Nitrofurantoin 100mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Nitrofurantoin

Available from:

Advanz Pharma

ATC code:

J01XE01

INN (International Name):

Nitrofurantoin

Dosage:

100mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05011300; GTIN: 5021691020387

Patient Information leaflet

1607482F
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 50mg or 100mg capsules,
Hard. It will be referred to as Nitrofurantoin capsules for ease
hereafter.
WHAT IS IN THIS LEAFLET:
1.
What Nitrofurantoin Capsules are and what they are used for
2.
What you need to know before you take Nitrofurantoin Capsules
3.
How to take Nitrofurantoin Capsules
4.
Possible side effects
5.
How to store Nitrofurantoin Capsules
6.
Contents of the pack and other information
1. WHAT NITROFURANTOIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Nitrofurantoin (the active substance in Nitrofurantoin Capsules) is an
antibiotic.
It is used to prevent and treat infections of the bladder, kidney and
other parts of the urinary tract.
You must talk to a doctor if you do not feel better or if you feel
worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NITROFURANTOIN CAPSULES
DO NOT TAKE NITROFURANTOIN CAPSULES:
•
if you are allergic to nitrofurantoin, other medicines containing
nitrofurantoin or to 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 suffer from a blood disorder called porphyria
•
if you are deficient in an enzyme called G6PD (glucose-6-phosphate
dehydrogenase)
•
if your child under three months of age
•
if you are breast feedi

Summary of Product characteristics

OBJECT 1
NITROFURANTOIN 100MG CAPSULES
Summary of Product Characteristics Updated 13-Apr-2022 | ADVANZ Pharma
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Macrodantin 100mg Capsules
Nitrofurantoin 100mg Capsules, Hard
2. Qualitative and quantitative composition
Each capsule contains 100 mg Nitrofurantoin Ph. Eur. in
macrocrystalline form.
Excipients with known effect
Lactose-207mg per capsule
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
The 100 mg hard gelatin capsule has an opaque yellow cap and opaque
yellow body with the Logo 'Eaton
009' divided between the body and the cap.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of and prophylaxis against acute or recurrent,
uncomplicated lower urinary tract
infections or pyelitis either spontaneous or following surgical
procedures. It is indicated in adults,
children and infants over 3 months old.
Nitrofurantoin is specifically indicated for the treatment of
infections wh