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PACKAGE LEAFLET: INFORMATION FOR THE USER Nitrofurantoin 50 and 100mg tablets

Read all of this leaflet carefully before you start using this medicine.

In this leaflet:

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

2.    Before you take Nitrofurantoin Tablets

3.    How to take Nitrofurantoin Tablets

4.    Possible side effects

5.    How to store Nitrofurantoin Tablets

6.    Further information

1.    WHAT NITROFURANTOIN TABLETS ARE AND WHAT THEY ARE USED FOR

Nitrofurantoin the active substance in Nitrofurantoin Tablets 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 Tablets

DO NOT TAKE Nitrofurantoin Tablets 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 Nitrofurantoin Tablets (listed in Section 6 at the end of the leaflet) 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 have porphyria (blood disorder)

•    you have G6PD (glucose-6-phosphate dehydrogenase) deficiency

•    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 Nitrofurantoin Tablets and speak to your doctor or pharmacist before taking the tablets 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, like 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 Tablets for a number of months, your doctor may want to regularly check how your lungs and liver are working

•    you have false positive results on testing your urine for glucose

•    your urine is dark yellow or brown coloured.

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 Tablets their effect or the effect of Nitrofurantoin Tablets 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 contraceptives “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 Tablets may interfere with the results of some tests for glucose in the urine.

Taking Nitrofurantoin Tablets with food and drink:

Nitrofurantoin Tablets 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 is known Nitrofurantoin Tablets 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 Tablets 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 Nitrofurantoin Tablets:

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 Nitrofurantoin Tablets

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. Tablets 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 tablet or one 100mg tablet four times a day for seven days

•    For prevention of further infections: Either one 50mg tablet or one 100mg tablet at bedtime

•    For prevention of infections during surgery: One 50mg tablet four times a day on the day of the operation and three days thereafter.

Children 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 Tablets.

Medical Checks:

Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system. Nitrofurantoin Tablets may interfere with the results of some tests for glucose in the urine.

If you TAKE MORE Nitrofurantoin Tablets than you should:

Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left over tablets 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 Tablets:

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 tablet. If you are not sure ask your doctor or pharmacist.

If you STOP TAKING Nitrofurantoin Tablets:

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, Nitrofurantoin Tablets can cause side effects, although not everybody gets them. Most of them are mild and disappear when you stop taking Nitrofurantoin Tablets.

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 Tablets and consult your doctor.

•    Your lungs may react to Nitrofurantoin Tablets. 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 Tablets 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 gland (causing severe abdominal pain) and joint pains

•    Short-term hair loss

•    Urinary infection by germs which are not sensitive to Nitrofurantoin Tablets.

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.

Remember:

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 Nitrofurantoin Tablets

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package to protect from light and moisture..

Do not use Nitrofurantoin Tablets after the expiry date which is stated on the carton (EXP). 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 Tablets contains:

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

The other ingredients are talc, maize starch, lactose, alginic acid, magnesium stearate and purified water.

What Nitrofurantoin Tablets looks like and contents of the pack:

Appearance: Both the 50mg and 100mg tablets are yellow and pentagonal. Each tablet has a break line on one face and the tablet strength on the opposite face.

Packaging: The tablets are supplied to pharmacists in bottles of 100.

Marketing Authorisation Holder: Mercury Pharmaceuticals Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer: Custom Pharmaceuticals Limited, Conway Street, Hove, East Sussex, BN3 3LW, UK

This leaflet was last revised in December 2013