Codipar 15mg/500mg Effervescent Tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Paracetamol; Codeine phosphate hemihydrate

から入手可能:

Mercury Pharmaceuticals Ltd

ATCコード:

N02AJ06

INN（国際名）:

Paracetamol; Codeine phosphate hemihydrate

投薬量:

15/500 milligram(s)

医薬品形態:

Effervescent tablet

処方タイプ:

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

治療領域:

codeine and paracetamol

認証ステータス:

Marketed

承認日:

2010-10-08

情報リーフレット

PROOF
2
25/08/2014
Product Description:
Originated by
Date:
Tech Approved
Date:
Codipar Effervescent Tablets
DMN
02/12/11 No
Component:
Revised by
Version:
Leaflet
SMT
101715/LF/4
Manufacturer:
File Name:
CRF No.:
Unither Industries
101715LF CodiparEffTabs Unither v4_2
AMCo.CRF.269.2014
Market:
Software Package:
Barcode:
UK/ROI
Quark Xpress 9
N/A
Minimum Font Size & Typeface:
Dimensions:
Pharma Code:
9pt Swiss 721BT
210 x 250mm
N/A
COLOURS:
KEY LINE:
PMS
Black
Magenta
Date of Approval:
N/A
To be implemented by:
N/A
P4
P1
LAETUS
NO.
LAETUS
NO.
LAETUS
NO.
Ireland
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: [phone];
Fax: [phone];
Website: www.hpra.ie;
e-mail: [e-mail].
By reporting side effects you can help provide more information on the
safety
of this medicine.
5. HOW TO STORE CODIPAR EFFERVESCENT TABLETS
• Keep this medicine out of the sight and reach of children.
• Do not use Codipar Effervescent Tablets after the expiry date
which is
stated on the carton and the blister. The expiry date refers to the
last day of
that month.
• Do not store above 25
o
C.
Medicines should not be disposed of via wastewater. Ask your
pharmacist
how to dispose of medicines no longer required. These measures will
help to
protect the environment.
6. FURTHER INFORMATION
WHAT CODIPAR EFFERVESCENT TABLETS CONTAIN
• The active substances are codeine phosphate hemihydrate, 15mg and
paracetamol, 500mg
• The other ingredients are sodium hydrogen carbonate, sodium
carbonate
anhydrous, citric acid anhydrous, sorbitol neosorb P60 W, povidone
K30,
sodium saccharin, macrogol 6000 and grapefruit flavour.
WHAT CODIPAR EFFERVESCENT TABLETS LOOK LIKE AND CONTENTS OF THE PACK
Codipar Effervescent tablets are white circular tablets,
Codipar Effervescent tablets are available in aluminium: polyethylene
foils
strips packs of 100 effervescent tablets (25 strips of 4 tablets).
MARKETING AUTHORISATION HOLDER:
Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street,
London, EC4N 7BL, UK
MANUFACT

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Codipar 15mg/500mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Codeine Phosphate hemihydrate 15mg and
Paracetamol 500mg.
Excipients: Each tablet also contains 389mg of sorbitol and 379 mg of
sodium.
For a full list of excipients, see 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet
Bevelled, flat, round, white tablet
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of mild to severe acute pain
Codeine is indicated for the treatment of acute moderate pain which is
not considered to be relieved by other analgesics
such as paracetamol or ibuprofen.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Oral
The tablets should be placed in a glass of water and allowed to be
dissolved completely. The resulting solution should
be drunk immediately.
Adults: The usual dose is two tablets every six hours as required. The
total daily dose should not exceed 4 g
paracetamol (8 tablets in a day).
Codeine should be used at the lowest effective dose for the shortest
period of time. This dose may be taken, up to 4
times a day at intervals of not less than 6 hours. Maximum daily dose
should not exceed 240 mg.
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the patients/carers
should be advised to seek the views of a physician.
Elderly; As for adults, however a reduced dose may be required (see
section 4.4)
Paediatric population: Not recommended in children below the age of 18
years (see section 5.1).
4.3 CONTRAINDICATIONS
Hypersensitivity to either paracetamol or codeine, or any of the
excipients of Codipar tablets.
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