Penbritin 500mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ampicillin

Available from:

Chemidex Pharma Ltd

ATC code:

J01CA01

INN (International Name):

Ampicillin

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: 5050204100254

Patient Information leaflet

71-72A/L/x/2
In this leaflet:
1. What this medicine is and what it is used for
2. Before you take
3. How to take
4. Possible side effects
5. How to store
6. Further information
1. What this medicine is and what it is
used for
Penbritin capsules contain ampicillin which belongs to
the penicillin group of antibiotics.
Ampicillin works by killing bacteria that cause infections
such as:

ear, nose and throat infections

bronchitis, pneumonia, chest infections

urinary tract infections

sexually transmitted infections

skin and soft tissue infections

gastrointestinal infections

blood poisoning.
2. Before you take
Do NOT take Penbritin capsules if you:

are allergic to ampicillin, other antibiotics called
beta-lactams (e.g. penicillin or cephalosporin) or any
of the other ingredients (see Section 6).
If this applies to you, speak to your doctor or pharmacist.
Take special care with Penbritin capsules
Before taking the capsules, tell your doctor if you:

have ever had a skin rash or swelling of the face or
neck when taking any antibiotic

are already being treated with another antibiotic

have glandular fever or low immune system

have leukaemia

have kidney problems.
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, and herbal
preparations.
Some medicines may be affected by Penbritin or they
may affect how well Penbritin will work. Tell your doctor
or pharmacist if you are taking:

any other antibiotics

allopurinol or probenecid for conditions such as gout

oral contraceptives (the pill). You will need an
additional method of contraception, such as
condoms. Speak to your doctor or pharmacist
about how long you need to take extra precautions
for.
Urine tests: Tell the doctor if you are having urine tests
for glucose, as your medicine may affect the results.
Pregnancy and breast-feeding
Penbritin will not harm your unborn baby. Small
quantities of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Penbritin 500mg Capsules
Ampicillin 500mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
(Ampicillin Capsules): 500mg ampicillin as Ampicillin Trihydrate
3
PHARMACEUTICAL FORM
Black and red capsules overprinted Penbritin 500
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ampicillin is a broad-spectrum penicillin, indicated for the treatment
of a wide
range of bacterial infections caused by ampicillin-sensitive
organisms.
Typical indications include: ear, nose and throat infections,
bronchitis,
pneumonia, urinary tract infections, gonorrhoea, gynaecological
infections,
septicaemia, peritonitis, endocarditis, meningitis, enteric fever,
gastro-
intestinal infections.
Parenteral usage is indicated where oral dosage is inappropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
USUAL ADULT DOSAGE (INCLUDING ELDERLY PATIENTS):
_Ear, nose and throat infections:_ 250mg four times a day.
_Bronchitis:_
Routine therapy: 250mg four times a day.
High-dosage therapy: 1 g four times a day.
_Pneumonia:_
500 mg four times a day.
_Urinary tract infections: _ 500 mg three times a day.
_Gonorrhoea_: 2 g orally with 1 g probenecid as a single dose.
Repeated doses
are recommended for the treatment of females.
_Gastro-intestinal infections:_ 500-750 mg three to four times daily.
_Enteric: _
_Acute:_ 1-2 g four times a day for two weeks.
_Carriers:_ 1-2 g four times a day for four to twelve weeks
USUAL CHILDREN’S DOSAGE (UNDER 10 YEARS):
Half adult routine dosage.
All recommended dosages are a guide only. In severe infections the
above
dosages may be increased, or ampicillin given by injection. Oral doses
of
ampicillin should be taken half to one hour before meals.
RENAL IMPAIRMENT:
In the presence of severe renal impairment (creatinine clearance
<10ml/min) a
reduction in dose or extension of dose interval should be considered.
In cases
of dialysis, an additional dose should be administered after the
procedure.
4.3
CONTRAINDICATIONS
Ampicillin is a penicillin and