Solpadeine TabletsParacetamol 500mg, Codeine Phosphate Hemihydrate 8mg, Caffeine 30mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate; Caffeine

Available from:

Chefaro Ireland DAC

ATC code:

N02AJ; N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate; Caffeine

Dosage:

500 mg/8 mg/30 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

1993-10-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLPADEINE TABLETS
Paracetamol 500mg, codeine phosphate hemihydrate 8mg and caffeine 30mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist have told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS IN THIS LEAFLET
1.
What this medicine is and what it is used for
2.
What you need to know before you take this medicine
3.
How to take this medicine
4.
Possible side effects
5.
How to store this medicine
6.
Contents of the pack and other information
1.
WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Solpadeine soluble tablets contains the active substances paracetamol
500 mg and codeine phosphate
hemihydrate 8 mg , which are both pain-relieving drugs, and caffeine
30 mg, a stimulant which acts to
enhance the pain-relieving effects of paracetamol.
Codeine belongs to a group of medicines called opioid analgesics which
act to relieve pain. It can be
used on its own or in combination with other pain killers such as
paracetamol. Paracetamol also helps
to reduce temperature when you have a fever. Codeine has some cough
suppressant action.
Solpadeine soluble tablets can be used in patients over 12 years of
age for the short-term relief of
acute, moderate pain that is not relieved by other painkillers such as
paracetamol or ibuprofen alone.
This medicine is not recommended for use in children aged 12 years to
18 years with compromised
respiratory function for the symptomatic treatment of cough and/or
cold.
Solpadeine tablets provide effective relief from pain, including:
•
Headache, including migraine
•
Tooth

Summary of Product characteristics

Health Products Regulatory Authority
04 July 2022
CRN00CZQ5
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpadeine TabletsParacetamol 500mg, Codeine Phosphate Hemihydrate
8mg, Caffeine 30mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains paracetamol 500 mg, codeine phosphate hemihydrate
8 mg and caffeine 30.0 mg.
Excipients: contains Carmoisine (E122)
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White capsule shaped tablets, printed ‘Solpadeine’ in red on one
side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Codeine-containing products are indicated in patients older than 12
years of age for the short-term treatment of acute,
moderate pain which is not relieved by paracetamol or ibuprofen alone.
Solpadeine is indicated in the management of symptoms of headache,
including migraine, toothache, backache, common cold,
influenza, menstrual pain, musculoskeletal pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
1-2 tablets up to four times daily as required to a 8 tablets in 24
hours.
The dose should not be repeated more frequently than every 4 hours.
_Adolescents aged 16 to 18 years of age_
1-2 tablets every 6 hours. Do not exceed 4 doses, equivalent to 8
tablets.
_Adolescents aged 12 years to 18 years:_
This medicine is not recommended for use in children aged 12 years to
18 years with compromised respiratory function for the
symptomatic treatment of cough and/or cold (see section 4.4).
_ _
_Adolescents aged 12 to 15 years of age_
1 tablet every 6 hours. Do not exceed 4 doses, equivalent to 4
tablets.
_Paediatric population_
_ _
_Children aged less than 12 years:_
This medicine is contraindicated in children below the age of 12 years
for the symptomatic treatment of cough and/or cold
(see section 4.3).
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).
Healt