Codipar 15 mg/ 500 mg Capsules

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Codeine phosphate hemihydrate; Paracetamol

Fáanlegur frá:

Mercury Pharmaceuticals Ltd

ATC númer:

N02AJ; N02AJ06

INN (Alþjóðlegt nafn):

Codeine phosphate hemihydrate; Paracetamol

Skammtar:

15/500 milligram(s)

Lyfjaform:

Capsule, hard

Gerð lyfseðils:

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

Lækningarsvæði:

Opioids in combination with non-opioid analgesics; codeine and paracetamol

Leyfisstaða:

Marketed

Leyfisdagur:

2012-07-13

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Codipar 15 mg/ 500 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Paracetamol 500mg, and Codeine Phosphate
Hemihydrate 15mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Codipar Capsules are size 0 hard gelatin capsules consisting of a red
cap and white body, filled with a homogenous
white powder.
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 alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration: Oral
Adults: The usual dose is two capsules every six hours as required.
Codeine should be used at the lowest effective dose for the shortest
period of time. The dose must be limited up to 4
times a day at intervals of not less than 6 hours. Maximum daily dose
of codeine should not exceed 240 mg and that for
paracetamol should not exceed 4 g. The maximum daily dose of this
combination product is 8 capsules in a day.
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 capsules listed in section 6.1.
Conditions where morphine and opioids are contraindicated e.g., acute
asthma, respiratory depression, acute
alcoholism, head injuries, raised intra-cranial pressure and following
biliary tract surgery; monoamine oxidase inhibitor
therapy, concurrent or within 14 days.
Codipar is also contraindicated in severe liver disease and severe
renal impairment. The hazards of overdose c