Amoxicillin 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amoxicillin trihydrate

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

J01CA04

INN (International Name):

Amoxicillin trihydrate

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010103

Patient Information leaflet

The name of your medicine is Amoxicillin 250mg Capsules or Amoxi-
cillin 500mg Capsules. They contain the active ingredient called
Amoxicillin.
Amoxicillin
capsules
are
antibiotics
for
treating
infections.
They
belong to a group of antibiotics called “Penicillins” and work by
killing
the bacteria that can cause infections.
Amoxicillin capsules can treat a wide range of infections including
those of the chest (bronchitis or pneumonia), tonsils (tonsillitis),
ears
(otitis media), the bladder or the urethra (the tube which carries
urine
from the bladder), kidneys, the female reproductive system including
infections caused by difficulties during childbirth (puerperal sepsis
and septic abortion), abdomen (intra-abdominal sepsis and peritoni-
tis), heart (endocarditis), blood (septicaemia), skin, teeth and gum
(abscesses).
They are also used to treat gonorrhoea (a sexually transmitted
infection),
infections
associated
with
pregnancy
&
typhoid
and
Paratyphoid fevers (caused by a group of bacteria called Salmonella),
inflammation of the bone and bone marrow (osteomyelitis) and
inflammation of the membranes that cover the brain and spinal cord
(meningitis).
DO NOT TAKE AMOXICILLIN CAPSULES
if you are allergic (hypersensitive) to Amoxicillin Trihydrate,
Penicillin
(or any other antibiotics) or any of the other ingredients in the
product.
See section 6.
TAKE SPECIAL CARE WITH AMOXICILLIN CAPSULES
Seek advice from your doctor before treatment if you
• have, or think you have glandular fever
• have been taking Amoxicillin for a long time
• suffer from kidney problems
In premature children and during the neonatal period: renal,
hepatic and haematological functions should be monitored.
TAKING OTHER MEDICINES
Please tell your doctor or pharmacist if you
are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Certain medicines may be affected by treatment with Amoxicillin
capsules, for example:
• Warfarin, used to prevent blood clots
• Contraceptive Pills
• Metho

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amoxicillin 250 mg Capsules BP
Respillin 250mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains amoxicillin trihydrate equivalent to 250 mg
amoxicillin.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard
Size 2 for the 250 mg capsules, with a scarlet/ivory opaque hard
gelatin capsule with
‘AMOX 250’ printed on the capsule shell.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicillin Capsules are indicated for the treatment of the following
infections in
adults and children (see sections 4.2, 4.4 and 5.1):
•
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 Capsules are also indicated for the prophylaxis of
endocarditis.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose of Amoxicillin Capsules 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 spre