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MacroBID100mg Prolonged-release Capsules

Active Ingredient:
nitrofurantoin monohydrate
Company:  
ADVANZ Pharma See contact details
ATC code: 
J01XE01
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) Safety Alert HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 22 Aug 2023
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 12762/0052.

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Nitrofurantoin Mercury Pharma 100mg Prolonged-Release Capsules

Package leaflet: Information for the user

Nitrofurantoin Mercury Pharma 100mg Prolonged-Release Capsules

Nitrofurantoin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Nitrofurantoin Mercury Pharma 100mg Prolonged-Release Capsules, but it will be referred to as Nitrofurantoin 100mg Prolonged-Release Capsules throughout the rest of this leaflet.

What is in this leaflet:

1. What Nitrofurantoin 100mg Prolonged-Release Capsules is and what it is used for
2. What you need to know before you take Nitrofurantoin 100mg Prolonged-Release Capsules
3. How to take Nitrofurantoin 100mg Prolonged-Release Capsules
4. Possible side effects
5. How to store Nitrofurantoin 100mg Prolonged-Release Capsules
6. Contents of the pack and other information

1. WHAT NITROFURANTOIN 100MG PROLONGED-RELEASE CAPSULES IS AND WHAT IT IS USED FOR

Nitrofurantoin (the active substance in Nitrofurantoin 100mg Prolonged-Release Capsules) 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 100MG PROLONGED-RELEASE CAPSULES
DO NOT TAKE Nitrofurantoin 100mg Prolonged-Release Capsules
  • if you are allergic to Nitrofurantoin, other nitrofurans or any of the other ingredients of this medicine (listed in section 6)
  • if you have a disease of the kidneys which is severely affecting the way they work (ask your doctor if you are not sure)
  • if you are in the final stages of pregnancy (labour or delivery) as there is a risk that it might affect the baby
  • if you have porphyria (blood disorder)
  • if in patients with G6PD (glucose-6-phosphate dehydrogenase) deficiency
  • if in infants under three months of age
  • if 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.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Nitrofurantoin 100mg Prolonged-Release Capsules:

  • if you have diabetes
  • if you are suffering from any illness causing severe weakness

Driving and using machines:

Nitrofurantoin 100mg Prolonged-Release Capsules may cause dizziness and drowsiness. You should not drive or operate machinery if you are affected this way until such symptoms go away.

Nitrofurantoin 100mg Prolonged-Release Capsules contains lactose and sucrose

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 100MG PROLONGED-RELEASE CAPSULES

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 recommended dose is:

Adults and children over 12 years old:

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 bladder infections: One capsule twice a day for seven days
  • For prevention of bladder infections during surgery: One capsule twice a day on the day of the operation and three days thereafter.

Use in children

Nitrofurantoin 100mg Prolonged-Release Capsules is not recommended for children under 12 years of age.

Nitrofurantoin 100mg Prolonged-Release Capsules 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. Nitrofurantoin may interfere with the results of some tests for glucose in the urine.

Method of administration

Capsules should be swallowed whole.

If you take more Nitrofurantoin 100mg Prolonged-Release 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 know what you have taken.

If you forget to take Nitrofurantoin 100mg Prolonged-Release 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 your doctor or pharmacist.

If you stop taking Nitrofurantoin 100mg Prolonged-Release 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 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. If you experience any of the side effects detailed below or any other side effects, stop taking Nitrofurantoin and consult your doctor. 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.

Please note that while taking Nitrofurantoin your urine may become coloured dark yellow or brown. This is quite normal and not a reason to stop taking the medicine.

If you notice any of the following side effects consult your doctor immediately

5. HOW TO STORE NITROFURANTOIN 100MG PROLONGED-RELEASE CAPSULES

Keep this medicine out of the sight and reach of children.

Do not store above 30°C (aluminium/aluminium). Do not store above 25°C (For PVC/polyethylene/aclar/aluminium blisters).

Store in the original package to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Nitrofurantoin 100mg Prolonged-Release Capsules contains:

The active substance is 100mg nitrofurantoin in each capsule.

The other ingredients are talc, corn starch, lactose, carbopol, povidone, sugar and magnesium stearate.

The capsule shell contains gelatin, quinoline yellow (E104), titanium dioxide (E171) and FD&C Blue No.2 (E132). The printing ink contains shellac, propylene glycol (E1520), titanium dioxide (E171) black iron oxide (E172), ammonium hydroxide (E527) and simethicone.

What Nitrofurantoin 100mg Prolonged-Release Capsules looks like and contents of the pack:

Nitrofurantoin 100mg Prolonged-Release Capsules has an opaque blue cap and opaque yellow body and bears the monogram “GS 100”.

The capsules are available in blister strips of 14.

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

Manufacturer:
Famar Italia S.P.A
Via Zambeletti
25
Baranzate
20021
Italy

This leaflet was last revised in July 2023.

ADVANZ Pharma
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Address
Dashwood House, 69 Old Broad Street, London, EC2M 1QS, UK
WWW
www.advanzpharma.com
Telephone
+44 (0)208 588 9131
Medical Information Direct Line
+44 (0)208 588 9131
Medical Information e-mail
[email protected]
Customer Care direct line
+44 (0)208 588 9273