Augmentin 375mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Potassium clavulanate; Amoxicillin trihydrate

Available from:

DE Pharmaceuticals

ATC code:

J01CR02

INN (International Name):

Potassium clavulanate; Amoxicillin trihydrate

Dosage:

125mg ; 250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN
® 375 MG TABLETS
co-amoxiclav (amoxicillin and clavulanic acid)
The name of your medicine is Augmentin 375mg Tablets, but will be
referred to as Augmentin throughout the remainder of the leaflet.
Your medicine is also available in the following strength 625mg
Tablets.
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 or pharmacist.
•
This medicine has been prescribed for you (or for your child) 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 or pharmacist. This
includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Augmentin is and what it is used for
2.
What you need to know before you take Augmentin
3.
How to take Augmentin
4.
Possible side effects
5.
How to store Augmentin
6.
Contents of the pack and other information
1.
WHAT AUGMENTIN IS AND WHAT IT IS USED FOR
Augmentin is an antibiotic and works by killing bacteria that cause
infections. It contains two different medicines called amoxicillin and
clavulanic acid. Amoxicillin belongs to a group of medicines called
“penicillins” that can sometimes be stopped from working (made
inactive). The other active component (clavulanic acid) stops this
from
happening.
Augmentin is used in adults and children to treat the following
infections:
•
sinus infections
•
urinary tract infections
•
skin infections
•
dental infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AUGMENTIN
DO NOT TAKE AUGMENTIN:
•
if you are allergic to amoxicillin, clavulanic acid, penicillin or any
of
the other ingredients of this medicine (listed in section 6)
•
if you have ever had a severe allergic reaction to any other
antibiotic.
This can include a skin rash or swelling of the fac

Summary of Product characteristics

OBJECT 1
AUGMENTIN 375MG TABLETS
Summary of Product Characteristics Updated 07-Apr-2020 |
GlaxoSmithKline UK
•
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
Augmentin 375 mg Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains amoxicillin trihydrate equivalent to
250 mg amoxicillin and potassium
clavulanate equivalent to 125 mg of clavulanic acid.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White to off-white, oval shaped tablets debossed with “Augmentin”
on one side.
4. Clinical particulars
4.1 Therapeutic indications
Augmentin is indicated for the treatment of the following infections
in adults and children (see sections 4.2,
4.4 and 5.1):
• Acute bacterial sinusitis (adequately diagnosed)
• Cystitis
• Pyelonephritis
• Cellulitis
• Animal bites
• Severe dental abscess with spreading cellulitis.
Consideration should be given to official guidance on the appropriate
use of ant