Amoxicillin 500mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amoxicillin trihydrate

Available from:

Almus Pharmaceuticals Ltd

ATC code:

J01CA04

INN (International Name):

Amoxicillin trihydrate

Dosage:

500mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103; GTIN: 05060057400067 05060057400050 05055382300670

Patient Information leaflet

A0066a/Lt6
A0003/Lt6
A0067a/Lt6
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V6P2
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN 250MG CAPSULES BP
AMOXICILLIN 500MG CAPSULES BP
Amoxicillin (as amoxicillin trihydrate)
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 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 Amoxicillin Capsules are and what they are used for
2. What you need to know before you take Amoxicillin Capsules
3. How to take Amoxicillin Capsules
4. Possible side effects
5. How to store Amoxicillin Capsules
6. Contents of the pack and other information WHAT AMOXICILLIN CAPSULES ARE AND WHAT THEY ARE USED FOR
WHAT AMOXICILLIN CAPSULES ARE
Amoxicillin Capsules are antibiotics. The active
ingredient is amoxicillin. This belongs to a group
of medicines called ‘penicillin’.
WHAT AMOXICILLIN CAPSULES ARE USED FOR
Amoxicillin Capsules are used to treat infections
caused by bacteria in different parts of the body.
Amoxicillin Capsules may also be used in
combination with other medicines to treat
stomach ulcers. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE AMOXICILLIN CAPSULES
DO NOT TAKE AMOXICILLIN CAPSULES:
- if you are allergic to amoxicillin, penicillin or
any of the other ingredients of this medicine
(listed in section 6).
- if you have ever had an allergic reaction to
any antibiotic. This can include a skin rash or
swelling of the face or throat.
Do not take Amoxicillin Capsules if any of the
above apply. If you are not sure, talk to your
doctor or pharmacist before taking Amoxicillin
Capsules.
WARNINGS AND PRECAUTIONS
Talk to your d

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amoxicillin 500mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains Amoxicillin trihydrate BP 586mg equivalent
to
Amoxicillin 500mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard
EHG capsule size ‘0’ red cap and white body printed ‘AMOX’ on
cap and ‘500’ on
body in black.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicillin is indicated for the treatment of the following infections
in adults and
children (see sections 4.2, 4.4 and 5.1):
INDICATIONS:
•
Acute bacterial sinusitis
•
Acute otitis media
•
Acute streptococcal tonsillitis and pharyngitis
•
Acute exacerbations of chronic bronchitis
•
Community acquired pneumonia
•
Acute cystitis
•
Asymptomatic bacteriuria in pregnancy
•
Acute pyelonephritis
•
Typhoid and paratyphoid fever
•
Dental abscess with spreading cellulitis
•
Prosthetic joint infections
•
_Helicobacter pylori _eradication
•
Lyme disease
Amoxicillin is also indicated for the prophylaxis of endocarditis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of Amoxicillin that is selected to treat an individual
infection should take
into account:
•
The expected pathogens and their likely susceptibility to
antibacterial agents
(see section 4.4)
•
The severity and the site of the infection
•
The age, weight and renal function of the patient; as shown below
The duration of therapy should be determined by the type of infection
and the
response of the patient, and should generally be as short as possible.
Some infections
require longer periods of treatment (see section 4.4 regarding
prolonged therapy).
ADULTS AND CHILDREN
≥
40 KG
INDICATION*
DOSE*
Acute bacterial sinusitis
Asymptomatic bacteriuria in pregnancy
Acute pyelonephritis
Dental abscess with spreading cellulitis
Acute cystitis
250 mg to 500 mg every 8 hours or 750 mg to
1 g every 12 hours
For severe infections 750 mg to 1 g every 8
hours
Acute cystiti