Codasolve 8mg/500mg/30mg effervescent tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Hent Indlægsseddel (PIL)
01-04-2020
Hent Produktets egenskaber (SPC)
16-06-2020

Aktiv bestanddel:

Caffeine; Codeine phosphate; Paracetamol

Tilgængelig fra:

Kent Pharma (UK) Ltd

INN (International Name):

Caffeine; Codeine phosphate; Paracetamol

Dosering:

30mg ; 8mg ; 500mg

Lægemiddelform:

Effervescent tablet

Indgivelsesvej:

Oral

Klasse:

Schedule 5 (CD Inv)

Recept type:

Never Valid To Prescribe As A VMP

Produkt oversigt:

BNF: 04070100; GTIN: 5015201009627

Indlægsseddel

                                BXP064BPC
BXP064BPC
PATIENT INFORMATION LEAFLET
CODASOL E 8MG/500MG/30MG EFFERVESCENT TABLETS
(CODEINE, PARACETAMOL AND CAFFEINE)
The name of this medicine is Codasolve 8mg/500mg/30mg Effervescent
Tablets. This medicine will be
referred to as Codasolve Effervescent Tablets throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• This medicine can only be used for the short term treatment of
acute moderate pain which is not relieved
by paracetamol, ibuprofen or aspirin alone.
• You should only take this product for a maximum of three days at a
time. If you need to take it for longer
than three days you should see your doctor or pharmacist for advice.
• This medicine contains codeine which can cause addiction if you
take it continuously for more than three
days. This can give you withdrawal symptoms from the medicine when you
stop taking it.
• If you take this medicine for headaches for more than three days
it can make them worse.
• Keep this leaflet. You may need to read it again.
IN THIS LEAFLET:
1. What Codasolve Effervescent Tablets are and what they are used for
2. Before you take Codasolve Effervescent Tablets
3. How to take Codasolve Effervescent Tablets
4. Possible side effects
5. How to store Codasolve Effervescent Tablets
6. Further information 1. WHAT CODASOLVE EFFERVESCENT TABLETS ARE AND WHAT THEY ARE USED FOR
Codasolve Effervescent Tablets contain the active ingredients codeine
phosphate hemihydrate 8 mg,
paracetamol 500 mg and caffeine 30 mg.
This medicine can be used in patients over 12 years of age for the
short term treatment of acute moderate
pain which is not relieved by paracetamol, ibuprofen or aspirin alone.
They are used to relieve migraine,
headache, dental pain, period pain, backache, rheumatic pain, strains
and sprains, and sciatica. 2. BEFORE YOU TAKE CODASOLVE EFFERVESCENT TABLETS
THIS MEDICINE CONTAINS CODEINE WHICH CAN CAUSE ADDICTION IF YOU TAKE
IT CONTINUOUSLY FOR MORE THAN
THREE DAYS. THIS CAN GIVE YOU WITHDRAWAL SYM
                                
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Produktets egenskaber

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paracetamol, Codeine and Caffeine 500mg/8mg/30mg Effervescent Tablets.
Codasolve 8mg/500mg/30mg Effervescent Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
E
ach tablet contains paracetamol 500mg, codeine phosphate hemihydrate
8mg and caffeine 30mg.
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Effervescent tablet.
White to off-white coloured circular flat bevelled tablets plain on
both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Codeine is indicated in patients older than 12 years of age for the
short term treatment
of acute moderate pain which is not relieved by paracetamol, ibuprofen
or aspirin
alone.
This medicine is recommended for the relief of migraine, headache,
backache,
rheumatic pain, period pain, dental pain, strains and sprains and
sciatica.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicine should be dissolved in at least half a tumbler of water.
DOSAGE
ADULTS
One to two tablets dissolved in water not more frequently than every
4-6 hours
when necessary to a maximum of 8 tablets in 24 hours.
ELDERLY
Same as adult dose. A reduced dose may be required
PAEDIATRIC POPULATION:
Children aged 16-18 years:
One to two tablets dissolved in water every 6 hours when necessary to
a
maximum of 8 tablets in 24 hours.
Children aged 12-15 years:
One tablet dissolved in water every 6 hours when necessary to a
maximum of
4 tablets in 24 hours.
Children aged less than 12 years:
Codeine should not be used in children below the age of 12 years
because of
the risk of opioid toxicity due to the variable and unpredictable
metabolism of
codeine to morphine (see sections 4.3 and 4.4).
Method of Administration
This medicine is for oral administration only.
Do not take for more than 3 days continuously and if no effective pain
relief is
achieved the patients/carers should be advised to seek medical review.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol, codeine, caffeine, opioid analgesics
or any of
the other c
                                
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