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Metwest

Final Preparation Date For Submission: 31/07/2014 Packing Site Technical Approval:

00/00/0000

Authority Approval Date:    00/00/0000

Latest Implementation Deadline:    00/00/0000

Print Proof Approval:

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Read all of this leaflet carefully before you start taking 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

NITROFURANTOIN 50 mg & 100 mg TABLETS

Read all of this leaflet carefully before you start taking 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

THIS LEAFLET CONTAINS

1.    What Nitrofurantoin is for

2.    Before you take Nitrofurantoin

3.    How to take Nitrofurantoin

4.    Possible side effects

5.    How to store Nitrofurantoin

6.    Further information

1. WHAT NITROFURANTOIN IS FOR

Nitrofurantoin is an antibiotic. It can be used to treat and prevent bacterial infections of the bladder, kidney and other parts of the urinary tract.

If you are not sure why you have been prescribed these tablets then please ask your doctor.

2. BEFORE YOU TAKE NITROFURANTOIN

Do not take Nitrofurantoin and tell your doctor if:

•    you are allergic to Nitrofurantoin, any of the other ingredients in the tablets (listed in section 6 of this leaflet) or to other nitrofuran antibiotics. The signs of an allergic reaction include a rash, itching or shortness of breath

•    you have problems with your kidneys (other than infection). Your doctor will assess whether you may take nitrofurantoin depending on how well your kidneys are working.

•    you have a blood problem known as porphyria where you may have too many red blood cells

•    you have glucose-6-phosphate dehydrogenase (G6PD) deficiency. This is a genetic disorder where the red blood cells are broken down under stressful conditions or due to taking medicines

•    you are breast-feeding an infant with G6PD deficiency

•    you are in the last month of your pregnancy.

This medicine should not be given to infants under 3

months old.

Take special care with Nitrofurantoin

Tell your doctor before you take this medicine if:

•    any member of your family has G6PD deficiency

•    you have problems with your liver, lungs or nervous system

•    you have anaemia ordiabetes

•    you have a vitamin B deficiency, especially folate

•    you have an electrolyte (e.g. calcium, potassium or sodium) imbalance

•    you are weak or feeble.

If you are not sure if any of the above apply to you, talk to

your doctor or pharmacist before taking this medicine.

Having tests

Your doctor will monitor you closely for any effects on your liver, lungs, blood or nervous system, especially if you are taking Nitrofurantoin for long-term treatment.

If you are having urine tests, tell the doctor that you are taking Nitrofurantoin as it may interfere with the results.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription. This is because Nitrofurantoin can affect the way some other medicines work. Also, some medicines can affect the way Nitrofurantoin works.

In particular, tell your doctor or pharmacist if you are taking any of the following:

•    Other medicines to treat bacterial infections such as Quinolone antibiotics (e.g. Norfloxacin)

•    Medicines to make your urine less acidic such as Sodium Bicarbonate

•    Antacids for indigestion or heartburn such as Magnesium Trisilicate

•    Barbiturates or Phenytoin for epilepsy

•    Probenecid or Sulfinpyrazone to treat pain and swelling of the joints (gout)

•    Medicines called Anticholinergics (e.g. Atropine) used for lots of different types of illness such as eye, kidney, breathing or bowel problems

•    Carbonic Anhydrase Inhibitors (e.g. Acetazolamide) to treat increased eyeball pressure (glaucoma).

Nitrofurantoin can make birth control pills less effective. An additional form of contraception should be used.

Taking Nitrofurantoin with food and drink

Nitrofurantoin should be taken with food or milk. This lowers the chance of getting an upset stomach.

Avoid alcohol whilst taking Nitrofurantoin.

Pregnancy and breast-feeding

Do not take Nitrofurantoin if you are pregnant, planning a pregnancy or breast-feeding, unless your doctor has told you to.

Driving and using machines

Nitrofurantoin may cause drowsiness, dizziness or headaches. Do not drive or operate machinery if you are affected in this way and avoid alcohol, as it can make these effects worse.

Important information about some of the ingredients of Nitrofurantoin

This medicine contains lactose (a type of sugar). If you know you have an intolerance to some sugars contact your doctor before taking this medicine.

3. HOW TO TAKE NITROFURANTOIN

Always take Nitrofurantoin tablets exactly as your doctor has told you.

Taking this medicine

•    take this medicine by mouth with food or milk

•    as this medicine is an antibiotic, always finish the prescribed course.

The usual doses are given below. These may be changed by your doctor:

Adults:

For treatment of infections: 50 mg or 100 mg four times a day for seven days.

For prevention of further infections: 50 mg or 100 mg

once a day, at night.

For prevention of infections during surgery: 50 mg four times a day for the duration of the surgical procedure and three days thereafter.

Elderly:

Same dosage as adults unless you suffer from kidney problems. Follow your doctor’s advice.

Children over 3 months old:

Your doctor will work out the exact amount that your child should take.

For treatment of infections: The usual dose is 3 mg for

each kilogram of the child’s body weight, divided into four doses per day for seven days.

For prevention of further infections: The usual daily dose is 1 mg for each kilogram of the child’s body weight, given at night.

Children under 3 months old:

Not recommended.

If you take more Nitrofurantoin than you should

Contact your doctor or go to a hospital immediately. Take the package or container with you so the doctor knows what you have taken. The symptoms of an overdose may include nausea, vomiting or an upset stomach.

If you forget to take Nitrofurantoin

Don’t worry, just take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.

If you stop taking Nitrofurantoin

Keep taking this medicine until the course is finished, unless you get any of the side effects listed in section 4 below. Keep taking the tablets even if you feel better after a few days.

Tell your doctor if you get any of these side effects:

•    feeling sick (nausea)

•    being sick (vomiting)

•    stomach pain

•    diarrhoea

•    loss of appetite

•    drowsiness

•    dizziness or a feeling of spinning

•    headache

•    weakness

•    uncontrollable eye movements

•    temporary hair loss

•    changesinthecolourofyoururine

•    infections of the genitals or urinary tract, caused by bacteria which are not sensitive to Nitrofurantoin.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

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

5. HOW TO STORE NITROFURANTOIN

4. POSSIBLE SIDE EFFECTS

Like all medicines, Nitrofurantoin can cause side effects, although not everybody gets them.

If you have an allergic reaction to Nitrofurantoin see a doctor straight away

An allergic reaction may include:

•    any kind of skin rash, flaking skin, itching or red and raised lumps (hives)

•    blistering of the skin, mouth, eyes and genitals

•    swelling of the face or throat

•    sudden wheezing, fluttering or tightness of the chest or collapse

•    fever or joint pain

•    inflammation of the salivary glands causing unusual tastes

•    inflammation of the pancreas causing severe pain in the stomach and back.

If you get any of the following side effects, STOP TAKING Nitrofurantoin and see your doctor as soon as possible:

•    problems with your lungs, which may cause difficulty in breathing, shortness of breath, chest pain, chills, cough, general illness or fever

•    feeling confused ordepressed

•    changes of mood or mental state

•    fever, sore throat, ulcers in the mouth and throat, unusual tiredness or weakness, unusual bleeding and unexplained bruises. These may be a sign that you have a blood disorder

•    severe headache. This may be due to an increase in pressure inside the head

•    disorder of the nerves, which may cause weakness, tingling or numbness

•    yellowing of the skin or whites of the eyes (jaundice) or inflammation of the liver (hepatitis), which may cause tiredness, loss of appetite or aching muscles and joints.

Keep out of the sight and reach of children.

Do not store above 25°C. Store in the original package or container and keep the container tightly closed.

Do not use these tablets after the expiry date, which is stated on the package or container. 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 contain

The active ingredient in Nitrofurantoin 50 mg and 100 mg tablets is nitrofurantoin. The other ingredients are lactose, maize starch, pregelatinised maize starch, sodium starch glycollate and magnesium stearate.

What Nitrofurantoin tablets look like and contents of the pack

Nitrofurantoin 50 mg tablets are round yellow tablets with the marking MP23 on one side and a break line engraved on the other.

Nitrofurantoin 100 mg tablets are round yellow tablets with the marking MP24 on one side and a break line engraved on the other.

The tablets come in blister packs and containers of 28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Metwest Pharmaceuticals Limited,

15 Runnelfield, Harrow on the Hill,

Middlesex HA1 3NY

Manufacturer

Haupt Pharma Berlin GmbH,

Gradestrasse 13, Moosrosenstrasse 5 and Britzer Damm 120,

12347 Berlin, Germany

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 07/2014

M0023-0024/O/PIL2/M1