Patient leaflet - Nitrofurantoin 100 mg capsules
1. WHAT NITROFURANTOIN CAPSULES ARE AND WHAT THEY ARE 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. You must talk to a doctor if you do not feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITROFURANTOIN CAPSULES
Do not take Nitrofurantoin Capsules if:
you are allergic to nitrofurantoin, other medicines
containing nitrofurantoin or to any of the other ingredients of this medicine (listed in Section 6).
you have a disease of the kidneys which is severely
affecting the way they work (ask your doctor if you are not sure).
you are in the final stages of pregnancy (labour
or delivery) as there is a risk that it might affect the baby.
- you suffer from a blood disorder called porphyria.
you are deficient in an enzyme called G6PD
(glucose-6-phosphate dehydrogenase).
- your child is under three months of age.
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.
you are suffering from any illness causing
severe weakness.
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).
- you have a history of allergic reactions.
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.
- you have any problems with your kidneys.
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).
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.
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.
- 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-coloured stools. It may be symptoms of liver disorder.
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.
Other medicines and Nitrofurantoin Capsules
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 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:
- 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 anhydrase inhibitors (e.g. acetazolamide).
Medicines which make the urine less acidic
(e.g. potassium citrate mixture).
- Medicines for infections, known as quinolones.
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 may interfere with the results of some tests for glucose in the urine.
Nitrofurantoin Capsules with food and drink
Nitrofurantoin Capsules 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.
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 contain lactose and sodium
This medicine contains lactose. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.
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.
The recommended dose is:
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 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 operation and three days thereafter. Use in children and infants over three months of age:
The dose depends on the weight of the child and will be provided by your doctor. Follow your doctor’s instructions exactly.
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 the results of some tests for glucose in the urine.
Method of administration
Nitrofurantoin Capsules should be taken with food or milk.
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 left over capsules with you, as well as the container and label, so that the medical staff knows 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 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 or lips, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately.
If you notice any of the following side effects consult your doctor immediately.
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.
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 colouration 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 autoimmune hepatitis.
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 are Rare (may affect up to 1 in 1,000 people)
- Loss of consciousness (collapse).
Not known (frequency cannot be estimated from the available data)
- Feeling sick (nausea) and headache.
Loose stools.
- Loss of appetite, stomach ache, and being sick (vomiting).
- Diarrhoea.
- 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 (causing severe abdominal pain) and joint pains.
- 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.
- Short-term hair loss.
- Urinary infection by germs which are not sensitive to Nitrofurantoin Capsules.
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 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.
5. HOW TO STORE NITROFURANTOIN CAPSULES
Keep this medicine out of the sight and reach of children.
Store in the original container in order to protect from light.
Do not use this medicine after the expiry date which is printed on the carton and blister. The expiry date refers to the last day of that month.
Do not throw away any medicine via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nitrofurantoin Capsules contain
The active substance is nitrofurantoin. Nitrofurantoin
Capsules are available in two strengths, containing either 50 mg or 100 mg nitrofurantoin.
- The other ingredients are lactose monohydrate, maize starch, purified talc, gelatin, sodium lauryl sulphate, iron oxide yellow (E172), titanium dioxide (E171).
What Nitrofurantoin Capsules look like and contents of the pack
Nitrofurantoin 50 mg Capsules are yellow coloured free flowing granules filled in hard gelatine capsule with white body printed with “50” in black and yellow cap printed with “NTF” in black.
Nitrofurantoin 100 mg Capsules are yellow coloured free flowing granules filled in hard gelatine capsule with white body printed with “100” in black and yellow cap printed with “NTF” in black.
They are available in blister packs of 10, 14, 15, 20, 28, 30 and 100 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Morningside Healthcare Ltd.
Unit C, Harcourt Way, Leicester, LE19 1WP, UK
Manufacturer
Morningside Pharmaceuticals Ltd.
Pavillion Way, Loughborough, LE11 5GW, UK
Morningside Pharmaceuticals Ltd. & Aspire Pharma Ltd. Second Floor, Boss Court, 7 Barton Close, Grove Park, Leicester, LE19 1SJ, UK
Aspire Pharma Ltd.
Unit 4, Rotherbrook Court, Bedford Road, Petersfield, GU32 3QG, UK