PACKAGE LEAFLET: INFORMATION FOR THE USER

Nitrofurantoin 50mg and 100mg Capsules

Nitrofurantoin

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Nitrofurantoin Capsules are and what they are used for

2.    Before you take Nitrofurantoin Capsules

3.    Howto take Nitrofurantoin Capsules

4.    Possible side effects

5.    How to store Nitrofurantoin Capsules

6.    Further information

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.

2. 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 Nitrofurantoin 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 sufferfrom a blood disorder called porphyria.

•    you are deficient in an enzyme called G6PD (glucose-6-phosphate dehydrogenase).

•    in infants underthree 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 Nitrofurantoin 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 yourblood (yourdoctorwill 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. Yourdoctorwill 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.

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 Nitrofurantoin Capsules their effect or the effect of Nitrofurantoin 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.

Nitrofurantoin Capsules may interfere with the results of some tests for glucose in the urine.

Taking 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 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 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 yourdoctor 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.

Important information about some of the ingredients of Nitrofurantoin Capsules

This medicine 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 medicine.

3. HOWTO TAKE NITROFURANTOIN 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.

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 10Omg capsule four times a day for seven days.

•    For prevention of further infections: Either one 50mg capsule or one 10Omg 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.

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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 forglucose in the urine.

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 you r 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 prod uct, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nitrofurantoin Capsules 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 Nitrofurantoin Capsules and consult your doctor.

•    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.

•    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).

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:

•    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 Nitrofurantoin 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.

5. HOW TO STORE NITROFURANTOIN CAPSULES

Keep out of the reach and sight of children.

Store in the original container in order to protect from light.

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 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.

6. FURTHER INFORMATION

What Nitrofurantoin Capsules contain

The active substance is Nitrofurantoin. Nitrofurantoin Capsules are available in two strengths, containing either 50mg or 100mg 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 50mg 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 100mg 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

115 Narborough Road

Leicester

LE30PA

UK

Manufacturer

Morningside Pharmaceuticals Ltd

Pavillion Way

Loughborough

LE11 5GW

UK

This leaflet was last revised in August 2013

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