Land: Malta
Taal: Engels
Bron: Medicines Authority
PHENOXYMETHYLPENICILLIN
Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta
J01CE02
PHENOXYMETHYLPENICILLIN 250 mg
TABLET
PHENOXYMETHYLPENICILLIN 250 mg
POM
ANTIBACTERIALS FOR SYSTEMIC USE
Authorised
2019-05-20
PATIENT INFORMATION LEAFLET PHENOXYMETHYLPENICILLIN CRESCENT 250MG TABLETS Phenoxymethylpenicillin KEEP THE LEAFLET; YOU MAY NEED TO READ IT AGAIN. IF YOU HAVE ANY QUESTIONS OR ARE NOT SURE ABOUT ANYTHING, ASK YOUR DOCTOR OR PHARMACIST. THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. DO NOT PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS YOURS. IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR, PHARMACIST OR NURSE. THIS INCLUDES ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4. IN THIS LEAFLET: 1. What Phenoxymethylpenicillin Tablets are and what they are used for 2. Before you take Phenoxymethylpenicillin Tablets 3 . How to take Phenoxymethylpenicillin Tablets 4. Possible side effects 5. How to store Phenoxymethylpenicillin Tablets 6. Further information 1. WHAT PHENOXYMETHYLPENICILLIN TABLETS ARE AND WHAT THEY ARE USED FOR This medicine belongs to the penicillin group of antibiotics. It is an antibacterial drug used in the treatment of mild to moderately severe infections such as chest and throat infections , skin and soft t i ssue infections , infections of the mouth , gums and teeth , scarlet fever (characterised by high fever, sore throat and skin rashes) and mild erysipelas (a disease marked by red skin eruptions , chills and fever). It is also used in the prevention of rheumatic fever and chorea (a group of disorders characterised by brief rapid involuntary movements of limbs, face, trunk and head). 2. BEFORE YOU TAKE PHENOXYMETHYLPENICILLIN TABLETS DO NOT TAKE THESE TABLETS IF: • you are allergic to Phenoxymethylpenicillin or to any of the other ingredients (see section 6). CHECK WITH YOUR DOCTOR BEFORE TAKING THESE TABLETS IF: • you have a history of allergic reaction to penicillins, cephalosporins or other allergy causing agents • you are suffering from severe illness, nausea, vomiting, stomach bloating/cramping, difficulty swallowing or chest pain you have kidney problems • you are pregnant, think you may be pregnant or you are breast feeding. (This medicine i Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Phenoxymethylpenicillin Crescent 250 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each tablet contains Phenoxymethylpenicillin Potassium (1515 I-U/mg) BP 280.00 mg 3. PHARMACEUTICAL FORM White, flat bevelled edged tablets, engraved on one side with company logo and with breakline and A057 on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Phenoxymethylpenicillin and potassium phenoxymethylpenicillin are indicated in the treatment of mild to moderately severe infections associated with micro-organisms whose susceptibility to penicillin is within the range of serum levels attained with these dosage forms. The following infections will usually respond to adequate doses: Streptococcal infections (without bacteraemia): Mild to moderate infections of the upper respiratory tract, scarlet fever and mild erysipelas. Pneumococcal infections: Mild to moderately severe infections of the respiratory tract. Staphylococcal infections sensitive to penicillin: Mild infections of the skin and soft tissues. Fusospirochaetosis (vincent’s gingivitis and pharyngitis): Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin. Prophylactic use: Prophylaxis with oral penicillin has proved effective in preventing recurrence of rheumatic fever and chorea. Patients with a past history of rheumatic fever receiving continuous prophylaxis may harbour penicillin-resistant organisms. In these patients, the use of another prophylactic agent should be considered. Note: Severe empyema, bacteraemia, pericarditis, meningitis and arthritis should not be treated with Phenoxymethylpenicillin during the acute phase. Consideration should be given to official guidance on the appropriate use antibacterial agent. Posology and method of administration Adults: 125 – 500 mg every 4 – 6 hours depending on the severity of the condition. Prophylactic use: 125 mg twice daily is recommended for long term prophylaxi Lees het volledige document