Patient leaflet - Nitrofurantoin Bristol Laboratories 50 mg capsules hard
1. What Nitrofurantoin Capsules is and what it is used for
The active substance in this medicine is Nitrofurantoin, which 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 if :
- you are allergic (causing itching, reddening of the skin or difficulty in breathing) to nitrofurantoin or any of the ingredients of this medicine (listed in Section 6) or other medicines containing nitrofurantoin
- 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) • in infants 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 the 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.
- 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, causes altered sense of feeling, pins and needles. • 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. • 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 this medicine their effect or the effect of Nitrofurantoin may be changed.
- 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
- Oral contraceptive “the pill”. You will need to use extra contraceptive precautions such as using a condom, as antibiotics can make the contraceptive pill less effective • 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 may interfere with the results of some tests for glucose in the urine.
Nitrofurantoin Capsules with food and drink
Nitrofurantoin 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 and breast-feeding
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 any medicine. As far as it is known Nitrofurantoin 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 may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.
Important information regarding the ingredients of this medicine
Nitrofurantoin Capsules contains lactose. If you have been told by your doctor that you are intolerant to some sugars and have to avoid them, 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. Follow your doctor’s instructions exactly and complete the course of treatment even if you feel better. Do not forget to take your medicine.
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 50mg capsule or one 100mg capsule four times a day for seven days
- For prevention of further infections: Either one 50mg capsule or one 100mg capsule at bedtime
- For prevention of infections during surgery: One 50mg capsule four times a day on the day of the operation and three days thereafter.
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
Nitrofurantoin Capsules should be taken with food or milk.
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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
Capsules should be swallowed whole.
Nitrofurantoin capsules should always be taken with food or milk. Taking this medicine with food or milk makes it work more effectively.
If you take more of this medicine 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 this medicine
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 this medicine
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 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 experience any of the side effects detailed below stop taking this medicine and consult your doctor.
- Your lungs may react to Nitrofurantoin. This may develop quickly, within a week of starting treatment or very slowly, especially in elderly patients. This may produce chest pain, fever, chills, cough and shortness of breath. Scaring due to damaged lung tissue may occur.
- 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 coloration 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 jaundice, 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 include:
Rare: may affect up to 1 in 1,000 people
- Loss of consciousness (collapse)
- Damage to bone marrow causing deficiency of the red blood cells (Anaemia)
Not known: frequency cannot be estimated from the available data
- Feeling sick (nausea) and headache
- Loose stools
- 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 (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
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 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 below 300C.
- Do not take 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 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 anhydrous in macrocrystalline form. Each capsule contains 50 mg or 100 mg Nitrofurantoin.
- The other ingredients:
Capsule content: Maize starch, lactose monohydrate and purified talc. Capsule shell: Iron oxide yellow (E172), titanium dioxide (E171) and gelatin. Printing ink: Shellac (E904), propylene glycol (E1520), black iron oxide (E172).
What Nitrofurantoin Capsules look like and contents of the pack
- 50 mg: Yellow / White hard gelatin capsules of size “4” and imprinted with ‘BL’ on cap and ‘50’ on body, containing light yellow crystalline powder.
- 100 mg: Yellow / Yellow hard gelatin capsules of size “2” and imprinted with ‘BL’ on cap and ‘100’ on body, containing light yellow crystalline powder. • The capsules 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:
Bristol Laboratories Limited
Unit 3, Canalside, Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1 EG, United Kingdom
Telephone: 0044 (0) 1442 200922
Fax: 0044 (0) 1442 873717
Email: info@bristol-labs.co.uk
Manufacturer:
Bristol Laboratories Limited
Laporte Way, Luton,
LU48WL, United Kingdom
Nitrofurantoin 50 mg Capsules; PL 17907/0520
Nitrofurantoin 100 mg Capsules; PL 17907/0521
This leaflet was last revised in May 2023
To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
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