PACKAGE LEAFLET: INFORMATION FOR THE USER

Macrodantin 50mg hard 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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Macrodantin 50mg hard capsules but it will be referred to as Macrodantin throughout this leaflet. Please note that the leaflet also contains information about another strength Macrodantin 100mg hard capsules.

In this leaflet:

1.    What Macrodantin is and what it is used for

2.    Before you take Macrodantin

3.    How to take Macrodantin

4.    Possible side effects

5.    How to store Macrodantin

6.    Further information

1. WHAT MACRODANTIN IS AND WHAT IT IS 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

DO NOT TAKE Macrodantin 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 (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 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 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 their effect or the effect of Macrodantin 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 may interfere with the results of some tests for glucose in the urine.

Taking Macrodantin with food and drink:

Macrodantin 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 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 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:

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

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 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.

Macrodantin should be taken with food or milk.

Medical Checks:

Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system.

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

If you TAKE MORE Macrodantin 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:

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:

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

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 and consult your doctor.

•    Your lungs may react to Macrodantin. 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 Macrodantin 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.

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. 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 at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

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 MACRODANTIN

Keep out of the sight and reach of children.

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

Do not take the medicine after the expiry date which is stated on the carton and blister label after ‘Exp'. The expiry date refers to the last day of that month.

If the capsules become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

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 Macrodantin contains:

The active ingredient in Macrodantin is Nitrofurantoin. Each capsule contains 50mg nitrofurantoin (in macrocrystalline form).

The other ingredients are talc, maize starch, lactose. The capsule shell contains gelatin, sodium laurilsulfate, quinoline yellow (E104) and titanium dioxide (E171).

What Macrodantin looks like and contents of the pack:

Macrodantin is a hard gelatin capsule with an opaque yellow cap and white body, marked with ‘Eaton 008' on both cap and body.

It is available in blister packs of 50.

Manufactured by: Lusomedicamenta S.A., Sociedade Tecnica Farmaceutica, Estrada Consiglieri Pedroso, 69-B, Queluz de Baixo, 2730-055 Barcarena, Portugal.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Macrodantin® 50mg hard capsules, PL 18799/2953

Leaflet date: 19.09.2016