RIMAPEN PENICILLIN VK 250 Milligram Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

PHENOXYMETHYLPENICILLIN POTASSIUM

Beschikbaar vanaf:

Ranbaxy Ireland Limited

INN (Algemene Internationale Benaming):

PHENOXYMETHYLPENICILLIN POTASSIUM

Dosering:

250 Milligram

farmaceutische vorm:

Tablets

Autorisatie-status:

Withdrawn

Autorisatie datum:

2008-04-07

Productkenmerken

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rimapen Penicillin VK 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of phenoxymethylpenicillin
as Phenoxymethylpenicillin Potassium.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round white biconvex film coated tablets.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
In the management of mild to moderately severe infections due to
penicillin sensitive organisms.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For Oral administration.
Adults: 250mg 6 times daily.
Children 6-12 years: 125-250mg 6 times daily.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to penicillins.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Prolonged use of an anti-infective may lead to super-infection by
resistant micro-organisms such as Proteus, 
Pseudomonas and Candida.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
The excretion of phenoxymethylpenicillin in urine is retarded by
probenecid as is the case for all penicillins.
4.6 PREGNANCY AND LACTATION
The product should not be used during pregnancy unless considered
essential by the physician. The product is excreted 
in breast milk, presenting the risk of candidiasis and also
of central nervous system toxicity due to prematurity of the 
blood brain barrier. There is a theoretical possibility
of later sensitization.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 02/11/2005_
_CRN 2016251_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8 UNDESIRABLE EFFECTS
Side effects include maculopapular rashes, urticaria and
other evidence of hypersensitivity, gastrointestinal 
disturbances, and diarrhoea. Transient induction
of