Solpa-Plus with Caffeine Soluble Tablets Paracetamol 500 mg Codeine Phosphate Hemihydrate 12.8 mg Caffeine 30 mg

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 /12.8 /30 milligram(s)

Pharmaceutical form:

Effervescent tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

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

Authorization status:

Not marketed

Authorization date:

2017-03-10

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLPA-PLUS WITH CAFFEINE SOLUBLE TABLETS
PARACETAMOL 500 MG, CODEINE PHOSPHATE HEMIHYDRATE 12.8 MG, CAFFEINE 30
MG
-
This medicine is for the short term treatment of acute moderate pain
when other painkillers have not
worked.
-
You should only take this product for a maximum of 3 days at a time.
If you need to take it for longer
than 3 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
3 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 3 days, it can
make them worse.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU. ALWAYS TAKE THIS MEDICINE EXACTLY AS DESCRIBED IN
THIS LEAFLET OR AS YOUR DOCTOR
OR PHARMACIST HAS 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.
WHAT IS IN THIS LEAFLET
1.
WHAT SOLPA-PLUS TABLETS IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLPA-PLUS TABLETS
3.
HOW TO TAKE SOLPA-PLUS TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SOLPA-PLUS TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SOLPA-PLUS TABLETS IS AND WHAT IT IS USED FOR
Solpa-Plus Tablets can be used in patients over 12 years of age for
the short-term relief of moderate pain
which requires stronger relief than other painkillers such as
paracetamol, ibuprofen or aspirin alone.
It can be used for headaches, migraine with or without warning signs
(aura), dental pain (including pain
after extraction), period pain, neuralgia, strains and sprains,
backache, pain in bones and joints arising
from a

Summary of Product characteristics

Health Products Regulatory Authority
13 December 2022
CRN00CZJQ
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpa-Plus with Caffeine Soluble Tablets Paracetamol 500 mg Codeine
Phosphate Hemihydrate 12.8 mg Caffeine 30 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg, Codeine Phosphate Hemihydrate
12.8 mg and Caffeine 30 mg.
Excipients with known effect:
- 24mmol (427mg) sodium per tablet
- 50mg sorbitol per tablet
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet.
White bevel-edged scored tablets.
The score line is non-functional and not to divide the tablet into
equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solpa-Plus with Caffeine Soluble Tablets are recommended for the short
term relief of acute moderate pain which requires
stronger analgesia than single ingredient analgesics alone. For the
treatment of: headache, migraine (with and without aura),
dental pain (including pain after extraction), dysmenorrhea, muscle
ache, neuralgia, backache, pain in bones and joints arising
from arthritis and rheumatism, strains and sprains, sciatica.
The product is indicated to use in age of 12 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Oral administration only.
Adults:
Dissolve one to two tablets in at least half a tumbler of water (200
ml) every 4-6 hours up to four times a day if necessary.
Adolescents 16 to 18 years of age:
Dissolve one to two tablets in at least half a tumbler of water (200
ml) every 6 hours up to four times a day if necessary.
Do not exceed 8 tablets (equivalent to paracetamol 4 g, codeine
phosphate hemihydrate102.4 mg and caffeine 240 mg) in 24
hours.
Adolescents 12 to 15 years of age:
Dissolve one tablet in at least half a tumbler of water (200 ml) every
6 hours up to four times a day if necessary.
Do not take more than 4 tablets in (equivalent to 2 g paracetamol and
51.2 mg codeine phosphate hemihydrate and caffeine
120 mg) in 24 hours
The tablet