Solpadein 500mg+30mg+8mg tablets soluble

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

paracetamol, caffeine, codeine (codeine phosphate)

Available from:

GlaxoSmithKline Dungarvan Limited

ATC code:

N02BE51

INN (International Name):

paracetamol, caffeine, codeine (codeine phosphate)

Dosage:

500mg+30mg+8mg

Pharmaceutical form:

tablets soluble

Units in package:

(12/6x2/) strips

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-05-30

Summary of Product characteristics

SUMMARYOFPRODUCTCHARACTERISTICS
_ _
1.
NAME OFTHE MEDICINAL PRODUCT
_ _
SolpadeineSolubleTablets
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each tablet contains Paracetamol PhEur500 mg, Codeine Phosphate
HemyhydratePhEur8 mgand CaffeinePhEur30.0 mg.
_ _
3.
PHARMACEUTICAL FORM
_ _
Solubletablets
_ _
Whiteflattabletswithbevelsmoothononesideandwithscorelineontheother
side.
_ _
_ _
4.
CLINICAL PARTICULARS
_ _
4.1.
THERAPEUTICINDICATIONS
_ _
Solpadeinesoluble tablets arerecommended forthe relief of
acutemoderate
pain, including:headache, migraine, toothache (pain afterdental
procedures/
tooth extraction), musculoskeletal pain, neuralgia,dysmenorrhoea,
sciatica,
pain associated with sinusitis and sorethroat.
Relief ofpain associated with fever.
_ _
4.2.
POSOLOGY ANDMETHOD OFADMINISTRATION
_ _
_ _
Adultsaged18years andover(includingtheelderly):
_ _
Dissolve1-2 tablets in ahalf tumblerof water. Take every4-6 hours as
required. Minimum dosinginterval: 4 hours. Maximum single doseis2
tablets. Maximumdailydoseis 8 tablets.
_ _
_ _
Medicineshould not be taken morethan 3 days without consulting
yourdoctor. Do not exceed the recommended dose.
Should not beusedwith other paracetamol or codeine containing
products.
_ _
4.3.
CONTRAINDICATIONS
Paracetamol-caffeine-codeine is contraindicated in patients:
_ _
_ _

With a previous historyof hypersensitivityto paracetamol, caffeine,
codeine, opioid analgesics or any of excipients

under theageof 18years becauseof therisk of opioid toxicitydueto the
variable and unpredictable metabolism of codeine to morphine
_ _

who arebreastfeeding

whoareknowntobeCYP2D6ultra-rapidmetabolisers.Ifthepatientis
anextensiveorultra-rapidCYP2D6 metaboliser thereis an increased risk
ofdevelopingsymptomsofopioidtoxicity,evenatcommonlyprescribed
doses.General symptoms of opioid toxicityinclude
confusion, somnolence, shallow breathing, small pupils,
nausea, vomiting, constipation and lack of appetite. In severe
cases this mayincludesymptoms of circulatoryand respiratory
depression which m