystalline form
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Nitrofurantoin Capsules is and what it is used for
2. What you need to know before you take Nitrofurantoin Capsules
3. How to take Nitrofurantoin Capsules
4. Possible side effects
5. How to store Nitrofurantoin Capsules
6. Contents of the pack and other information
1. What Nitrofurantoin Capsules is and what it is used for
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.
2. What you need to know before you take Nitrofurantoin Capsules
Do not take Nitrofurantoin Capsules:
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:
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.
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.
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.
3. How to take Nitrofurantoin Capsules
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:
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.
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 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.
Other side effects include:
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
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.
5. How to store Nitrofurantoin Capsules
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.
6. Contents of the pack and other information
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
Manufacturer
This leaflet was last revised in January 2022
Building 2, 1st Floor, Croxley Park, Watford, WD18 8YA
+44 (0)1923 202 950
+44 (0)1923 202 950