Solpadol 500 mg/30 mg Effervescent Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate

Available from:

Opella Healthcare France SAS T/A Sanofi

ATC code:

N02AJ; N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate

Dosage:

500mg/30 milligram(s)

Pharmaceutical form:

Effervescent tablet

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

1991-06-26

Patient Information leaflet

SOLPADOL® 500MG/30MG EFFERVESCENT TABLETS
_Paracetamol _
_Codeine Phosphate Hemihydrate _
_ _
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any side effects gets serious, or if you notice any side effect not
listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Solpadol is and what it is used for
2.
What you need to know before you take Solpadol
3.
How to take Solpadol
4.
Possible side effects
5.
How to store Solpadol
6.
Contents of the pack and other information
1.
WHAT SOLPADOL IS AND WHAT IT IS USED FOR
The name of this medicine is Solpadol 500mg/30mg Effervescent Tablets.
Solpadol belongs to a group of medicines called analgesics
(painkillers) and is used to treat
severe pain. Solpadol can be used in children over 12 years of age for
the short-term relief
of moderate pain that is not relieved by other painkillers such as
paracetamol or ibuprofen
alone.
This product contains codeine. 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLPADOL
DO NOT TAKE SOLPADOL:
•
For pain relief in children and adolescents (0-18 years of age) after
removal of their tonsils
or adenoids due to obstructive sleep apnoea syndrome
•
If you know that you metabolise very rapidly codeine into morphine
•
If you are pregnant or are breastfeeding
•
If you are allergic to codeine, paracetamol or any of the other
ingredients
•
If you have asthma or severe breathing problems
•
If you have recently had a head injury
•
If you have recently had gall bladder surgery or a simila

Summary of Product characteristics

Health Products Regulatory Authority
31 May 2023
CRN00DLJY
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpadol 500 mg/30 mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Paracetamol 500.0 mg
Codeine Phosphate Hemihydrate 30.0 mg
Excipients: Contains 388mg of sodium and 50mg of sorbitol (E420) per
tablet.
For a full list of excipeints see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet.
A white bevelled‐edge tablet scored on one face and plain on the
reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of severe pain.
Solpadol is indicated in patients older than 12 years of age 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
Solpadol should be used at the lowest effective dose for the shortest
period of time. This dose may be taken, up to 4 times a
day at intervals of not less than 6 hours. Maximum daily dose of
codeine should not exceed 240mg.
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.
Adults (18 years and over):
Two tablets every 4‐6 hours to a maximum of four doses in any 24
hours.
Do not exceed eight tablets in 24 hours.
Elderly
The initial dosage should be reduced to half the recommended dosage
and should be titrated to the individuals need and
overall medical condition.
Paediatric Population
Children aged 16 to 18 years:
One to two tablets every 6 hours to a maximum of four doses in any 24
hours.
Do not exceed 8 tablets in 24 hours.
Children (12-15 years):
One tablet every 6 hours to a maximum of four doses in any 24 hours.
Do not exceed 4 tablets in 24 hours.
Health Products Regulatory Authority
31 May 2023
CRN00DLJY
Page 2 of 10
Children aged less than 12 years:
Solpadol should not be used in children below the age of 12 years
because of th