Phenoxymethylpenicillin 250mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Phenoxymethylpenicillin potassium

Saatavilla:

Crescent Pharma Ltd

ATC-koodi:

J01CE02

INN (Kansainvälinen yleisnimi):

Phenoxymethylpenicillin potassium

Annos:

250mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 05010101; GTIN: 5017123057137

Pakkausseloste

Continued, please turn over
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PHENOXYMETHYLPENICILLIN
250mg TABLETS BP
(Phenoxymethylpenicillin potassium)
Front of leaflet - 148.5mm
Back of leaflet - 148.5mm
What is in this leaflet
1. What Phenoxymethylpenicillin tablet is and what it is used for
2. What you need to know before you take
Phenoxymethylpenicillin tablet
3. How to take Phenoxymethylpenicillin tablet
4. Possible side effects
5. How to store Phenoxymethylpenicillin tablet
6. Contents of the pack and other information
1. WHAT PHENOXYMETHYLPENICILLIN TABLET IS
AND WHAT IT IS USED FOR
Phenoxymethylpenicillin, is an antibiotic, which belongs to a
group of medicines called penicillins, which are used to kill
bacteria that cause infections in your body.
Each tablet contains 250mg of Phenoxymethylpenicillin
potassium as the active ingredient.
The strength you are given will be decided by your doctor.
Phenoxymethylpenicillin potassium is used to treat infections
caused by bacteria that are sensitive to penicillins. These
infections include:
• Infections of the lungs (such as pneumonia and bronchitis)
• Ear and throat infections (such as otitis media and
pharyngitis)
• Other infections (such as infections of the skin and soft
tissue, respiratory tract, scarlet fever and erysipelas)
Phenoxymethylpenicillin is also used to prevent infections
such as:
• Prevention of recurrent attacks of rheumatic fever or chorea
(infection of the nervous system)
• Prevention of lung infections in patients with no spleen or
sickle cell disease
• Prevention of pneumococcal infection (e.g. in asplenia)
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PHENOXYMETHYLPENICILLIN TABLET
Do not take Phenoxymethylpenicillin tablet:
• If you have ever had a bad reaction or allergic to any
penicillin or cephalosporin antibiotics, or any of the other
ingredients listed in section 6
• If you have ever had a skin rash or swelling of the face or
neck or shortness of breath when taking any antibiotic
Warnings and precautions
Talk to your doctor

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenoxymethylpenicillin 250mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Phenoxymethylpenicillin Potassium (1515 I-U/mg)
BP
280.00 mg
_ _
Excipient with known effect
Each tablet contains 52 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White flat tablet with break line on the one side & plain on other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Phenoxymethylpenicillin is indicated in the treatment of mild to
moderately
severe infections caused by penicillin sensitive organisms.
Phenoxymethylpenicillin is indicated for the treatment of the
following
infections:
Streptococcal infections: Pharyngitis, scarlet fever, skin and soft
tissue
infections (eg. erysipelas).
Pneumococcal infections:
Mild to moderately severe infections of the respiratory tract.
Vincent’s gingivitis and pharyngitis, pneumonia, otitis media.
Prophylactic use: Prophylaxis with oral penicillin has proved
effective in
preventing recurrence of rheumatic fever and chorea.
Consideration should be given to official guidance on the appropriate
use
antibacterial agent.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
250 – 500 mg every 6 hours depending on the severity of the
condition.
Prophylactic use: 250 mg twice daily is recommended for long term
prophylaxis
of rheumatic fever.
The Elderly:
As for adults. Reduce dosage if renal function is markedly
impaired._ _
Paediatric population:
Over 12 years: As adult dose.
6 – 12 years:
250 mg 6 hourly
1 – 5 years:
125 mg 6 hourly
In children under 5 years of age or those who have difficulty
swallowing the
tablet, a more appropriate solution form of the medicine is
recommended for
use.
In patients with beta-haemolytic streptococcal infection, it is usual
to continue
treatment at the full dosage for 10 days, in order to minimise the
occurrence of
secondary complications such as acute nephritis and rheumatic fever.
The treatment of otitis me