Patient Leaflet Updated 05-Apr-2019 | ADVANZ Pharma
Nitrofurantoin Oral Suspension 25mg/5ml
PACKAGE LEAFLET: INFORMATION FOR THE USER
Nitrofurantoin 25mg/5ml Oral Suspension
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This product will be referred to as Nitrofurantoin Oral Suspension for ease hereafter.
What is in this leaflet:
1. What Nitrofurantoin Oral Suspension is and what it is used for
2. What you need to know before you take Nitrofurantoin Oral Suspension
3. How to take Nitrofurantoin Oral Suspension
4. Possible side effects
5. How to store Nitrofurantoin Oral Suspension
6. Contents of the pack and other information
1. WHAT NITROFURANTOIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR
Nitrofurantoin (the active substance in Nitrofurantoin Oral Suspension) is an antibiotic.
It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITROFURANTOIN ORAL SUSPENSION
DO NOT TAKE Nitrofurantoin Oral Suspension:
Tell your doctor if you are not sure about any of the above.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Nitrofurantoin Oral Suspension:
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
Other medicines and Nitrofurantoin Oral Suspension:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines without a prescription.
If they are taken with Nitrofurantoin Oral Suspension their effect or the effect of Nitrofurantoin Oral Suspension may be changed. In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
If you are in doubt about any of these medicines ask your doctor or pharmacist.
Nitrofurantoin Oral Suspension with food and drink:
Nitrofurantoin Oral Suspension 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:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
As far as it is known Nitrofurantoin Oral Suspension 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 Oral Suspension may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.
Nitrofurantoin Oral Suspension contains Methylhydroxybenzoate and Glycerol:
This medicine contains:
3. HOW TO TAKE NITROFURANTOIN ORAL SUSPENSION
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
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:
Use in children and infants aged over three months:
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 Oral Suspension.
Your doctor will watch carefully for any effects on the liver, lungs, blood or nervous system.
Nitrofurantoin Oral Suspension may interfere with the results of some tests for glucose in the urine.
Method of administration
Nitrofurantoin Oral Suspension should be taken with food or milk.
If you take more Nitrofurantoin Oral Suspension than you should:
Consult your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Always take any left over medicine 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 Oral Suspension:
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 dose. If you are not sure ask your doctor or pharmacist.
If you stop taking Nitrofurantoin Oral Suspension:
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 medicine, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of them are mild and disappear when you stop taking Nitrofurantoin Oral Suspension.
All medicines can cause allergic reactions although serious allergic reactions are rare. If you notice any suddenwheeziness, 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 or any other side effects, stop taking Nitrofurantoin Oral Suspension and consult your doctor.
Please note that while taking Nitrofurantoin Oral Suspension 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:
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Other reactions may include inflammation of salivary glands (causing facial pains), inflammation of the pancreas gland (causing severe abdominal pain) and joint pains.
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 the MHRA yellow card scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE NITROFURANTOIN ORAL SUSPENSION
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the bottle in the outer carton in order to protect from light. Do not freeze.
Do not use Nitrofurantoin Oral Suspension after the expiry date which is stated on the pack. 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. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nitrofurantoin Oral Suspension contains:
The active substance is nitrofurantoin. Each 5ml spoonful contains 25mg of the nitrofurantoin.
The other ingredients are glycerol, polysorbate 20, carbomer, saccharin sodium, methylhydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sodium hydroxide and purified water.
What Nitrofurantoin Oral Suspension looks like and contents of the pack:
Nitrofurantoin Oral Suspension is an opaque yellow liquid with a lemon/apricot characteristic odour.
This medicine is supplied in 300ml amber glass bottles.
Marketing Authorisation Holder:
This leaflet was revised in February 2019.
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