Calvepen 666 mg Tablets

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

PHENOXYMETHYLPENICILLIN CALCIUM

זמין מ:

Clonmel Healthcare Ltd

קוד ATC:

J01CE; J01CE02

INN (שם בינלאומי):

PHENOXYMETHYLPENICILLIN CALCIUM

כמות:

666 milligram(s)

טופס פרצבטיות:

Film-coated tablet

סוג מרשם:

Product subject to prescription which may not be renewed (A)

איזור תרפויטי:

Beta-lactamase sensitive penicillins; phenoxymethylpenicillin

מצב אישור:

Marketed

תאריך אישור:

1977-04-01

עלון מידע

Package Leaflet: Information for the User
CALVEPEN
TM
333MG TABLETS
CALVEPEN
TM
666MG TABLETS
PHENOXYMETHYLPENICILLIN CALCIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Calvepen
TM
tablets are and what they are used for
2.
What you need to know before you take Calvepen
TM
tablets
3.
How to take Calvepen
TM
tablets
4.
Possible side effects
5.
How to store Calvepen
TM
tablets
6.
Contents of the pack and other information
1.
WHAT CALVEPEN
TM
TABLETS ARE AND WHAT THEY ARE USED FOR
Calvepen
TM
tablets belong to a group of medicines called antibiotics. Calvepen
TM
is a member of the
penicillin family and is used to kill bacteria which cause a number of
different infections.
Calvepen
TM
333mg tablets contain 333 mg of Phenoxymethylpenicillin Calcium
equivalent to 300 mg
of Phenoxymethylpenicillin.
Calvepen
TM
666 mg tablets contains 666 mg of Phenoxymethylpenicillin Calcium
equivalent to 600 mg
of Phenoxymethylpenicillin
Calvepen
TM
tablets are used to treat certain kinds of infection. Your doctor will
decide if this
treatment is suitable for your infection. Calvepen
TM
is also used in patients with rheumatic fever to
prevent the infection returning.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CALVEPEN
TM
TABLETS
DO NOT TAKE CALVEPEN
TM
TABLETS

if you are allergic to penicillin or any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Potentially life-threatening skin rashes (Stevens Johnson syndrome,
toxic epidermal necrolysis) have
been reported with the use

מאפייני מוצר

Health Products Regulatory Authority
23 November 2020
CRN009WVX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calvepen 666 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 666 mg of Phenoxymethylpenicillin Calcium
equivalent to 600 mg (1,000,000 IU) of
Phenoxymethylpenicillin.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets.
White, oval, film-coated tablet having “104” engraved on one side
and Clonmel logo on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of infection due to micro-organisms sensitive to this
anti-infective.
In the prophylactic management of patients with rheumatic fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Each 666mg Calvepen tablet is the equivalent of 600mg of
Phenoxymethylpenicillin (PMP)
Oral penicillin should be given before meals, and in divided doses,
preferably four times per day.
ADULTS AND OVER 12 YEARS:
Typical dose is 666mg (equivalent to 600mg PMP) given four times
daily.
See local/national prescribing guidance for further detail including
weight based dosing, max daily doses and treatment
duration. Doses may be modified depending on the severity of the
condition.
CHILDREN: 6-12 YEARS:
Calvepen 333mg tablets are recommended.
Typical dose is 333mg (equivalent to 300mg PMP) given four times
daily.
See local/national prescribing guidance for further detail including
weight based dosing, max daily doses and treatment
duration. Doses may be modified depending on the severity of the
condition.
UNDER 6 YEARS:
Calvepen 250mg/5ml oral suspension is recommended.
Health Products Regulatory Authority
23 November 2020
CRN009WVX
Page 2 of 5
RHEUMATIC FEVER PROPHYLAXIS
Typical dose is 333mg (equivalent to 300mg PMP) twice daily.
Dosage may be modified at the discretion of the physician according to
the severity of the condition.
Method of administration
For oral use.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, penicillins, incl