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NITROFURANTOIN 100MG CAPSULES
Active substance(s): NITROFURANTOIN MACROCRYSTALS / NITROFURANTOIN MACROCRYSTALS / NITROFURANTOIN MACROCRYSTALS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Macrodantin® 50mg and 100mg Capsules
Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed
for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects becomes serious, or if
you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
What Macrodantin Capsules are and what they are used for
Before you take Macrodantin Capsules
How to take Macrodantin Capsules
Possible side effects
How to store Macrodantin Capsules
1. WHAT MACRODANTIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Nitrofurantoin (the active substance in Macrodantin Capsules) is an antibiotic.
It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.
2. BEFORE YOU TAKE MACRODANTIN CAPSULES
DO NOT TAKE Macrodantin Capsules and talk to your doctor if:
• you are allergic (causing itching, reddening of the skin or difficulty in breathing) to nitrofurantoin or any of the ingredients of Macrodantin
Capsules (listed in Section 6 at the end of the leaflet) 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.
TAKE SPECIAL CARE with Macrodantin Capsules and speak 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.
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 Macrodantin Capsules for a number of months, your doctor
may want to regularly check how your lungs and liver are working.
Taking other medicines:
Please 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 Macrodantin Capsules their effect or the effect of Macrodantin Capsules 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.
Macrodantin Capsules may interfere with the results of some tests for glucose in the urine.
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 Macrodantin Capsules.
Macrodantin Capsules should be taken with food or milk.
Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system.
Macrodantin Capsules may interfere with the results of some tests for glucose in the urine.
If you TAKE MORE Macrodantin 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 Macrodantin 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 Macrodantin 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, Macrodantin Capsules can cause side effects, although not everybody gets them. Most of them are mild and disappear when
you stop taking Macrodantin 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 Macrodantin Capsules and consult your doctor.
• Your lungs may react to Macrodantin 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
• 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
• Raised pressure in the skull (causing severe headaches).
Please note that while taking Macrodantin 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:
• Feeling sick (nausea) and headache
• Loose stools
• Loss of appetite, stomach ache, 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 Macrodantin Capsules.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
This medicine is only for you. Only a doctor can prescribe it for you. Never give this medicine to someone else. It could harm them, even if their
symptoms seem the same as yours.
5. HOW TO STORE MACRODANTIN CAPSULES
Keep this medicine out of the sight and reach of children.
Do not store above 30°C. Store in the original package to protect from light and moisture.
Do not use Macrodantin 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 disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
Taking Macrodantin Capsules with food and drink:
Macrodantin Capsules should be taken at meal times with food or milk. This will help to avoid stomach upset and also to help the absorption.
Pregnancy and breast-feeding:
Ask your doctor or pharmacist for advice before taking any medicine. As far as it is known Macrodantin 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:
Macrodantin Capsules 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 about some of the ingredients in Macrodantin Capsules:
This medicine contains lactose and sucrose (sugars). 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 medicine.
3. HOW TO TAKE MACRODANTIN CAPSULES
Follow your doctor’s instructions exactly and complete the course of treatment even if you feel better. You should check with your doctor or
pharmacist if you are not sure.
Do not forget to take your medicine.
Capsules should be swallowed whole.
6. FURTHER INFORMATION
What Macrodantin Capsules contains:
The active substance is Nitrofurantoin. Macrodantin Capsules are available in two strengths, containing either 50mg or 100mg nitrofurantoin.
The other ingredients are talc, maize starch, lactose monohydrate. The capsule shell contains gelatin, sodium lauryl sulphate, quinoline yellow
(E104) and titanium dioxide (E171). The printing ink contains shellac and black iron oxide (E172).
What Macrodantin Capsules looks like and contents of the pack:
Appearance: The 50mg capsule is a no. 3 size hard gelatin capsule with an opaque yellow cap and white opaque body. The capsules are printed
in edible black ink and bears the monogram “Eaton 008”.
The 100mg capsule is a no. 2 size hard gelatin capsule with an opaque yellow cap and yellow opaque body. The capsules are printed in edible
black ink and bears the monogram “Eaton 009”.
Packaging: The capsules are available in blister packs of 30.
Marketing Authorisation Holder: Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK
Manufacturer: Lusomedicamenta S.A., Sociedade Técnica Farmacêutica, Estrada Consiglieri Pedroso, 69-B, Queluz de Baixo, 2730-055
This leaflet was last revised in December 2013.
Macrodantin is the registered trademark of Mercury Pharma Group Limited.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.